238例中成药不良反应报告分析

Analysis of 238 ADR Reports Induced by Chinese Patent Medicine

目的：分析我院门诊中成药不良反应（ADR）报告,为临床合理使用中成药提供参考。方法：对我院门诊2013年9月~2014年8月上报的238例中成药ADR报告中的患者年龄、性别、临床表现等进行分析。结果：238例中成药不良反应中,女性例数多于男性;年龄段为50岁以上例数较多;原发疾病主要为心脑血管疾病（40.8%）;不良反应主要为消化系统损害;75种中成药的说明书仅有34种药物的说明书较明确地标注了ADR的具体内容,说明书存在问题的有7种,标注尚不明确的34种（45.3%）,1例患者使用中药注射剂发生了严重ADR。结论：中成药的不良反应不容忽视。7种药品可能发现了新的不良反应,药品说明书需完善。

Objective： To analyze adverse reaction of Chinese patent medicine in our hospital report,and to provide the reference for the clinical rational use of Chinese patent medicine. Methods： A total of 238 ADR cases of Chinese patent medicines reported from Sep. 2013 to Aug. 2014 were analyzed retrospectively in respect of patient＇age and gender,clinical manifestation of ADRs. Results： Within the 238 cases of adverse reactions of traditional Chinese medicine,the number of women was more than that of men,and most patients were over the age of 50. The primary disease was cardiovascular and cerebrovascular diseases（ 40. 8%）,and adverse reactions were mainly digestive system damage. In 75 kinds of proprietary Chinese medicines instructions,7 kinds of them had problem,only 34 kinds of drug instructions were clearly marked with the specific content of ADR. 34 kinds（ 45. 3%） were not yet clear,and only 1 patient caught severe adverse reaction. Conclusion： The ADR of Chinese patent medicine shouldn＇t be neglected. 7 kinds of drugs may be found new adverse reactions,and the drug instructions needed to be improved.