中药制剂不良反应分析及防治对策

Analysis of adverse reactions and countermeasures for Chinese medicine preparation

目的中药不良反应问题日益突出,其安全性问题引起广泛的关注。本文对丽水市中医院中药制剂不良反应的报告进行分析,总结其发生的典型表现,并探讨相应的防治对策。方法选择2007年1月—2013年7月收集的中药不良反应350例,对患者的性别、年龄、中药剂型、中药品种、给药途径、累及器官和临床表现等进行统计和分析,针对数据结果提出合理的防治建议。结果 350例中药不良反应中男性155例占44.29%,女性195例占55.71%;年龄超过60岁的老年人例数最多为130例,占37.14%;中药不良反应剂型主要为静脉注射剂且给药途径主要为静脉滴注,均为188例,占53.71%;排名前3位的中药品种依次为黄芪注射液28例(8.00%)、参麦注射液23例(6.57%)和鱼腥草注射液21例(6.00%);不良反应主要累及皮肤及附件系统,共106例,占30.29%,其次为消化系统,共76例,占21.71%。结论中药制剂不良反应多发于60岁以上的老年人,以中药注射剂及静脉滴注发生率最高。今后应当加强对中药制剂尤其是中药注射剂的安全监测,对中药制剂引起的不良反应应当给予足够重视,以期提高临床合理用药。

Objective To analyze the reported adverse reactions to traditional Chinese medicines（TCM） in our hospital, summarize its typical symptoms, and discuss the appropriate prevention countermeasures. Methods 350 reports of ad- verse reactions to traditional Chinese medicines were collected in our hospital from Jan. 2007 to July 2013;the sex and age of patients, herbal formulations and species, route of administration, involved organs and other clinical manifestations were summarized and analyzed statistically. The appropriate prevention countermeasures were proposed based on the data. Results Among the 350 patients, 155 cases were male （44.29%） and 195 cases were female （55.71%） ; 130 cases （37.14%） aged over 60 years old. The main formulations resulted in the adverse events were intravenous injection and the intravenous route was the main route of administration （both 188 cases,53.71% ）. The top three drugs were Astragalus injection （ 28 cases, 8.00% ）, ShenMai Injection （23 cases, 6.57 % ） and Houttuyniain injection （ 21 cases, 6.00% ） ; the most common adverse events mainly involved the damage of skin and appendages （106 cases, 30.29% ）, followed by the damage of digestive system（76 cases,21.71% ）. Conclusion The adverse reactions to traditional Chinese medicine are reported mostly in the elderly patients aged over 60 years, easily caused by injection and intravenous drip. The active surveillance for the traditional Chinese medicines especially TCM injections should be strengthened, and the adverse reactions caused by traditional Chinese medicine should be paid enough attentions, thereby improve the drug use.