异甘草酸镁注射液治疗药物性肝损伤的有效性、安全性和经济性的快速卫生技术评估

Rapid Health Technology Assessment on the Efficacy,Safety and Economy of Magnesium Isoglycyrrhizinate Injection in the Treatment of Drug-Induced Liver Injury

目的:系统评价异甘草酸镁注射液治疗药物性肝损伤(drug-induced liver injury,DILI)的有效性、安全性和经济性。方法:采用快速卫生技术评估(health technology assessment,HTA)方法,由2名评估者独立检索Pub Med、the Cochrane Library、CRD Web、中国知网和万方数据等数据库,纳入异甘草酸镁注射液与对照药物治疗DILI的HTA报告、系统评价/Meta分析和药物经济学研究等文献,根据纳入与排除标准筛选文献、评估质量,提取数据,综合比较研究结果,得出结论。结果:共纳入2篇系统评价/Meta分析和2篇药物经济学研究文献。在治疗DILI的有效性方面,异甘草酸镁注射液的有效率优于注射用硫普罗宁、甘草酸二铵注射液,其降低丙氨酸转氨酶、天冬氨酸转氨酶的效果优于注射用硫普罗宁、甘草酸二铵注射液、注射用还原型谷胱甘肽和注射用复方甘草酸单铵S,其降低总胆红素、碱性磷酸酶的效果仅优于甘草酸二铵注射液;在安全性方面,异甘草酸镁注射液的不良反应发生率低于甘草酸二铵注射液、注射用复方甘草酸单铵S;在经济性方面,与甘草酸二铵注射液、注射用还原型谷胱甘肽相比,异甘草酸镁注射液具有一定的成本-效果优势。结论:异甘草酸镁注射液治疗DILI有效性和安全性良好,在我国应用具有一定的经济学优势。

OBJECTIVE:To systematically evaluate the efficacy,safety and economy of Magnesium isoglycyrrhizinate injection in the treatment of drug-induced liver injury(DILI).METHODS:Rapid health technology assessment method(HTA)was adopted,Pub Med,Cochrane Library,CRD Web,CNKI,Wanfang database were retrieved by two evaluators independently,HTA reports,system review/Meta-analysis and pharmacoeconomic studies about Magnesium isoglycyrrhizinate injection and control drugs in the treatment of DILI were enrolled,literature screen and quality evaluation were conducted according to the inclusion and exclusion criteria,then the conclusion was drawn after data extracting and comprehensive comparison.RESULTS:Totally 2 system review/Meta-analysis and 2 pharmacoeconomic studies were involved.In terms of the effectiveness in the treatment of DILI,the effective rate of magnesium isoglycyrrhizinate injection was better than that of tiopronin injection and diammonium glycyrrhizinate injection,and it had better effect on reducing alanine aminotransferase and aspartate aminotransferase than that of tiopronin injection,diammonium glycyrrhizinate injection,reduced glutathione injection and compound monoammonium glycyrrhizinate S injection,and it had only better effect on reducing total bilirubin and alkaline phosphatase than those of diammonium glycyrrhizinate injection;in terms of safety,the incidence of adverse drug reactions of magnesium isoglycyrrhizinate injection was lower than that of diammonium glycyrrhizinate injection and compound monoammonium glycyrrhizinate S injection;in terms of economy,magnesium isoglycyrrhizinate injection had a certain cost-effectiveness advantage in comparison with diammonium glycyrrhizinate injection and reduced glutathione injection.CONCLUSIONS:Magnesium isoglycyrrhizinate injection has good effect and safety in the treatment of DILI,which has certain economic advantages in my country.