注射用炎琥宁不良反应文献分析

Adverse drug reactions induced by potassium sodium dehydroandroandrographolide succinate for injection: analysis of literature

目的:分析炎琥宁不良反应的发生情况及临床特点,为其合理用药提供参考。方法:检索2006年以来中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)收载的注射用炎琥宁不良反应文献,以及2015年国家药品不良反应监测中心病例报告数据库登记的不良反应信息,进行统计分析。结果:文献共报道炎琥宁不良反应653例次;其年龄分布以0~17岁较多(398例,61%);多发生在用药后30 min内(510例,78%);累及的器官或系统较多,以皮肤及其附件损害和全身性损害多见(358例,51%);不良反应结局绝大多数是治愈和好转(605例,92.6%),未发现死亡病例报告。结论:临床合理使用炎琥宁的同时,应加强用药监测,以减少不良反应的发生。

Objective： To analyze the general patterns and characteristics of the adverse drug reactions （ADRs） induced by potassium sodium dehydroandroandrographolide succinate for injection, and provide references for the clinical medication. Methods： ADRs of potassium sodium dehydroandroandrographolide suecinate for injection reported by medical science journals were collected from China National Knowledge Infrastructure （CNKI） and Chinese Scientific Journals Database （VIP） from 2006 to 2016, and ADRs reported in National Adverse Drug Reaction Monitoring Center in 2015, and analyzed statistically. Results： A total of 653 ADRs were identified and included in the analysis. Patients at the age of 0 to 17 years showed the highest incidence （n = 398, 61% ）. ADRs of potassium sodium dehydroandroandrographolide succinate for injection frequently occurred during 30 minutes after medication （n = 510, 78% ）. The main ADRs were damage of skin and its appendages and systemic damage （n =358, 51%）. The vast majority results of ADRs were cured and improved （n = 605, 92.6% ）, no death report was found. Conclusion： Clinicians should reasonably use potassium sodium dehydroandroandrographolide succinate for injection and tightly monitor its use to reduce the incidences of ADRs.