582例炎琥宁注射剂不良反应文献分析

Literature Review of 582 Adverse Reaction Cases Induced by Potassium Sodium Dehydroandrographolide Succinate Injection

目的探讨炎琥宁注射剂致不良反应的一般规律和特点,寻找相关风险因素,为临床安全、合理用药提供参照。方法以"炎琥宁","不良反应"为检索词,检索中国期刊全文数据库,按纳入与排除标准共纳入53篇文献,进行资料的提取与统计分析。结果儿童患者发生率高,累及系统-器官主要为皮肤及其附件损害、全身性损害、呼吸系统损害等,不良反应以皮疹、发热、过敏反应等最为常见,严重可致过敏性休克。结论重视炎琥宁注射剂引起的不良反应,加强儿童用药监测,防范不良反应发生,确保临床用药安全。

Objective Through investigating the characteristics and mechanism of adverse reactions induced by potassium sodium dehydroandrographolide succinate injection to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using＂potassium sodium dehydroandrographolide succinate＂ and ＂adverse reaction＂as key words to retrieve the CNKI database. Fifty-three articles which met the inclusion and exclusion criteria were extracted and analyzed. Results Pediatric patients appear to have higher ADR occurrence rate by using succinate injection. Systems and organs mainly involved in adverse reactions are skin and its appendages, systemic damage, respiratory damage, and etc. Rash, fever, and allergic reaction are the most common reported adverse reactions. Anaphylactic shock which is life threatening is also reported in several cases. Conclusion It is important to pay attention to the adverse reactions caused by potassium sodium dehydroandrographolidesuccinate injection, specially to strengthen pediatric postmarketing surveillance, in order to prevent adverse drug reactions and ensure the safe drug use in clinic.