Thulesius O, Lundvall J, Kroese A, Stranden E, Hallböök T, Brunes L, Gjöres J E, Akesson H, Einarsson E, Ohlin P
J Cardiovasc Pharmacol. 1987 Jun;9(6):728-33.
In a 7-center Scandinavian double-blind placebo-controlled study of 179 patients with intermittent claudication, the effect of the serotonin antagonist ketanserin was evaluated on walking distance, brachial and ankle blood pressure, and symptoms. For all centers together, pain-free walking distance was significantly increased after 6 months with both ketanserin (+65%; 71 patients) and placebo (+42%; 78 patients), with no significant difference. However, there was large variability among centers. Classification of "responders" (doubling of walking distance) and patients who deteriorated (decrease of walking distance or dropout for inefficacy) showed significantly more patients responding and significantly fewer patients deteriorating with ketanserin than with placebo. Systemic blood pressure was significantly decreased by ketanserin in hypertensive, but not normotensive, patients, while ankle pressure was unaffected. The incidence and nature of side effects were equal with ketanserin and placebo, but there were more side effects causing dropout in the ketanserin group. An unexpected and possibly important observation was the occurrence of six serious cardiovascular events (myocardial infarction, cerebrovascular complications, and development of rest pain) in the placebo group but none in ketanserin-treated patients. Moreover, there were four additional similar complications in the placebo run-in period. Ketanserin appears to be beneficial in a subgroup of patients with intermittent claudication. A fortuitous finding of this study is that ketanserin might possess a protective effect against thrombovascular complications in patients with intermittent claudication.
在一项针对179例间歇性跛行患者的7中心斯堪的纳维亚双盲安慰剂对照研究中，评估了血清素拮抗剂酮色林对步行距离、肱动脉和踝部血压以及症状的影响。对于所有中心而言，6个月后，酮色林组（71例患者，步行距离增加65%）和安慰剂组（78例患者，步行距离增加42%）的无痛步行距离均显著增加，两者无显著差异。然而，各中心之间存在很大差异。对“反应者”（步行距离翻倍）和病情恶化患者（步行距离减少或因无效而退出）进行分类后发现，与安慰剂组相比，酮色林组中反应的患者显著更多，病情恶化的患者显著更少。酮色林可使高血压患者而非血压正常患者的全身血压显著降低，而踝部血压不受影响。酮色林组和安慰剂组的副作用发生率和性质相同，但酮色林组因副作用导致退出的情况更多。一个意外且可能重要的观察结果是，安慰剂组发生了6例严重心血管事件（心肌梗死、脑血管并发症和静息痛的发生），而酮色林治疗的患者中无一例发生。此外，在安慰剂导入期还出现了另外4例类似并发症。酮色林似乎对一部分间歇性跛行患者有益。本研究的一个偶然发现是，酮色林可能对间歇性跛行患者的血栓血管并发症具有保护作用。
