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: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
Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be rep...Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.展开更多
Tacrolimus(Tac)is a cornerstone immunosuppressant in the treatment regimens for organ transplant recipients.However,its extensive clinical use has brought attention to its associated drug safety concerns.Recent case r...Tacrolimus(Tac)is a cornerstone immunosuppressant in the treatment regimens for organ transplant recipients.However,its extensive clinical use has brought attention to its associated drug safety concerns.Recent case reports highlighting Tac-induced gastrointestinal ulcers have prompted further investigation.In the present study,we analyzed Tac-associated adverse events using data from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)to identify potential adverse event signals.Adverse event reports were collected up to the third quarter(Q3)of 2023,revealing 339 cases of Tac-related gastrointestinal ulcers.A disproportionality analysis was conducted utilizing the Bayesian confidence propagation neural network of information component(IC)and reporting odds ratio(ROR)methods.All statistical analyses were performed using R version 3.6.1.The findings demonstrated a significant signal for gastrointestinal ulcers associated with Tac use,with a ROR1 of 1.87(95%CI:1.68-2.08)and an IC1 of 0.89(95%CI:0.73-1.05)when compared to all other drugs.When compared specifically to cyclosporine,Tac also showed a significant signal(ROR2=1.55,95%CI:1.28-1.86;IC2=0.24,95%CI:0.04-0.44).Further analysis identified age,male gender,and European descent as risk factors for mortality outcomes in patients with Tac-associated gastrointestinal ulcers.These findings highlighted the critical need for clinicians to strengthen the monitoring and early detection of gastrointestinal ulcers in patients undergoing Tac therapy.Enhanced vigilance in this regard is essential to optimize the management and care of transplant patients.展开更多
Drug-induced liver injury(DILI) is a leading reason for preclinical safety attrition and postmarket drug withdrawals.Drug-induced mitochondrial toxicity has been shown to play an essential role in various forms of DIL...Drug-induced liver injury(DILI) is a leading reason for preclinical safety attrition and postmarket drug withdrawals.Drug-induced mitochondrial toxicity has been shown to play an essential role in various forms of DILI,especially in idiosyncratic liver injury.This study examined liver injury reports submitted to the Food and Drug Administration(FDA) Adverse Event Reporting System(FAERS) for drugs associated with hepatotoxicity via mitochondrial mechanisms compared with non-mitochondrial mechanisms of toxicity.The frequency of hepatotoxicity was determined at a group level and individual drug level.A reporting odds ratio(ROR) was calculated as the measure of effect.Between the two DILI groups,reports for DILI involving mitochondrial mechanisms of toxicity had a 1.43(95% CI 1.42-1.45;P <0.0001) times higher odds compared to drugs associated with non-mitochondrial mechanisms of toxicity.Antineoplastic,antiviral,analgesic,antibiotic,and antimycobacterial drugs were the top five drug classes with the highest ROR values.Although the top 20 drugs with the highest ROR values included drugs with both mitochondrial and non-mitochondrial injury mechanisms,the top four drugs(ROR values> 18:benzbromarone,troglitazone,isoniazid,rifampin) were associated with mitochondrial mechanisms of toxicity.The major demographic influence for DILI risk was also examined.There was a higher mean patient age among reports for drugs that were associated with mitochondrial mechanisms of toxicity [56.1±18.33(SD)] compared to non-mitochondrial mechanisms [48±19.53(SD)](P <0.0001),suggesting that age may play a role in susceptibility to DILI via mitochondrial mechanisms of toxicity.Univariate logistic regression analysis showed that reports of liver injury were 2.2(odds ratio:2.2,95% CI 2.12-2.26) times more likely to be associated with older patient age,as compared with reports involving patients less than 65 years of age.Compared to males,female patients were 37% less likely(odds ratio:0.63,95% CI 0.61-0.64) to be subjects of liver injury reports for drugs associated with mitochondrial toxicity mechanisms.Given the higher proportion of severe liver injury reports among drugs associated with mitochondrial mechanisms of toxicity,it is essential to understand if a drug causes mitochondrial toxicity during preclinical drug development when drug design alternatives,more clinically relevant animal models,and better clinical biomarkers may provide a better translation of druginduced mitochondrial toxicity risk assessment from animals to humans.Our findings from this study align with mitochondrial mechanisms of toxicity being an important cause of DILI,and this should be further investigated in real-world studies with robust designs.展开更多
Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational u...Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.展开更多
Introduction:Event reports recorded by intelligent electronic devices(IEDs)such as digital relays and fault recorders during disturbances depict the status and system parameters of the power system.Incorrect relay set...Introduction:Event reports recorded by intelligent electronic devices(IEDs)such as digital relays and fault recorders during disturbances depict the status and system parameters of the power system.Incorrect relay settings and unknown system parameters can lead to relay misoperation but information regarding these are available by performing a comprehensive analysis of fault records.Hence,it is necessary to regularly make a comprehensive assessment of the functioning of the relay to ensure reliable operation.Case description:The objective of this paper is to demonstrate various aspects of evaluating relay performance and verifying circuit parameters which are used in relay settings using field data in two case studies.Discussion and Evaluation:While scrutinizing the relay’s operation,this paper also presents key insights on verifying circuit parameters using the same relay event records.Conclusions:The lessons learned from the case studies presented in this paper will equip a protection engineer to inspect the operation of a relay during a transmission line fault,help gain a better understanding of the fault event and take possible actions to prevent future occurrence of similar events.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Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.
文摘Tacrolimus(Tac)is a cornerstone immunosuppressant in the treatment regimens for organ transplant recipients.However,its extensive clinical use has brought attention to its associated drug safety concerns.Recent case reports highlighting Tac-induced gastrointestinal ulcers have prompted further investigation.In the present study,we analyzed Tac-associated adverse events using data from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)to identify potential adverse event signals.Adverse event reports were collected up to the third quarter(Q3)of 2023,revealing 339 cases of Tac-related gastrointestinal ulcers.A disproportionality analysis was conducted utilizing the Bayesian confidence propagation neural network of information component(IC)and reporting odds ratio(ROR)methods.All statistical analyses were performed using R version 3.6.1.The findings demonstrated a significant signal for gastrointestinal ulcers associated with Tac use,with a ROR1 of 1.87(95%CI:1.68-2.08)and an IC1 of 0.89(95%CI:0.73-1.05)when compared to all other drugs.When compared specifically to cyclosporine,Tac also showed a significant signal(ROR2=1.55,95%CI:1.28-1.86;IC2=0.24,95%CI:0.04-0.44).Further analysis identified age,male gender,and European descent as risk factors for mortality outcomes in patients with Tac-associated gastrointestinal ulcers.These findings highlighted the critical need for clinicians to strengthen the monitoring and early detection of gastrointestinal ulcers in patients undergoing Tac therapy.Enhanced vigilance in this regard is essential to optimize the management and care of transplant patients.
文摘Drug-induced liver injury(DILI) is a leading reason for preclinical safety attrition and postmarket drug withdrawals.Drug-induced mitochondrial toxicity has been shown to play an essential role in various forms of DILI,especially in idiosyncratic liver injury.This study examined liver injury reports submitted to the Food and Drug Administration(FDA) Adverse Event Reporting System(FAERS) for drugs associated with hepatotoxicity via mitochondrial mechanisms compared with non-mitochondrial mechanisms of toxicity.The frequency of hepatotoxicity was determined at a group level and individual drug level.A reporting odds ratio(ROR) was calculated as the measure of effect.Between the two DILI groups,reports for DILI involving mitochondrial mechanisms of toxicity had a 1.43(95% CI 1.42-1.45;P <0.0001) times higher odds compared to drugs associated with non-mitochondrial mechanisms of toxicity.Antineoplastic,antiviral,analgesic,antibiotic,and antimycobacterial drugs were the top five drug classes with the highest ROR values.Although the top 20 drugs with the highest ROR values included drugs with both mitochondrial and non-mitochondrial injury mechanisms,the top four drugs(ROR values> 18:benzbromarone,troglitazone,isoniazid,rifampin) were associated with mitochondrial mechanisms of toxicity.The major demographic influence for DILI risk was also examined.There was a higher mean patient age among reports for drugs that were associated with mitochondrial mechanisms of toxicity [56.1±18.33(SD)] compared to non-mitochondrial mechanisms [48±19.53(SD)](P <0.0001),suggesting that age may play a role in susceptibility to DILI via mitochondrial mechanisms of toxicity.Univariate logistic regression analysis showed that reports of liver injury were 2.2(odds ratio:2.2,95% CI 2.12-2.26) times more likely to be associated with older patient age,as compared with reports involving patients less than 65 years of age.Compared to males,female patients were 37% less likely(odds ratio:0.63,95% CI 0.61-0.64) to be subjects of liver injury reports for drugs associated with mitochondrial toxicity mechanisms.Given the higher proportion of severe liver injury reports among drugs associated with mitochondrial mechanisms of toxicity,it is essential to understand if a drug causes mitochondrial toxicity during preclinical drug development when drug design alternatives,more clinically relevant animal models,and better clinical biomarkers may provide a better translation of druginduced mitochondrial toxicity risk assessment from animals to humans.Our findings from this study align with mitochondrial mechanisms of toxicity being an important cause of DILI,and this should be further investigated in real-world studies with robust designs.
文摘Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.
文摘Introduction:Event reports recorded by intelligent electronic devices(IEDs)such as digital relays and fault recorders during disturbances depict the status and system parameters of the power system.Incorrect relay settings and unknown system parameters can lead to relay misoperation but information regarding these are available by performing a comprehensive analysis of fault records.Hence,it is necessary to regularly make a comprehensive assessment of the functioning of the relay to ensure reliable operation.Case description:The objective of this paper is to demonstrate various aspects of evaluating relay performance and verifying circuit parameters which are used in relay settings using field data in two case studies.Discussion and Evaluation:While scrutinizing the relay’s operation,this paper also presents key insights on verifying circuit parameters using the same relay event records.Conclusions:The lessons learned from the case studies presented in this paper will equip a protection engineer to inspect the operation of a relay during a transmission line fault,help gain a better understanding of the fault event and take possible actions to prevent future occurrence of similar events.
