Brensike J F, Kelsey S F, Passamani E R, Fisher M R, Richardson J M, Loh I K, Stone N J, Aldrich R F, Battaglini J W, Moriarty D J, Myrianthopoulos M B, Detre K M, Epstein S E, Levy R I
Control Clin Trials. 1982 Jun;3(2):91-111. doi: 10.1016/0197-2456(82)90038-1.
The Type II Coronary Intervention Study (Type II Study) is a double-blind, randomized, placebo-controlled clinical trial conducted by the Division of Intramural Research of the National Heart, Lung, and Blood Institute of Bethesda, Maryland. The study was designed to evaluate the 5-year treatment effect of cholestyramine on low density lipoprotein (LDL) cholesterol and on lesions in the coronary arteries. One hundred forty-three patients with Type II hyperlipoproteinemia (elevated LDL cholesterol) and coronary artery disease (CAD) were entered into the study between 1972 and 1976. Patients were stratified by sex and extent of coronary disease as defined angiographically and were randomly allocated to a daily dosage of 24 g cholestyramine and diet (treatment group) or placebo and diet (control group). Changes in the coronary arteries were evaluated by sequential coronary angiography carried out before and after five years of treatment. This report describes the trial design and baseline characteristics of the study patients.
II型冠状动脉介入研究（II型研究）是一项由位于马里兰州贝塞斯达的国立心肺血液研究所内部研究部开展的双盲、随机、安慰剂对照临床试验。该研究旨在评估消胆胺对低密度脂蛋白（LDL）胆固醇及冠状动脉病变的5年治疗效果。1972年至1976年间，143例II型高脂蛋白血症（LDL胆固醇升高）和冠状动脉疾病（CAD）患者纳入该研究。患者按性别及血管造影定义的冠状动脉疾病程度分层，随机分配至每日服用24克消胆胺及饮食组（治疗组）或安慰剂及饮食组（对照组）。通过治疗5年前后进行的系列冠状动脉造影评估冠状动脉变化。本报告描述了该试验设计及研究患者的基线特征。
