Gøtzsche P C
Medical Department A, Rigshospitalet, Copenhagen, Denmark.
J Clin Epidemiol. 1990;43(12):1313-8. doi: 10.1016/0895-4356(90)90097-9.
In a meta-analysis of placebo controlled NSAID trials, the sensitivity of the effect variables was calculated as the correlation coefficient and as the difference between drug and placebo, divided by the placebo group standard deviation. The patient's global evaluation was the most sensitive variable overall. Pain was more sensitive than Ritchie's index. Several variables may be omitted from clinical trials, especially if two active drugs are being compared. For example, the best maximum estimate for the difference in ESR between NSAIDs and placebo was 1.0 mm/hr (95% confidence interval -1.5 to 3.4 mm/hr), and for joint size 0.44% (-1.0 to 1.9%), corresponding to a quarter of a millimeter for each of the 10 joints usually measured. It is suggested to record only the patient's global evaluation, pain, and morning stiffness.
在一项对安慰剂对照的非甾体抗炎药试验的荟萃分析中,效应变量的敏感性通过相关系数以及药物与安慰剂之间的差异(除以安慰剂组标准差)来计算。患者的整体评估总体上是最敏感的变量。疼痛比里奇指数更敏感。临床试验中可能会省略几个变量,尤其是在比较两种活性药物时。例如,非甾体抗炎药与安慰剂之间血沉差异的最佳最大估计值为1.0毫米/小时(95%置信区间为-1.5至3.4毫米/小时),关节大小差异为0.44%(-1.0至1.9%),这相当于通常测量的10个关节中每个关节相差四分之一毫米。建议仅记录患者的整体评估、疼痛和晨僵情况。