亚胺培南/西司他丁不良反应回顾性调查分析

Retrospective study of adverse drug reactions induced by imipenem-cilastatin

目的:了解亚胺培南/西司他丁不良反应(ADR)发生情况及相关影响因素。方法:全面收集1994–2009年有关亚胺培南/西司他丁不良反应文献资料,将文献分为同期对照临床研究、个案或典型病例报告两类,重点分析发生不良反应的患者年龄、临床表现、用药合理性等。结果:共有70篇同期对照临床研究文献纳入统计,其中使用药物总人数7595例,发生ADR153例,ADR发生率为2.01%,最常见ADR为神经系统损害占37.25%(57/153),其次为胃肠道系统损害占30.72%(47/153);个案或典型病例报告文献有39篇,发生ADR72例,主要为神经系统损害占45.83%(33/72),胃肠道系统损害占13.89%(10/72)。结论:亚胺培南/西司他丁致神经系统、胃肠道系统损害较为常见,临床使用过程中应关注其不良反应的发生,确保临床合理用药。

Objective： To investigate the adverse drug reactions （ADRs） induced by imipenem-cilastatin and their relevant influence factors. Methods： The literatures about ADRs caused by imipenem-cilastatin over the past 15 years （1994 – 2009） were collected and classified into 2 groups： the controlled clinical trial group and the typical case-reporting group. The data were analyzed in respect of the age of the patients, clinical manifestation, rationality of clinical drug use etc. Results： A total of 70 controlled clinical trial articles involving 7595 patients were collected, 153 cases of ADRs were reported, and the incidence of ADRs was 2.01%. The central peripheral nervous system disorders were the most common clinical manifestations of ADRs （37.25%, 57/153）, and followed by gastrointestinal system disorders （30.72%, 47/153）. There were 39 typical case-reporting literatures which reported 72 cases of ADRs with the central peripheral nervous system disorders （45.83%, 33/72） and the lesions of gastrointestinal system （13.89%, 10/72）. Conclusion： The ADRs induced by imipenem-cilastatin involved multiple organs and systems, while the central peripheral nervous system disorders and the lesions of gastrointestinal system disorders were the most common clinical manifestations. It should be paid attention to ADRs induced by imipenem-cilastatin in order to promote rational use of drugs.