Tonstad S, Pometta D, Erkelens D W, Ose L, Moccetti T, Schouten J A, Golay A, Reitsma J, Del Bufalo A, Pasotti E
Department of Medicine, National Hospital, Oslo, Norway.
Eur J Clin Pharmacol. 1994;46(5):405-10. doi: 10.1007/BF00191901.
The effect of orlistat, a nonabsorbed inhibitor of gastric and pancreatic lipases, was examined in patients with primary hyperlipidaemia (serum cholesterol > or = 6.2 mmol.l-1 and triglycerides < or = 5.0 mmol.l-1) not responsive to dietary change alone. In a multicentre, randomised, double-blind study, 103 men and 70 women received 30, 90, 180, or 360 mg or orlistat or placebo for 8 weeks. Total and low-density lipoprotein cholesterol levels were reduced by 4% and 5% with 30 mg orlistat, by 7% and 8% with 90 mg orlistat, by 7% and 7% with 180 mg orlistat and by 11% and 10% with 360 mg orlistat compared to placebo. High density lipoprotein cholesterol levels significantly decreased in the 360 mg orlistat group. Triglyceride levels significantly increased in the placebo group but not in the drug groups. Body weight decreased by 1.2 kg with 360 mg orlistat, despite a weight maintenance diet. Decreases in vitamin E and D levels occurred, although both vitamins remained within the normal range. Adverse effects from the gastrointestinal tract were frequent, but led to discontinuation of therapy in only seven patients. Orlistat is a new therapeutic drug for the treatment of hyperlipidaemia that may be particularly useful among overweight patients. Its potential place in therapy will await long-term studies. Vitamin supplementation should be considered during treatment.
对单独饮食改变无反应的原发性高脂血症患者（血清胆固醇≥6.2 mmol·l⁻¹且甘油三酯≤5.0 mmol·l⁻¹），研究了未被吸收的胃和胰脂肪酶抑制剂奥利司他的效果。在一项多中心、随机、双盲研究中，103名男性和70名女性接受30、90、180或360 mg奥利司他或安慰剂治疗8周。与安慰剂相比，30 mg奥利司他使总胆固醇和低密度脂蛋白胆固醇水平分别降低4%和5%，90 mg奥利司他使其分别降低7%和8%，180 mg奥利司他使其分别降低7%和7%，360 mg奥利司他使其分别降低11%和10%。360 mg奥利司他组的高密度脂蛋白胆固醇水平显著下降。安慰剂组甘油三酯水平显著升高，而药物组未升高。尽管采用维持体重饮食，360 mg奥利司他仍使体重下降1.2 kg。维生素E和D水平下降，尽管两种维生素仍在正常范围内。胃肠道不良反应常见，但仅7例患者因不良反应停止治疗。奥利司他是一种治疗高脂血症的新型治疗药物，对超重患者可能特别有用。其在治疗中的潜在地位有待长期研究。治疗期间应考虑补充维生素。
