目的 对维立西呱治疗射血分数降低心力衰竭（HFrEF）的有效性、安全性和经济性进行快速卫生技术评估，明确该药在HFrEF治疗中的价值。方法 系统检索国内外卫生技术评估机构官方网站以及PubMed、EMBASE、The Cochrane Library和University of York’s Centre for Reviews and Dissemination、中国学术期刊全文数据库（http://www.cnki.net）、万方、中国生物医学文献数据库，筛选出符合标准的HTA报告、系统综述、Meta分析、临床研究等，2～4名研究人员独立进行文献筛选、数据提取和质量评价后，对结果进行描述性分析。结果 最终纳入HTA报告2篇，指南6篇，随机对照临床试验（RCT）2篇，经济学研究4篇。标准优化治疗上加用维立西呱可能可以降低年龄＜75岁，近期经历心衰恶化且经静脉治疗后病情稳定的射血分数降低的症状性慢性心衰患者的心衰住院风险。现有证据未显示维立西呱可改善全因死亡、心血管死亡、生活质量；未显示增加总不良事件发生率、严重不良事件发生率、因不良事件而终止治疗率、高钾血症和肾功能异常发生率。维立西呱可能带来更高的血液和淋巴系统不良事件风险，主要表现为贫血；是否增加低血压风险尚不明确。国内经济学研究均完成于维立西呱价格调整前，结果显示维立西呱不具备成本效益，价格调整后的经济性尚待研究。结论 维立西呱可能可以减少特定心衰人群的住院风险；安全性可接受，使用过程中需注意贫血、低血压；价格调整后的经济性待进一步研究。

Objective To conduct a rapid health technology assessment of the efficacy, safety and economics of vericiguat in the treatment of heart failure with reduced ejection fraction (HFrEF). Methods The official websites of HTA organizations were systematically searched, as well as PubMed, EMBASE, The Cochrane Library and University of York's Center for Reviews and Dissemination, China Academic Journals Full Text Database (http://www.cnki.net), Wanfang, and China Biomedical Literature Database. HTA reports, systematic reviews, Meta-analyses, clinical studies, etc., that met the criteria were screened. The results were descriptively analyzed after two to four researchers independently carried out literature screening, data extraction, and quality evaluation. Results Two HTA reports, six guidelines, two randomized controlled clinical trials (RCTs) and four economics studies were finally included. There was a hint of added benefit of vericiguat in comparison with optimized standard therapy for the treatment of symptomatic HFrEF in adult patients < 75 years old who were stabilized after a recent decompensation event requiring IV therapy. But there was no hint of added benefit in all-cause mortality, cardiovascular mortality and quality of life. There was no hint of increasing the risk of total adverse events, serious adverse events, discontinuation of therapy due to adverse events, hyperkalemia and renal function abnormalities but anemia. Whether it increases the risk of hypotension remained unclear. Economic studies in China, all completed before the price adjustment of vericiguat, showed that vericiguat was not cost-effective. Conclusion Vericiguat may reduce the risk of hospitalization for certain heart failure patients; The safety profile is acceptable, and attention should be paid to anemia and hypotension. Its economics value after price adjustment should be further studied.

R972

中国医药教育协会《临床用药卫生技术评估》专项课题（2023WSJSPGZXKT-15）