脑梗死中药临床试验的纳入标准与疗效评估中的若干思考

Some of problems in inclusion criteria and evaluation indexes of clinical trials in traditional herbs medicine for patients with cerebral infarction

根据脑梗死的病理和临床分型,作者提出脑梗死中药临床试验的纳入标准和疗效评价方法应当与中药的治疗定位相适应。起病时间、梗死类型和病情程度应当在纳入时作分层处理,并在统计时注意分析上述因素与疗效的关系。疗效指标的选择和测量时间依据脑梗死类型不同而异,腔隙性脑梗死的中药疗效评价应当有专门的试验设计,以增强疗效评价的客观性。建议制定临床试验设计指南,进一步规范脑梗死的中药临床试验。

Depending upon the characteristics of the pathological and clinical types encountered, inclusion criteria and evaluation indexes should be done in accordance with the treatment purpose. The duration of the trail, types and degree of the infarction should be delaminated, and the relationship between these factors and the evaluative indexes analized. A standardized procedures for clinical trials on cerebral infarction should be established for clinical trails of Traditional Chinese Medicine.