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奥美沙坦对于2型糖尿病中微量白蛋白尿的延缓及预防作用
Olmesartan for the Delay or Prevention of Microalbuminuria in Type 2 Diabetes


Hermann Haller ... 糖尿病 • 2011.03.10
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摘要


背景

微量白蛋白尿是糖尿病肾病及早期心血管疾病的早期预测指标。此研究旨在探索血管紧张素受体拮抗剂(ARB)治疗是否可以延缓或预防无白蛋白尿的2型糖尿病患者中微量白蛋白尿的发生。

 

方法

在一项随机、双盲、多中心的对照试验里,我们将4,447位2型糖尿病患者随机分配到奥美沙坦组(40 mg,每天一次)和安慰剂组,中位随访时间为3.2年。若需要将血压降至130/80 mmHg以下,可按需使用ACEI及ARB以外的其他降压药物。主要结局为微量白蛋白尿发病时间。肾脏及心血管事件的发病时间则作为该研究的次要终点。

 

结果

近80%的奥美沙坦组及71%的安慰剂组中的患者达到了目标血压值(<130/80 mmHg);在临床血压测定中,奥美沙坦组较安慰剂组的血压低3.1/1.9 mmHg。分别有8.2%的奥美沙坦组患者(在2,160名患者检测出178名,即178/2,160)及9.8%的安慰剂组患者(210/2,139)中出现了微量白蛋白尿;奥美沙坦组的微量白蛋白尿的发病时间推迟了23%(微量白蛋白尿发生风险比,0.77;95%可信区间,0.63~0.94;P=0.01)。两组中均有1%的患者出现了血肌酐水平的双倍增高。奥美沙坦组中发生非致死性心血管事件的患者人数(81/2,232,3.6%)较安慰剂组(91/2,215,4.1%)略低(P=0.37),但奥美沙坦组中致命性心血管事件数量较安慰剂组数量更多(15例对3例,0.7%对0.1%;P=0.01),这一差异至少部分归因于患有冠心病的患者在奥美沙坦组中心源性死亡率高于安慰剂组(11/564 [2.0%]对1/540 [0.2%],P=0.02)。

 

结论

尽管两组患者的血压都有效地控制到现行标准范围内,奥美沙坦与微量白蛋白尿的推迟发生存在关联。值得关注的是,患有冠心病的患者中奥美沙坦组致死性心血管事件发生率较高(由第一三共株式会社[Daiichi Sankyo]赞助;ClinicalTrials.gov注册号为NCT00185159)。





作者信息

Hermann Haller, M.D., Sadayoshi Ito, M.D., Ph.D., Joseph L. Izzo, Jr., M.D., Andrzej Januszewicz, M.D., Shigehiro Katayama, M.D., Ph.D., Jan Menne, M.D., Albert Mimran, M.D., Ton J. Rabelink, M.D., Ph.D., Eberhard Ritz, M.D., Luis M. Ruilope, M.D., Lars C. Rump, M.D., and Giancarlo Viberti, M.D., for the ROADMAP Trial Investigators *
From the Department of Nephrology and Hypertension, Hannover Medical School, Hannover (H.H., J.M.); the Department of Nephrology, University of Heidelberg, Heidelberg (E.R.); and the Department of Nephrology, Heinrich-Heine-University Düsseldorf (L.C.R.) — all in Germany; the Department of Clinical Medicine, Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai (S.I.); and the Department of Endocrinology and Diabetes, Saitama Medical School, Iruma, Saitama (S.K.) — both in Japan; the Department of Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo (J.L.I.); the Institute of Cardiology, Department of Hypertension, Warsaw, Poland (A.J.); Hospital Lapeyronie, Montpellier, France (A.M.); the Department of Nephrology and Einthoven Laboratory for Vascular Medicine, Leiden University Medical Center, Leiden, the Netherlands (T.J.R.); the Division of Hypertension, Hospital 12 de Octubre, Madrid (L.M.R.); and King's College London School of Medicine, Guy's Hospital, London (G.V.). Address reprint requests to Dr. Haller at the Department of Nephrology and Hypertension, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany, or at haller.hermann@mh-hannover.de. * The investigators in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial are listed in the Supplementary Appendix,available at NEJM.org.

 

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