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目的:了解中成药不合理使用对用药安全性的影响。方法:回顾性分析我院2013年1月~2016年10月上报的中成药(含中药注射剂)不良反应报告。从适应证、用法用量、中成药联用、中西药联用、用药疗程等5个方面分析评价处方或医嘱中的用药合理性,计算不合理用药比例。结果:共收集中成药不良反应报告217份,涉及患者217例,用药原因排前3位为心脑血管疾病、消化系统疾病及呼吸系统疾病。共涉及药品81个品种,发生例数最多的为参麦注射液(37例)。217份不良反应报告中适应证、用法用量、中成药联用、中西药联用、用药疗程的不合理比例分别为6.45%,5.99%,2.76%,0.92%,1.84%,共计17.97%。结论:不合理用药可能是引起中成药不良反应的重要因素之一。中成药使用需根据中医辨证,规范使用,加强用药监护,降低ADR的发生率。
Objective: To understand the impact of improper use of proprietary Chinese medicines on drug safety. Methods: A retrospective analysis of our hospital from January 2013 to October 2016 reported proprietary Chinese medicine (including Chinese medicine injection) adverse reaction reports. From the indications, usage and dosage, the combination of Chinese patent medicine, Chinese and Western medicine, medication course analysis and evaluation of prescriptions or doctor’s advice in the rational use of drugs to calculate the proportion of irrational drug use. Results: A total of 217 reports of adverse reactions of proprietary Chinese medicines were collected, involving 217 patients, the top three reasons for medication were cardiovascular and cerebrovascular diseases, digestive diseases and respiratory diseases. A total of 81 varieties of drugs involved, the largest number of cases occurred for the Senate injection (37 cases). 217 adverse reactions in indications, usage, traditional Chinese medicine combined with traditional Chinese and western medicine, medication treatment unreasonable proportions were 6.45%, 5.99%, 2.76%, 0.92%, 1.84%, a total of 17.97%. Conclusion: Irrational drug use may be one of the important factors that cause adverse reactions of proprietary Chinese medicines. The use of traditional Chinese medicine must be based on TCM Syndrome, regulate the use of drugs to strengthen monitoring and reduce the incidence of ADR.