雷珠单抗治疗湿性年龄相关性黄斑变性的快速卫生技术评估

Rapid health technology assessment of ranibizumab for wet age-related macular degeneration

目的:雷珠单抗通过抑制血管内皮生长因子(VEGF)阻止新生血管的形成并降低血管通透性,临床上主要用于治疗湿性年龄相关性黄斑变性(wet age-related macular degeneration,wAMD),本文通过对雷珠单抗进行快速卫生技术评估,系统评价雷珠单抗的有效性、安全性和经济性,为临床合理用药提供循证依据。方法:通过系统检索Pubmed,Ovid,the Cochrane Library,CNKI,CBM和Wanfang等数据库,由2位研究者独立地根据纳入排除标准进行文献筛选、质量评价及数据提取,并对数据结果进行分析。结果:共纳入17篇系统评价/Meta分析和27篇经济学研究。结果显示,应用雷珠单抗治疗wAMD时,其临床疗效与贝伐单抗、康柏西普及阿柏西普相当,并没有明显的优势,但单用雷珠单抗比其与光动力疗法(PDT)联合治疗时对患者的视力改善更加明显,尤其对最佳矫正视力(BCVA)的改善较为显著。安全性方面,雷珠单抗较贝伐单抗不良反应发生率更低。经济学方面,雷珠单抗与哌加他尼钠、常规治疗、PDT疗法相比,具有明显的经济性,而与贝伐单抗、阿柏西普、康柏西普相比,雷珠单抗没有经济性。结论:在治疗wAMD时,雷珠单抗有效性与临床现有药物相比没有显著优势,安全性较贝伐单抗高,经济性较贝伐单抗、阿柏西普、康柏西普差。

Objective:Ranibizumab prevents the formation of new blood vessels and reduces blood vessel permeability via inhibiting vascular endothelia growth factor(VEGF).In clinical,it is mainly used to treat wet age-related macular degeneration(wAMD).In this study,the safety,effectiveness and economics of ranibizumab in the treatment of wAMD were evaluated in order to provide an evidence-based basis for clinical rational use.Methods:Databases were systematically searched,including Pubmed,Ovid,the Cochrane Library,CNKI,Wanfang and CMB,according to the inclusion and exclusion criteria.The literatures were screened,the data were extracted,and then qualitative analysis on the results was conducted by 2 researchers separately.Results:17 Meta-analyses and 27 pharmacoeconomic studies were included.The results showed that the clinical effectiveness of ranibizumab in the treatment of wAMD was similar to bevacizumab,conbercept and aflibercept.However,compared with the combination of photodynamic therapy(PDT),the single use of ranibizumab had more benefit in improving patients'vision,especially on BCVA.In terms of safety,ranibizumab is safer than bevacizumab.Ranibizumab appeared significantly more cost-effective than the usual treatments,pegaptanib and PDT,while it is not cost-effective compared with bevacizumab,aflibercept and conbercept.Conclusion:In the treatment of wAMD,ranibizumab has no significant advantage over other clinically available drugs in effectiveness,but higher safety than bevacizumab,and lower economical than bevacizumab,aflibercept and conbercept.