中国已上市中药注射剂品种分析报告

目的:系统分析中国已上市中药注射剂品种概况,包括品种分布、国家收载及药品不良反应或事件情况。方法:通过查阅国家食品药品监督管理总局网站数据库,系统梳理了中国已上市中药注射剂品种分布情况;详细分析了中国已上市中药注射剂在国家法典和相关目录中的收载情况;通过查阅历版《国家药品不良反应监测报告》及近13年国内三大中文期刊数据库(中国知网数据库、重庆维普数据库、万方数据库)收录文献,全面总结了中国已上市中药注射剂药品不良反应或事件报道情况。结果:中国已上市中药注射剂通用名称共134个,涉及批准文号923个,生产厂家216家;有冻干粉品种7个,独家品种74个;以清热剂、理血剂、祛湿剂、补益剂和抗肿瘤剂品种为主;给药途径主要有肌肉注射、静脉滴注、静脉推注、特殊方式、皮下注射、穴位注射及腱鞘注射7种,其中单一给药方式有94个品种,混合给药方式40个品种。历版《中国药典》收载中药注射剂品种不同但趋于理性,历版《国家基本药物目录》收载中药注射剂品种基本保持不变,而历版《国家基本保险目录》收载中药注射剂品种则在逐渐增加。历版《国家药品不良反应监测报告》显示中药注射剂药品不良反应或事件报道病历数量及比例越来越高;国内三大中文期刊数据库显示有关中药注射剂药品不良反应或事件文献报道亦越来越多,尤其是进入2009年后中药注射剂药品不良反应或事件文献报道数量进入高峰平台期。结论:中国已上市中药注射剂品种分析报告可为后续开展中药注射剂系统研究,尤其是中药注射剂临床使用合理性与安全性再评价研究提供依据和参考。

Report on species of traditional Chinese medicine injections postmarket in China

OBJECTIVE To systemically analyze the species of traditional Chinese medicine injections (TCMIs) marketed in China, including species distribution, national inclusion and adverse reactions/events.METHODS By searching database on the website of State Food and Drug Administration, distribution of TCMI products were systemically rearranged; the marketed TCMI products were analyzed in details for whether listed in Pharmacopoeia of People's Republic of China (CP), National Essential Drugs List (NED) and Catalogue of National Essential Drugs for Medical, Work Injury and Maternity Insurance (NEDMWM); by referring to historical editions of National Adverse Drug Reaction Monitoring Report (NADRMR) and three major Chinese databases (CNKI database, VIP database, WANFANG database) in recent 13 years, the reports on adverse reactions/events of TCMI products were comprehensively summarized.RESULTS There were 134 generic names of TCMIs marketed in China, involving 923 TCMIs approval numbers and 216 TCMIs manufacturers, 7 species of freeze-dried powder and 74 exclusive varieties, most of which were formula for heat clearing, blood regulating, desiccating, supplementing and anti-tumor. There were 7 major approaches for administration including intramuscular injection, intravenous injection, intravenous bolus injection, special approach, subcutaneous injection, acupoint injection and sheath injection, 94 drugs were administrated by a single approach, and 40 drugs by the mixed approaches. Different TCMI products were included in CPs of different version, but tended to be reasonable. TCMI products basically maintained unchanged in NEDs, but gradually increased in NEDMWMs. NADRMRs of varied editions showed a higher and higher proportion of reports on adverse reactions/events for TCMI, which was also the fact in the three major domestic journal databases, especially since 2009, number of reports on adverse reactions/events for TCMI reached a peak plateau phase.CONCLUSION Report of analysis on TCMI species marketed in China can provide basis and reference for further systemic study on TCMI, especially the study on reevaluation of reasonability and safety of TCMI.