O'Donnell Mark E, Badger Stephen A, Sharif Mohammed A, Young Ian S, Lee Bernard, Soong Chee V
Department of Vascular and Endovascular Surgery, Belfast City Hospital, Belfast, Northern Ireland, United Kingdom.
J Vasc Surg. 2009 May;49(5):1226-34. doi: 10.1016/j.jvs.2008.11.098. Epub 2009 Feb 14.
Cilostazol improves walking distance and quality of life in patients with peripheral arterial disease (PAD). This study assessed the vascular and biochemical effects of cilostazol therapy in PAD patients.
PAD patients were prospectively recruited to a randomized, double-blinded, placebo-controlled trial. Baseline clinical data were recorded. Clinical assessment included measurement of arterial compliance, transcutaneous oxygenation, ankle-brachial index (ABI), and treadmill walking distance. Blood analyses included a full blood panel, coagulation screen, urea and electrolytes, liver function tests, estimated glomerular filtration rate, and lipid profiles. Quality of life indices were recorded using validated generic and walking-specific questionnaires. All tests were performed at baseline, 6, and 24 weeks.
Eighty patients (53 men) were recruited from December 2004 to January 2006. The cilostazol group had a significant reduction in the augmentation index compared with the placebo group at 6 weeks (19.7% vs 26.7%, P = .001) and at 24 weeks (19.7% vs 27.7%, P = .005). A paradoxic reduction in transcutaneous oxygenation levels was identified in the cilostazol group for the left foot at 6 weeks and for the right foot at both 6 and 24 weeks. The ABIs were not significantly different between treatment groups at baseline, 6 weeks, or 24 weeks for the left and right lower limbs. The mean percentage change in walking distance from baseline improved more markedly in the cilostazol compared with the placebo group for absolute claudication distance at 6 (78.6% vs 26.4%, P = .20) and 24 weeks (173.1% vs 92.1%, P = .27); however, these failed to reach significance. Significant improvements in lipid profiles were demonstrated with cilostazol therapy at 6 weeks (triglycerides, high-density lipoprotein [HDL]) and at 24 weeks (cholesterol, triglycerides, HDL, and low-density lipoprotein). The cilostazol treatment group demonstrated significant improvements in the Short Form-36 (physical functioning, physical component score), Walking Impairment (distance and speed), and Vascular Quality of Life (pain) indices at 6 and 24 weeks. Although cilostazol was associated with side effects in approximately one-third of patients, most settled within 6 weeks, facilitating the continuation of therapy in >89%.
Cilostazol is a well-tolerated, safe, and efficacious treatment for PAD patients. It not only improves patients' symptomatology and quality of life but also appears to have beneficial effects on arterial compliance, possibly through its lipid-lowering property.
西洛他唑可改善外周动脉疾病（PAD）患者的步行距离和生活质量。本研究评估了西洛他唑治疗对PAD患者的血管和生化影响。
前瞻性招募PAD患者进行随机、双盲、安慰剂对照试验。记录基线临床数据。临床评估包括测量动脉顺应性、经皮氧分压、踝臂指数（ABI）和跑步机步行距离。血液分析包括全血细胞计数、凝血筛查、尿素和电解质、肝功能检查、估算肾小球滤过率和血脂谱。使用经过验证的通用问卷和特定于步行的问卷记录生活质量指数。所有测试均在基线、6周和24周时进行。
2004年12月至2006年1月招募了80名患者（53名男性）。与安慰剂组相比，西洛他唑组在6周时（19.7%对26.7%，P = 0.001）和24周时（19.7%对27.7%，P = 0.005）的增强指数显著降低。西洛他唑组在6周时左脚以及6周和24周时右脚的经皮氧分压水平出现反常降低。治疗组在基线、6周或24周时左右下肢的ABI无显著差异。与安慰剂组相比，西洛他唑组在6周时（绝对跛行距离为78.6%对26.4%，P = 0.20）和24周时（173.1%对92.1%，P = 0.27）从基线开始的步行距离平均百分比变化改善更为明显；然而，这些差异未达到显著水平。西洛他唑治疗在6周时（甘油三酯、高密度脂蛋白[HDL]）和24周时（胆固醇、甘油三酯、HDL和低密度脂蛋白）显示血脂谱有显著改善。西洛他唑治疗组在6周和24周时在简明健康状况调查量表（身体功能、身体成分评分）、步行障碍（距离和速度）和血管生活质量（疼痛）指数方面有显著改善。尽管约三分之一的患者出现了西洛他唑相关的副作用，但大多数在6周内缓解，使得超过89%的患者能够继续治疗。
西洛他唑是一种耐受性良好、安全且有效的PAD患者治疗药物。它不仅改善了患者的症状和生活质量，而且似乎对动脉顺应性有有益影响，可能是通过其降脂特性实现的。
