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
目的为临床合理使用拉莫三嗪(LTG)提供参考。方法检索中国知网、万方、维普、PubMed、Web of Science数据库自建库起至2023年11月的LTG治疗药物监测相关文献,从治疗窗、药物代谢动力学(简称药动学)特征,特殊人群(妊娠期女性、儿童、老...目的为临床合理使用拉莫三嗪(LTG)提供参考。方法检索中国知网、万方、维普、PubMed、Web of Science数据库自建库起至2023年11月的LTG治疗药物监测相关文献,从治疗窗、药物代谢动力学(简称药动学)特征,特殊人群(妊娠期女性、儿童、老年人等)药动学特征及代谢酶相关基因多态性对血药浓度的影响等方面,总结LTG治疗药物监测研究进展。结果LTG是治疗癫痫发作和双相情感障碍的药物,临床应用时需参考最新治疗窗;临床监测样本以血浆为主,头发和唾液也可作为非入侵样本;血药浓度检测的主要方法为液相色谱法,荧光光谱法和电化学传感器正逐渐被应用。LTG生物利用度约为98%,蛋白质结合率约为55%,达峰时间不受给药剂量限制;在与其他药物联用时要注意调整剂量。有潜在生育能力的癫痫女性用药首选LTG,用于老年癫痫时更适用于新发患者,对于癫痫患儿应重点监测血药浓度,以避免发生不良反应。尿苷5'-二磷酸-葡萄糖醛酸糖基转移酶是参与LTG代谢的主要酶,其相关基因的多态性也是血药浓度的重要影响因素。结论应采用合适的样本和方法检测LTG血药浓度,并关注不同人群及不同基因型,以预防严重不良反应的发生。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.
文摘目的为临床合理使用拉莫三嗪(LTG)提供参考。方法检索中国知网、万方、维普、PubMed、Web of Science数据库自建库起至2023年11月的LTG治疗药物监测相关文献,从治疗窗、药物代谢动力学(简称药动学)特征,特殊人群(妊娠期女性、儿童、老年人等)药动学特征及代谢酶相关基因多态性对血药浓度的影响等方面,总结LTG治疗药物监测研究进展。结果LTG是治疗癫痫发作和双相情感障碍的药物,临床应用时需参考最新治疗窗;临床监测样本以血浆为主,头发和唾液也可作为非入侵样本;血药浓度检测的主要方法为液相色谱法,荧光光谱法和电化学传感器正逐渐被应用。LTG生物利用度约为98%,蛋白质结合率约为55%,达峰时间不受给药剂量限制;在与其他药物联用时要注意调整剂量。有潜在生育能力的癫痫女性用药首选LTG,用于老年癫痫时更适用于新发患者,对于癫痫患儿应重点监测血药浓度,以避免发生不良反应。尿苷5'-二磷酸-葡萄糖醛酸糖基转移酶是参与LTG代谢的主要酶,其相关基因的多态性也是血药浓度的重要影响因素。结论应采用合适的样本和方法检测LTG血药浓度,并关注不同人群及不同基因型,以预防严重不良反应的发生。
