司美格鲁肽治疗2型糖尿病的快速卫生技术评估

Semaglutide in the treatment of type 2 diabetes mellitus:rapid health technology assessment

目的评价司美格鲁肽治疗2型糖尿病(T2DM)的有效性、安全性和经济性,为临床用药提供参考。方法采用快速卫生技术评估(HTA)方法。计算机检索PubMed、Embase、Cochrane Library、Web of Science、中国知网、万方数据、中国生物医学文献服务系统及国内外HTA机构官方网站,收集司美格鲁肽治疗T2DM的HTA报告、系统评价/Meta分析和药物经济学研究,检索时限均为建库起至2022年5月1日。资料提取和质量评价后,对纳入研究的结果进行描述性分析。结果共纳入22篇文献,包括7篇Meta分析和15篇药物经济学研究。有效性和安全性方面,司美格鲁肽在控制糖化血红蛋白(HbA1c)、空腹血糖、餐后平均血糖、体质量指数、HbA1c水平<7%达标率方面疗效显著,未增加低血糖和严重不良反应的发生风险,但胃肠道不良反应发生率较高。经济性方面,国外研究结果显示,与其他胰高血糖素样肽1受体激动剂、钠-葡萄糖协同转运蛋白2抑制剂、二肽基肽酶4抑制剂等比较,司美格鲁肽均具有经济学优势;基于中国卫生体系角度下的研究表明,以2020年我国人均国内生产总值(72477元)作为意愿支付阈值时,司美格鲁肽较度拉糖肽具有经济学优势。结论司美格鲁肽治疗T2DM的有效性和安全性均较好,且与其他治疗药物比较具有经济学优势,但需注意胃肠道反应的发生风险。

OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of semaglutide in the treatment of type 2 diabetes mellitus(T2DM),and to provide reference for clinical drug use.METHODS Rapid health technology assessment was adopted.Retrieved from PubMed,Embase,Cochrane Library,Web of Science,CNKI,Wanfang database,CBM,domestic and foreign HTA official websites,HTA reports,systematic evaluation/meta-analysis and pharmacoeconomic studies about semaglutide in the treatment of T2DM were collected during the inception to May 1st,2022.After data extraction and quality evaluation,descriptive analysis was performed on the results of included studies.RESULTS A total of 22 pieces of literature were included,involving 7 meta-analyses and 15 pharmacoeconomic studies.In terms of efficacy and safety,semaglutide showed significant advantages in controlling glycated hemoglobin(HbA1c),fasting blood glucose,postprandial mean glucose,body mass index and achieving a target of glycosylated hemoglobin level<7%;also,there was no increased risk of hypoglycaemia or the incidence of serious adverse effects,but the risk of gastrointestinal adverse effects was significantly higher than other interventions.In terms of cost-effectiveness,results of foreign studies showed that semaglutide was more cost-effective,compared with other glucagon-like peptide-1 receptor agonists,sodium-glucose transporter protein 2 inhibitors,dipeptidyl peptidase-4 inhibitors.Research based on the perspective of China’s health system showed that semaglutide had a clear cost-effectiveness advantage over dulaglutide when using GDP per capita in 2020(72477 yuan)as the payment threshold.CONCLUSIONS The semaglutide has excellent efficacy and good safety for the treatment of T2DM,with cost-effectiveness advantages over a number of drugs,but attention should be paid to the occurrence of gastrointestinal adverse effects.