Pullar T, Capell H A
Ann Rheum Dis. 1985 Feb;44(2):134-40. doi: 10.1136/ard.44.2.134.
The question 'Does the use of second-line therapy confer long-term benefit on outcome measures in rheumatoid arthritis?' remains unanswered. The major obstacle which prevents collection of the necessary data is the lack of a suitable control group. In this report experience with three 'second-line placebo groups' is described, and previous studies in the literature which incorporated a placebo group are reviewed. In the absence of concurrent corticosteroid therapy very few patients remain on placebo second-line medication after one year. Those that do, appear to have milder disease and are not representative of the group as a whole. Data on outcome measures need to be collected over two to five years, but the answer to the question which is posed does not depend upon larger and larger placebo groups which constitute increasing bias. To define the extent of benefit offered by the more powerful therapeutic agents a novel approach in regard to drug assessment will be required.
“类风湿关节炎二线治疗的使用是否能在结局指标上带来长期益处？”这一问题仍未得到解答。阻碍收集必要数据的主要障碍是缺乏合适的对照组。在本报告中，描述了三个“二线安慰剂组”的经验，并回顾了文献中纳入安慰剂组的先前研究。在没有同时使用皮质类固醇治疗的情况下，很少有患者在一年后仍继续使用二线安慰剂药物。那些继续使用的患者，似乎病情较轻，并不代表整个群体。关于结局指标的数据需要收集两到五年，但所提出问题的答案并不取决于越来越大且会造成越来越大偏差的安慰剂组。为了确定更强效治疗药物所带来的益处程度，将需要一种关于药物评估的新方法。
