Dawson D L, DeMaioribus C A, Hagino R T, Light J T, Bradley D V, Britt K E, Charles B E
Department of General Surgery, Wilford Hall Medical Center, Lackland AFB, Texas, USA.
Am J Surg. 1999 Aug;178(2):141-6. doi: 10.1016/s0002-9610(99)00147-6.
Pharmacologic treatment for intermittent claudication is a management option. This study evaluated the effect of withdrawal of drug therapies, cilostazol and pentoxifylline, on the walking ability of peripheral artery disease patients.
Single-blind placebo crossover from a randomized, double-blind trial; 45 claudication patients received either cilostazol 100 mg orally twice daily (n = 16), pentoxifylline 400 mg orally three times daily (n = 13), or placebo (n = 16) for 24 weeks. After 24 weeks of double-blind therapy, treatment for all groups was placebo only, and follow-up continued through week 30. Treatment efficacy was established with treadmill testing.
Profile analysis demonstrated a highly significant loss of treatment benefit after crossover (P = 0.001) for cilostazol-treated patients, but no significant change after crossover was observed with pentoxifylline.
Drug withdrawal worsened the walking of claudicants who had benefited from cilostazol therapy. This decline with crossover to placebo suggests that the initial improvement with cilostazol treatment was due to the drug's action. Withdrawal of pentoxifylline did not adversely affect walking.
间歇性跛行的药物治疗是一种治疗选择。本研究评估了停用西洛他唑和己酮可可碱这两种药物疗法对外周动脉疾病患者行走能力的影响。
来自一项随机双盲试验的单盲安慰剂交叉试验；45例跛行患者接受以下治疗，为期24周：每日口服两次西洛他唑100毫克（n = 16）、每日口服三次己酮可可碱400毫克（n = 13）或安慰剂（n = 16）。双盲治疗24周后，所有组均仅接受安慰剂治疗，并持续随访至第30周。通过跑步机测试确定治疗效果。
轮廓分析表明，西洛他唑治疗的患者在交叉治疗后治疗益处显著丧失（P = 0.001），但己酮可可碱治疗的患者在交叉治疗后未观察到显著变化。
停药使受益于西洛他唑治疗的跛行患者的行走能力恶化。交叉使用安慰剂后的这种下降表明，西洛他唑治疗最初的改善是由于药物的作用。停用己酮可可碱对行走没有不利影响。
