Jayaram S, Prasad H B, Sovani V B, Langade D G, Mane P R
Department of Medicine, Grant Medical College and JJ Hospital, Mumbai 400008.
J Indian Med Assoc. 2007 Mar;105(3):142-5, 150.
Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).
已表明，可溶性纤维可增强低脂饮食对轻度至中度高胆固醇血症患者的降胆固醇作用。在某些情况下，他汀类药物联合治疗具有优势，可能允许使用较低剂量的多种药物，而不是单一药物的最大剂量。本研究的主要目的是比较在治疗12周后，同剂量的伊索佳（isapgol）与阿托伐他汀联合用药和单独使用阿托伐他汀在降低高胆固醇血症患者低密度脂蛋白胆固醇（LDL-C）、总胆固醇水平方面的疗效。在一项为期12周的研究中，纳入了100名年龄大于20岁的高脂血症患者，男女不限，LDL-C水平>130mg/dl，总胆固醇>220mg/dl，并随机分为两组，一组每天两次服用5.6g伊索佳（Naturolax）粉末和每天一次服用10mg阿托伐他汀，另一组仅每天一次口服10mg阿托伐他汀。在第8周和第12周评估血清总胆固醇、LDL-C、高密度脂蛋白胆固醇（HDL-C）和甘油三酯水平。97名患者完成了研究。在第8周结束时，与基线相比，两组的平均LDL-C均显著降低（伊索佳+阿托伐他汀组降低20.5%，单独使用阿托伐他汀组降低16.0%）。但两组之间的差异不显著。在第12周结束时，伊索佳+阿托伐他汀组LDL-C下降31.4%，显著大于阿托伐他汀组的22.8%（p<0.05）。在第8周和第12周时，两组内血清总胆固醇、HDL-C和甘油三酯均显著降低，但两组之间的差异不显著。两组不良事件情况比较显示，单独使用阿托伐他汀组有更多患者出现不良反应（n = 14，28%），多于联合用药组（n = 4，8%；p<0.05）。
