Objective To briefly introduce the construction and operation of the National Sentinel Alliance for Adverse Drug Reaction(ADR)Monitoring,and provide reference for strengthening the safety monitoring of drugs after lis...Objective To briefly introduce the construction and operation of the National Sentinel Alliance for Adverse Drug Reaction(ADR)Monitoring,and provide reference for strengthening the safety monitoring of drugs after listing in China.Methods The literature research method was used to analyze the establishment and promotion measures of the National Sentinel Alliance for ADR Monitoring,and then some countermeasures and suggestions were put forward to enhance the construction of the alliance.Results and Conclusion The alliance based on Chinese hospital pharmacovigilance system(CHPS)has played an important role in ADR monitoring and reporting.Promoting the construction of the alliance can provide a new method for improving the scientific evaluation system and active supervision system of drug safety after listing.Therefore,the construction of alliances at the national and provincial levels should be strengthened.Besides,relevant laws and regulations must be improved to accelerate the research and development of information systems,which will deepen the active monitoring of the alliance continuously.展开更多
Objective:To investigate the influencing factors of adverse drug reaction(ADR)in Qingkailing injection.Methods:Based on the hospitals centralized monitoring data of multicenter and prospective,the patients who used Qi...Objective:To investigate the influencing factors of adverse drug reaction(ADR)in Qingkailing injection.Methods:Based on the hospitals centralized monitoring data of multicenter and prospective,the patients who used Qingkailing injection from January 2013 to March 2016 were monitored in 48 medical institutions in China.The nesting case-control study was used and the random forest was used for analysis.The main contents of the analysis are as follows:past history,past allergy history and ADR history,clinical diagnosis,dosage,interval drug,solvent type,combined drug use,etc.Results:A total of 30842 cases with Qingkailing injection were included,with 92 cases of adverse reactions and the incidence of adverse reactions was 3‰.According to the nested case-control study design,the influencing factors of 92 patients with ADR and 276 non-drug-related adverse reactions were displayed on the basis of statistical description(significance level P≤0.2 and clinical information)using Random forest analysis shows that the factors affecting the ADR of the Qingkailing injection according to the MeandecaseGini are from high to low in the first 15 positions:Vitamin supplements,tumors,gastrointestinal diseases,traditional Chinese medicine,previous allergic history,cerebral insufficiency,rash,urinary tract infection,vascular and lymphovascular diseases,pioglitazone,metabolic and endocrine system drugs,past ADR history,respiratory and mediastinal diseases,dioxpromazide,pneumonia.Conclusion:The incidence of adverse reactions in Qingkailing injection hospital is 3%.The factors closely related to the occurrence of ADR are previous tumors,gastrointestinal diseases,history of adverse reactions of rash,urinary tract infection,insufficient cerebral blood supply,respiratory system and other diseases,pioglitazone and other combined drugs.展开更多
目的现有关于信迪利单抗不良反应(adverse drug reactions,ADRs)的研究多为个案报告和文献汇总,缺乏对上市后人群ADRs的真实世界数据进行评估和分析。本研究致力于填补这一研究空白,以便为临床上的安全用药提供重要的参考依据。方法数...目的现有关于信迪利单抗不良反应(adverse drug reactions,ADRs)的研究多为个案报告和文献汇总,缺乏对上市后人群ADRs的真实世界数据进行评估和分析。本研究致力于填补这一研究空白,以便为临床上的安全用药提供重要的参考依据。方法数据来源为北京市药品不良反应监测系统数据库,涵盖了北京地区截至2023年近五年涉及信迪利单抗的ADRs报告。这些报告以信迪力单抗为怀疑药品上报。通过SPSS 22.0软件对数据进行统计分析。结果本研究共分析了155例信迪利单抗相关的ADRs报告。在性别分布上,男性患者与女性患者的比例为1.77∶1。在ADRs报告中,以皮肤反应最为常见。在24 h内发生的ADRs报告中,过敏反应占主导。严重ADRs的报告占比达到26.45%,且这些严重反应多在用药24 h后发生,差异具有统计学意义(P=0.005)。非适应证肿瘤患者用药后发生严重ADRs的风险要明显高于适应证患者(P=0.006)。9例患者药物剂量超出说明书推荐剂量导致ADRs。与仑伐替尼联合用药时,可引起心肌梗死和糖尿病酮症酸中毒,属新的安全性信号,在临床使用时应予以关注。结论本研究发现非适应证人群用药后发生严重ADRs的风险增加,因此对于非适应证给药患者需更加严密监测患者用药后的反应,以及时进行干预。严重ADRs多发生于24 h后,在日间24 h治疗的患者,出院后需嘱咐患者密切监测用药后情况,如有不适需及时就诊。临床存在未按说明书推荐剂量用药情况,应予以关注。与仑伐替尼合用时,可引起心肌梗死和糖尿病酮酸中毒,属新的安全性信号,需临床密切关注。展开更多
[目的]分析中国人民解放军陆军第七十三集团军医院(后称我院)严重药品不良反应(severe adverse drug reaction,SADR)发生的规律和特点,为临床合理用药提供参考.[方法]采用回顾性分析方法,对我院2013年1月至2022年1月收集上报的SADR报告...[目的]分析中国人民解放军陆军第七十三集团军医院(后称我院)严重药品不良反应(severe adverse drug reaction,SADR)发生的规律和特点,为临床合理用药提供参考.[方法]采用回顾性分析方法,对我院2013年1月至2022年1月收集上报的SADR报告进行统计分析.[结果]1315例SADR报告中,60岁以上患者最多,占39.85%;静脉滴注给药途径出现最多,占75.51%;注射剂引起的占89.05%;用药后出现SADR的时间在1 h至1 d的占26.31%;SADR累及的系统或器官损害以消化系统为主,占38.53%;抗肿瘤药物引起的占67.98%.[结论]应加强SADR监测和上报工作,尤其是抗肿瘤药物和抗感染药物,以降低用药风险,保障患者用药安全.展开更多
文摘Objective To briefly introduce the construction and operation of the National Sentinel Alliance for Adverse Drug Reaction(ADR)Monitoring,and provide reference for strengthening the safety monitoring of drugs after listing in China.Methods The literature research method was used to analyze the establishment and promotion measures of the National Sentinel Alliance for ADR Monitoring,and then some countermeasures and suggestions were put forward to enhance the construction of the alliance.Results and Conclusion The alliance based on Chinese hospital pharmacovigilance system(CHPS)has played an important role in ADR monitoring and reporting.Promoting the construction of the alliance can provide a new method for improving the scientific evaluation system and active supervision system of drug safety after listing.Therefore,the construction of alliances at the national and provincial levels should be strengthened.Besides,relevant laws and regulations must be improved to accelerate the research and development of information systems,which will deepen the active monitoring of the alliance continuously.
基金This work was financially sponsored by National Natural Science Foundation of China(No.81473514).
文摘Objective:To investigate the influencing factors of adverse drug reaction(ADR)in Qingkailing injection.Methods:Based on the hospitals centralized monitoring data of multicenter and prospective,the patients who used Qingkailing injection from January 2013 to March 2016 were monitored in 48 medical institutions in China.The nesting case-control study was used and the random forest was used for analysis.The main contents of the analysis are as follows:past history,past allergy history and ADR history,clinical diagnosis,dosage,interval drug,solvent type,combined drug use,etc.Results:A total of 30842 cases with Qingkailing injection were included,with 92 cases of adverse reactions and the incidence of adverse reactions was 3‰.According to the nested case-control study design,the influencing factors of 92 patients with ADR and 276 non-drug-related adverse reactions were displayed on the basis of statistical description(significance level P≤0.2 and clinical information)using Random forest analysis shows that the factors affecting the ADR of the Qingkailing injection according to the MeandecaseGini are from high to low in the first 15 positions:Vitamin supplements,tumors,gastrointestinal diseases,traditional Chinese medicine,previous allergic history,cerebral insufficiency,rash,urinary tract infection,vascular and lymphovascular diseases,pioglitazone,metabolic and endocrine system drugs,past ADR history,respiratory and mediastinal diseases,dioxpromazide,pneumonia.Conclusion:The incidence of adverse reactions in Qingkailing injection hospital is 3%.The factors closely related to the occurrence of ADR are previous tumors,gastrointestinal diseases,history of adverse reactions of rash,urinary tract infection,insufficient cerebral blood supply,respiratory system and other diseases,pioglitazone and other combined drugs.
