中药作为药品, 其新药的疗效评价应遵循药物疗效评价的一般科学准则, 疗效确证性临床试验一般应为随机盲法对照试验。证的疗效评价是中药新药临床试验疗效评价的一大特色, 病、症结合模式有助于证的疗效评价。但在考虑证的疗效评价时, 要避免无证可辨时的牵强附会。科学地对中药新药的疗效进行评价, 有利于弘扬祖国医学。本文围绕中药新药疗效的判定, 并联系药品注册技术审评中发现的问题, 对随机盲法对照、样本例数与数据集、基线可比性与组间均衡性、剂量与疗程、合理的因果推断、证的疗效判定六个关键因素进行了扼要论述, 并认为中药新药的疗效评价方法随着我国药物临床试验水平的不断提高, 正处在不断探索、完善、丰富之中。

New TCM, as a pharmaceutical product, and its therapeutic effects shall be evaluated in line with scientific standards generally applied in the industry. A randomized, blinded, and controlled process makes a typical approach for such evaluation. Syndrome is a major element for clinical evaluation, as the combination of both syndrome and disease may lead to a more convincing result. However, syndrome related evaluation shall not be based on a syndrome that does not exist. Scientific evaluation of therapeutic effects of new TCM drugs makes a key link in boosting the TCM development. This paper discusses a range of issues concerning the evaluation of the therapeutic effects of new TCM drugs, and associated registration and technical reviews, including six major elements that are generally used in evaluation. Author be lieves that therapeutic evaluation of new TCM drugs will gradually be perfected and enriched, a long with increasingly raised level of China′s clinical research.