生脉注射液治疗心力衰竭的快速卫生技术评估

Rapid Health Technology Assessment of Shengmai Injection in the Treatment of Cardiac Failure

目的:基于快速卫生技术评估(HTA),评价生脉注射液治疗心力衰竭的有效性、安全性和经济性,为临床合理用药提供循证证据。方法:通过对万方数据库、中国知网、中国生物医学文献数据库、the Cochrane Library、Embase、PubMed以及卫生技术评估国际(HTAi)、国际卫生技术评估网络(INAHTA)等网站进行检索,纳入生脉注射液治疗心力衰竭的HTA报告、系统评价/Meta分析和药物经济学研究,对纳入的资料汇总分析,并对文献及其方法学进行质量评价。结果:共纳入12篇文献,其中9篇为系统评价/Meta分析,3篇为药物经济学研究,未检索到HTA报告。分析结果显示,生脉注射液联合西药治疗心力衰竭,在提高总有效率,提高左心室射血分数、6 min步行试验距离、心输出量和每搏输出量,改善纽约心脏病协会心功能分级、明尼苏达心力衰竭生活质量量表积分、心脏指数,降低N末端B型利钠肽原水平、左心室舒张末期内径等方面均有一定的优势;在改善左心室短轴缩短率、降低脑钠肽水平等方面,各研究结论不一致;同时,生脉注射液的不良反应发生概率与对照方案相近。结论:生脉注射液治疗心力衰竭可有效改善相关临床症状。未来可针对该药开展更深入的药物经济学研究以及更为规范的临床观察、安全性评价,补充相关用药循证证据。

OBJECTIVE:To rapidly evaluate the efficacy,safety and economical efficiency of Shengmai injection in the treatment of cardiac failure based on rapid health technology assessment(HTA),so as to provide evidence-based evidence for clinical rational drug use.METHODS:Wanfang Data,CNKI,CBM,the Cochrane Library,Embase,PubMed and HTA organization websites(HTAi and INAHTA)were searched systematically,HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies of Shengmai injection in the treatment of heart failure were included.The included data were summarized and analyzed,and the quality of literature and methodology was evaluated.RESULTS:A total of 12 literature were included,including 9 systematic reviews/Meta-analysis and 3 pharmacoeconomic studies,yet no HTA report was retrieved.The results show that Shengmai injection combination with western medicine in the treatment of cardiac failure can improve the total effective rate,increase the left ventricular ejection fraction(LVEF),6 min walking test distance,cardiac output,stroke volume,improve New York Heart Association cardiac function classification,Minnesota heart failure quality of life scale score and cardiac index,reduce the N-terminal pro-B-type natriuretic peptide level,left ventricular end-diastolic diameter.In terms of improving the short-axis shortening rate of the left ventricle and reducing the level of brain natriuretic peptide,the conclusions of various studies were inconsistent.Meanwhile,the incidence of adverse drug reactions of Shengmai injection was similar to that of the control regimen.CONCLUSIONS:Shengmai injection can effectively improve the clinical symptoms of heart failure.In the future,more in-depth pharmacoeconomic studies and more standardized clinical observation and safety evaluation of the drug can be carried out to supplement relevant evidence-based evidence for medication.