摘要
目的对维立西呱治疗心力衰竭的有效性、安全性和经济性进行综合评价,为临床应用提供循证依据。方法检索PubMed、、Embase、the Cochrane Library、Web of Science、中国知网、万方数据知识服务平台等数据库及卫生技术评估(HTA)相关学术机构网站,经文献筛选、资料提取、质量评价后,对研究结果进行描述性分析。结果共纳入12篇文献,包括8篇系统评价(SR)/meta分析、4篇药物经济学研究。有效性方面,与安慰剂相比,维立西呱能降低心血管死亡和心力衰竭住院复合事件率,改善堪萨斯城心肌病问卷评分(P<0.05),但在因心力衰竭住院率、全因死亡率及心血管死亡风险等方面差异无统计学意义(P>0.05)。间接证据显示,维立西呱较沙库巴曲缬沙坦在临床疗效方面有非劣效性。安全性方面,维立西呱与安慰剂相比,轻微增加了患者的症状性低血压(RR=1.17,95%CI:0.98~1.39,P>0.05)、晕厥(RR=1.18,95%CI:0.90~1.55,P>0.05)发生风险,但差异无统计学意义(P>0.05);在不良反应总发生率、严重不良反应发生率方面差异无统计学意义(P>0.05)。经济学研究显示,与安慰剂相比,维立西呱在美国有成本-效果优势;维立西呱未纳入我国医保目录前(2024年1月),在中国HFrEF患者中并不具有经济性。结论维立西呱治疗心力衰竭的安全性良好,但在有效性和经济性方面尚需开展更多高质量研究。
Objective To evaluate the effectiveness,safety and economy of vericiguat in the treatment of heart failure,and to provide evidence basis for clinical application.Methods Retrieved from PubMed,Embase,the Cochrane Library,Web of Science,CNKI,Wanfang database,official websites and relevant databases of health technology assessment(HTA)institutions,the results of the included studies were descriptively analyzed after literature screening,data extraction and quality evaluation.Results A total of 12 studies were included,involving 8 systematic reviews/meta-analyses and 4 pharmacoeconomic studies.Compared with placebo,vericiguat significantly reduced the composite rate of cardiovascular death or heart failure hospitalization,improved the Kansas City cardiomyopathy questionnaire score(P<0.05).There were no significant differences in reducing the risk of hospitalization for heart failure,all-cause mortality and cardiovascular death(P>0.05).The circumstantial evidence showed that the clinical efficacy of vericiguat was not worse than that of sacubitril-valsartan.In terms of safety,compared with placebo,vericiguat slightly increased the risk of symptomatic hypotension(RR=1.17,95%CI:0.98 to 1.39,P>0.05)and syncope(RR=1.18,95%CI:0.90 to 1.55,P>0.05)without statistically difference.However,there were no significant differences in overall adverse drug reactions and severe adverse reactions(P>0.05).Compared with placebo,existing pharmacoeconomic studies show that vericiguat has a cost-effectiveness advantage in the United States,but it was not economical in Chinese HFrEF patients until January 2024 when it was not included in the Chinese medical insurance list.Conclusion Current evidence supports the use of vericiguat for the treatment of heart failure has good safety,but further high-quality studies are still needed regarding its economy and efficacy.
作者
王惠铎
张文静
杨宏昕
郭浩
Huiduo WANG;Wenjing ZHANG;Hongxin YANG;Hao GUO(Baotou Medical College,Inner Mongolia Autonomous Region Baotou 014060,China;Department of Pharmacy,Inner Mongolia Autonomous Region People's Hospital,Hohhot 010017,China;Inner Mongolia Autonomous Region Center for Essential Drug Monitoring and Clinical Comprehensive Evaluation,Hohhot 010017,China)
出处
《临床药物治疗杂志》
2024年第9期64-69,共6页
Clinical Medication Journal
基金
内蒙古自治区人民医院院内基金项目(2020YN23)。
作者简介
通信作者:郭浩,博士,副主任药师,研究方向:药品卫生技术评估。E-mail:guohao19870323@yeah.net。
