沙库巴曲缬沙坦治疗心力衰竭的快速卫生技术评估

Sacubitril-valsartan in Treatment of Heart Failure:A Rapid Health Technology Assessment

目的 快速评估沙库巴曲缬沙坦治疗心力衰竭的有效性、安全性和经济性,为药物遴选和准入决策提供循证证据。方法 系统检索2021年5月前发表的PubMed、Cochrane Library、中国国家知识基础设施(CNKI)、维普中文科技期刊数据库(VIP)和万方数据库等数据库,收集沙库巴曲缬沙坦与对照药物治疗(包括射血分数降低、射血分数保留及射血分数中间值的心力衰竭)的系统评价/Meta分析、卫生技术评估(HTA)报告和药物经济学研究等文献。由2名评价者根据纳入和排除标准独立筛选文献、提取资料和评价质量后,综合比较研究结果,对有效性、安全性、经济学结果进行定性描述。结果 共纳入文献25篇,其中HTA报告1篇、系统评价/Meta分析13篇,药物经济学研究11篇。有效性方面,与血管紧张素转化酶抑制药(ACEI)/血管紧张素受体阻断药(ARB)比较,沙库巴曲缬沙坦可显著降低所有心力衰竭患者再住院率、纽约心脏病学会(NYHA)心功能分级,提高心衰患者生活质量,可显著降低射血分数降低的心力衰竭患者心血管死亡风险、全因病死率、N末端B型利钠肽原(NT-proBNP),对超声心动图相关参数也有显著改善。安全性方面,与ACEI/ARB比较,沙库巴曲缬沙坦对心力衰竭患者低血压风险显著增加,不良反应停药率降低。经济学方面,长期使用沙库巴曲缬沙坦对于射血分数降低的心力衰竭患者具有成本-效果优势。结论 沙库巴曲缬沙坦治疗射血分数降低的心力衰竭患者的有效性、安全性和经济性较好,但对射血分数保留及射血分数中间值的心力衰竭患者治疗价值尚待进一步研究。

Objective To rapidly evaluate the effectiveness,safety,and economy of sacubitril-valsartan in the treatment of heart failure(HF),to provide evidence for medication selection and access decisions.Methods PubMed,Cochrane Library,China National Knowledge Infrastructure(CNKI)、VIP Database for Chinese Technical Periodicals(VIP),and Wanfang Data published from inception to May 2021 were systematically retrieved in order to collect literature,including systematic review/Meta-analysis,HTA reports,and pharmacoeconomic studies of sacubitril-valsartan and control drugs in the treatment of HF,including heart failure with reduced ejection fraction(HFrEF),heart failure with preserved ejection fraction(HFpEF),and heart failure with mid-range ejection fraction(HFmEF).Two reviewers independently screened literatures,extracted data,and evaluated the quality of studies,and then compared the research results comprehensively according to the inclusion and exclusion criteria.The effectiveness,safety and economic results were qualitatively described.Results A total of 25 works of literature were included,including one HTA report,13 systematic reviews/meta-analyses,and 11 pharmacoeconomic studies.In terms of effectiveness,compared with ACEI/ARB,sacubitril-valsartan significantly reduced the rehospitalization rate and New York Heart Association(NYHA)grade,improving the life quality of patients with HF.Sacubitril-valsartan significantly reduced the risk of cardiovascular death,all-cause mortality,and N-terminal pro-BNP(NT-proBNP)in patients with HFrEF,and improved the echocardiographic parameters(LVEF,LVESV).In terms of safety,compared with ACEI/ARB,sacubitril-valsartan significantly increased the risk of hypotension while reducing the cessation rate by adverse reactions in patients with HF.In terms of economy,the long medication of sacubitril-valsartan had a cost-effectiveness advantage for patients with HFrEF.Conclusion Sacubitril-valsartan has good efficacy,safety,and economy in treating patients with HFrEF,but its therapeutic value in those with HFpEF and HFmEF needs further investigation.