糖尿病下肢血管病变的思考与实践专家版_培训课件.pptVIP

另外，间歇性跛行是PAD患者最主要的临床症状，本研究显示，凯那对PAD患者间歇性跛行改善率显著优于安慰剂组。 这是2000年美国《循环》杂志发表的一篇观察凯那治疗422例间歇性跛行患者的双盲，随机，多国家多中心的临床研究。 间歇性跛行患者接受凯那或安慰剂治疗，40μg/次，3次/天，为期6个月。分别在服药后0,1.5,3,4.5，和6个月对疗效进行评价，从图中可以看到治疗1.5个月开始，各时间点，无痛步行距离与最大步行距离的改善率均显著优于安慰机组。 * 这是2004年《日本药学杂志》上发表的一个研究，比较了西洛他唑与凯那改善间歇性跛行患者最大步行距离的Meta 分析。分析显示：凯那对最大步行距离的改善显著优于西洛他唑组。如图所示：凯那组的最大步行距离的加权均数差为119米，西洛他唑组为52.19米。 * 同样比较西洛他唑与凯那改善患者无痛步行距离的Meta 分析，结果显示：凯那对无痛步行距离的改善也显著优于西洛他唑组。凯那组的无痛步行距离的加权均数差为69米，西洛他唑组39.75米。 * 研究还同时观察了患者的总体改善率，凯那的总体改善率同样优于噻氯匹定。 * 这是一个自身前后对照研究。试验选取动脉粥样硬化患者，口服凯那（120μg/天）治疗3个月后，踝肱指数在静息时显著增加，运动后呈显著增加趋势。 * 2. Circulation. 2000 Jul 25;102(4):426-31. Oral Beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double-blind, randomized, multicenter controlled trial. Beraprost et Claudication Intermittente (BERCI) Research Group. Lièvre M, Morand S, Besse B, Fiessinger JN, Boissel JP. Service de Pharmacologie Clinique, H?pitaux de Lyon. Abstract BACKGROUND: Beraprost sodium (BPS) is a new stable, orally active prostaglandin I(2) analogue with antiplatelet and vasodilating properties. We report the results of a phase III clinical trial of BPS in patients with intermittent claudication. METHODS AND RESULTS: Patients (n=549) with a pain-free walking distance of between 50 and 300 m were entered into a 4-week single-blind placebo run-in phase. Patients whose pain-free walking distance had changed by 25% were then randomized to receive either BPS (40 microg TID, n=209) or placebo (n=213) in a double-blind manner for 6 months. Pain-free and maximum walking distances were measured on the occasion of treadmill exercise tests performed at baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was defined as an improvement of 50% in pain-free walking distance at month 6 and in or =1 earlier treadmill exercise test in the absence of critical cardiovascular events. Success was observed more frequently in the BPS group (43.5%) than in the placebo group (33.3%, P=0.036). Pain-free walk