基础胰岛素联合口服降糖药治疗效果不佳的2型糖尿病患者的治疗策略选择:伞形评价  

Treatment strategy selection for T2DM patients poorly treated with basal insulin combined with oral hypoglycemic agents:umbrella review

作　　者：牛亚平 柴三葆[2] 马璟籽 章萌 刘佐相 武珊珊[3] 孙凤[1] Ya-Ping NIU;San-Bao CHAI;Jing-Zi MA;Meng ZHANG;Zuo-Xiang LIU;Shan-Shan WU;Feng SUN(Department of Epidemiology and Health Statistics,School of Public Health,Peking University,Beijing 100191,China;Department of Endocrinology,Peking University International Hospital,Beijing 102206,China;National Clinical Research Center for Digestive Diseases,Department of Clinical Epidemiology and Evidence-based Medicine,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [2]北京大学国际医院内分泌科,北京102206 [3]首都医科大学附属北京友谊医院临床流行病学与循证医学研究室/国家消化系统疾病临床医学研究中心,北京100050

出　　处：《药物流行病学杂志》2023年第11期1275-1284,共10页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金青年科学基金项目(72074011);中国药品监管科学行动计划第二批重点项目([2021]37-10);海南省博鳌乐城国际医疗旅游先行区管理局真实世界研究专项计划项目(HNLC2022RWS012)。

摘　　要：目的对基础胰岛素联合一线口服降糖药(二甲双胍/磺脲类药物)治疗效果不佳的2型糖尿病(T2DM)患者的不同治疗策略进行伞形评价,为患者推荐最佳治疗策略提供科学依据。方法计算机检索PubMed、Embase、Cochrane Library、SinoMed、CNKI、WanFang Data和VIP数据库,搜集基础胰岛素联合一线口服降糖药治疗T2DM效果不佳的系统评价(SR)/Meta分析(MA),其原始研究为随机对照试验(RCT),检索时限均从建库至2023年9月13日,由2名研究者独立进行文献筛选、数据提取和文献质量评估,采用R 4.2.2软件中的metaumbrella包进行伞形评价。结果共纳入1篇SR和8篇MA,包括72个RCT,24095例患者,涉及的后续治疗措施有胰高糖素样肽1受体激动剂(GLP-1RA)、二肽基肽酶Ⅳ抑制剂(DPP-4i)、钠葡萄糖共转运蛋白2抑制剂(SGLT-2i)、噻唑烷二酮类药(TZD)等。结果显示,与安慰剂相比,GLP-1RA[WMD=-3.67,95%CI(-5.81,-1.53),P=0.001]、DPP-4i[WMD=-5.56,95%CI(-7.40,-3.73),P<0.001]和SGLT-2i[WMD=-5.34,95%CI(-9.56,-1.13),P=0.013]均可显著降低糖化血红蛋白(%)水平;阳性药物比较中,GLP-1RA vs.甘精胰岛素利司那肽固定比例复方制剂(IGlarLixi)[WMD=7.49,95%CI(7.01,7.92),P<0.001],GLP-1RA vs.德谷胰岛素利拉鲁肽注射液(IDegLira)[WMD=0.83,95%CI(0.11,1.54),P=0.023],显示GLP-1RA的降血糖效果不及IGlarLixi和IDegLira。与安慰剂相比,GLP-1RA可显著减轻体重(kg)[WMD=-3.46,95%CI(-5.30,-1.63),P<0.001];阳性药物比较中,GLP-1RA vs.IGlarLixi[WMD=-8.40,95%CI(-8.86,-7.93),P<0.001],GLP-1RA vs.IDegLira[WMD=-0.53,95%CI(-0.99,-0.07),P=0.025],显示GLP-1RA的降体重效果优于IGlarLixi和IDegLira。与安慰剂相比,TZD[OR=1.51,95%CI(1.11,2.05),P=0.009]和GLP-1RA[OR=1.24,95%CI(1.03,1.49),P=0.023]均会增加低血糖发生风险;阳性药物比较中,GLP-1RA vs.IDegLira[OR=1.22,95%CI(1.04,1.43),P=0.014],显示GLP-1RA导致的低血糖发生风险高于IDegLira。结论后续治疗使用GLP-1RA、DPP-4i、SGLT-2i能更好地控制血糖,且Objective To evaluate different treatment strategies for type 2 diabetes mellitus(T2DM)patients with poor response to basal insulin in combination with firstline oral hypoglycemic agents(metformin/sulfonylureas),and provide scientific basis for recommending the optimal treatment strategy for patients.Methods The databases of PubMed,EMbase,The Cochrane Library,SinoMed,CNKI,WanFang Data and VIP were searched to collect the systematic review(SR)/Meta-analysis(MA)on the poor effects after basal insulin in combination with first-line oral hypoglycemic agents from inception to September 13,2023.The original studies for SR/MA were randomized controlled trials(RCTs).Literature screening,data extraction,and quality assessment were carried out independently by two researchers,and data analysis was carried out by the umbrella package of R 4.2.2 software.Results A total of 1 SR and 8 MA were included in this study,totaling 72 RCTs involving 24095 patients were included.The main subsequent therapeutic agents involved in the included literature were GLP-1 receptor agonists(GLP-1RA),DPP-4 inhibitors(DPP-4i),SGLT-2 inhibitors(SGLT-2i)and thiazolidinediones(TZD).The result of umbrella review showed that,compared with placebo,GLP-1RA(WMD=-3.67,95%CI-5.81 to-1.53,P=0.001),DPP-4i(WMD=-5.56,95%CI-7.40 to-3.73,P<0.001),SGLT-2i(WMD=-5.34,95%CI-9.56 to-1.13,P=0.013)significantly reduced HbA1c(%);GLP-1RA vs.IGlarLixi(WMD=7.49,95%CI 7.01 to 7.92,P<0.001),GLP-1RA vs.IDegLira(WMD=0.83,95%CI 0.11 to 1.54,P=0.023),showing that GLP-1RA had a lower effect to reduce HbA1c(%)than IGlarLixi and IDegLira.Compared with placebo,GLP-1RA significant reduced weight(kg)(WMD=-3.46,95%CI-5.30 to-1.63,P<0.001);GLP-1RA vs.IGlarLixi(WMD=-8.40,95%CI-8.86 to-7.93,P<0.001),GLP-1RA vs.IDegLira(WMD=-0.53,95%CI-0.99 to-0.07,P=0.025),showing that GLP-1RA has a better weight-loss effect than IGlarLixi and IDegLira.Compared with placebo,TZD(OR=1.51,95%CI 1.11 to 2.05,P=0.009)and GLP-1RA(OR=1.24,95%CI 1.03 to 1.49,P=0.023)significantly increased the risk of hypoglycemi

关 键 词：基础胰岛素 口服降糖药 2型糖尿病 治疗效果不佳 伞形评价 

分 类 号：R587.1[医药卫生—内分泌]