中药注射剂致不良反应分析与防范

Analysis and Prevention of ADRs Induced by Traditional Chinese Medicine Injections

目的:就中药注射剂的不良反应(ADR)及导致的因素进行分析,并提出解决措施,确保用药安全有效。方法:通过2007～2008年茂名地区各医疗单位呈报的456份中药注射剂ADR报告,对ADR的临床表现和累及系统-器官、给药途径及处理结果等进行统计分析。结果:中药注射剂导致ADR的原因包括成分、工艺、个体差异、质量标准及配伍等因素,并就防范做了一定阐述。结论:中药注射剂是一把双刃剑,ADR危害大,应引起高度重视,只有加强基础研究,提高质量,完善安全性再评价,并加强临床合理使用的管理和监管等工作,才能确保患者用药安全有效。

OBJECTIVE：To analyze the contributing factors of the adverse reactions（ADRs） of traditional Chinese medicine injections,and put forward solutions to ensure safe and effective medication.METHODS：A total of 456 ADR cases induced by traditional Chinese medicine injections reported by medical units of Maoming area during 2007 ～ 2008 were analyzed statistically in regard to the clinical manifestations,systems and organs involved,route of administration and the outcomes etc.RESULTS：The contributing factors of the ADRs of the traditional Chinese medicine injections included drug composition themselves,preparation process,individual differences,quality standards and compatibility etc.The preventive measures of the ADRs of the traditional Chinese medicine injections were also put forward in this study.CONCLUSION：Traditional Chinese medicine injection is a double-edged sword,and great attention should be attached to the high risk of their ADRs.Only through strengthening basic research,improving drug quality,improving the re-evaluation on drug safety meanwhile intensifying the management and monitoring on clinical rational drug use can patient＇s safe medication be ensured.