Finci L, Höfling B, Ludwig B, Bulitta M, Steffenino G, Etti H, Meier B
Cardiology Center, University Hospital, Geneva, Switzerland.
Z Kardiol. 1989;78 Suppl 3:50-4.
Sulotroban, a sulphonamide derivative, causes an inhibition of platelet aggregation by blocking thromboxane A2 receptors. We tested the effects of Sulotroban (4 x 800 mg per day) on acute events during and recurrence rate after coronary angioplasty, and compared it with placebo in a double-blind randomized fashion. The follow-up protocol included regular compliance control by pill count, stress testing, and coronary angiography at 6 months. Restenosis was defined as a loss of 50% of the initial gain in luminal diameter. A total of 107 patients were randomized. There were no differences between the groups in terms of age, sex, artery distribution, or left ventricular function. Primary success per vessel was 86% for the Sulotroban group (50/58), and 88% for the placebo group (51/58). Complications occurred in nine patients (8%): five emergency bypass operations and three myocardial infarctions. There were no differences between the centers, or the study groups. The study protocol was completed for 57 patients. There was one death in the placebo group. Restenosis was found in 65% of patients in the Sulotroban group (19/29) and 61% of patients in the placebo group (17/28) (ns). If all patients were included on an intention to treat basis, regardless of primary success and compliance with the protocol, the recurrence rate was 57% in the Sulotroban group (20/35), compared with 56% in the Placebo group (20/36) (ns). This randomized, double-blind study failed to show that Sulotroban is superior to placebo in preventing acute problems during, or restenosis after, coronary angioplasty.
舒洛托溴铵是一种磺胺衍生物，通过阻断血栓素A2受体来抑制血小板聚集。我们测试了舒洛托溴铵（每日4次，每次800毫克）对冠状动脉血管成形术期间急性事件及术后复发率的影响，并以双盲随机方式将其与安慰剂进行比较。随访方案包括通过药丸计数进行定期依从性控制、压力测试以及6个月时的冠状动脉造影。再狭窄定义为管腔直径初始增加量减少50%。共有107例患者被随机分组。两组在年龄、性别、动脉分布或左心室功能方面无差异。舒洛托溴铵组每支血管的主要成功率为86%（50/58），安慰剂组为88%（51/58）。9例患者（8%）出现并发症：5例急诊搭桥手术和3例心肌梗死。各中心及研究组之间无差异。57例患者完成了研究方案。安慰剂组有1例死亡。舒洛托溴铵组65%的患者（19/29）出现再狭窄，安慰剂组为61%（17/28）（无显著性差异）。如果将所有患者按意向性治疗原则纳入，无论主要成功率及是否遵守方案，舒洛托溴铵组的复发率为57%（20/35），安慰剂组为56%（20/36）（无显著性差异）。这项随机双盲研究未能表明舒洛托溴铵在预防冠状动脉血管成形术期间的急性问题或术后再狭窄方面优于安慰剂。
