Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-...Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.展开更多
BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery ...BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery and long-term survival.Accurate preoperative identification of high-risk patients is critical for improving outcomes.AIM To establish and validate a risk prediction and stratification model for the risk of SAEs in patients with MIE.METHODS This retrospective study included 747 patients who underwent MIE at two centers from January 2019 to February 2024.Patients were separated into a train set(n=549)and a validation set(n=198).After screening by least absolute shrinkage and selection operator regression,multivariate logistic regression analyzed clinical and intraoperative variables to identify independent risk factors for SAEs.A risk stratification model was constructed and validated to predict the probability of SAEs.RESULTS SAEs occurred in 10.2%of patients in train set and 13.6%in the validation set.Patients with SAE had significantly higher complication rate and a longer hospital stay after surgery.The key independent risk factors identified included chronic obstructive pulmonary disease,a history of alcohol consumption,low forced expiratory volume in the first second,and low albumin levels.The stratification model has excellent prediction accuracy,with an area under the curve of 0.889 for the training set and an area under the curve of 0.793 for the validation set.CONCLUSION The developed risk stratification model effectively predicts the risk of SAEs in patients undergoing MIE,facilitating targeted preoperative interventions and improving perioperative management.展开更多
Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for me...Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.展开更多
BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study desc...BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study described the outcomes and adverse events from a single center in South India.AIM To describe the challenges,treatment outcomes,and complications of selective IAC for RB in Indian eyes.METHODS This study was a single center,retrospective study that included 17 patients with RB who underwent IAC using melphalan(5/7.5 mg)and topotecan(1/2 mg)(n=12)or melphalan(5 mg)alone(n=3)or triple therapy that included carboplatin(30 mg)along with these drugs(n=2)between January 2018 and December 2023.In all,17 IAC procedures were performed using selective ophthalmic artery cannulation.Treatment outcomes were evaluated in terms of tumor control,vitreous and subretinal seed control,complications,and globe salvage rates.RESULTS Out of the 17 patients,11 were diagnosed with unilateral RB and 6 were diag-nosed with bilateral RB.The mean age at the time of diagnosis was 19.8 months.The mean interval between the first symptom and presentation was 6.5 months.IAC was employed as the primary(n=9)or secondary(n=8)modality of treatment.Each eye received a mean of 1.5 IAC sessions(median:1 session;range:1-3 sessions).Eyes were classified according to the international classification of RB as group B(n=5),group C(n=1),group D(n=4),and group E(n=7).Following IAC,complete regression of the main tumor was seen in 15 eyes(88%)and partial regression in 2 eyes(12%).Globe salvage was achieved in 15 eyes(88%).Adverse effects included vitreous hemorrhage(n=3),rhegmatogenous retinal de-tachment(n=2),choroidal ischemia(n=1),isolated subretinal hemorrhage(n=2),retinal pigment epithelium degeneration(n=2),forehead pigmentation(n=1),third nerve palsy with complete ptosis(n=1),and 30-degree exotropia(n=1).The mean follow-up period was 28.6 months(median:24 months,range:1–72 months).CONCLUSION IAC is an effective way to control RB and globe preservation.In the Indian context we encountered many cha-llenges highlighting the importance of case selection.Further studies in India are required to thoroughly un-derstand IAC as a treatment for RB.展开更多
This study sought to investigate adverse drug event(ADE)signals associated with eltrombopag use in pediatric patients aged 0–18 years,utilizing data from the U.S.Food and Drug Administration Adverse Event Reporting S...This study sought to investigate adverse drug event(ADE)signals associated with eltrombopag use in pediatric patients aged 0–18 years,utilizing data from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS).By analyzing this extensive pharmacovigilance database,the study aimed to offer meaningful insights for improving the clinical safety of eltrombopag in children.Data covering eltrombopag-related ADEs from Q12004 to Q42023 were extracted from FAERS,and signal detection was conducted using both the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.ADEs were categorized based on the System Organ Class(SOC)classification in MedDRA version 25.0.A total of 582 reports involving pediatric patients receiving eltrombopag were identified,encompassing 21 SOC categories.The analysis revealed that,in addition to the known ADEs listed in the drug label,clinicians should remain vigilant for potential off-label ADE signals.These included abnormal platelet counts,thrombocytosis,antiphospholipid syndrome,myelofibrosis,reduced serum iron levels,myelodysplastic syndrome,hepatic infections,and other related conditions.Given these findings,it is strongly recommended that serum iron and ferritin levels should be routinely monitored in pediatric patients undergoing eltrombopag therapy,particularly during long-term treatment.Such proactive surveillance may help prevent the onset of iron deficiency anemia and enhance overall treatment safety.展开更多
BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead...BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead to severe consequences such as suicidal thoughts.Respiratory failure,a disorder of pulmonary ventilation and gas exchange,is frequently complicated by depression,aggravating the condition and creating complications in treatment.Patients with both conditions tend to exhibit poor compliance with medical advice,resulting in adverse outcomes such as sleep disorders,arrhythmias,and electrolyte imbalances.Therefore,effective nursing interventions are crucial for improving patient outcomes.While routine nursing care can provide basic support,dedicated nursing,which involves specialized and personalized care by highly trained professionals,may offer additional benefits.AIM To examine the effect of dedicated nursing intervention on medical advice compliance and adverse event incidence in patients with depression complicated by respiratory failure.METHODS A total of 160 patients with depression complicated by respiratory failure admitted to the Second Affiliated Hospital of Soochow University from January to December 2024 were randomly categorized into a control group(n=80)receiving routine nursing care and observation group(n=80)receiving routine nursing combined with dedicated nursing care.The establishment of a specialized nursing team;the development of a personalized nursing plan;and the implementation of comprehensive care strategies targeting emotional support,sleep improvement,pulmonary function enhancement,and adherence to medical advice were included in the dedicated nursing intervention.Emotional state[evaluated using the Self-Rating Depression Scale(SDS)],sleep quality[assessed using the Pittsburgh Sleep Quality Index(PSQI)],hope level[measured using the Herth Hope Scale(HHS)],pulmonary function[comprising forced vital capacity(FVC)and forced expiratory volume in the first second(FEV1)],exercise endurance[6-minute walk distance test(6MWD)],compliance with medical advice,and incidence of adverse events were compared between the two groups.RESULTS No significant differences were observed in SDS,PSQI,HHS,FVC,FEV1,6MWD,or compliance with medical advice between the two groups(P>0.05)before the intervention.However,after the intervention,the control group exhibited significantly lower SDS and PSQI scores;higher HHS scores;greater improvements in FVC,FEV1,and 6MWD;and higher compliance with medical advice compared with the control group(P<0.05).In addition,the incidence of adverse events was significantly lower in the control group(P<0.05).CONCLUSION Dedicated nursing intervention significantly improves emotional state,sleep quality,hope level,pulmonary function,exercise endurance,and compliance with medical advice while reducing adverse events in patients with depression complicated by respiratory failure.Therefore,dedicated nursing appears to be an effective approach to enhance patient outcomes in this population.展开更多
Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).ir...Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).irAEs can affect a wide range of organ systems and are characterized by heterogeneous onset,broad toxicity spectra,and complex management requirements,thus ultimately impairing treatment continuation and patient quality of life.This review systematically summarizes the epidemiological features,clinical progression,and current management of irAEs.Existing guidelines largely focus on acute toxicities but have not provided structured strategies for chronic,delayed-onset,or multisystem irAEs.Moreover,clinical practice is hampered by incomplete multidisciplinary collaboration,insufficient training of oncologists,and fragmented treatment pathways,all of which limit the efficacy of irAE management.We propose incorporating irAE management into core oncology training and call for the establishment of comprehensive interdisciplinary frameworks to ensure the standardized long-term use of immunotherapy.展开更多
Background Coronary artery calcification(CAC),a hallmark of atherosclerosis,paradoxically associates with reduced cardiovascular risk under statin therapy despite accelerated calcification progression,prompting this s...Background Coronary artery calcification(CAC),a hallmark of atherosclerosis,paradoxically associates with reduced cardiovascular risk under statin therapy despite accelerated calcification progression,prompting this study to explore CAC metrics as potential mediators between statin use and major adverse cardiovascular events(MACE).Methods Clinical data of 246 hospitalized patients who underwent coronary computed tomography angiography(CCTA)at Guangdong Provincial People's Hospital from January 2023 to June 2023 were retrospectively analyzed.Linear regression was used to evaluate the relationship between statin use and CAC parameters.Multivariable Poisson regression models were applied to explore the associations of statin use and CAC parameters with MACE risk.A mediation analysis was performed to assess the role of CAC parameters in the statin-MACE relationship.Results Statin use was independently associated with increased calcification score(β=0.648,P<0.001),CAC volume(β=0.623,P<0.001),and calcified plaque proportion(β=0.606,P=0.002).Multivariable Poisson regression indicated that statin use significantly reduced MACE risk[incidence rate ratio(IRR):0.33,P=0.018],whereas calcification score(IRR:2.63,P=0.026)and CACvolume(IRR:2.66,P=0.044)were associated with elevated MACE risk;Calcified plaque proportion showed no significant association.Mediation analysis revealed that calcification score(β=0.035,P=0.021)and CAC volume(β=0.023,P=0.018)exerted masking effects,while calcified plaque proportion had no mediating role.Conclusions Calcification score and CACvolume demonstrated limited masking effects in the association between statin use and MACE.展开更多
Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary informati...Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary information about adverse reactions is principally derived from clinical trials;however,there is a notable dearth of substantial real-world studies.Methods:In this research,an examination of the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database was performed to evaluate the potential side effects of lenvatinib.The FAERS database revealed a total of 20,290 reported adverse events associated with lenvatinib.Different algorithms for repeated measure analysis were employed to ascertain the significance of these adverse reactions.Results:The study identified 170 instances of adverse events(AEs)induced by lenvatinib,incorporating several significant adverse reactions that the product label does not mention.The investigation also evaluated the onset periods of the adverse reactions,pinpointing a median time of 43 days.The majority of adverse reactions manifested within the initial month of lenvatinib use.Sex-specific analysis revealed disparities in high risk adverse reactions between females(vascular and lymphatic diseases,and neuronal organ diseases)and males(death and infectious diseases).Our data mining has unveiled adverse reactions beyond those mentioned within the instructions,such as osteonecrosis of the jaw,cholecystitis,cholangitis,dehydration,tumor lysis syndrome,type 1 diabetes,hyperammonemia,liver abscess,interstitial lung disease,pneumothorax,sudden death,and aortic dissection.Conclusion:The insights derived from these findings contribute significant nuances for optimizing lenvatinib use,enhancing its efficacy,and substantially mitigating potential side effects.These data elements will substantially enhance the implementation of the drug in a clinical environment.展开更多
Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniq...Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniques such as laparoscopic,thoracoscopic,and robotic-assisted approaches,MIE mini-mizes surgical trauma while maintaining oncological thoroughness.However,it also presents unique challenges,including risks of complications such as ana-stomotic leakage,pulmonary complications,and atrial fibrillation.Zhong et al developed and validated a risk stratification model for predicting surgical adverse events after MIE,enhancing preoperative assessment and patient management.This editorial further examines the advantages of MIE,its comparable oncological and long-term outcomes,as well as the incidence and contributing factors of post-operative complications.Emerging technologies,including machine learning models,intraoperative nerve monitoring,and robotic-assisted surgery,are high-lighted as innovative solutions for risk prediction and prevention.Strategies such as enhanced recovery after surgery protocols and multidisciplinary collaboration are emphasized for their critical roles in minimizing complications and optimizing patient outcomes.By addressing these aspects,this editorial provides guidance to surgical teams in maximizing the benefits of MIE while effectively managing its associated risks.展开更多
BACKGROUND Major adverse cardiovascular(CV)events(MACEs)are the primary cause of morbidity and mortality in kidney transplantation(KT)recipients.The risk for MACEs is impacted by an array of traditional and transplant...BACKGROUND Major adverse cardiovascular(CV)events(MACEs)are the primary cause of morbidity and mortality in kidney transplantation(KT)recipients.The risk for MACEs is impacted by an array of traditional and transplant-related non-traditional CV risk factors.AIM To investigate the association between potential CV risk factors related to KT and MACEs,and their potential modification by hyperuricemia(HU).METHODS The relationship between CV risk factors related to KT and MACEs was examined in a cohort of 545 patients who underwent transplantation between 2008 and 2019.The mean age of patients at KT was 55.0 years±14.2 years(range 15.0–89.0 years).Univariate and multivariate logistic regression models were constructed to identify risk factors influencing MACEs.To explore the potential effect modification by uric acid(UA),patients were categorized into groups based on UA levels:(1)Low(<356μmol/L);(2)Normal(356–416μmol/L);(3)High(416–475μmol/L);and(4)Very high(>475μmol/L).RESULTS MACEs occurred in 145 of 545(26.6%)KT recipients.The most prevalent comorbidities were hypertension(87%),dyslipidemia(78%),secondary hyperparathyroidism(68%),HU(63%)and anemia(33%).In the multivariate logistic regression model,the most significant factors associated with MACEs were previous CV events[odds ratio(OR)=70.6,95%CI:24.9–200.1],left ventricular hypertrophy(LVH)(OR=12.6,95%CI:2.7–58.3),HU treatment(OR=4.3,95%CI:2.4–7.6),and anemia(OR=5.3,95%CI:2.9–9.8).Effect modification by the presence of HU revealed that independent factors associated with MACEs were age(OR=1.03,95%CI:1.0–1.1),previous CV events(OR=41.7,95%CI:13.6–127.6),LVH(OR=15.3,95%CI:2.0–116.6),HU treatment(OR=2.5,95%CI:1.3–4.6)and anemia(OR=5.4,95%CI:2.8–10.5).Effect modification by UA levels dichotomized at 475μmol/L(very high level of UA)revealed that HU treatment was not associated with MACEs in groups with or without very high UA levels.CONCLUSION A very high level of UA was observed to act as an effect-modifying factor for MACEs,especially when combined with other risk factors such as age,previous CV events,LVH,and anemia.展开更多
This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk facto...This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk factors such as chronic obstructive pulmonary disease and hypoalbuminemia,the model demonstrated strong predictive accuracy and offered a pathway to personalized perioperative care.This correspondence highlighted the clinical significance,emphasizing its potential to optimize patient outcomes through tailored inter-ventions.Further prospective validation and application across diverse settings are essential to realize its full potential in advancing esophageal surgery practices.展开更多
BACKGROUND Recent studies have indicated that triglyceride glucose(TyG)-waist height ratio(WHtR)and TyG-waist circumference(TyG-WC)are effective indicators for evaluating insulin resistance.However,research on the ass...BACKGROUND Recent studies have indicated that triglyceride glucose(TyG)-waist height ratio(WHtR)and TyG-waist circumference(TyG-WC)are effective indicators for evaluating insulin resistance.However,research on the association in TyG-WHtR,TyG-WC,and the risk and prognosis of major adverse cardiovascular events(MACEs)in type 2 diabetes mellitus(T2DM)cases are limited.AIM To clarify the relation in TyG-WHtR,TyG-WC,and the risk of MACEs and overall mortality in T2DM patients.METHODS Information for this investigation was obtained from Action to Control Cardiovascular Risk in Diabetes(ACCORD)/ACCORD Follow-On(ACCORDION)study database.The Cox regression model was applied to assess the relation among TyG-WHtR,TyG-WC and future MACEs risk and overall mortality in T2DM cases.The RCS analysis was utilized to explore the nonlinear correlation.Subgroup and interaction analyses were conducted to prove the robustness.The receiver operating characteristic curves were applied to analysis the additional predicting value of TyG-WHtR and TyG-WC.RESULTS After full adjustment for confounding variables,the highest baseline TyG-WHtR cohort respectively exhibited a 1.353-fold and 1.420-fold higher risk for MACEs and overall mortality,than the lowest quartile group.Similarly,the highest baseline TyG-WC cohort showed a 1.314-fold and 1.480-fold higher risk for MACEs and overall mortality,respectively.Each 1 SD increase in TyG-WHtR was significantly related to an 11.7%increase in MACEs and a 14.9%enhance in overall mortality.Each 1 SD increase in TyG-WC corresponded to an 11.5%in MACEs and a 16.6%increase in overall mortality.Including these two indexes in conventional models significantly improved the predictive power for MACEs and overall mortality.CONCLUSION TyG-WHtR and TyG-WC were promising predictors of MACEs and overall mortality risk in T2DM cases.展开更多
Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using...Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using big data for post-colonoscopy complications have been reported. A colon perforation is a severe complication with a relatively high mortality rate. The perforation rate, as reported in large studies(≥ 50,000 colonoscopies) published since 2000, ranges from 0.005-0.085%. The trend in the overall perforation rate in the past 15 years has not changed significantly. Bleeding is a more common adverse event than perforation. Recent large studies(≥ 50,000 colonoscopies) have reported postcolonoscopy bleeding occurring in 0.001-0.687% of cases. Most studies about adverse events related to colonoscopy were performed in the West, and relatively few studies have been conducted in the East. The incidence of post-colonoscopy complications increases in elderly patients or patients with inflammatory bowel diseases. It is important to use a unified definition and refined data to overcome the limitations of previous studies. In addition, a structured training program for endoscopists and a systematic national management program are needed to reduce post-colonoscopy complications. In this review, we discuss the current trends in colonoscopy related to adverse events, as well as the challenges to be addressed through future research.展开更多
AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to Octob...AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.展开更多
AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles pu...AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and Cvs those with Child-Pugh class A: 22%vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2%vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001). CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.展开更多
Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurren...Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurrence of AREs,the impact of AREs on length of stay(LOS)in post-anesthesia care unit(PACU)and postoperative time in hospital,and PACU cost and in patient healthcare costs.A retrospective,matched-cohort study was conducted by prospectively collecting the data of 159 AREs in PACU during 2016-2017 in an university hospital in China.Records were reviewed by pre-trained,qualified nurses and/or anesthesiologists.The incidence and the impact of AREs were analyzed.The LOS in PACU and postoperative time in hospital and the costs in PACU and inpatient healthcare costs were also obtained.Results showed that there were 253 AREs involving 156 patients.Hypoxia(n=141,55.73%)and respiratory depression(n=70,27.67%)were the most common AREs.Measurement data including body mass index(BMI)(22.85±4.36 vs.22.32±3.83),duration of procedure(138.47±77.33 min vs.137.44±72.33 min),duration of anesthesia(176.35±82.66 min vs.174.61±78.08 min),LOS(16.53±10.65 days vs.16.57±9.56 days),inpatient healthcare costs($9465.57±9416.33 vs.$8166.51±5762.01),and postoperative LOS(11.26±8.77 days vs.11.9±8.30 days)showed no significant differences between ARE and matched groups(P<0.05).Duration(81.65±54.79 min vs.38.89±26.09 min)and costs($31.99±17.80 vs.$18.72±8.39)in PACU were significantly different in ARE group from those in matched group(P<0.001).Proportion of patients with prolonged stay in PACU was significantly higher in ARE group than in matched group(18.59%vs.1.28%),with an odds ratio(after matching)of 17.58(95%CI=4.11 to 75.10;P<0.001).The AREs that occurred during the immediate postoperative period in PACU increased the incidence rate of prolonged stay,delayed the PACU stay,and increased the costs in PACU,resulting in the need of higher levels of postoperative care than anticipated,but the postoperative LOS and inpatient healthcare costs were unchanged.展开更多
AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk...AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk. However, there is a paucity of literature describing the indications and outcomes of ERCP procedures in patients with cirrhosis, especially focusing on adverse events.METHODS We performed a systematic appraisal of major literature databases, including PubMed and EMBASE, with a manual search of literature from their inception until April 2017.RESULTS A total of 6,505 patients from 15 studies were analyzed(male ratio 59%, mean age 59 years), 11% with alcoholic and 89% with non-alcoholic cirrhosis, with 56.2% Child-Pugh class A, and 43.8% class B or C. Indications for ERCP included choledocholithiasis 60.9%, biliary strictures 26.2%, gallstone pancreatitis 21.1% and cholangitis 15.5%. Types of interventions included endoscopic sphincterotomy 52.7%, biliary stenting 16.7% and biliary dilation 4.6%. Individual adverse events included hemorrhage in 4.58%(95%CI: 2.77-6.75%, I^2 = 85.9%), post-ERCP pancreatitis(PEP) in 3.68%(95%CI: 1.83-6.00%, I^2 = 89.5%), cholangitis in 1.93%(95%CI: 0.63-3.71%, I^2 = 87.1%) and perforation in 0.00%(95%CI: 0.00-0.23%, I^2 = 37.8%). Six studies were used for comparison of ERCPrelated complications in cirrhosis vs non-cirrhosis, which showed higher overall rates of complications in cirrhosis patients with pooled OR of 1.63(95%CI: 1.27-2.09, I2 = 65%): higher rates of hemorrhage with OR of 2.05(95%CI: 1.62-2.58, I^2 = 2.1%) and PEP with OR of 1.33(95%CI: 1.04-1.70, I2=65%), but similar cholangitis rates with OR of 1.23(95%CI: 0.67-2.26, I^2 = 44.3%).CONCLUSION There is an overall higher rate of adverse events related to ERCP in patients with cirrhosis, especially hemorrhage and PEP. A thorough risk/benefit assessment should be performed prior to undertaking ERCP in patients with cirrhosis.展开更多
Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpo...Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.展开更多
文摘Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.
基金Supported by Joint Funds for the Innovation of Science and Technology,Fujian Province,No.2023Y9187 and No.2021Y9057.
文摘BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery and long-term survival.Accurate preoperative identification of high-risk patients is critical for improving outcomes.AIM To establish and validate a risk prediction and stratification model for the risk of SAEs in patients with MIE.METHODS This retrospective study included 747 patients who underwent MIE at two centers from January 2019 to February 2024.Patients were separated into a train set(n=549)and a validation set(n=198).After screening by least absolute shrinkage and selection operator regression,multivariate logistic regression analyzed clinical and intraoperative variables to identify independent risk factors for SAEs.A risk stratification model was constructed and validated to predict the probability of SAEs.RESULTS SAEs occurred in 10.2%of patients in train set and 13.6%in the validation set.Patients with SAE had significantly higher complication rate and a longer hospital stay after surgery.The key independent risk factors identified included chronic obstructive pulmonary disease,a history of alcohol consumption,low forced expiratory volume in the first second,and low albumin levels.The stratification model has excellent prediction accuracy,with an area under the curve of 0.889 for the training set and an area under the curve of 0.793 for the validation set.CONCLUSION The developed risk stratification model effectively predicts the risk of SAEs in patients undergoing MIE,facilitating targeted preoperative interventions and improving perioperative management.
文摘Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.
文摘BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study described the outcomes and adverse events from a single center in South India.AIM To describe the challenges,treatment outcomes,and complications of selective IAC for RB in Indian eyes.METHODS This study was a single center,retrospective study that included 17 patients with RB who underwent IAC using melphalan(5/7.5 mg)and topotecan(1/2 mg)(n=12)or melphalan(5 mg)alone(n=3)or triple therapy that included carboplatin(30 mg)along with these drugs(n=2)between January 2018 and December 2023.In all,17 IAC procedures were performed using selective ophthalmic artery cannulation.Treatment outcomes were evaluated in terms of tumor control,vitreous and subretinal seed control,complications,and globe salvage rates.RESULTS Out of the 17 patients,11 were diagnosed with unilateral RB and 6 were diag-nosed with bilateral RB.The mean age at the time of diagnosis was 19.8 months.The mean interval between the first symptom and presentation was 6.5 months.IAC was employed as the primary(n=9)or secondary(n=8)modality of treatment.Each eye received a mean of 1.5 IAC sessions(median:1 session;range:1-3 sessions).Eyes were classified according to the international classification of RB as group B(n=5),group C(n=1),group D(n=4),and group E(n=7).Following IAC,complete regression of the main tumor was seen in 15 eyes(88%)and partial regression in 2 eyes(12%).Globe salvage was achieved in 15 eyes(88%).Adverse effects included vitreous hemorrhage(n=3),rhegmatogenous retinal de-tachment(n=2),choroidal ischemia(n=1),isolated subretinal hemorrhage(n=2),retinal pigment epithelium degeneration(n=2),forehead pigmentation(n=1),third nerve palsy with complete ptosis(n=1),and 30-degree exotropia(n=1).The mean follow-up period was 28.6 months(median:24 months,range:1–72 months).CONCLUSION IAC is an effective way to control RB and globe preservation.In the Indian context we encountered many cha-llenges highlighting the importance of case selection.Further studies in India are required to thoroughly un-derstand IAC as a treatment for RB.
文摘This study sought to investigate adverse drug event(ADE)signals associated with eltrombopag use in pediatric patients aged 0–18 years,utilizing data from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS).By analyzing this extensive pharmacovigilance database,the study aimed to offer meaningful insights for improving the clinical safety of eltrombopag in children.Data covering eltrombopag-related ADEs from Q12004 to Q42023 were extracted from FAERS,and signal detection was conducted using both the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.ADEs were categorized based on the System Organ Class(SOC)classification in MedDRA version 25.0.A total of 582 reports involving pediatric patients receiving eltrombopag were identified,encompassing 21 SOC categories.The analysis revealed that,in addition to the known ADEs listed in the drug label,clinicians should remain vigilant for potential off-label ADE signals.These included abnormal platelet counts,thrombocytosis,antiphospholipid syndrome,myelofibrosis,reduced serum iron levels,myelodysplastic syndrome,hepatic infections,and other related conditions.Given these findings,it is strongly recommended that serum iron and ferritin levels should be routinely monitored in pediatric patients undergoing eltrombopag therapy,particularly during long-term treatment.Such proactive surveillance may help prevent the onset of iron deficiency anemia and enhance overall treatment safety.
文摘BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
基金Supported by the Second Nursing Research Project of the Humanities Nursing Professional Committee,No.RW2024PY03the Open Project of Suzhou Key Laboratory of Elderly Smart Nursing and Health Care in 2024.
文摘BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead to severe consequences such as suicidal thoughts.Respiratory failure,a disorder of pulmonary ventilation and gas exchange,is frequently complicated by depression,aggravating the condition and creating complications in treatment.Patients with both conditions tend to exhibit poor compliance with medical advice,resulting in adverse outcomes such as sleep disorders,arrhythmias,and electrolyte imbalances.Therefore,effective nursing interventions are crucial for improving patient outcomes.While routine nursing care can provide basic support,dedicated nursing,which involves specialized and personalized care by highly trained professionals,may offer additional benefits.AIM To examine the effect of dedicated nursing intervention on medical advice compliance and adverse event incidence in patients with depression complicated by respiratory failure.METHODS A total of 160 patients with depression complicated by respiratory failure admitted to the Second Affiliated Hospital of Soochow University from January to December 2024 were randomly categorized into a control group(n=80)receiving routine nursing care and observation group(n=80)receiving routine nursing combined with dedicated nursing care.The establishment of a specialized nursing team;the development of a personalized nursing plan;and the implementation of comprehensive care strategies targeting emotional support,sleep improvement,pulmonary function enhancement,and adherence to medical advice were included in the dedicated nursing intervention.Emotional state[evaluated using the Self-Rating Depression Scale(SDS)],sleep quality[assessed using the Pittsburgh Sleep Quality Index(PSQI)],hope level[measured using the Herth Hope Scale(HHS)],pulmonary function[comprising forced vital capacity(FVC)and forced expiratory volume in the first second(FEV1)],exercise endurance[6-minute walk distance test(6MWD)],compliance with medical advice,and incidence of adverse events were compared between the two groups.RESULTS No significant differences were observed in SDS,PSQI,HHS,FVC,FEV1,6MWD,or compliance with medical advice between the two groups(P>0.05)before the intervention.However,after the intervention,the control group exhibited significantly lower SDS and PSQI scores;higher HHS scores;greater improvements in FVC,FEV1,and 6MWD;and higher compliance with medical advice compared with the control group(P<0.05).In addition,the incidence of adverse events was significantly lower in the control group(P<0.05).CONCLUSION Dedicated nursing intervention significantly improves emotional state,sleep quality,hope level,pulmonary function,exercise endurance,and compliance with medical advice while reducing adverse events in patients with depression complicated by respiratory failure.Therefore,dedicated nursing appears to be an effective approach to enhance patient outcomes in this population.
基金supported by grants from the Beijing Natural Science Foundation,Beijing Economic and Technological Development Zone Innovation Joint Fund(Grant no.L248072).
文摘Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).irAEs can affect a wide range of organ systems and are characterized by heterogeneous onset,broad toxicity spectra,and complex management requirements,thus ultimately impairing treatment continuation and patient quality of life.This review systematically summarizes the epidemiological features,clinical progression,and current management of irAEs.Existing guidelines largely focus on acute toxicities but have not provided structured strategies for chronic,delayed-onset,or multisystem irAEs.Moreover,clinical practice is hampered by incomplete multidisciplinary collaboration,insufficient training of oncologists,and fragmented treatment pathways,all of which limit the efficacy of irAE management.We propose incorporating irAE management into core oncology training and call for the establishment of comprehensive interdisciplinary frameworks to ensure the standardized long-term use of immunotherapy.
文摘Background Coronary artery calcification(CAC),a hallmark of atherosclerosis,paradoxically associates with reduced cardiovascular risk under statin therapy despite accelerated calcification progression,prompting this study to explore CAC metrics as potential mediators between statin use and major adverse cardiovascular events(MACE).Methods Clinical data of 246 hospitalized patients who underwent coronary computed tomography angiography(CCTA)at Guangdong Provincial People's Hospital from January 2023 to June 2023 were retrospectively analyzed.Linear regression was used to evaluate the relationship between statin use and CAC parameters.Multivariable Poisson regression models were applied to explore the associations of statin use and CAC parameters with MACE risk.A mediation analysis was performed to assess the role of CAC parameters in the statin-MACE relationship.Results Statin use was independently associated with increased calcification score(β=0.648,P<0.001),CAC volume(β=0.623,P<0.001),and calcified plaque proportion(β=0.606,P=0.002).Multivariable Poisson regression indicated that statin use significantly reduced MACE risk[incidence rate ratio(IRR):0.33,P=0.018],whereas calcification score(IRR:2.63,P=0.026)and CACvolume(IRR:2.66,P=0.044)were associated with elevated MACE risk;Calcified plaque proportion showed no significant association.Mediation analysis revealed that calcification score(β=0.035,P=0.021)and CAC volume(β=0.023,P=0.018)exerted masking effects,while calcified plaque proportion had no mediating role.Conclusions Calcification score and CACvolume demonstrated limited masking effects in the association between statin use and MACE.
基金The 2022 Educational Teaching Reform and Research Project of Guangxi University of Traditional Chinese Medicine(2022C032).
文摘Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary information about adverse reactions is principally derived from clinical trials;however,there is a notable dearth of substantial real-world studies.Methods:In this research,an examination of the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database was performed to evaluate the potential side effects of lenvatinib.The FAERS database revealed a total of 20,290 reported adverse events associated with lenvatinib.Different algorithms for repeated measure analysis were employed to ascertain the significance of these adverse reactions.Results:The study identified 170 instances of adverse events(AEs)induced by lenvatinib,incorporating several significant adverse reactions that the product label does not mention.The investigation also evaluated the onset periods of the adverse reactions,pinpointing a median time of 43 days.The majority of adverse reactions manifested within the initial month of lenvatinib use.Sex-specific analysis revealed disparities in high risk adverse reactions between females(vascular and lymphatic diseases,and neuronal organ diseases)and males(death and infectious diseases).Our data mining has unveiled adverse reactions beyond those mentioned within the instructions,such as osteonecrosis of the jaw,cholecystitis,cholangitis,dehydration,tumor lysis syndrome,type 1 diabetes,hyperammonemia,liver abscess,interstitial lung disease,pneumothorax,sudden death,and aortic dissection.Conclusion:The insights derived from these findings contribute significant nuances for optimizing lenvatinib use,enhancing its efficacy,and substantially mitigating potential side effects.These data elements will substantially enhance the implementation of the drug in a clinical environment.
文摘Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniques such as laparoscopic,thoracoscopic,and robotic-assisted approaches,MIE mini-mizes surgical trauma while maintaining oncological thoroughness.However,it also presents unique challenges,including risks of complications such as ana-stomotic leakage,pulmonary complications,and atrial fibrillation.Zhong et al developed and validated a risk stratification model for predicting surgical adverse events after MIE,enhancing preoperative assessment and patient management.This editorial further examines the advantages of MIE,its comparable oncological and long-term outcomes,as well as the incidence and contributing factors of post-operative complications.Emerging technologies,including machine learning models,intraoperative nerve monitoring,and robotic-assisted surgery,are high-lighted as innovative solutions for risk prediction and prevention.Strategies such as enhanced recovery after surgery protocols and multidisciplinary collaboration are emphasized for their critical roles in minimizing complications and optimizing patient outcomes.By addressing these aspects,this editorial provides guidance to surgical teams in maximizing the benefits of MIE while effectively managing its associated risks.
文摘BACKGROUND Major adverse cardiovascular(CV)events(MACEs)are the primary cause of morbidity and mortality in kidney transplantation(KT)recipients.The risk for MACEs is impacted by an array of traditional and transplant-related non-traditional CV risk factors.AIM To investigate the association between potential CV risk factors related to KT and MACEs,and their potential modification by hyperuricemia(HU).METHODS The relationship between CV risk factors related to KT and MACEs was examined in a cohort of 545 patients who underwent transplantation between 2008 and 2019.The mean age of patients at KT was 55.0 years±14.2 years(range 15.0–89.0 years).Univariate and multivariate logistic regression models were constructed to identify risk factors influencing MACEs.To explore the potential effect modification by uric acid(UA),patients were categorized into groups based on UA levels:(1)Low(<356μmol/L);(2)Normal(356–416μmol/L);(3)High(416–475μmol/L);and(4)Very high(>475μmol/L).RESULTS MACEs occurred in 145 of 545(26.6%)KT recipients.The most prevalent comorbidities were hypertension(87%),dyslipidemia(78%),secondary hyperparathyroidism(68%),HU(63%)and anemia(33%).In the multivariate logistic regression model,the most significant factors associated with MACEs were previous CV events[odds ratio(OR)=70.6,95%CI:24.9–200.1],left ventricular hypertrophy(LVH)(OR=12.6,95%CI:2.7–58.3),HU treatment(OR=4.3,95%CI:2.4–7.6),and anemia(OR=5.3,95%CI:2.9–9.8).Effect modification by the presence of HU revealed that independent factors associated with MACEs were age(OR=1.03,95%CI:1.0–1.1),previous CV events(OR=41.7,95%CI:13.6–127.6),LVH(OR=15.3,95%CI:2.0–116.6),HU treatment(OR=2.5,95%CI:1.3–4.6)and anemia(OR=5.4,95%CI:2.8–10.5).Effect modification by UA levels dichotomized at 475μmol/L(very high level of UA)revealed that HU treatment was not associated with MACEs in groups with or without very high UA levels.CONCLUSION A very high level of UA was observed to act as an effect-modifying factor for MACEs,especially when combined with other risk factors such as age,previous CV events,LVH,and anemia.
文摘This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk factors such as chronic obstructive pulmonary disease and hypoalbuminemia,the model demonstrated strong predictive accuracy and offered a pathway to personalized perioperative care.This correspondence highlighted the clinical significance,emphasizing its potential to optimize patient outcomes through tailored inter-ventions.Further prospective validation and application across diverse settings are essential to realize its full potential in advancing esophageal surgery practices.
文摘BACKGROUND Recent studies have indicated that triglyceride glucose(TyG)-waist height ratio(WHtR)and TyG-waist circumference(TyG-WC)are effective indicators for evaluating insulin resistance.However,research on the association in TyG-WHtR,TyG-WC,and the risk and prognosis of major adverse cardiovascular events(MACEs)in type 2 diabetes mellitus(T2DM)cases are limited.AIM To clarify the relation in TyG-WHtR,TyG-WC,and the risk of MACEs and overall mortality in T2DM patients.METHODS Information for this investigation was obtained from Action to Control Cardiovascular Risk in Diabetes(ACCORD)/ACCORD Follow-On(ACCORDION)study database.The Cox regression model was applied to assess the relation among TyG-WHtR,TyG-WC and future MACEs risk and overall mortality in T2DM cases.The RCS analysis was utilized to explore the nonlinear correlation.Subgroup and interaction analyses were conducted to prove the robustness.The receiver operating characteristic curves were applied to analysis the additional predicting value of TyG-WHtR and TyG-WC.RESULTS After full adjustment for confounding variables,the highest baseline TyG-WHtR cohort respectively exhibited a 1.353-fold and 1.420-fold higher risk for MACEs and overall mortality,than the lowest quartile group.Similarly,the highest baseline TyG-WC cohort showed a 1.314-fold and 1.480-fold higher risk for MACEs and overall mortality,respectively.Each 1 SD increase in TyG-WHtR was significantly related to an 11.7%increase in MACEs and a 14.9%enhance in overall mortality.Each 1 SD increase in TyG-WC corresponded to an 11.5%in MACEs and a 16.6%increase in overall mortality.Including these two indexes in conventional models significantly improved the predictive power for MACEs and overall mortality.CONCLUSION TyG-WHtR and TyG-WC were promising predictors of MACEs and overall mortality risk in T2DM cases.
基金Supported by the National R&D Program for Cancer Control,No.HA17C0046the Korean National Health Clinical Research(NHCR)Project,No.HC16C2320
文摘Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using big data for post-colonoscopy complications have been reported. A colon perforation is a severe complication with a relatively high mortality rate. The perforation rate, as reported in large studies(≥ 50,000 colonoscopies) published since 2000, ranges from 0.005-0.085%. The trend in the overall perforation rate in the past 15 years has not changed significantly. Bleeding is a more common adverse event than perforation. Recent large studies(≥ 50,000 colonoscopies) have reported postcolonoscopy bleeding occurring in 0.001-0.687% of cases. Most studies about adverse events related to colonoscopy were performed in the West, and relatively few studies have been conducted in the East. The incidence of post-colonoscopy complications increases in elderly patients or patients with inflammatory bowel diseases. It is important to use a unified definition and refined data to overcome the limitations of previous studies. In addition, a structured training program for endoscopists and a systematic national management program are needed to reduce post-colonoscopy complications. In this review, we discuss the current trends in colonoscopy related to adverse events, as well as the challenges to be addressed through future research.
文摘AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.
文摘AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and Cvs those with Child-Pugh class A: 22%vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2%vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001). CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.
文摘Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurrence of AREs,the impact of AREs on length of stay(LOS)in post-anesthesia care unit(PACU)and postoperative time in hospital,and PACU cost and in patient healthcare costs.A retrospective,matched-cohort study was conducted by prospectively collecting the data of 159 AREs in PACU during 2016-2017 in an university hospital in China.Records were reviewed by pre-trained,qualified nurses and/or anesthesiologists.The incidence and the impact of AREs were analyzed.The LOS in PACU and postoperative time in hospital and the costs in PACU and inpatient healthcare costs were also obtained.Results showed that there were 253 AREs involving 156 patients.Hypoxia(n=141,55.73%)and respiratory depression(n=70,27.67%)were the most common AREs.Measurement data including body mass index(BMI)(22.85±4.36 vs.22.32±3.83),duration of procedure(138.47±77.33 min vs.137.44±72.33 min),duration of anesthesia(176.35±82.66 min vs.174.61±78.08 min),LOS(16.53±10.65 days vs.16.57±9.56 days),inpatient healthcare costs($9465.57±9416.33 vs.$8166.51±5762.01),and postoperative LOS(11.26±8.77 days vs.11.9±8.30 days)showed no significant differences between ARE and matched groups(P<0.05).Duration(81.65±54.79 min vs.38.89±26.09 min)and costs($31.99±17.80 vs.$18.72±8.39)in PACU were significantly different in ARE group from those in matched group(P<0.001).Proportion of patients with prolonged stay in PACU was significantly higher in ARE group than in matched group(18.59%vs.1.28%),with an odds ratio(after matching)of 17.58(95%CI=4.11 to 75.10;P<0.001).The AREs that occurred during the immediate postoperative period in PACU increased the incidence rate of prolonged stay,delayed the PACU stay,and increased the costs in PACU,resulting in the need of higher levels of postoperative care than anticipated,but the postoperative LOS and inpatient healthcare costs were unchanged.
文摘AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk. However, there is a paucity of literature describing the indications and outcomes of ERCP procedures in patients with cirrhosis, especially focusing on adverse events.METHODS We performed a systematic appraisal of major literature databases, including PubMed and EMBASE, with a manual search of literature from their inception until April 2017.RESULTS A total of 6,505 patients from 15 studies were analyzed(male ratio 59%, mean age 59 years), 11% with alcoholic and 89% with non-alcoholic cirrhosis, with 56.2% Child-Pugh class A, and 43.8% class B or C. Indications for ERCP included choledocholithiasis 60.9%, biliary strictures 26.2%, gallstone pancreatitis 21.1% and cholangitis 15.5%. Types of interventions included endoscopic sphincterotomy 52.7%, biliary stenting 16.7% and biliary dilation 4.6%. Individual adverse events included hemorrhage in 4.58%(95%CI: 2.77-6.75%, I^2 = 85.9%), post-ERCP pancreatitis(PEP) in 3.68%(95%CI: 1.83-6.00%, I^2 = 89.5%), cholangitis in 1.93%(95%CI: 0.63-3.71%, I^2 = 87.1%) and perforation in 0.00%(95%CI: 0.00-0.23%, I^2 = 37.8%). Six studies were used for comparison of ERCPrelated complications in cirrhosis vs non-cirrhosis, which showed higher overall rates of complications in cirrhosis patients with pooled OR of 1.63(95%CI: 1.27-2.09, I2 = 65%): higher rates of hemorrhage with OR of 2.05(95%CI: 1.62-2.58, I^2 = 2.1%) and PEP with OR of 1.33(95%CI: 1.04-1.70, I2=65%), but similar cholangitis rates with OR of 1.23(95%CI: 0.67-2.26, I^2 = 44.3%).CONCLUSION There is an overall higher rate of adverse events related to ERCP in patients with cirrhosis, especially hemorrhage and PEP. A thorough risk/benefit assessment should be performed prior to undertaking ERCP in patients with cirrhosis.
基金This work was supported by grants from the National Key R&D Program of China(Grant No.2016YFC1303800)Jilin Provincial Key Laboratory of Biological Therapy(Grant No.20170622011JC)+1 种基金Jilin Provincial Science and Technology Department(Grant No.20190303146SF)Jilin Province Finance Department(Grant No.2018SCZWSZX-010).
文摘Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.
