Huskisson E C
Agents Actions Suppl. 1977(3):165-9. doi: 10.1007/978-3-0348-7290-4_16.
New methodology is required to evaluate new drugs. Trials designs and measurements developed for conventional anti-inflammatory therapy will fail to demonstrate the properties of a group of novel anti-rheumatic agents including gold, penicillamine and levamisole. These compounds act slowly, producing their maximum effect after 6 months of treatment. Trials must therefore be of at least this duration and it is useful to document the time course of the action. Measurements of rheumatoid arthritis must include not only conventional indices of disease activity (pain, morning stiffness, articular index, swelling) but also extra-articular features such as nodules, E.S.R., and rheumatoid factor titre. Reduction in technetium index is a feature of the action of drugs of this type. Changes in immunoglobulins and in some other immunological measurements may also be useful. Future trials must look increasingly at modes of action of drugs and the factors which determine the presence or absence of a response in an individual patient.
需要新的方法来评估新药。为传统抗炎疗法开发的试验设计和测量方法无法证明包括金制剂、青霉胺和左旋咪唑在内的一组新型抗风湿药物的特性。这些化合物起效缓慢，治疗6个月后才产生最大效果。因此，试验必须至少持续这么长时间，记录作用的时间过程是有用的。类风湿性关节炎的测量不仅必须包括疾病活动的传统指标（疼痛、晨僵、关节指数、肿胀），还必须包括关节外特征，如结节、血沉和类风湿因子滴度。锝指数降低是这类药物作用的一个特征。免疫球蛋白和其他一些免疫学测量的变化也可能有用。未来的试验必须越来越关注药物的作用方式以及决定个体患者是否有反应的因素。
