Hommel E, Andersen P, Gall M A, Nielsen F, Jensen B, Rossing P, Dyerberg J, Parving H H
Steno Memorial and Hvidöre Hospital, Copenhagen, Denmark.
Diabetologia. 1992 May;35(5):447-51. doi: 10.1007/BF02342442.
The aim of this study was to assess the effect of simvastatin on plasma lipoproteins and renal function in hypercholesterolaemic Type 1 (insulin-dependent) diabetic patients with diabetic nephropathy. Twenty-six hypercholesterolaemic (total cholesterol greater than or equal to 5.5 mmol/l) Type 1 diabetic patients with nephropathy were enrolled in a double-blind randomized placebo-controlled study for 12 weeks. The active treatment group (n = 14) received simvastatin (10-20 mg/day) for 12 weeks while the remaining 12 patients received treatment with placebo. The results during simvastatin treatment (baseline vs 12 weeks): total cholesterol 6.6 vs 4.8 mmol/l (p less than 0.01), LDL-cholesterol 4.25 vs 2.57 mmol/l (p less than 0.01) and apolipoprotein B 1.37 vs 1.06 mmol/l (p less than 0.01). HDL-cholesterol, and apolipoprotein A-I remained unchanged. Total cholesterol, LDL-cholesterol, HDL-cholesterol, apolipoprotein A-I, apolipoprotein B remained unchanged during placebo treatment. Albuminuria measured during the simvastatin and the placebo treatment (baseline vs 12 weeks) (the data are logarithmically transformed before analysis because of their positively skewed transformation; geometric mean (x/divided by antilog SE) is indicated) was 458 (x/divided by 1.58) vs 393 (x/divided by 1.61) and 481 (x/divided by 1.62) vs 368 (x/divided by 1.78 micrograms/min (NS). Glomerular filtration rate during simvastatin and placebo treatment (baseline vs 12 weeks) was 64 vs 63 and 72 vs 74 ml.min-1.1.73 m-2, respectively. Two patients receiving simvastatin treatment were withdrawn, one due to gastrointestinal side effects and one due to myalgia.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究旨在评估辛伐他汀对患有糖尿病肾病的高胆固醇血症1型(胰岛素依赖型)糖尿病患者血浆脂蛋白和肾功能的影响。26名患有肾病的高胆固醇血症(总胆固醇大于或等于5.5 mmol/l)1型糖尿病患者被纳入一项为期12周的双盲随机安慰剂对照研究。活性治疗组(n = 14)接受辛伐他汀(10 - 20 mg/天)治疗12周,其余12名患者接受安慰剂治疗。辛伐他汀治疗期间(基线与12周)的结果:总胆固醇6.6 vs 4.8 mmol/l(p < 0.01),低密度脂蛋白胆固醇4.25 vs 2.57 mmol/l(p < 0.01),载脂蛋白B 1.37 vs 1.06 mmol/l(p < 0.01)。高密度脂蛋白胆固醇和载脂蛋白A-I保持不变。安慰剂治疗期间总胆固醇、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、载脂蛋白A-I、载脂蛋白B保持不变。辛伐他汀和安慰剂治疗期间测量的蛋白尿(基线与12周)(由于其正偏态分布,数据在分析前进行对数转换;给出几何均值(x/反对数标准误))分别为458(x/1.58)vs 393(x/1.61)和481(x/1.62)vs 368(x/1.78微克/分钟(无显著性差异)。辛伐他汀和安慰剂治疗期间的肾小球滤过率(基线与12周)分别为64 vs 63和72 vs 74 ml·min⁻¹·1.73 m⁻²。两名接受辛伐他汀治疗的患者退出,一名因胃肠道副作用,一名因肌痛。(摘要截断于250字)