172例中药注射剂不良反应分析与原因探讨

Reasons analysis and evaluation of 172 cases of adverse drug reactions induced by TCM injections

目的:对医院患者因使用中药注射剂所致的不良反应进行统计,并分析其原因,为临床合理用药提供参考。方法:对医院2008年1月-2010年12月收集的172例中药注射剂不良反应报告进行统计分析。结果:172例不良反应中,60岁以上患者96例,占55.81%。痰热清注射液引起的药品不良反应占首位,其次为脉络宁注射液、生脉注射液等。不良反应的临床表现主要为皮肤系统损害(占34.04%)。中药注射剂不良反应主要由药物自身因素、患者因素以及临床使用不当等原因造成。结论:中药注射剂不良反应危害大,应引起高度重视。应加强基础研究,规范临床合理使用,同时完善安全性再评价,加强对中药注射剂生产和临床使用的监管力度,才能确保患者用药安全有效。

Objective： To survey and analyze the contributing factors of the adverse reactions of traditional Chinese medicine injections and provide clinical reference for their safe use. Methods： 172 ADR reports of Nanjing Drum Tower Hospital during 2008-2009 were classified and analyzed. Results： 96 cases of patients over the age of 60 accounted for 55.81%. In all case, Tanreqing injection was the leading causes of ADR, and the next were Mailuoning injection and Shengmai injection. Skin allergies were clinically common ADR, which accounted for 34.04% of the total ADR. The contributing factors of the ADRs included the herbs or medicines themselves, patients individual differences and the factors appearing in the process of drug use. Conclusion： Great attention should be attached to the high risk of ADRs of traditional Chinese medicine injections. Only through strengthening basic research, promoting the clinical rational drug use meanwhile improving the re-evaluation on drug safety and intensifying the management and monitoring the pharmaceutical production process and clinical rational drug use can patient＇s safe medication be ensured.