目的 對維立西呱治療射血分?jǐn)?shù)降低心力衰竭（HFrEF）的有效性、安全性和經(jīng)濟性進(jìn)行快速衛(wèi)生技術(shù)評估，明確該藥在HFrEF治療中的價值。方法 系統(tǒng)檢索國內(nèi)外衛(wèi)生技術(shù)評估機構(gòu)官方網(wǎng)站以及PubMed、EMBASE、The Cochrane Library和University of York’s Centre for Reviews and Dissemination、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（http://www.cnki.net）、萬方、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫，篩選出符合標(biāo)準(zhǔn)的HTA報告、系統(tǒng)綜述、Meta分析、臨床研究等，2～4名研究人員獨立進(jìn)行文獻(xiàn)篩選、數(shù)據(jù)提取和質(zhì)量評價后，對結(jié)果進(jìn)行描述性分析。結(jié)果 最終納入HTA報告2篇，指南6篇，隨機對照臨床試驗（RCT）2篇，經(jīng)濟學(xué)研究4篇。標(biāo)準(zhǔn)優(yōu)化治療上加用維立西呱可能可以降低年齡＜75歲，近期經(jīng)歷心衰惡化且經(jīng)靜脈治療后病情穩(wěn)定的射血分?jǐn)?shù)降低的癥狀性慢性心衰患者的心衰住院風(fēng)險?，F(xiàn)有證據(jù)未顯示維立西呱可改善全因死亡、心血管死亡、生活質(zhì)量；未顯示增加總不良事件發(fā)生率、嚴(yán)重不良事件發(fā)生率、因不良事件而終止治療率、高鉀血癥和腎功能異常發(fā)生率。維立西呱可能帶來更高的血液和淋巴系統(tǒng)不良事件風(fēng)險，主要表現(xiàn)為貧血；是否增加低血壓風(fēng)險尚不明確。國內(nèi)經(jīng)濟學(xué)研究均完成于維立西呱價格調(diào)整前，結(jié)果顯示維立西呱不具備成本效益，價格調(diào)整后的經(jīng)濟性尚待研究。結(jié)論 維立西呱可能可以減少特定心衰人群的住院風(fēng)險；安全性可接受，使用過程中需注意貧血、低血壓；價格調(diào)整后的經(jīng)濟性待進(jìn)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

中國醫(yī)藥教育協(xié)會《臨床用藥衛(wèi)生技術(shù)評估》專項課題（2023WSJSPGZXKT-15）