Cilostazol has beneficial effects in treatment of intermittent claudication - Results from a multicenter, randomized, prospective, double-blind trial
Cilostazol has beneficial effects in treatment of intermittent claudication - Results from a multicenter, randomized, prospective, double-blind trial
复制标题
DOI：
10.1161/01.cir.98.7.678
复制
发表时间：
1998-08-18
期刊：
影响因子：
37.8
通讯作者：
Strandness, DE
中科院分区：
文献类型：
--
作者：
Dawson, DL;Cutler, BS;Strandness, DE
背景-西洛他唑是一种新型磷酸二酯酶抑制剂，可抑制血小板聚集，还可作为直接动脉血管扩张剂。这项前瞻性、随机、安慰剂对照、平行组临床试验评估了西洛他唑治疗稳定型、中重度间歇性跛行的疗效。方法和结果研究纳入标准包括年龄大于或等于 40 岁、跑步机上初始跛行距离 (ICD)（12.5% 坡度，3.2 km/h）30 至 200 m 以及慢性下肢动脉诊断的确认闭塞性疾病。在稳定和单盲安慰剂导入后，来自 3 个中心的 81 名受试者（62 名男性，19 名女性）被不等地随机 (2:1) 接受西洛他唑 100 mg PO BID 或安慰剂治疗 12 周。主要结果指标包括 ICD 和最大步行距离（绝对跛行距离，或 ACD）。次要结果指标包括踝关节压力、患者和医生对获益的主观评估以及安全性。治疗组和对照组在年龄、症状严重程度、脚踝压力和吸烟状况方面相似。统计分析对 77 名受试者中的每一位进行了意向治疗分析，这些受试者在治疗开始后进行了大于或等于 1 次跑步机测试。组间比较基于最后一次治疗访视时使用方差分析检验的 ICD 和 ACD 相对于基线变化的比率的对数。估计的治疗效果显示 ICD 增加了 35%（P
Background-Cilostazol is a new phosphodiesterase inhibitor that suppresses platelet aggregation and also acts as a direct arterial vasodilator. This prospective, randomized, placebo-controlled, parallel-group clinical trial evaluated the efficacy of cilostazol for treatment of stable, moderately severe intermittent claudication.Methods and Results-Study inclusion criteria included age greater than or equal to 40 years, initial claudication distance (ICD) on treadmill (12.5% incline, 3.2 km/h) between 30 and 200 m, and confirmation of diagnosis of chronic lower-extremity arterial occlusive disease. After stabilization and single-blind placebo lead-in, 81 subjects (62 male, 19 female) from 3 centers were randomized unequally (2:1) to 12 weeks of treatment with cilostazol 100 mg PO BID or placebo. Primary outcome measures included ICD and maximum distance walked (absolute claudication distance, or ACD). Secondary outcome measures included ankle pressures, subjective assessments of benefit by patients and physicians, and safety. Treatment and control groups were similar with respect to age, severity of symptoms, ankle pressures, and smoking status. Statistical analyses used intention-to-treat analyses for each of 77 subjects who had greater than or equal to 1 treadmill test after initiation of therapy. Comparisons between groups were based on logarithms of ratios of ICD and ACD changes from baseline using ANOVA test at last treatment visit. The estimated treatment effect showed a 35% increase in ICD (P