Goldberg Anne C, Ostlund Richard E, Bateman Joyce H, Schimmoeller Linda, McPherson Timothy B, Spilburg Curtis A
Department of Internal Medicine, Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA.
Am J Cardiol. 2006 Feb 1;97(3):376-9. doi: 10.1016/j.amjcard.2005.08.056.
The objective of this study was to show that plant sterols in tablet form provide additional low-density lipoprotein (LDL) cholesterol lowering for patients on statin therapy. Dispersible phytosterol tablets were tested in a double-blind, placebo-controlled, parallel clinical trial. Twenty-six patients who were following the American Heart Association Heart Healthy Diet and on long-term statin therapy were studied for 9 weeks. After 3 weeks of placebo treatment, the subjects were randomized to receive either 1.8 g of soy stanols or placebo for 6 weeks in addition to their usual statin regimen. Stanol tablets reduced LDL cholesterol 9.1% (p = 0.007) or 12.2 mg/dl. Total cholesterol was reduced by 12.9 mg/dl (p = 0.03). A strong inverse correlation (r(s) = -0.82, p = 0.0007) was found between the baseline LDL cholesterol and the percent change in LDL cholesterol observed after stanol treatment. The additional LDL cholesterol lowering with stanol/lecithin tablets provided a potential adjunctive therapy for patients who have not reached their target LDL cholesterol goal during statin therapy.
本研究的目的是表明片剂形式的植物甾醇可为接受他汀类药物治疗的患者提供额外的低密度脂蛋白（LDL）胆固醇降低作用。在一项双盲、安慰剂对照、平行临床试验中对可分散片剂形式的植物甾醇进行了测试。对26名遵循美国心脏协会心脏健康饮食并接受长期他汀类药物治疗的患者进行了为期9周的研究。在接受3周安慰剂治疗后，受试者被随机分组，除了其常规他汀类药物治疗方案外，再接受6周的1.8克大豆甾醇或安慰剂治疗。甾醇片使LDL胆固醇降低了9.1%（p = 0.007）或12.2毫克/分升。总胆固醇降低了12.9毫克/分升（p = 0.03）。在基线LDL胆固醇与甾醇治疗后观察到的LDL胆固醇变化百分比之间发现了强烈的负相关（r(s) = -0.82，p = 0.0007）。对于在他汀类药物治疗期间未达到其LDL胆固醇目标值的患者，甾醇/卵磷脂片额外降低LDL胆固醇提供了一种潜在的辅助治疗方法。
