Probucol Suppresses Initiation of Chronic Hemodialysis Therapy and Renal Dysfunction-Related Death in Diabetic Nephropathy Patients: Sakura Study
Probucol Suppresses Initiation of Chronic Hemodialysis Therapy and Renal Dysfunction-Related Death in Diabetic Nephropathy Patients: Sakura Study
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DOI：
10.5551/jat.15263
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发表时间：
2013-01-01
影响因子：
4.4
通讯作者：
Tatsuno, Ichiro
中科院分区：
文献类型：
--
作者：
Endo, Kei;Saiki, Atsuhito;Tatsuno, Ichiro
目的：普罗布考具有抗氧化和降胆固醇作用。我们研究了普罗布考对糖尿病肾病进展的影响。方法：我们对162例临床白蛋白尿（尿白蛋白排泄> 300 mg/g肌酐）的2型糖尿病患者进行了一项随机开放试验。80例患者被分配到普罗布考治疗（500毫克/天）和82例患者没有普罗布考治疗。所有患者均随访5年。主要结果是肾功能不全事件的时间，定义为慢性血液透析治疗和肾功能不全相关的death.Results：普罗布考降低总胆固醇，HDL-胆固醇，LDL-胆固醇相比，对照组。普罗布考组的血清肌酐增加率（0.066 mg/dL/月）显著低于非普罗布考组（0.116 mg/dL/月）（p=0.015）。本研究期间，72例患者发生肾功能不全事件。69例开始接受长期血液透析的患者包括非普罗布考组42例和普罗布考组27例。非普罗布考组有3例患者死于肾功能不全，而普罗布考组无患者死于肾功能不全。普罗布考组无肾功能不全事件生存率显著高于非普罗布考组（log-rank：p=0.02）。结论：普罗布考可抑制糖尿病肾病和肾功能不全事件的进展。
Aim: Probucol has antioxidant as well as cholesterol-lowering effects. We examined the effect of probucol on the progression of diabetic nephropathy. We named this study 'Sakura Study' after our hospital and city.Methods: We performed a randomized, open trial on 162 type 2 diabetic patients with clinical albuminuria (urinary albumin excretion > 300 mg/g creatinine). Eighty patients were assigned to probucol treatment (500 mg/day) and 82 patients to no probucol treatment. All patients were followed for five years. The primary outcome was the time to renal dysfunction events, defined as the initiation of chronic hemodialysis therapy and renal dysfunction-related death.Results: Probucol decreased total cholesterol, HDL-cholesterol, and LDL-cholesterol compared to the control group. The serum creatinine increase rate was significantly lower (p=0.015) in the probucol group (0.066 mg/dL/month) than in the non-probucol group (0.116 mg/dL/month). Renal dysfunction events occurred in 72 patients during this study. The 69 patients who were initiated on chronic hemodialysis comprised 42 in the non-probucol group and 27 in the probucol group. Three patients in the non-probucol group, but no patients in the probucol group died of renal dysfunction. The renal dysfunction event-free survival rate was significantly higher (log-rank: p=0.02) in the probucol group than in the non-probucol group.Conclusion: Probucol suppressed the progression of diabetic nephropathy and renal dysfunction events.