欧洲治疗慢性周围动脉闭塞性疾病药物临床试验指导原则(译文)

EUROPEAN GUIDANCE ON CLINICAL INVESTIGATIONS ON MEDICAL PRODUCTS FOR THE TREATMENT OF CHRONIC PERIPHERAL ARTERIAL OCCLUSIVE DISEASE

本试验指导原则对疾病的诊断、分期及影响因素进行了详细描述。指出治疗的最终目的是预防和推迟大的截肢手术时间并延长寿命。在病人选择上，必须使用客观方法对其诊断并明确其闭塞类型及部位。建议使用随机、双盲、平行、安慰剂对照的设计。主要评价标准应该是行走距离、静息疼痛缓解和溃疡的愈合。治疗时间应该是２～３个月，并采用４～６周的安慰剂预试验。

These notes provide a good description of diagnosis, stages and influential factors of the disease, show that the ultimate goal of treatment is to prevent or postpone major amputation and to prolong life. On the selection of patients recruited in the clinical trials, the diagnosis, types of occlusive lesion and its location have to be confirmed by objective means. A randomized, double-blinded, parallel group, placebo-controlled design is recommended. The primary assessment criteria should be walking distance (stage Ⅱ), relief of test pain (stage Ⅲ) and healing of ulceration (stage Ⅳ). Treatment period should be 2 to 3 months. In addition, a placebo run-in period of 4～6 weeks is recommended. The duration of the follow-up periods of clinical safety should cover 6 months to 2 years.