146例中药制剂不良反应报告分析

目的：对某院146例中药制剂不良反应（ADR）发生的规律、特点以及原因进行了解，为临床治疗提供合理用药依据。方法：对某院2012年1月-2013年12月上报的146例中药制剂ADR报告按照性别、年龄、用药方式、涉及药物、不良反应的主要临床表现、ADR报告类型、合并用药及转归情况进行回顾性统计分析。结果：146例报告中涉及8类85种药品，其中严重ADR报告18例（12.33%），多发于中药注射剂，新的ADR有92例（63.01%）；年龄阶段以40-60岁以上的人群为主；以口服为主要给药方式；临床多表现为胃肠道系统病变，为79例（54.11%）。结论：中药制剂ADR与多种因素有关。临床治疗中，要对药物适应症进行严格掌控，加强对药物的监测，

Analysis report on adverse reaction of 146 cases in Chinese medicine preparation

Objective： To find out the rules, characteristics and reasons of the adverse reactions of 146 cases in Chinese medicine preparation in order to provide the appropriate medicine application reference. Methods： 146 cases of adverse reactions in Chinese medicine preparation from January, 2011 to December, 2013 were retrospectively analyzed in the aspects of gender, age, medication methods, related medicines, main clinical manifestations of adverse reaction, ADR report type and combined application of medicines and its prognosis.Results：In the 146 cases, it was related to 8 types 85 kinds of medicines, 18 cases had severe adverse reaction（12.33%）, most occurred to Chinese medicine injections, 92 cases were new（63.01%）;for the age phrase, the ADR frequently occurred to 40-60 group, as mostly oral administration;79 cases（54.11%）had gastrointestinal system diseases as main clinical manifestation. Conclusion：The adverse reactions of Chinese medicine preparation has various factors. In clinic, the indications of medicines need to be strictly controlled and the monitoring need to be strengthened.