“长期”应该有多长？风湿性疾病的长期试验。
How long should long be? Long-term trials in rheumatic diseases.
作者信息
Ciccolunghi S N, Chaudri H A, Schubiger B I
出版信息
Ann Rheum Dis. 1979 Apr;38(2):155-60. doi: 10.1136/ard.38.2.155.
In the interests of the safety of patients it is necessary to collect long-term clinical data. It is often assumed that the longer the trial the better. However, the longer the trial the more scientific compromises are necessary if it is to be carried out in a practical way. Because the therapeutic efficacy of and tolerance to the nonsteroidal anti-inflammatory drug diclofenac was established after 6 months' trial the optimal duration for a comparative long-term trial of this preparation is 6 months. The small amount of information gained from trials of diclofenac longer than this did not justify the reduction in quality of trial design and performance that they required. Thus it would appear that at least for 1 antirheumatic drug the assumption that 'the longer the trial the better' is not true.
为了患者安全，有必要收集长期临床数据。人们通常认为试验时间越长越好。然而，如果要以切实可行的方式进行试验，试验时间越长，就越需要做出科学上的妥协。由于非甾体抗炎药双氯芬酸的治疗效果和耐受性在6个月的试验后已得到证实，因此该制剂比较性长期试验的最佳时长为6个月。超过这一时长的双氯芬酸试验所获得的少量信息，不足以证明为此而降低试验设计和实施的质量是合理的。因此，至少对于1种抗风湿药物来说，“试验时间越长越好”这一假设似乎并不成立。
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