西洛他唑治疗下肢缺血的疗效与安全性观察

Treatment of the Ischemia of the Lower Extremities with Cilostazol

目的:观察西洛他唑(培达)治疗下肢缺血的疗效和不良反应。方法:口服培达100mg,bid治疗多种原因引起的下肢缺血,观察4周和8周时下肢疼痛、冷觉、麻感的变化,以及相关的不良反应或者不良事件。结果:全国共有208家医院参加,录入2689例患者,其中最终完成疗效评价1636例。治疗至4周:3.0%的患者(49例)疼痛消失,96.9%的患者(1586例)疼痛有不同程度的减轻,仅0.1%的患者(1例)疼痛无缓解;治疗至8周40.0%的患者(654例)疼痛消失,其余60%的患者(982例)疼痛有不同程度的减轻。6.0%的患者(98例)在治疗4周后冷觉即消失,其余94.0%的患者(1538例)冷觉有不同程度减轻,继续治疗4周后冷觉消失的患者增至52.6%(847例)。主要的不良反应是头痛和心悸,分别占9.2%和4.7%。无不良事件发生。结论:口服培达100mg,bid,4～8周可以显著缓解多种原因导致的下肢缺血。

Objective： To evaluate the efficacy and potential side effect of cilostazol in treatment of the ischemia of lower extremities. Methods： Patients with ischemia of lower extremities were given the oral administration of Cilostazol 100mg, twice a day for 8 weeks. The alleviation of the clinical manifestations of pain, coldness and numbness of the lower extremities and any side effects were recorded and analyzed at 4 and 8 weeks, respectively. Results： Totally, 2689 candidates were enrolled in 208 hospitals throughout China. Of them, 1636 cases ultimately fulfilled the follow-up. At 4 weeks, pain of the lower extremities was completely relieved in 3%（49） of the eases, alleviated in 96.9% （1586）, and remained unchanged in 0. 1 %（1）. At 8 weeks, pain was completely relieved in 40% （654） of the cases, and alleviated in 60% （982）. At 4 weeks, coldness of the lower extremities disappeared in 6% （98） of the patients, and was extenuated in 94% （1538）. The most common side effects were headache and palpitation, accounting for 9. 2G and 4. 7%, respectively. Conclusion： The oral administration of Cilostazol 100mg, twice a day, for 4 to 8 weeks appeared to be effective in treatment of isehemia of the lower extremities.