van Riel P L, van de Putte L B
Department of Rheumatology, University Hospital, Nijmegen, The Netherlands.
J Rheumatol Suppl. 1994 Sep;41:54-5; discussion 56.
In most clinical trials, patients' mean improvement scores are compared either for active against active treatment or active against placebo treatment. Testing drugs or strategies to qualify as disease controlling antirheumatic therapy will require treated patients to satisfy set criteria. But what proportion must fulfill the requirement if the therapy is to be classified as DC-ART? While the answer must address the problems of semantics, disease characteristics, and absolute levels of improvement, it may be easiest to begin by defining a significant degree of change in terms of a single disease activity index.
在大多数临床试验中,会比较患者在活性药物与活性药物治疗之间或活性药物与安慰剂治疗之间的平均改善分数。测试药物或策略以符合疾病控制抗风湿疗法的标准,将要求接受治疗的患者满足既定标准。但是,如果要将该疗法归类为DC-ART,必须有多大比例的患者满足要求呢?虽然答案必须解决语义、疾病特征和绝对改善水平等问题,但从单一疾病活动指数的角度定义显著程度的变化可能是最容易入手的。