253例莲必治注射液不良反应/事件文献分析

Analysis of 253 Cases of ADR/AE Induced by Lianbizhi Injection

目的探讨莲必治注射液致不良反应，事件（ADIVAE）发生的发生类型、特点及相关风险因素，为临床安全用药提供参考。方法检索中国期刊全文数据库、万方数据、维普医药信息资源系统等期刊数据库（1978年1月～2012年3月），以“莲必治注射液”、“不良反应”、“治疗”、“病例报道”等为检索词，检索文献全文136篇，纳入分析的文献36篇，进行统计学分析。结果该药不良反应可累积多个系统一器官，以皮肤损害、过敏反应、胃肠道损害最为常见，严重者可致过敏性休克，急性肾功能衰竭；男女比例各占53．23％、41．94％，19～60岁占比为43．48％，不良反应发生在30分钟以内的占45．05％，1小时内占51．37％，联合用药时占70．36％，结论莲必治注射液的不良反应以速发型为主兼具迟发型，多发于青壮年，并且联合用药时不良反应发生率较高。

Objective To analyse the types and risk factors of adverse reactions of Lianbizhi injection in order to provide the reference for safe use of this drug. Methods We used ＂Lianbizhi Injection＂, ＂adverse reaction＂, ＂treatment＂, ＂ care report＂, ect. as the key words, downloaded the original case reports from Chinese Journal Full-text Database （1978.1-2012.3）, CNKI and VIP. 36 literatures were picked up from the whole 136 results. Results Adverse drug reactions can be accumulated and prompted several organ systems to skin damage, such as allergic reactions and gastrointestinal damage, ect. The adverse drug reaction was abrupt and usually occured within 30 minutes and it also could be delayed a few days. The severe cases can cause anaphylactic shock and acute renal failure. Conclusion Lianbizhi injection can cause varies type of adverse drug reactions, it happens mainly to the young adults and those use the combination of Lianbizhi InJection and other drugs at the same time.