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[摘要]
目的 探讨中药注射剂不良反应的发生率及其临床表现类型,分析武警上海市总队医院中药注射剂发生不良反应的影响因素。方法 通过回顾性分析武警上海市总队医院2009年8月—2012年8月发生中药注射剂不良反应的病历,收集中药注射剂不良反应详细病案,使用计量学方法对病案资料进行整理。结果 在病例中怀疑中药注射剂不良反应117例,其中男性58例,女性59例;60岁以上患者不良反应发生率最高,为48.72%,且其治愈时间与其他各组相比显著延长(P<0.05);不良反应发生在用药后10~30 min较多,占41.03%;2种以上药物联合应用时发生不良反应占61.54%;中药注射剂引发不良反应的主要表现为皮肤损害和心血管循环系统症状,其中以皮肤损害比例最高,达55.56%,循环系统症状占23.93%。较严重的不良反应有过敏性休克、喉头水肿、呼吸困难等。造成中药注射剂不良反应构成比最高的为喜炎平注射液69例,占58.97%。结论 熟练掌握中药注射剂的不良反应,积极应对不良反应,有利于提高中药注射剂的合理使用水平,提高临床疗效,做到安全、合理用药。
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[Abstract]
Objective To evaluate the characteristics and patterns of adverse drug reaction (ADR) induced by Chinese materia medica injections (CMMI) in Shanghai Armed Police Corps Hospital. Methods Statistical data from August 2009 to August 2012 were analyzed. The categories of ADR induced by CMMI were statistically analyzed by systematic evaluation and retrospective analysis. Results Cases (117) of ADR were suspected CMMI, 58 male and 59 female patients; Elderly (>60 years) patients with a higher incidence of ADR, accounting for 48.72%, and the healing time compared with the younger patients was significantly longer (P<0.05); ADR mostly occurred in 10—30 min after administration, accounting for 41.03%; Combination therapy accounted for 61.54% of ADR; Xiyanping injection had the highest ratio of ADR (69cases), accounting for 58.97% of the total number of reported ADR. The major ADR were skin damage (55.56%) and circulatory system symptoms (23.93%). The bad responses such as allergic shock, laryngeal edema, and dyspnoea were severe, which were mainly caused by allergy. Conclusion It is useful to improve the level of rational usage of CMMI by mastering ADR of CMMI, so as to improve the clinical efficacy and safety and use the drugs rationally.
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