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中国全科医学

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维立西呱治疗射血分数下降心衰的指南推荐意见质量评价

利亭婷1，2，陈玲3，陈秋岑1，2，魏志梅4，蔡庆群1，2*   

  1. 1. 广州中医药大学第一附属医院药学部；2. 广东省中医临床研究院；3. 广州市花都区人民医院药学部；4. 广州中医药大学第一附属医院心血管科；5. 广东省生物制品与药物研究所
  • 收稿日期:2025-02-20 修回日期:2025-03-24 接受日期:2025-03-27
  • 通讯作者: 蔡庆群
  • 基金资助:
    中国医药教育协会《临床用药卫生技术评估》专项课题(2023WSJSPGZXKT-15)

Assessment of the Recommendation of vericiguat in treatment of heart failure with reduced ejection fraction

  • Received:2025-02-20 Revised:2025-03-24 Accepted:2025-03-27
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摘要： 背景　心力衰竭疾病负担重，维立西呱是唯一证实可以改善心衰预后的可溶性鸟苷酸环化酶激动剂，但上市时间短，临床对其认知不足。目的　采用AGREE Ⅱ工具评价维立西呱治疗射血分数下降心衰（HFrEF）的指南推荐意见质量，为临床决策提供参考。方法　计算机检索中国知网、万方、维普、中国生物医学数据库、Cochrane Library、Pubmed、Embase、University of York’s Centre for Reviews and Dissemination数据库及相关网站。检索时限为建库至2024年3月31日。根据事先制定的纳入排除标准，双人独立进行文献筛选。由4名专业背景不同的研究人员采用第二版《临床指南研究与评价系统》（AGREE Ⅱ）评分表评价临床指南质量，分析指南对维立西呱治疗HFrEF的推荐意见。结果　共纳入 7 部指南。总评分最高的是AHA发布的指南，其次是加拿大心血管学会和ESC心衰指南；我国国家心力衰竭指南2023评分中等。6个领域中“参与人员”“严谨性”和“独立性”3个领域指南得分差距大。各指南对维立西呱治疗HFrEF的推荐内容接近，证据质量均评价为中等，多数指南推荐级别为弱推荐，仅中国和韩国指南为强推荐。结论　临床实践建议参考质量评分较高的指南，维立西呱可能可以考虑用于近期有心衰恶化的特定HFrEF人群。各指南对维立西呱的推荐高度依赖VICTORIA研究，具有一定偏倚风险；可能需要更多的研究确立其地位。

关键词: 维立西呱, 射血分数下降心衰, 指南, 质量评价, AGREE Ⅱ

Abstract: Background　The incidence of heart failure is increasing and mortality is high; vericiguat is the only soluble guanylate cyclase agonist proven to improve the prognosis of heart failure, but it has been on the market for a short period of time, and is poorly recognized in clinical practice. Objective　To evaluate the quality of guideline recommendations for vericiguat for heart failure with reduced ejection fraction (HFrEF) using the AGREE II tool and provide a reference for clinical decision-making. Methods　Computerized searches were performed on CNKI, Wangfang, VIP, SinoMed, Cochrane Library, Pubmed, Embase, University of York's Centre for Reviews and Dissemination databases and related websites. The search timeframe was from the construction of the databases to March 31, 2024. Literature screening was conducted by two researchers independently according to pre-established inclusion and exclusion criteria. The quality of clinical guidelines was evaluated by four researchers with different professional backgrounds using the second edition of the Clinical Guidelines Research and Evaluation System (AGREE II) scale and guideline recommendations for vericiguat in the treatment of HFrEF were analyzed. Results　A total of 7 guidelines were included. The guideline from American Heart Association (AHA) got the highest score, followed by those from Canadian Cardiovascular Society (CCS) and European Society of Cardiology (ESC); Guideline from China got a moderate score. Among the 6 domains, there were big gaps in scores in the domains of “stakeholder involvement ”“rigor of development” and “editorial independence”. Recommendations of vericiguat for HFrEF were similar and the level of evidence was judged as moderate in all guidelines. The Class of recommendation was weak in most guidelines except the guidelines from China and Korea, which was Class IIa. Conclusions　Veliciguat may be considered in specific HFrEF populations with recent worsening heart failure. The guidelines' recommendations for vericiguat depended on the VICTORIA study, which carries some risk of bias; more studies are needed to establish its status.

Key words: Vericiguat, Heart failure with decreased ejection fraction, Guideline, Quality assessment, AGREE II

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