Department of Clinical Medicine, 'Tor Vergata' University, Rome, Italy.
Clin Drug Investig. 2002 Nov;22(Suppl 1):1-6. doi: 10.2165/00044011-200222001-00001.
To compare the efficacy and tolerability of propionyl-1-carnitine with those of pentoxifylline in the treatment of intermittent claudication.
This study was a phase II multicentre (n = 14), randomised, open trial.
114 patients were enrolled who had intermittent claudication [as diagnosed by an ankle/brachial pressure index (ABPI) ≤0.8 that decreased by ≥20% after exercise].
After a 6-week run-in phase, patients were randomised to 12 months of treatment with propionyl-L-carnitine (500mg orally, three times daily) or pentoxifylline (400mg orally, three times daily).
Primary outcome measures included 12-month changes from baseline in claudication distance and maximal walking distance, as assessed by treadmill. Secondary outcome measures included ABPI and safety. Statistical analyses were performed in the per-protocol population (34 patients in each group). Compared with baseline, improvement in initial claudication distance was 174% with propionyl-L-carnitine versus 67% with pentoxifylline (p = 0.020). The improvement in maximal walking distance was 123 versus 54% (p = 0.004). There were no changes in electrocardiographic and routine biochemical and haematological tests that would indicate an adverse effect of either drug. Adverse events requiring drug discontinuation were five in the propionyl-L-carnitine group and eight in the pentoxifylline group. Resting and postexercise ABPI was not modified by treatments.
The findings of this study suggest that propionyl-L-carnitine, a safe and well tolerated drug, is more effective than pentoxifylline in improving walking capacity in patients with intermittent claudication.
比较丙酰-L-肉碱与己酮可可碱治疗间歇性跛行的疗效和耐受性。
这是一项 II 期多中心（n = 14）、随机、开放试验。
共纳入 114 例间歇性跛行患者[诊断依据为踝臂血压指数（ABPI）≤0.8，运动后下降≥20%]。
经过 6 周的导入期后，患者被随机分为 12 个月的丙酰-L-肉碱（500mg，口服，每日 3 次）或己酮可可碱（400mg，口服，每日 3 次）治疗组。
主要观察指标包括跑步机评估的跛行距离和最大步行距离的 12 个月的基线变化。次要观察指标包括 ABPI 和安全性。在符合方案人群（每组 34 例）中进行了统计分析。与基线相比，丙酰-L-肉碱组跛行初始距离的改善率为 174%，己酮可可碱组为 67%（p = 0.020）。最大步行距离的改善率分别为 123%和 54%（p = 0.004）。两种药物均未引起心电图和常规生化及血液学检查的变化，表明无不良反应。丙酰-L-肉碱组有 5 例和己酮可可碱组有 8 例因不良事件而停药。治疗未改变静息和运动后 ABPI。
本研究结果表明，丙酰-L-肉碱是一种安全且耐受性良好的药物，在改善间歇性跛行患者的步行能力方面比己酮可可碱更有效。
