Wälti U, Kuenzler M, Schild J, Vassella F, Pavlincova E, Bircher J, Herschkowitz N
Pediatr Res. 1975 Sep;9(9):717-21. doi: 10.1203/00006450-197509000-00006.
Pyritinol-HCl was tested for its impact on the cognitive functions of children with learning disabilities. This study is a contribution to scientific discussion on the complicated methodologic problems in evaluating the clinical efficacy of psychopharmacologic agents. Sixty-seven pupils of slow learner classes between the ages of 11 and 16 years were treated for 6 months with 300 mg pyritinol-HCl/24 hr or placebo under strict double-blind conditions. Drug intake was stimulated and controlled by means of intense psychosocial interaction with the mothers of the subjects. The dependence variables used to test medication effects were 22 parameters of cognitive performance measured in psychologic tests for perceptual and intellectual functions which were administered immediately before and after the medication phase. First the gainscores before and after treatment with pyritinol or placebo within the 22 cognitive parameters were statistically compared. In addition, an analysis of covariance on the corrected results of the second test (treating the results of first testing as covariates) and a two group discriminant analysis for overall differences were performed. None of the 22 parameters showed statistically significant treatment effects with respect to average performance (t (pyritinol - placebo) = 1.96 to 1.31), neither could the two groups be separated by discriminant analysis (Hotelling's T2 = 35.4, df - 22 and 43, P = 0.465). With respect to a variability of gainscores, however, in four parameters there was a significantly higher variance in the pyritinol group (F = 1.85-2.33, P less than 0.05, less than 0.02, respectively). This fact may signify that pyritinol-HCl had different effects on different subjects. By means of prognostic stratification we therefore attempted to define objective criteria for a selection of subjects with probable positive treatment effects. None of the 15 tested criteria, such as body weight, age, perceptual handicaps, or reduced short term memory, IQ range, proved, however, to be critical for a prognosis of pyritinol effects within the present test population.
对盐酸吡硫醇对学习障碍儿童认知功能的影响进行了测试。本研究有助于就评估精神药物临床疗效时复杂的方法学问题展开科学讨论。67名年龄在11至16岁之间的慢班学生，在严格的双盲条件下，接受了为期6个月的治疗，分别服用300毫克盐酸吡硫醇/24小时或安慰剂。通过与受试者的母亲进行密切的心理社会互动来促进和控制药物摄入。用于测试药物效果的因变量是在用药阶段前后立即进行的感知和智力功能心理测试中测量的22个认知表现参数。首先，对22个认知参数在使用盐酸吡硫醇或安慰剂治疗前后的增益分数进行统计学比较。此外，对第二次测试的校正结果进行协方差分析（将第一次测试的结果作为协变量），并进行两组判别分析以找出总体差异。22个参数中没有一个在平均表现方面显示出统计学上显著的治疗效果（t（盐酸吡硫醇-安慰剂）=1.96至1.31），判别分析也无法将两组区分开来（霍特林T2 = 35.4，自由度-22和43，P = 0.465）。然而，就增益分数的变异性而言，在四个参数中，盐酸吡硫醇组的方差显著更高（F = 1.85 - 2.33，P分别小于0.05、小于0.02）。这一事实可能表明盐酸吡硫醇对不同受试者有不同影响。因此，我们试图通过预后分层来确定可能产生积极治疗效果的受试者选择的客观标准。然而，在本测试人群中，所测试的15个标准，如体重、年龄、感知障碍、短期记忆减退、智商范围等，没有一个被证明对盐酸吡硫醇效果的预后至关重要。
