山东省寿光市2012-2014年中成药不良反应报告分析

Analysis of adverse drug reaction induced by Chinese patent medicine in Shouguang city from 2012 to 2014

目的：了解中成药不良反应（ADR）特征及发生原因，促进临床安全用药。方法采用回顾性研究方法，对寿光市药品不良反应监测中心2012-2014年收集的中成药 ADR 报告进行统计分析。结果共收集到符合标准的中成药 ADR 报告479份，涉及患者479例，其中男性224例，女性255例，多发于50岁以上老年人，占53．0％（254／479）。ADR 报告中涉及中成药品种以理血剂、清热剂和开窍剂为主，分别为278例（58．0％）、64例（13．4％）、51例（10．6％）。静脉给药方式是引发中成药 ADR 的重要途径[占78．5％（376／479）]，注射剂发生率78．5％，不合理用药率为55．9％。ADR 临床表现以皮肤及其附件损害、消化系统损害为主，分别占35．1％（183／522）、18．4％（96／522）。结论应用中成药应以辩证施治为首要原则，重视患者个体差异，提高合理用药水平，加强中成药制备工艺，完善药品说明书可在一定程度上减少中成药 ADR 的发生。

Objective To recognize the characteristics and causes of the adverse drug reaction （ADR）of traditional Chinese patent medicine,and promote the clinical safe drug use.Methods By retrospective study,ADR reports about Chinese patent medicine collected by Shouguang adverse drug reaction monitoring center from January 1,2012 to December 31,2014 were analyzed statistically.Results A total of 479 reports in accordance with the inclusion criteria were collected,which comprised 479 patients.Of them,224 were male and 255 were female,often occurs in patients over 50 years old[53.0%（254 /479）].Chinese patent medicine involved in these reports were mainly blood -regulating formula,heat agent and formula for resuscitation,respectively 278 cases（58.0%）,64 cases （13.4%）,51 cases （10.6%）.Intravenous administration was an important way to trigger ADR [78.5%（376 /479）],78.5% injection had adverse effects and suitability of medicine were 55.9%.Main clinical manifesta-tions were lesion of skin and its appendages[35.1%（183 /522）]and digestive system damage[18.4%（96 /522）]. Conclusion The application of traditional Chinese medicine syndrome differentiation as the primary principle,atten-tion to individual differences of patients,improve the level of rational use drugs,strengthen the proprietary Chinese medicine preparation process and improve the drug instructions can reduce the adverse reaction occurred to some extent of Chinese patent medicine.