Hwu C M, Shih K C, Kwok C F, Chang C L, Ho L T
Department of Internal Medicine, Veterans General Hospital-Taipei, Taiwan, R.O.C.
Zhonghua Yi Xue Za Zhi (Taipei). 1996 Mar;57(3):169-76.
Lovastatin, a potent 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, has been widely used in the treatment of hypercholesterolemia. It is also applied to dyslipidemia in patients with diabetes mellitus. The influence of lovastatin on insulin sensitivity was evaluated in twelve Chinese non-insulin-dependent diabetes mellitus (NIDDM) patients with hypercholesterolemia.
This double-blind, randomized, placebo-controlled, and two-period cross-over experiment enrolled 12 patients. After a run-in period of two months, the patients were randomized into 2 groups to receive either lovastatin (20 mg once daily) or placebo treatment. Eight weeks later, two groups of patients exchanged their treatment for another 8 weeks. Blood samples were collected at the end of the run-in period and at 4-week intervals during the study to observe serum lipid profiles. A modified insulin suppression test was made to assess insulin sensitivity three times: at the end of run-in period, in week 8 and week 16, respectively. Wilcoxon signed rank test was used for analysis of statistical significance of the difference between lovastatin and placebo treatments.
As compared with the placebo, lovastatin reduced serum total cholesterol (TC) levels significantly. Serum total triglyceride (TG) concentrations decreased slightly by lovastatin. The ratio of TC to high density lipoprotein-cholesterol (HDL-C) also decreased significantly in lovastatin period. No difference was found in serum apolipoprotein A1 levels. A significant reduction of serum apolipoprotein B concentrations was also noted in lovastatin period. No difference in glycemic indices and insulin sensitivity was observed in the base-line, placebo or lovastatin periods.
The results demonstrated that lovastatin significantly lowered the serum TC levels without perturbation of insulin sensitivity in hypercholesterolemic NIDDM patients.
洛伐他汀是一种强效的3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂，已广泛用于治疗高胆固醇血症。它也适用于糖尿病患者的血脂异常。对12例中国非胰岛素依赖型糖尿病（NIDDM）合并高胆固醇血症患者评估了洛伐他汀对胰岛素敏感性的影响。
本双盲、随机、安慰剂对照、两阶段交叉试验纳入12例患者。经过两个月的导入期后，患者被随机分为两组，分别接受洛伐他汀（每日一次，20毫克）或安慰剂治疗。8周后，两组患者交换治疗，再进行8周。在导入期结束时以及研究期间每隔4周采集血样，以观察血脂情况。进行改良的胰岛素抑制试验，分别在导入期结束时、第8周和第16周评估三次胰岛素敏感性。采用Wilcoxon符号秩检验分析洛伐他汀与安慰剂治疗之间差异的统计学显著性。
与安慰剂相比，洛伐他汀显著降低了血清总胆固醇（TC）水平。洛伐他汀使血清总甘油三酯（TG）浓度略有下降。在洛伐他汀治疗期，TC与高密度脂蛋白胆固醇（HDL-C）的比值也显著降低。血清载脂蛋白A1水平未发现差异。在洛伐他汀治疗期还注意到血清载脂蛋白B浓度显著降低。在基线、安慰剂或洛伐他汀治疗期，血糖指数和胰岛素敏感性均未观察到差异。
结果表明，洛伐他汀可显著降低高胆固醇血症NIDDM患者的血清TC水平，而不影响胰岛素敏感性。
