阿柏西普治疗糖尿病性黄斑水肿的快速卫生技术评估

Rapid Health Technology Assessment of Aflibercept in the Treatment of Diabetic Macular Edema

目的:评价阿柏西普(AFL)在糖尿病性黄斑水肿(DME)治疗中的获益与风险,为各层次的决策提供循证证据,指导临床实践。方法:采用快速卫生技术评估(HTA)方法,系统检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库和中国生物医学文献服务系统,检索时限为建库至2021年11月11日,语言不限。纳入研究AFL治疗DME的临床有效性和安全性的HTA报告、系统评价/Meta分析以及药物经济学研究,同时手工检索纳入研究的参考文献列表作为补充。使用AMSTAR和CHEERS工具评价纳入研究和报告的质量。通过对纳入证据的研究设计和方法学质量等情况进行综合比较和描述性分析。结果:初筛获得1912篇文献,最终纳入20篇研究(12篇系统评价/Meta分析和8篇药物经济学研究),研究质量为中等质量或高质量。评估结果提示,与雷珠单抗(RAN)、贝伐珠单抗(BEV)或激光光凝疗法(LP)相比,AFL可获得更佳的视力改善(以最佳矫正视力、ETDRS字母行数的得失为结局指标)和更少的注射次数;相比LP,AFL的解剖学指标(中央黄斑厚度或黄斑中心凹处视网膜厚度)改善更佳;AFL的严重不良事件、眼部严重不良事件等安全性与其他药物相当。在我国,AFL的经济性优于RAN。结论:AFL治疗DME的有效性较RAN、BEV或LP更佳,安全性与RAN、BEV或LP相当,在我国具有经济学优势。将来应基于我国人群数据,进一步研究DME患者使用AFL的最佳方案以及长期用药的有效性、安全性和经济性。

OBJECTIVE:To evaluate the benefits and risks of aflibercept(AFL)in the treatment of diabetic macular edema(DME),so as to provide evidence-based support for clinical decisions and practice.METHODS:According to the method of rapid health technology assessment(HTA),PubMed,Embase,the Cochrane Library,CNKI,Wanfang Data and SinoMed were systematically retrieved with no limits on languages.The retrieval time was from the establishment of the database to Nov.11 th,2021.HTA reports,systematic reviews/Meta-analyses,and pharmacoeconomic studies on the clinical efficacy and safety of AFL in the treatment of DME were included.The list of references included in the studies was supplemented by a manual search.The quality of included studies and reports was evaluated by using the AMSTAR and CHEERS tools.A comprehensive comparative and descriptive analysis of the included evidence was performed by comparing the study design and methodological quality of the included evidence.RESULTS:The initial screening obtained 1912 publications,and 20 studies(12 systematic reviews/Meta-analysis and 8 pharmacoeconomic studies)of moderate or high quality were finally included.The results demonstrated that compared with ranibizumab(RAN),bevacizumab(BEV)or laser photocoagulation(LP),AFL showed superiority in vision improvement(as an outcome indicator of best corrected visual acuity,gain or loss of ETDRS letters)and reducing the number of injections.Compared with LP,AFL showed better improvement in anatomical parameters(central macular thickness or retinal thickness at macular fovea).The safety of AFL in severe adverse events and eye severe adverse events was comparable to that of other drugs.Additionally,AFL had economic advantages compared with RAN in China.CONCLUSIONS:AFL is more effective than RAN,BEV or LP in the treatment of DME,and its safety is similar to that of RAN,BEV or LP,which has economic advantages in China.In the future,based on the population data in China,further research should be performed on the optimal regimen of AFL in the treatment of DME patients and the efficacy,safety and economics of long-term medication.