罗沙司他治疗慢性肾脏病贫血的快速卫生技术评估

Roxadustat for Treatment of Anemia in Patients with Chronic Kidney Disease:a Rapid Health Technology Assessment

关键词:  罗沙司他  有效性  安全性  经济性  快速卫生技术评估

Key words:  roxadustat  effectiveness  safety  economical efficacy  health technology assessment

摘要:

目的 利用快速卫生技术评估方法，评价罗沙司他治疗慢性肾脏病贫血的有效性、安全性和经济性，为临床合理用药和医疗机构遴选新药提供循证依据。方法 系统检索PubMed、the Cochrane Library、Embase、CRD datebase、CNKI、万方数据库、Sinomed及相关HTA网站，检索时限截止至2020年10月。由2名评价者根据纳入和排除标准独立筛选文献、提取资料和评价质量后，对结果进行定性分析。结果 纳入4篇系统评价/meta分析(荟萃分析)和1篇经济学研究。罗沙司他与安慰剂相比，可升高慢性肾脏病非透析患者血红蛋白水平，降低铁调素，升高总铁结合力和转铁蛋白。与促红细胞生成素刺激剂相比，提高慢性肾脏病透析患者血红蛋白水平、总铁结合力，下调铁蛋白和铁调素水平。国内的经济学模型研究表明，罗沙司他具有成本效果优势。结论 罗沙司他具有良好的有效性与安全性，与安慰剂相比，罗沙司他具有一定的经济性，应进一步开展经济学研究。

Abstract:

OBJECTIVE To evaluate the effectiveness, safety and economy of the clinical use of roxadustat in the treatment of chronic kidney disease anemiausing rapid health technology assessment methods, and to provide evidence-based evidence for clinical rational use of drugs and selection of new drugs by medical institutions. METHODS PubMed, the Cochrane Library, Embase, CRD database, CNKI, Wanfang Data, Sinomed and related HTA website were systematically searched to collect systematic reviews from inception to October 2020. Two reviewers independently identified according to the inclusion criteria, extracted data and assessed quality of includedstudies. Qualitative analysis were performed. RESULTS Four systematic reviews/meta analysis and one pharmacoeconomic studies were included. Compared with placebo, roxadustat could increase hemoglobin levels, reduce the hepcidin, and increase total iron binding capacity and transferrin in non-dialysis- dependent chronic kidney disease patients. Compared with erythropoiesis-stimulatingagents, it improved total iron binding capacity and hemoglobin levels in patients with dialysis-dependent chronic kidney disease, and down-regulated ferritin and hepcidin. Domestic economic model research showed that roxadustat had a cost-effective advantage.CONCLUSION Roxastat has good efficacy and safety. Compared with placebo, roxadustat has a certain economic efficiency, and further economic research should be carried out.