氟替美维吸入粉雾剂治疗中重度慢性阻塞性肺疾病的快速卫生技术评估

Rapid Health Technology Assessment of Fluticasone Furoate/Umeclidinium/Vilanterol Powder for Inhalation for Moderate to Severe Chronic Obstructive Pulmonary Disease

目的采用快速卫生技术评估方法,评价氟替美维吸入粉雾剂治疗中重度慢性阻塞性肺疾病的有效性、安全性、经济性,为临床决策提供依据。方法计算机检索PubMed、Cochrane Library、Embase、ScienceDirect、Medline、中国国家知识基础设施(CNKI)等中外数据库及INAHTA、HTAi等卫生技术评估相关网站,检索时限从建库至2022年4月,仅纳入氟替美维治疗中重度慢性阻塞性肺疾病的卫生技术评估、系统评价/Meta分析和药物经济学研究,由2名评价者独立筛选文献,提取所需数据并进行综合分析。结果共纳入文献18篇,包含卫生技术评估报告4篇,系统评价/Meta分析及药物经济学研究各7篇。有效性研究结果显示,氟替美维对比其他治疗组可降低中重度急性加重发生率、减缓肺功能下降速率并提升圣乔治呼吸问卷评分。安全性研究显示,氟替美维在降低死亡率的同时较其他治疗组不增加严重不良事件或心血管等特殊不良事件,但与乌美溴铵/维兰特罗相比肺炎风险增加[RR=1.78,95%CI=(1.13,2.82)]。经济学研究显示,在中国及欧美国家,氟替美维具有较好的经济性和成本效果优势,较其他治疗组增加生存年数(0.145~0.764 LYs)和质量调整生命年(0.118~0.492 QALYs)。结论氟替美维治疗中重度慢性阻塞性肺疾病有较好的有效性、安全性和经济性。

Objective To evaluate the efficacy,safety,and pharmacoeconomics of fluticasone furoate/umeclidinium/vilanterol powder for inhalation in the treatment of moderate to severe chronic obstructive pulmonary disease by rapid health technology assessment(HTA)to provide a basis for clinical decision-making.Methods The databases of PubMed,Cochrane Library,Embase,ScienceDirect,Medline,CNKI,and the HTA-related websites,such as INAHTA and HTAi,were systematically searched from their inception dates to April 2022 for collecting the health technology evaluation,systematic review/Meta-analysis and pharmacoeconomic research on treating moderate to severe chronic obstructive pulmonary disease with fluticasone furoate/umeclidinium/vilanterol.Two reviewers independently screened the literature,extracted the required data,and conducted a comprehensive analysis.Results Four HTA reports,seven systematic review/Meta-analyses and seven pharmacoeconomic studies were included.The results of effectiveness studies showed that compared with other treatment groups,fluticasone furoate/umeclidinium/vilanterol reduced the incidence of acute exacerbations,slowed the rate of decline in lung function and improved St.George's Respiratory Questionnaire score.The safety studies showed that fluticasone furoate/umeclidinium/vilanterol reduced mortality without an increase in serious adverse events or specific adverse cardiovascular events compared to other treatment groups.However,they increased the risk of pneumonia compared to the umeclidinium bromide/vilanterol[RR=1.78,95%CI=(1.13,2.82)].Pharmacoeconomic studies showed that fluticasone furoate/umeclidinium/vilanterol had better economic and cost-effectiveness results in China,European and American countries,increasing life years saved(0.145-0.764 LYs)and quality-adjusted life years(0.118-0.492 QALYs)compared to other treatment groups.Conclusion Fluticasone furoate/umeclidinium/vilanterol can achieve great effectiveness,safety,and economy in treating moderate to severe chronic obstructive pulmonary disease.