阿柏西普眼内注射溶液治疗新生血管型年龄相关性黄斑变性的快速卫生技术评估

Aflibercept for the treatment of neovascular age-related macular degeneration: a rapid health technology assessment

目的:评价眼内注射阿柏西普(AFL)相比其他治疗方案在治疗新生血管型年龄相关性黄斑变性(nAMD)的获益与风险,为各层次的决策提供合理选择该药品的循证证据。方法:系统检索PubMed, the Cochrane Library, Embase, CNKI,WanFang和SinoMed数据库,同时检索卫生技术评估机构官方网站及相关数据库,检索时间从建库至2021年7月9日。纳入研究AFL治疗nAMD的临床有效性和安全性的综合性卫生技术评估报告、系统评价(SR)/Meta分析以及药物经济学研究(PE)。使用AMSTAR和CHEERS工具评价纳入研究的质量。2位研究者独立进行筛选、数据提取与质量评价,并通过对纳入证据的研究设计、对比治疗方案以及方法学质量等情况的比较进行优选,对AFL与相关干预措施进行综合分析与评价。结果:初筛获得992篇文献,最终纳入15篇系统评价/Meta分析和16篇药物经济学研究,研究质量为中等或高质量。结果显示,与雷珠单抗(RAN)相比,AFL在视力改善、眼底解剖学指标改善等有效性方面,严重眼部或全身不良反应方面和生活质量方面相当,但注射次数更少。国内外PEs结果显示,在大部分国家和我国的医疗环境下,AFL相比RAN更具有经济学优势,部分国家由于药品价格、成本结构和研究设计差异等,AFL的经济性劣于贝伐珠单抗。结论:AFL相比RAN,在治疗nAMD的有效性与安全性相当,注射次数少于RAN,在我国及多数国家具有经济学优势。将来的研究应进一步探讨注射方案、潜在安全性风险以及价格调整等因素对该结论的影响。

Objective: To evaluate the benefits and risks of intraocular intravitreal aflibercept(AFL) in the treatment of neovascular age-related macular degeneration(nAMD) compared with other treatments, providing evidence-based reference for the rational use of AFL. Methods: PubMed, the Cochrane Library, Embase, CNKI, Wanfang Data, SinoMed, and the databases of health technology assessment(HTA) institutions were systematically retrieved, from the inception to July 7, 2021. HTA, systematic reviews(SR)/Meta-analyses and pharmacoeconomic evaluations(PE) of AFL in the treatment of nAMD were selected and evaluated by AMSTAR and CHEERS tools. Two researchers independently screened the literature, extracted data and conducted quality evaluations, and performed descriptive analysis comprehensively according to the research design, comparisons and quality. Results: Among 992 screened literatures, 15 SR/meta-analyses and 16 PE were finally included, and the qualities of which were medium or high. The analysis results showed that AFL was comparatively effective to ranibizumab(RAN) in terms of visual acuity improvement, fundus quantitative measures improvement, serious ocular or systemic adverse reactions, and quality of life. However, the number of injections was less when using AFL compared with RAN. The results of PE showed that AFL had economic advantages over RAN in the medical environments of most countries(including China). In some countries, AFL had inferior economic advantages to bevacizumab due to the differences in drug price, cost structure and research design. Conclusion: Compared with RAN, AFL has equivalent efficacy and safety in the treatment of nAMD, and the number of AFL injections is less than RAN, with economic advantages in China and most countries. Researches should be further conducted to explore the potential influences of various injection schemes, safety risks, and price adjustment.