63例碘海醇注射液严重不良反应/事件文献分析

目的 初步分析碘海醇注射液发生严重不良反应/事件的特点及相关因素,为临床合理用药提供参考依据.方法 对中国知网和万方数据库1998年1月至2012年3月发表的文献进行检索,按事先制定的文献纳入标准收集文献,提取其中涉及碘海醇注射液严重不良反应/事件的信息进行分析.结果 纳入文献25篇,安全证据等级主要为3b和2b;涉及病例63例,均为成人,其中以中老年患者居多；不良反应的临床表现主要为造影剂肾病、休克和过敏样反应.结论 应加强对碘海醇注射液的监测,药品生产企业应开展大规模的流行病学研究,探索碘海醇临床使用中的保护性因素和风险因素,进一步完善说明书,为控制临床使用风险提供科学依据.

Analysis of 63 Cases of Serious Adverse Drug Reacation/Event of Iohexol Injection

Objective To analyze the situation of serious adverse drug reaction/event（SADR/SADE） of Iohexol injection and related factors, provide a reference for clinical medication. Methods Literature published in CNKI and Wanfang database from January 1998 to March 2012, according to the literature of pre-established inclusion criteria to collect literature, extract and analyze information involving Iohexol injection SADR/SADE. Results 25 literatures were adopted, the level of evidence were 3b or 2b, 63 cases were involved and all cases are adults, which mostly middle-aged patients. The main clinical manifestations of SADR/SADE were contrast nephropathy, shock, and allergic-like reaction.Conclusions We should strengthen the monitoring of Iohexol injection. The pharmaceutical factories should carry out large-scale epidemiological studies to explore the protective factors and risk factors about Iohexol injection in clinical use, improve the instructions and provide scientific basis to control the risks in clinical use.