388例中药不良反应报告分析

Analysis of 388 Adverse Drug Reactions Reports

目的：了解定西市中药药品不良反应发生的特点，为临床合理用药提供参考。方法：统计定西市2012年中药药品不良反应报告（ADR），按年龄、性别、药物剂型、不良反应症状、涉及器官等类别考察不良反应发生的一般规律，分析其特点。结果：388例中药ADR涉及53种中药制剂，占全年ADR报告的25.03%，在小于10岁的患者中，男性ADR（70.45%）明显多于女性（29.55%）；11～50岁患者中，女性ADR（57.92%）发生率明显高于男性（42.18%），51岁以上患者中ADR无明显性别差异；按剂型考察，注射剂最多（67.78%），按给药途径考察，静脉滴注最多（83.76%）；ADR伤害涉及的器官以皮肤及附件最多（43.04%）；ADR居前的分别为清开灵注射液19.59%，双黄连注射液18.81%,生脉注射液6.76%等。结论：中药制剂ADR的发生，与患者个体差异、年龄、药品种类、剂型、给药途径、联合用药、超说明书用药等因素有关,应加强对中药制剂特别是中药注射剂ADR监测和合理使用中药制剂的监管工作。

To understand the features of side effects of Chinese medicine inDingxiand provide reference for clinical application. Methods： Adverse drug reactions （ADR） reports of Chinese medicine in 2012 in Dingxiwere generalized. Features of the reports were explored and analyzed on the basis of age, sex, formulation, syndrome and involved organs. Results： All 53 formulations were related to 388 cases with ADR, which accounted for 25.03% of ADR reports around the year. Among those cases who were younger than ten, male cases （70.45%） were much more than female ones （29.55%）; among cases who were aged from 11 to 50, female cases （57.92%） were more than male ones （42.18%）; there was no sex difference between cases aged more than 51; ADR cases relat-ed to injections were the most when it comes to formulations （67.78%）; ADR cases caused by intravenous drip were the most when it comes to routes of administration （83.76%）; the most common involved organs related to ADR were skin and adnexa（43.04%）. Top three injections that were related to ADR wereQingKaiLinginjection（19.59%）, ShuangHuangLianinjection （18.81%） andShengMaiinjection（6.76%）. Conclusion： ADR of Chinese medicine are related to individual difference, age, drug category, formulation, route of administration, drug combination and drug taking without following instructions. Monitoring of traditional Chinese medicine preparation, especially ADR of traditional Chinese medicine injection, and supervise of rational use of Chinese medicine preparation should be high-lighted.