目的 探讨β-内酰胺酶抑制剂复合制剂致药品不良反应(ADR)的规律和特点,为临床合理用药提供参考。方法 检索2004年1月－2015年8月中国期刊全文数据库(CNKI)、万方数字化期刊全文库、中文科技期刊全文数据库(维普)、中国医院知识总库(CHKD)报道的β-内酰胺酶抑制剂复合制剂致ADR的文献,并进行分析和讨论。结果 β-内酰胺酶抑制剂复合制剂引发的ADR男性明显多于女性,年龄多集中在70岁以上;呼吸道感染发生的ADR例数最多;在引发ADR的β-内酰胺酶抑制剂复合制剂中,头孢哌酮钠舒巴坦钠的发生率最高;用药1 d之内的例数最多,占72.8%;ADR累及器官/系统以全身性反应、皮肤系统、血液系统较为多见,构成比分别为49.4%、15.9%、11.6%;新的严重的ADR共138例,占38.8%。其中以过敏性休克最为多见。结论 β-内酰胺酶抑制剂复合制剂引发的ADR较为常见,临床使用时应及时处理,确保用药安全。

Objective To investigate the rules and characteristics of adverse drug reactions (ADR) induced by β-lactamase inhibitor combinations, and to provide the references for the rational use of drugs in clinic. Methods China Journal Full-text Database (CNKI), Wangfang Database, Chinese Science and Technology Journal Full-text Database (VIP), China Hospital Knowledge Database (CHKD), etc were retrieved from January 2004 to August 2015, and the documents of adverse drug reaction induced by β-lactamase inhibitor combinations were analyzed and discussed. Results Men with ADR induced by β-lactamase inhibitor combinations were more than women, and more were focused on above 70 years old. Respiratory tract infection patients had the most ADR cases. In the varieties of β-lactamase inhibitor combinations, cefoperazone/sulbactam had the highest ADR incidence. The most cases (72.8%) occured in the medication within 1 day. Organs/systems involved by ADR mainly were systemic reactions (49.4%), dermal system (15.9%), and hematologic system (11.6%). There were 138 cases of new and serious ADR (38.8%), the most common of which was anaphylactic shock. Conclusion ADR induced by β-lactamase inhibitor combinations is common in clinic. The using of them should be treated promptly, to ensure the medication safety.

国家自然科学基金资助项目(81403198);天津市第四中心医院2015年度院级课题