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Safety profile of artemether:Analysis based on 15-year data retrived from FDA adverse event reporting system(FAERS)
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作者 Bo Jiang Jiaxin Wei +3 位作者 Xiaochen Liu Longlin He Taotao Hou Bin Niu 《Asian Pacific Journal of Tropical Medicine》 2026年第1期33-44,共12页
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
关键词 ARTEMETHER adverse events FDA adverse event reporting system Signal detection Hematological toxicity HEPATOTOXICITY
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An anatomopathological examination of placentas associated with adverse pregnancy outcomes in Moroccan women-A case series
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作者 Chaimae Hilali Asmaa Mdaghri Alaoui +1 位作者 Najat Lamalmi Mounia Yousfi Malki 《Asian pacific Journal of Reproduction》 2026年第1期23-33,共11页
Objective:To characterize placental morphologic features in Moroccan women with adverse outcomes,across different clinical contexts,based on the Amsterdam consensus classification.Methods:A prospective analysis was co... Objective:To characterize placental morphologic features in Moroccan women with adverse outcomes,across different clinical contexts,based on the Amsterdam consensus classification.Methods:A prospective analysis was conducted on placentas with umbilical cords collected fresh between March 1,2024 and July 15,2024 from women with adverse pregnancy outcomes.Clinical data(age,parity,gravidity,complications)were retrieved.Macroscopic parameters(weight,dimensions,cord insertion,membranes,lesions)were assessed,followed by systematic sampling.Tissue was processed by standard histology(formalin fixation,paraffin embedding,hematoxylin and eosin staining),and lesions were classified per Amsterdam criteria.Results:16 placentas from patients with adverse pregnancy outcomes were included.The median maternal age was 30 years.Adverse conditions included placental abruption(50%),intrauterine growth restriction(IUGR,38%),intrauterine fetal death(IUFD,31%),pre-eclampsia/eclampsia(19%),premature rupture of membranes(13%),and oligohydramnios(13%).Several placentas were associated with more than one adverse condition.Histopathology revealed maternal vascular malperfusion lesions in 94%,particularly in pre-eclampsia,IUGR,and IUFD.Fetal vascular malperfusion was found in 88%,mainly in IUGR and IUFD.Inflammatory lesions,dominated by acute maternal and fetal responses stage 3(necrotizing chorioamnionitis and funisitis),were primarily linked to IUFD.Conclusions:Placental examination enhances understanding of the pathophysiology underlying adverse pregnancy outcomes,supports diagnostic confirmation,and guides preventive strategies for recurrence.This study highlights the prevalence of maternal vascular malperfusion in Moroccan women and emphasizes the importance of systematic placental histopathology in obstetric care. 展开更多
关键词 PLACENTA Anatomopathological examination adverse pregnancy outcomes Pathological lesions Amsterdam consensus Maternal vascular malperfusion Fetal vascular malperfusion
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Role of attachment style in the association between childhood adversities and non-suicidal self-injury among young adults:a multigroup structural equation study
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作者 Rodolfo Rossi Tommaso B Jannini +3 位作者 Valentina Socci Francesca Pacitti Alessandro Rossi Giorgio Di Lorenzo 《General Psychiatry》 2025年第2期103-112,共10页
Background Non-suicidal self-injury(NSSI)is a significant health concern among adolescents and young adults,often resulting from adverse childhood experiences(ACEs).Dissociation,post-traumatic symptoms and attachment ... Background Non-suicidal self-injury(NSSI)is a significant health concern among adolescents and young adults,often resulting from adverse childhood experiences(ACEs).Dissociation,post-traumatic symptoms and attachment style may have a role in shaping such associations.Aims This study aims to provide a unified model of the impact of ACEs on NSSI,exploring complex post-traumatic stress disorder(cPTSD)symptoms and dissociation as potential mediators and the role of the predominant attachment style in affecting such associations.Methods 1010 young individuals attending the last year of high school participated in this cross-sectional study.ACEs,cPTSD,dissociation and NSSI were evaluated using self-report questionnaires.We fitted a path model of NSSI,with ACEs as exogenous variables and cPTSD and dissociation as sequential mediators.Secure,fearful and preoccupied attachment styles were modelled as grouping variables.Results Our findings showed that dissociation mediated the impact of ACEs on NSSI in subjects with a fearful attachment style,as opposed to those with a preoccupied attachment for whom cPTSD symptoms mediated the ACEs-NSSI association.Conclusions Attachment styles moderate the relationship between ACEs and NSSI,with either dissociation or post-traumatic symptomatology mediating the impact of ACEs on NSSI,depending on the predominant attachment style.Our results highlight the importance of attachment as a pathway modifier in the relationships between different psychopathology dimensions,providing a useful framework to better conceptualise the ACEs-NSSI association. 展开更多
关键词 adverse childhood experiences aces dissociationpost traumatic non suicidal self injury childhood adversities complex post traumatic stress disorder attachment style DISSOCIATION unified model impact MEDIATION
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Machine Learning of Element Geochemical Anomalies for Adverse Geology Identification in Tunnels 被引量:1
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作者 Ruiqi Shao Peng Lin +2 位作者 Zhenhao Xu Fumin Liu Yilong Liu 《Journal of Earth Science》 2025年第3期1261-1276,共16页
Geological analysis,despite being a long-term method for identifying adverse geology in tunnels,has significant limitations due to its reliance on empirical analysis.The quantitative aspects of geochemical anomalies a... Geological analysis,despite being a long-term method for identifying adverse geology in tunnels,has significant limitations due to its reliance on empirical analysis.The quantitative aspects of geochemical anomalies associated with adverse geology provide a novel strategy for addressing these limitations.However,statistical methods for identifying geochemical anomalies are insufficient for tunnel engineering.In contrast,data mining techniques such as machine learning have demonstrated greater efficacy when applied to geological data.Herein,a method for identifying adverse geology using machine learning of geochemical anomalies is proposed.The method was identified geochemical anomalies in tunnel that were not identified by statistical methods.We by employing robust factor analysis and self-organizing maps to reduce the dimensionality of geochemical data and extract the anomaly elements combination(AEC).Using the AEC sample data,we trained an isolation forest model to identify the multi-element anomalies,successfully.We analyzed the adverse geological features based the multi-element anomalies.This study,therefore,extends the traditional approach of geological analysis in tunnels and demonstrates that machine learning is an effective tool for intelligent geological analysis.Correspondingly,the research offers new insights regarding the adverse geology and the prevention of hazards during the construction of tunnels and underground engineering projects. 展开更多
关键词 adverse geology TUNNELS geochemical anomalies machine learning Isolation Forest dimensional reduction
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Prediction and stratification for the surgical adverse events after minimally invasive esophagectomy:A two-center retrospective study
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作者 Qi-Hong Zhong Jiang-Shan Huang +7 位作者 Fei-Long Guo Jing-Yu Wu Mao-Xiu Yuan Jia-Fu Zhu Wen-Wei Lin Sui Chen Zhen-Yang Zhang Jiang-Bo Lin 《World Journal of Gastroenterology》 SCIE CAS 2025年第3期50-61,共12页
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
关键词 Surgical adverse events Minimally invasive esophagectomy Esophageal cancer Stratification model Perioperative management
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Exploring Independent and Cumulative Effects of Adverse Childhood Experiences on PTSD and CPTSD: A Study in Indian Adolescents
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作者 Paulo Ferrajão Francisco Frias Ask Elklit 《Open Journal of Epidemiology》 2025年第1期142-167,共26页
Background: Exposure to adverse childhood experiences (ACEs) is associated with a higher likelihood of developing psychological disorders among adolescents. The current study aimed to analyze the effect of independent... Background: Exposure to adverse childhood experiences (ACEs) is associated with a higher likelihood of developing psychological disorders among adolescents. The current study aimed to analyze the effect of independent and cumulative effects of ACEs exposure on the likelihood of Posttraumatic Stress Disorder (PTSD) and a Complex PTSD (CPSTD) diagnosis in Indian adolescents. Methods: A sample of 411 schoolchildren participated in the study. It was collected data on exposure to ACEs, PTSD, CPTSD, and attachment styles. Results: It was found that exposure to bullying and threats of violence was significantly associated with PTSD and CPTSD diagnosis, and exposure to physical violence and serious illness was associated with CPTSD diagnosis. Exposure to one ACE and exposure to 2 - 3 ACEs were associated with PTSD and CPTSD diagnosis, while exposure to 4 - 5 ACEs was associated with CPTSD diagnosis. Preoccupied and fearful attachment styles were significantly associated with PTSD and CPTSD diagnosis. Conclusion: The results of the study suggest that biological, psychological, and social factors interact and contribute to the differential prevalence of ACE, attachment styles, and PTSD/CPTSD. This study emphasizes the need of addressing childhood trauma as a public health priority in India. 展开更多
关键词 PTSD Complex PTSD COMORBIDITY adverse Childhood Experiences ADOLESCENCE
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Adverse Reactions Such as Fecal Incontinence Occurred in 1 Patient with Ovarian Cancer Induced by Paclitaxel Liposome Allergy
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作者 Gaijing Wang Haimei Ren +8 位作者 Ziyi Liu Jing Wang Lei Su Miaomiao Song Yanling Li Yuanyuan Yang Jiale Lu Zhihui Cai Jie Cui 《Journal of Biosciences and Medicines》 2025年第1期41-46,共6页
Paclitaxel is one of the commonly used drugs in postoperative chemotherapy for ovarian cancer patients. However, affected by drug dosage and individual differences in the course of medication, patients will have diffe... Paclitaxel is one of the commonly used drugs in postoperative chemotherapy for ovarian cancer patients. However, affected by drug dosage and individual differences in the course of medication, patients will have different degrees of adverse reactions, which will cause damage to the patient’s body once they occur. This paper retrospectively analyzed the clinical data of patients with severe allergic reactions such as fecal incontinence and numbness of hands and feet caused by the use of paclitaxel liposome during postoperative chemotherapy in a case of ovarian cancer admitted to our hospital. The causes and corresponding treatment measures were analyzed, in order to provide the reference for medical staff to take effective countermeasures in advance in the future. 展开更多
关键词 PACLITAXEL Drug Allergy adverse Reactions Ovarian Cancer
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Risk factors for drug-related urticaria:an analysis of the FDA Adverse Event Reporting System(FAERS)
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作者 Wenshan Yang Guoyou Zu +4 位作者 Pan Tian Shuang Liu Dan Meng Yudong Ma Zhi Mao 《Allergy Medicine》 2025年第2期27-33,共7页
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
关键词 URTICARIA adverse events PHARMACOVIGILANCE FAERS GENDER
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Outcomes and adverse events following intra-arterial chemotherapy for retinoblastoma:A single center study in South India
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作者 Abhishek Das Kothapally Saiteja +2 位作者 Parag K Shah Subramaniam Prema Venkatapathy Narendran 《World Journal of Clinical Pediatrics》 2025年第3期176-186,共11页
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
关键词 RETINOBLASTOMA Intra-arterial chemotherapy Treatment outcomes adverse events INDIA
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Factors related to adversity quotient in junior high school students
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作者 Wanita Kwansumran Jinjutha Chaisena Dallas +1 位作者 Sawitree Wonginjun Nattaya Sangsai 《Frontiers of Nursing》 2025年第1期19-26,共8页
Objectives: To determine the level of adversity quotient and its associations with rumination, optimism, and authoritative parenting style in junior high school students. Adversity quotient is the adaptation ability t... Objectives: To determine the level of adversity quotient and its associations with rumination, optimism, and authoritative parenting style in junior high school students. Adversity quotient is the adaptation ability to overcome problems and obstacles with a positive attitude. Early adolescence, as a critical stage of life, needs to cultivate adversity quotient. However, adversity quotient and its influencing factors in adolescents have not been fully understood. Methods: A total of 129 students from 3 junior high schools (grade 7-9) in Chon Buri province, Thailand, were randomly recruited to participate in this correlational research study. They completed 5 questionnaires including the demographic form, adversity quotient assessment, authoritative parenting style, optimism, and rumination. Descriptive statistics and Pearson’s correlation coefficient were used for data analysis. Results: Adversity quotient was at a moderate level with a mean of 138.78 (standard deviation [SD] = 21.25). Adversity quotient was significantly, positively correlated with authoritative parenting at the highest level (r = 0.60), followed by optimism at a moderate level (r = 0.38), and rumination at a low level (r = 0.25, P < 0.01). Conclusions: All parties responsible for early adolescents’ development should enhance the adversity quotient to a higher level through campaigns promoting authoritative parenting and optimism. An unexpected positive correlation between adversity quotient and rumination warrants cautious interpretation and more studies. 展开更多
关键词 adversity quotient authoritative parenting early adolescence OPTIMISM RUMINATION
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Endoscopic insights into digestive-related adverse effects of immune checkpoint inhibitors: A narrative review
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作者 Grigorios Petrousis Sylwester Szczegielniak +6 位作者 Haider Sabhan Peter Elbe Gulden Bilican Hans Strid Francesca Bresso Charlotte Hedin Stephan L Haas 《World Journal of Gastrointestinal Endoscopy》 2025年第7期28-41,共14页
Treatment with immune checkpoint inhibitors(ICIs)is an innovative therapy for managing certain types of malignancy and has the potential to improve overall patient survival significantly.The most widely used ICIs sele... Treatment with immune checkpoint inhibitors(ICIs)is an innovative therapy for managing certain types of malignancy and has the potential to improve overall patient survival significantly.The most widely used ICIs selectively target different receptors comprising programmed cell death-1 receptor,programmed cell death-ligand 1 receptor,and cytotoxic T lymphocyte antigen 4 receptor.The widespread utilization of ICIs over the past several years,however,is frequently accompanied by immune-related adverse events(irAEs)that substantially impact the patient’s quality of life,particularly those affecting the digestive system,including both the upper and lower gastrointestinal tract.Based on a literature search covering databases such as PubMed,Web of Science,Embase,and the Cochrane Library,we present an insight into primary gastrointestinal irAEs,with a special focus on endoscopic manifestations.Additionally,we analyze data regarding the pathogenetic mechanisms,diagnostic approaches,histological characteristics,and proposed therapeutic interventions for managing irAEs involving the gastrointestinal tract. 展开更多
关键词 Immune checkpoint inhibitors Gastrointestinal tract Endoscopy Immune-related adverse events Toxicity Colitis ENTERITIS Gastritis
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Adverse effects of dupilumab in a child with atopic dermatitis:A case report of anaphylaxis and literature review
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作者 Jing Zhang Zhouxian Pan +2 位作者 Shisu Zhao Jihan li Jinlyu Sun 《Allergy Medicine》 2025年第1期41-44,共4页
Atopic dermatitis(AD)is one of the most common chronic inflammatory skin diseases.It usually develops in childhood and may persist into adulthood.Dupilumab is a fully human monoclonal antibody directed against interle... Atopic dermatitis(AD)is one of the most common chronic inflammatory skin diseases.It usually develops in childhood and may persist into adulthood.Dupilumab is a fully human monoclonal antibody directed against interleukin-4R-alpha,the common chain of interleukin-4 and interleukin-13 receptors.Dupilumab showed clinical improvements in patients with atopic dermatitis,asthma,and chronic rhinosinusitis and is currently under development for other indications.However,there are many adverse effects reported after dupilumab therapy including local injection site reactions,conjunctivitis,headache,and nasopharyngitis.We report a new case of a 4-year-old child who experienced anaphylaxis after dupilumab injection.In addition to,we summary and disscuss the rare adverse reactions caused by dupilumab injection by searching the literature in pubmed. 展开更多
关键词 Atopic dermatitis Dupilumab INTERLEUKIN adverse effect
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Eltrombopag in pediatrics:revealing hidden signals of adverse drug events
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作者 Yingqiu Tu Tiantian Xu +1 位作者 Nan Zhong Xin Lai 《Journal of Chinese Pharmaceutical Sciences》 2025年第11期1033-1040,共8页
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
关键词 Children Off-label medication ELTROMBOPAG Signal mining adverse drug events
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Response rates,survival status and adverse events of placebo in randomized control trials for hepatocellular carcinoma:A metaanalysis
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作者 Wei-Yu Chen Qing Chen +6 位作者 Chen-Chen Wang Chen-Yue Zhang Si-Kun Chen Zhi-Qiang Meng Ping Han Shu Dong Qi-Wen Chen 《World Journal of Hepatology》 2025年第8期296-305,共10页
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
关键词 Hepatocellular carcinoma PLACEBO Randomized controlled trials Response rates Survival status adverse events
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A Real-world Study on Adverse Events Related to Mirogabalin Based on the VigiAccess Database
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作者 Shiliang Xi Heqing Tang 《Proceedings of Anticancer Research》 2025年第3期88-98,共11页
Objective:To utilize the VigiAccess database for data mining to analyze the characteristics of adverse reactions induced by mirogabalin,providing critical information for clinical medication use.Method:This study anal... Objective:To utilize the VigiAccess database for data mining to analyze the characteristics of adverse reactions induced by mirogabalin,providing critical information for clinical medication use.Method:This study analyzed data from the VigiAccess database,filtering out adverse reaction reports where mirogabalin was identified as the Primary Suspect Drug(PS).Reporting Odds Ratio(ROR),Proportional Reporting Ratio(PRR),Bayesian Confidence Propagation Neural Network(BCPNN),and Empirical Bayes Geometric Mean(EBGM)methods were employed as data mining algorithms for pharmacovigilance and adverse event monitoring.These methods identify potential drug-adverse event association signals by analyzing the relationship between drug use and adverse event reporting.ROR and PRR focus on calculating reporting ratios,while BCPNN and EBGM use neural networks and empirical Bayes models,respectively,to enhance the accuracy and reliability of signal detection.Results:A total of 734 adverse reaction reports associated with mirogabalin were obtained.The results showed that females reported the highest number of adverse reactions,accounting for 59.67%,while males accounted for 38.83%.In terms of age distribution,the highest number of reports came from individuals over 75 years old,accounting for 33.79%.Adverse reactions mainly involved the nervous system(33.45%),general diseases and reactions at the site of administration(11.62%),and gastrointestinal disorders(10.74%).The most common adverse reactions included dizziness(11.62%),somnolence(8.27%),renal dysfunction(2.90%),and edema(2.82%).Signal intensity analysis revealed that certain adverse reactions(such as renal dysfunction,rhabdomyolysis,and drug-induced liver injury)had significant signal strength,suggesting a strong association with mirogabalin.Conclusion:This study,through signal mining of the VigiAccess database,reveals the characteristics of mirogabalin’s adverse reactions in the real world,particularly in the nervous system and renal function.These findings provide important reference information for clinicians,aiding in the optimization of the safe use of mirogabalin.Future research should further validate the causal relationships of these signals and explore individualized treatment strategies to reduce the incidence of adverse reactions and improve patient outcomes. 展开更多
关键词 Mirogabalin VigiAccess adverse reactions Signal detection Proportional imbalance method
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A production term correction for Menter shear-stress transport turbulence model for adverse pressure gradient flows before separation
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作者 Hanqi SONG Mingze MA +2 位作者 Jinrong ZHANG Yifan LI Chao YAN 《Chinese Journal of Aeronautics》 2025年第5期28-38,共11页
To address the early separation problem in the Menter Shear-Stress Transport(SST)turbulence model,a correction for the Turbulent Kinetic Energy(TKE)production term,P_(k),is introduced to account for the effect of the ... To address the early separation problem in the Menter Shear-Stress Transport(SST)turbulence model,a correction for the Turbulent Kinetic Energy(TKE)production term,P_(k),is introduced to account for the effect of the Adverse Pressure Gradient(APG).The correction is determined based on the distribution of Pkin the APG region before separation.When the friction coefficient C_(f) is decomposed,its direct dependence on Pkis clearly observed.However,with the introduction of Bradshaw’s assumption,Pkin the SST turbulence model is over-suppressed,resulting in a lower inner peak or no significant inner peak distribution at all.To address this problem,this paper proposes a Gaussian function,HGauss,which corrects the numerical values of P_(k) involved in the calculation of the Menter SST model by focusing on the inner peak region of P_(k).The modified SST model is then applied to four cases with APGs.The modification leads to an increase in the wall friction coefficient C_(f)in the APG region and causes a downstream shift in the separation location,improving the model’s consistency with high-accuracy data and experimental results.It is demonstrated that this correction can improve the early separation problem in the Menter SST turbulence model. 展开更多
关键词 Early separation problem adverse pressuregradient Turbulencemodels Productionterm Gaussian function Boundary layer flow
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Glucagon-like peptide-1 receptor agonists:Evolution,gastrointestinal adverse effects,and future directions
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作者 Alaa Ismail Mohab Sherif Amer Ahmed Tawheed 《World Journal of Gastrointestinal Pharmacology and Therapeutics》 2025年第3期1-20,共20页
Obesity is a global pandemic that has been threatening the worldwide population.It has been reported to be associated with an increase in the risk of chronic diseases such as type 2 diabetes mellitus(T2DM),cardiovascu... Obesity is a global pandemic that has been threatening the worldwide population.It has been reported to be associated with an increase in the risk of chronic diseases such as type 2 diabetes mellitus(T2DM),cardiovascular disease,and other diseases,including some malignancies.Currently,the first line of management includes lifestyle modifications.However,recently,bariatric surgeries were introduced to combat obesity.The previous modalities of management are always challenging since lifestyle could have limited long-term effectiveness and difficulty to achieve,and surgeries are invasive and also require a lifestyle modification and commitment.Glucagon-like peptide-1 receptor agonists(GLP-1RAs)were initially introduced as a rising star for managing T2DM,with patients benefiting from the control of blood sugar and weight loss.These medications work by enhancing feelings of fullness,slowing down digestion,and ultimately reducing calorie intake.However,GLP-1RAs are not without side effects and have some costs.Common side effects include gastrointestinal(GI)adverse events such as nausea,vomiting,diarrhea,and a lack of GI motility,which is the main mechanism through which the drug induces a feeling of fullness and promotes weight loss,potentially resulting in treatment discontinuation.More serious,though less frequent,risks include pancreatitis,gallbladder diseases,and,rarely,thyroid Ccell cancers.This review aimed to discuss the globally emerging role of GLP-1RAs in obesity management and highlight some safety considerations for patients taking these drugs. 展开更多
关键词 Glucagon-like peptide-1 receptor agonists OBESITY GASTROINTESTINAL adverse events DIABETES
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ToxBERT:An explainable AI framework for enhancing prediction of adverse drug reactions and structural insights
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作者 Yujie He Xiang Lv +3 位作者 Wulin Long Shengqiu Zhai Menglong Li Zhining Wen 《Journal of Pharmaceutical Analysis》 2025年第8期1926-1936,共11页
Accurate prediction of drug-induced adverse drug reactions(ADRs)is crucial for drug safety evaluation,as it directly impacts public health and safety.While various models have shown promising results in predicting ADR... Accurate prediction of drug-induced adverse drug reactions(ADRs)is crucial for drug safety evaluation,as it directly impacts public health and safety.While various models have shown promising results in predicting ADRs,their accuracy still needs improvement.Additionally,many existing models often lack interpretability when linking molecular structures to specific ADRs and frequently rely on manually selected molecular fingerprints,which can introduce bias.To address these challenges,we propose ToxBERT,an efficient transformer encoder model that leverages attention and masking mechanisms for simplified molecular input line entry system(SMILES)representations.Our results demonstrate that ToxBERT achieved area under the receiver operating characteristic curve(AUROC)scores of 0.839,0.759,and 0.664 for predicting drug-induced QT prolongation(DIQT),rhabdomyolysis,and liver injury,respectively,outperforming previous studies.Furthermore,ToxBERT can identify drug substructures that are closely associated with specific ADRs.These findings indicate that ToxBERT is not only a valuable tool for understanding the mechanisms underlying specific drug-induced ADRs but also for mitigating potential ADRs in the drug discovery pipeline. 展开更多
关键词 Drug safety Drug-induced adverse drug reactions Deep learning INTERPRETABILITY Structural alerts
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Effects of professional nursing intervention on compliance and adverse events in patients with depression combined with respiratory failure
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作者 Xiao-Yun Zhang Xue-Ling Wu +1 位作者 Nai-Ting Du Xue-Qin Lu 《World Journal of Psychiatry》 2025年第11期196-204,共9页
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
关键词 DEPRESSION Respiratory failure Dedicated nursing Compliance with medical advice adverse events
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Effects of impulsive personality on suicide in adolescent depression: The chain mediating of perceived social adversity and security
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作者 Hua Zhang Hua-Bin Li +2 位作者 Fu-Sheng Sun Xue-Qiong Su Chun-Bo Sun 《World Journal of Psychiatry》 2025年第7期198-206,共9页
BACKGROUND Depression is a common mental disorder among adolescents,characterized by a high rate of suicide and self-harm,which not only is devastating to families but also has a negative impact on society.Psychologic... BACKGROUND Depression is a common mental disorder among adolescents,characterized by a high rate of suicide and self-harm,which not only is devastating to families but also has a negative impact on society.Psychological factors such as impulsive personality,perceived chronic social adversity(PCSA),and sense of security are closely associated with suicide risk in adolescents with depression.Few studies have been conducted on the relationship between these factors.AIM To explore the impact of impulsive personality on suicide risk in adolescents with depression and the chain mediating effect between PCSA and sense of security.METHODS This study is a retrospective study.A total of 200 adolescents with depression who visited the Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital from January 2021 to December 2023 comprised the study cohort.The PCSA scale,Security Questionnaire,Barratt Impulsiveness Scale,and Beck Scale for Suicide Ideation were used to evaluate depression.RESULTS Suicide risk was positively correlated with impulsive personality and PCSA(P<0.05),whereas sense of security was negatively correlated with suicide risk,impulsive personality,and PCSA(P<0.05).The total indirect effect of PCSA and sense of security on impulsive personality and suicide risk was 35.43%,with the mediating effect of PCSA and sense of security contributing 16.53%and 15.75%,respectively.PCSA and sense of security exhibited a chain mediating effect between impulsive personality and suicide risk,accounting for 3.15%.CONCLUSION The suicide risk of adolescents with depression is significantly associated with impulsive personality,PCSA,and sense of security.Impulsive personality affects the suicide risk of adolescents with depression both directly and indirectly,with the latter occurring via PCSA and sense of security. 展开更多
关键词 Adolescents Suicide risk Impulsive personality Perceived chronic social adversity Sense of security
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