维立西呱治疗心力衰竭有效性、安全性及经济性的快速卫生技术评估

Rapid health technology assessment of the efficacy,safety and cost-effectiveness of vericiguat in the treatment of heart failure

目的采用快速卫生技术评估方法,评价维立西呱治疗心力衰竭(HF)的有效性、安全性、经济性,为临床治疗方案的选择和决策提供参考依据。方法计算机检索中国知网、PubMed等中外数据库及相关卫生技术评估网站。相关研究人员独立筛选文献、提取资料,在文献质量评价的基础上,对纳入文献的结果进行综合分析。结果共纳入文献17篇,其中系统评价/Meta分析12篇,药物经济学研究5篇。有效性分析结果显示:对于HF患者,相比于安慰剂,维立西呱(10 mg/d)可显著改善欧洲五维生存质量量表(EQ-5D)指数和降低因HF住院发生率(P<0.05);对于射血分数降低的心力衰竭(HFrEF)患者,相比于钠-葡萄糖共转运蛋白2抑制剂(SGLT2i),维立西呱可显著降低因HF住院发生率(P<0.05),而相比于血管紧张素转化酶抑制剂,维立西呱可显著降低心血管死亡或因HF住院的复合终点事件的发生风险(P<0.05);对于HFrEF合并慢性肾脏病的患者,相比于神经激素抑制剂,维立西呱有降低心血管死亡或因HF住院的复合终点事件的发生风险的趋势。安全性分析结果显示:相比于安慰剂,维立西呱不会增加药物相关不良反应发生率(P>0.05)。经济学分析结果显示:国内研究表明维立西呱具有较高的增量成本-效果比。结论维立西呱治疗HF具有较好的安全性和有效性,但在中国人群中并不具有经济优势。

OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of vericiguat in the treatment of heart failure(HF)by rapid health technology evaluation method,and provide reference for the selection and decision-making of clinical treatment plans.METHODS Chinese and foreign databases such as CNKI,PubMed and related health technology evaluation websites were searched by computer.Relevant researchers independently screened literature,extracted data,and comprehensively analyzed the results of the included literature based on literature quality evaluation.RESULTS A total of 17 pieces of literature were included,involving 12 systematic reviews/meta-analyses and 5 pharmacoeconomic studies.The effectiveness analysis showed:for HF patients,compared with placebo,vericiguat(10 mg/d)significantly improved the EuroQol five dimensions questionnaire(EQ-5D)index and decreased the rate of hospitalization due to HF(P<0.05).For heart failure with reduced ejection fraction(HFrEF)patients,vericiguat reduced the incidence of hospitalization due to HF compared with sodium-glucose cotransporter 2 inhibitor(SGLT2i)(P<0.05);compared with angiotensin-converting enzyme inhibitor,vericiguat significantly reduced the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF(P<0.05).For HFrEF patients with chronic kidney disease,vericiguat had a tendency to reduce the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF compared with neurohormone inhibitors.Safety analysis showed:vericiguat did not increase drug-related adverse reactions compared to placebo(P>0.05).Economic analysis showed:domestic studies indicated that vericiguat had a higher incremental cost-effectiveness ratio.CONCLUSIONS Vericiguat has good safety and efficacy in the treatment of HF but does not possess an economic advantage in the Chinese population.