52例中药注射液不良反应报告分析

An analysis of 52 cases of adverse drug reactions caused by traditional Chinese medicine injection

目的统计分析中药注射液药品不良反应(ADR)发生规律、特点,为临床中药注射液合理用药提供参考依据。方法应用Excel回顾性统计宿州市立医院2016年1~6月各科室上报的52例中药注射液ADR报告。结果 52例ADR报告共涉及8个科室,以神经内科上报的ADR报告(30例,57.69%)最多;其中一般不良反应40例,占比76.92%,新的一般的不良反应12例(23.08%),无严重不良反应/事件发生;男性24例(46.15%);女性28例(3.85%),女性占比略高于男性;65岁以上老人26例(50%),占比最大;涉及的9种中药注射液中排名前三位的分别是丹红注射液(25例,48.08%),注射用血栓通(13例,25%)及喜炎平注射液(4例,7.69%);以头痛、头晕、麻木等神经系统损害(15例,28.85%)最为常见;52例中药注射液引起的ADR预后均良好。结论中药注射液成分复杂,ADR逐年增高,不断完善中药注射液ADR上报制度是科学合理应用中药注射液的动力。

Objective To investigate characteristics of the adverse drug reactions（ADRs） caused by traditional Chinese medicine and provide references for clinical drug use. Methods The 52 cases of ADRs caused by traditional Chinese medicine injection reported in the first half year of 2016 were collected and summarized by Excel. Results The 52 cases of ADR reports referred to 8 departments and the ADRs reported by Neurology Department（30 cases,57. 69 %） got the highest rank. The 52 cases of ADRs were divided into 40 cases of general ADR and 12 cases of new general ADR. No serious ADR was reported. The incidences for females（28 cases,53. 85%）were lower than males（24 cases,46. 15%）. Population over 65 years old accounted for the largest proportion（26 cases,50%）. The 52 cases of ADRs caused by 9 kinds of traditional Chinese medicine injection and the top 3 were Dan Hong injection（25 cases,48. 08%）,Xue Shuantong injection（13 cases,25 %） and Xi Yanping injection（4 cases,7. 69 %）. Among ADRs involving organs and/or systems,nervous system was damaged the most common（15 cases,28. 85 %）. All of the 52 cases of ADRs resulted from traditional Chinese medicine injection were cured afterwards. Conclusion The ingredients of traditional Chinese medicine were complex and more and more ADRs caused by traditional Chinese medicine injection happened. Measures should be taken to improve the ADR reporting system of traditional Chinese medicine injection and the measures would be power of scientific and reasonable application of traditional Chinese medicine injection.