雷珠单抗治疗糖尿病黄斑水肿的快速卫生技术评估

Rapid Health Technology Assessment of Ranibizumab for Diabetic Macular Edema Treatment

目的:建立快速卫生技术评估(HTA)方法,评价雷珠单抗治疗糖尿病黄斑水肿(DME)的有效性、安全性和经济性,为临床用药选择和医疗机构新药遴选提供决策参考。方法:系统检索PubMed、the Cochrane library、Embase、CNKI和WanFang Data。由2位评价者根据纳入与排除标准独立筛选文献、提取资料和评价质量后,对研究结果进行综合比较分析。结果:共纳入14篇系统评价/Meta分析和11篇药物经济学研究。结果显示,雷珠单抗治疗DME的临床疗效优于激光、地塞米松和曲安奈德;与贝伐珠单抗相当,不及阿柏西普和康柏西普,并无明显优势。雷珠单抗不良反应发生率较地塞米松低,与其他阳性对照药物安全性相似。雷珠单抗与安慰剂、激光疗法相比,具有明显的经济学优势;与贝伐珠单抗、康柏西普相比,缺乏经济性;在国外雷珠单抗与阿柏西普相比具有成本效果优势,而在我国则阿柏西普更具有经济学优势。结论:雷珠单抗治疗DME,从有效性、安全性和经济性综合考虑,相比于激光和激素治疗具有显著优势;而与贝伐珠单抗、阿柏西普和康柏西普相比则不具备优势。

Objective:To establish a rapid health technology assessment(HTA)method for evaluating the effectiveness,safety and economy of ranibizumab in the treatment of diabetic macular edema(DME),so as to provide reference for clinical drug selection and new drug selection in medical institutions.Methods:PubMed,the Cochrane Library,Embase,CNKI and WanFang databases were systematically searched.Two reviewers screened the literature according to the proposed inclusion and exclusion criteria,assessed the quality of the literature,and performed a comprehensive comparison and analysis of the results after data extraction.Results:Totally 14 systematic reviews/Meta-analyses and 11 pharmacoeconomic studies were included.The results showed that the clinical efficacy of ranibizumab was better than laser,dexamethasone and triamcinolone acetonide in the treatment of DME.It was comparable to bevacizumab,while inferior to aflibercept and conbercept,and had no significant advantages.The incidence of adverse reactions of ranibizumab was lower than that of dexamethasone,and the safety of ranibizumab was similar to other positive control drugs.Compared with placebo and laser therapy,ranibizumab had obvious economic advantages.Compared with bevacizumab and conbercept,ranibizumab lacked economic efficiency.In foreign countries,ranibizumab had a cost-effectiveness advantage compared with aflibercept,while in China,aflibercept showed an economic advantage.Conclusion:Compared with laser and hormone therapy,ranibizumab has significant advantages in the treatment of DME in terms of effectiveness,safety and economy.Ranibizumab has no advantage when compared with bevacizumab,aflibercept and conbercept.