2009-2012年常熟一院中成药不良反应报告分析

Analysis and Countermeasure on Related Factors of ADRs Caused by Chinese Patent Medicines Reported from 2009 to 2012 in Changshu NO.1 People's Hospital

目的:了解近4年我院中成药引起的药品不良反应(ADRs)情况,为临床合理使用中成药提供参考。方法:对2009年1月-2012年12月由中成药引起的ADRs报告进行回顾性分析和评价。结果:131例有效报告中,18岁及以下未成年患者所占比例最高,占83.21%(109例);热毒宁注射液引起的ADRs最多,占60.31%(79例);中药注射剂静脉给药引发的ADRs位居第一,高达94.66%(124例);中成药或中西药联合用药71例,占54.20%;ADRs所涉及的皮肤及附件损害最为常见,达82.35%。结论:剂量过大、静脉给药、联合用药是我院ADRs的主要成因;严格按照药品说明书合理用药是防止或减少ADRs发生的关键。

Objective： To understand the status of the adverse drug reactions （ADRs）in recent 4 years caused by Chinese Patent Medicines（ CPM ）in our hospital, so as to made reference to rational use the drugs in clinical. Methods： To analyze and evaluate the retrospective data of ADRs which reported to the center for ADRs Monitoring from 2009 January to 2012 year in December. Results： Among the 131 cases, the highest ADRs rate was observed in the 18 years and following minor patients with 83.21% （109 cases）. There were 60. 31% （79 cases） were caused by Reduning injection. Intravenous administration accounted for 94.66% （124 cases）. CPM were used one another or combined with Western Medicine in 71 cases （54.20%）. The damage of skin and its appendix was the most common clinical manifestation of ADRs, which accounted for 82.35%. Conclusion： The main cases of ADRs caused by CPM in our hospital related closely to the overdose, intravenous drip and combination with other drugs. The key to prevent or reduce the occurrence of ADRs is to carry out the drug instructions strictly and use CPM rationally.