由药品不良反应/事件看我院中药注射剂临床应用药物相关问题

Analysis on Drug-related Problems of TCM Injection in Clinical Application Based on Adverse Drug Reaction / Events in Our Hospital

目的：通过对我院中药注射剂不良反应/事件分析,探讨我院中药注射剂临床应用的药物相关问题（drug-related problems,DRPs）,为中药注射剂的临床合理应用提供参考。方法：以我院2012年1月-2016年6月收集的108例中药注射剂不良反应/事件（ADR/ADE）病历为研究对象,探讨我院中药注射剂ADR/ADE发生的药物流行病学特点,同时采用国际通用的西班牙药物相关性问题研究方法（Granada-Ⅱ分类法）对中药注射剂相关性问题进行必要性、安全性、有效性研究。结果：108例ADR/ADE病历中,主要为60岁以上患者（45.27%）,共涉及22个品种,血必净注射剂病例数最多（23例,占26.14%）累及的器官系统以皮肤及其附件损害为主（54.63%）,涉及DRPs具体问题分类有DRP2、DRP4、DRP5、DRP6,分别为13例、9例、82例及4例。结论：临床医生与药师应重视中药注射剂临床应用的DRPs,对中药注射剂ADR/ADE进行针对性预防,促进临床安全合理用药。

Objective： To discuss the causes and characteristics of drug-related problems of traditional Chinese medicine（ TCM） injections in clinical application based on adverse drug reaction / events in our hospital and provide reference for the rational drug use in clinic. Methods： Statistical analysis was conducted on 108 cases of ADR / ADE induced by TCM injections reported from January 2012 to June 2016. With the investigation methods of drug related problems of the Spanish Granada-Ⅱclassification,the clinical effectiveness,necessity,safety of TCM injections in our hospital were studied. Results： Of the 108 cases,mainly for patients over 60 years old（ 45. 27%）,22 varieties were involved,and the largest number were related to Xuebijing injection（ 23 cases,26. 14%）. Organs and（ or） systems involved in ADR / ADE mainly were lesion of skin and its appendants（ 54. 63%）. The drug-related problems were DRP2（ 13 cases）,DRP4（ 9cases）,DRP5（ 82 cases）,and DRP6（ 4 cases）. Conclusion： Clinicians and pharmacists should pay more attention to drug-related problems of TCM injection in clinical application,and prevent the occurrence of ADR / ADE induced by TCM injections,so as to promote rational and safe use of TCM injections.