盐酸伊伐布雷定治疗心力衰竭的快速卫生技术评估

A Rapid Health Technology Assessment of Ivabradine Hydrochloride in the Treatment of Heart Failure

目的:通过快速卫生技术评估的工具和方法,对盐酸伊伐布雷定治疗心力衰竭的有效性、安全性和经济性进行评估。方法:通过计算机检索PubMed、the Cochrane Library、中国知网和万方数据库,纳入盐酸伊伐布雷定治疗心力衰竭的卫生技术评估报告、系统评价或Meta分析和药物经济学研究,由2名评价者独立根据纳入和排除标准筛选文献,评价文献质量并进行分析。结果:共纳入8篇系统评价/Meta分析和7篇药物经济学研究。有效性方面,与标准治疗相比,盐酸伊伐布雷定联合标准治疗可显著降低患者的心率和N末端B型利钠肽原水平,缩小左心室舒张末期内径,减少左心室舒张末期和收缩末期容积,降低左心室收缩末期容积指数,提高左心室射血分数、6 min步行试验距离、生活质量和活动耐力,但对全因死亡率、心血管死亡率和心力衰竭住院率无显著影响。安全性方面,盐酸伊伐布雷定组患者的不良反应发生率与对照组相近。经济性方面,盐酸伊伐布雷定更具有成本-效果优势。结论:盐酸伊伐布雷定治疗心力衰竭,在心功能改善方面有良好的有效性、安全性和经济性。应开展更多的高质量研究,进一步探讨其临床使用价值。

OBJECTIVE:To rapidly evaluate the efficacy,safety and economical efficiency of ivabradine hydrochloride in treatment of heart failure by rapid health technology assessment(HTA).METHODS:PubMed,the Cochrane Library,CNKI,Wanfang Data were retrieved to collect the HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies related to ivabradine hydrochloride in treatment of heart failure.Two evaluators independently screened the literature according to inclusion and exclusion criteria,literature quality was evaluated and analyzed.RESULTS:A total of 8 systematic reviews/Meta-analysis and 7 pharmacoeconomic studies were enrolled.Compared with standard therapy,ivabradine hydrochloride combined with standard therapy can significantly reduce the patients’heart rate and N-terminal pro-B-type natriuretic peptide level,reduce left ventricular end-diastolic diameter,reduce left ventricular end-diastolic and end-systolic volumes,reduce ventricular end-systolic volume index,improved left ventricular ejection fraction,6-min walking test distance,quality of life and activity tolerance,yet had no significant effect on all-cause mortality,cardiovascular mortality,and hospitalization for heart failure.The incidence of adverse drug reactions in patients in the ivabradine hydrochloride group was similar to that in the control group.Ivabradine hydrochloride had more cost-effectiveness advantages.CONCLUSIONS:It is effective,safe and economical for ivabradine hydrochloride in the treatment of heart failure to improve cardiac function.More high-quality studies should be carried out to explore its clinical value.