中药注射剂安全性问题文献研究

Literature Study on the Security of TCM Injection

目的:为中药注射剂临床合理应用提供参考。方法:通过中国期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、万方数据知识服务平台、Pub Med文献数据库,检索国家食品药品监督管理总局(CFDA)ADR监测2014年度报告数量排名前10位的中药注射剂近30年的文献全文报道。采用文献回顾性研究,分析中药注射剂药品不良反应(ADR)/药品不良事件(ADE)案例。结合上市后药物再评价安全性及合理性研究,评价其临床用药安全问题。结果:共检索到文献2 013篇,纳入1 354篇。中药注射剂ADR常累及多器官/系统,其中尤以心血管系统、呼吸系统、皮肤及附件居多;引发ADR/ADE的主要以理血类功效的中药注射剂居多;临床表现以过敏反应最多,其中严重的ADR主要表现为过敏性休克。引发ADR/ADE的10种中药注射剂的原发病、溶剂、给药浓度合理率及配伍应用情况与说明书一致性普遍偏低,其中,原发病符合率为78.30%,溶剂种类一致率为77.94%,给药浓度一致率为74.64%,81.73%为单独配伍。结论:中药注射剂ADR/ADE较为严重,亟需从安全性及合理性方面完善其上市后再评价方案。

OBJECTIVE:To provide reference for rational use of TCM injection in the clinic.METHODS:Retrieved from CNKI,VIP,Wanfang database and PubMed database,literatures about top10TCM injections in the list of report number stated in2014CFDA ADR monitoring report were researched in recent30years.By literature retrospective study,ADR/ADE induced byTCM injection were analyzed.Combining with post-marketing drug safety re-evaluation and rationality study,the security of clinical use of TCM injection was evaluated.RESULTS:A total of2013literatures were retrieved,1354were.Most organs or systems were involved in ADR,especially cardiovascular system,respiratory system,skin and its appendants.Allergic reaction was main clinical manifestation,among which server ADR was allergic shock.Ten ADR/ADE-inducing TCM injections had the lower consistency with instructions in the original diseases,solvent,dosage concentration and compatibility application.Consistency rate of original diseases,solvent and dosage concentration was78.30%,77.94%and74.64%;81.73%of them were used individually.CONCLUSIONS:ADR/ADE induced by TCM injection is serious.It is urgent to improve post-marketing revaluation scheme from the aspects of safety and rationality.