注射用益气复脉(冻干)临床使用合理性再评价真实世界研究

Real world study on clinical rationality of Yiqifumai Injection(lyophilization)in certain hospital: An integrated approach

目的:开展注射用益气复脉(冻干)临床使用合理性再评价真实世界研究。方法:按月份分层随机抽取某医院2020年度1-12月份真实世界注射用益气复脉(冻干)住院病历240份,采用药品说明书评价、药物利用研究(即药物利用指数,drug utilization index for dose/concentration, dDUI/cDUI)及药品不良反应监测综合方法,探讨注射用益气复脉(冻干)临床使用合理性再评价问题。结果:注射用益气复脉(冻干)临床使用合理性评价指标给药浓度(22.50%)、给药剂量(27.50%)、中医辨病(28.75%)、中医辨证(43.75%)、溶媒剂量(44.17%)相对不高。药物利用研究提示,注射用益气复脉(冻干)临床给药剂量明显不足(dDUI=0.76<1),而超浓度使用情况严重(cDUI=1.73>1)。此外,药品不良反应监测办公室未收集到2020年度注射用益气复脉(冻干)药品不良反应病例报告;国内有关注射用益气复脉(冻干)药品不良反应文献报道主要涉及心血管系统、神经系统、消化系统、皮肤及其附件。结论:基于当前真实世界证据,应加强该医院注射用益气复脉(冻干)临床监测工作,尤其是超浓度使用、滴定速度以及联合配伍冲管问题。

OBJECTIVE To explore the clinical rationality of Yiqifumai Injection(lyophilization)(YQFM)by real world data.METHODS A total of 240 medical records containing YQFM prescription were collected from a certain hospital.The relevant data were evaluated by package insert, drug utilization index for dose/concentration(dDUI/cDUI)and adverse drug action(ADR).RESULTS Clinical rationality was poor for YQFM,such as dosing concentration(22.50%),actual dose(27.50%),disease & syndrome differentiation of traditional Chinese medicine(28.75% and 43.75%)and solvent dose(44.17%).Drug utilization research showed an insufficient dose(dDUI =0.76<1)and super-concentration dosing(cDUI=1.73>1).Also ADR monitoring office collected no ADR report of YQFM during 2020;ADR of YQFM was reported in the databases of Chinese National Knowledge Infrastructure, VIP and WanFang.It involved cardiovascular system, nervous system, digestive system, skin and accessories.CONCLUSION Based upon real world evidence, it is imperative to strengthen monitoring YQFM in clinical uses, especially dosing concentration and titration speed.When combined with other drugs, flushing infusion tube is necessary.