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吡格列酮对糖耐量受损患者的糖尿病预防研究
Pioglitazone for Diabetes Prevention in Impaired Glucose Tolerance


Ralph A. DeFronzo ... 糖尿病 • 2011.03.24
相关阅读
• 卡纳单抗抗炎治疗能否预防糖尿病 • 比较吡格列酮和磺酰脲类药作为添加治疗对于2型糖尿病的疗效

摘要


背景

糖耐量受损(IGT)与心血管疾病发病率增加和转化为2型糖尿病(T2DM)相关。因此,寻找预防或延缓以上事件发生的干预措施具有重要临床意义。

 

方法

我们采取了随机、双盲、安慰剂对照的临床研究以检验吡格列酮是否能够降低成人IGT发展为T2DM的风险。本研究共纳入622名患者,将其随机分为吡格列酮组和安慰剂组,中位随访期为2.4年。每季度检测一次空腹血糖,每年进行一次口服葡萄糖耐量试验(OGTT),并根据多次检测的结果判定患者是否发生糖尿病。

 

结果

吡格列酮组和安慰剂组的T2DM年发病率分别为2.1%和7.6%。在吡格列酮组,进展为糖尿病的相对风险比为0.28(95% CI,0.16~0.49;P<0.001)。吡格列酮组有48%的IGT患者转归为正常糖耐量,而安慰剂组则为28%(P<0.001)。吡格列酮与安慰剂相比可显著降低患者空腹血糖(降低11.7 mg/dL对8.1 mg/dL,亦即0.7 mmol/L对0.5 mmol/L,P<0.001),餐后2小时血糖(2h PG)(降低30.5 mg/dL对15.6 mg/dL,亦即1.6 mmol/L对0.9 mmol/L,P<0.001),以及糖化血红蛋白(HbA1c)(降低0.04个百分点对升高0.20个百分点,P<0.001)。同时,吡格列酮还可降低患者舒张压(DBP)(2.0 mmHg对0,P=0.03)和颈动脉内中膜厚度(31.5%,P=0.047),并显著升高高密度脂蛋白-胆固醇(HDL-C)水平(7.35 mg/dL对4.5 mg/dL,亦即0.4 mmol/L对0.3 mmol/L,P=0.008)。然而,吡格列酮组患者体重增加及水肿的发生较安慰剂组更显著(3.9 kg对0.77 kg,P<0.001;12.9%对6.4%,P=0.007)。

 

结论

与安慰剂组相比,吡格列酮使IGT患者向T2DM的转化风险降低72%,但是同时与体重增加和水肿显著关联(由武田制药[Takeda Pharmaceuticals]等赞助;ClinicalTrials.gov注册号为NCT00220961)。





作者信息

Ralph A. DeFronzo, M.D., Devjit Tripathy, M.D., Ph.D., Dawn C. Schwenke, Ph.D., MaryAnn Banerji, M.D., George A. Bray, M.D., Thomas A. Buchanan, M.D., Stephen C. Clement, M.D., Robert R. Henry, M.D., Howard N. Hodis, M.D., Abbas E. Kitabchi, M.D., Ph.D., Wendy J. Mack, Ph.D., Sunder Mudaliar, M.D., Robert E. Ratner, M.D., Ken Williams, M.Sc., Frankie B. Stentz, Ph.D., Nicolas Musi, M.D., and Peter D. Reaven, M.D., for the ACT NOW Study
From the Texas Diabetes Institute and University of Texas Health Science Center (R.A.D., D.T., N.M.) and KenAnCo Biostatistics (K.W.) — both in San Antonio; Phoenix Veterans Affairs (VA) Health Care System, Phoenix, AZ (D.C.S., P.D.R.); College of Nursing and Health Innovation, Arizona State University, Phoenix (D.C.S.); SUNY Health Science Center at Brooklyn, Brooklyn, NY (M.B.); Pennington Biomedical Research Center–Louisiana State University, Baton Rouge (G.A.B.); University of Southern California Keck School of Medicine, Los Angeles (T.A.B., H.N.H., W.J.M.); Division of Endocrinology and Metabolism, Georgetown University, Washington, DC (S.C.C.); VA San Diego Healthcare System and University of California at San Diego, San Diego (R.R.H., S.M.); University of Tennessee, Division of Endocrinology, Diabetes, and Metabolism, Memphis (A.E.K., F.B.S.); and Medstar Research Institute, Hyattsville, MD (R.E.R.). Address reprint requests to Dr. DeFronzo at the Diabetes Division, University of Texas Health Science Center, 7703 Floyd Curl Dr., San Antonio, TX 78229, or at albarado@uthscsa.edu.

 

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