中成药及中药饮片使用安全性分析

目的:了解近年来医疗机构中成药及中药饮片使用的安全性,发现其中规律,指导临床安全合理用药。方法:检索2004年-2009年CNKI收载的中医学与中药学、药学类影响因子≥0.5的统计源期刊中的中成药和中药饮片不良反应个案,收集药品、患者及不良反应/事件(ADR/ADE)的相关信息并分析评价。结果:共收集个案报道200篇,病例244例,涉及包括中药饮片在内的126个品种。女性人群,中药注射剂以及清热解表类、祛瘀类品种发生ADR/ADE几率较高;全身性损害、神经系统损害和皮肤损害是最常累及的系统或器官。结论:应正视中成药及中药饮片的安全性,着重加强患者过敏史的了解和辩证合理用药。

Analysis of the Safety of Chinese Patent Medicine and TCM Decoction Piece Use

OBJECTVE：To know more about the safety of Chinese patent medicine and TCM decoction piece use in medical institution,and to explore regulations and guide the rational use of drugs in the clinic.METHODS：Case reports about adverse drug reactions/events（ADR/ADE） associated with Chinese patent medicine and TCM decoction piece were retrieved from TCM and pharmaceutical journals of statistics source with impact factor 0.5 or above recorded in CNKI（2004-2009）.Information about medicine,patients and ADR were collected and analyzed statistically.RESULTS：Of total 200 case reports,244 cases were induced,and 126 kinds of drugs including TCM decoction pieces were involved.Female,TCM injection,qingre jiedu agents and quyu agents more likely caused ADR/ADE;systematic disorders,nervous system disorders and skin disorders were the most common system or organs involved.CONCLUSION：We should face the safety of Chinese patent medicine and decoction pieces squarely and emphasize the understanding of allergic history of patients and retional drug use.