Fuccella L M, Corvi G, Gorini F, Mandelli V, Mascellani G, Nobili F, Pedronetto S, Ragni N, Vandelli I
J Clin Pharmacol. 1977 Apr;17(4):177-84. doi: 10.1177/009127007701700401.
Parametric tests for bioassay data are commonly applied to scores of pain intensity and relief for the assessment of potency ratios of analgesic drugs. It has been demonstrated, however, that scores derived from semiquantitative scales often deviate from normal distribution. In addition, when scores decrease as a consequence of analgesic treatment, the variances may be nonhomogenous. Both parametric and nonparametric procedures have been employed in this study for the evaluation of results of a double-blind multicenter trial of the analgesic effect of indoprofen and ASA (both drugs at three dose levels) and placebo in episiotomy pain. There was a good agreement between potency ratios obtained with the two assays. Peak PID appeared a less efficient means of estimating potency ratio than other measurements such as SPID and TOTPAR. The nonparametric test for quantitative bioassay appears to be a valid statistical procedure for evaluating results of clinical trials, and it does not imply any assumptions as to the type of distribution of the data.
生物测定数据的参数检验通常应用于疼痛强度和缓解程度的评分，以评估镇痛药的效价比。然而，已经证明，从半定量量表得出的评分往往偏离正态分布。此外，当评分因镇痛治疗而降低时，方差可能不具有齐性。本研究采用参数和非参数方法评估了布洛芬和阿司匹林（两种药物均有三个剂量水平）及安慰剂对会阴切开术后疼痛镇痛效果的双盲多中心试验结果。两种测定方法得到的效价比之间有很好的一致性。与其他测量方法如SPID和TOTPAR相比，峰值PID似乎是一种效率较低的效价比估计方法。定量生物测定的非参数检验似乎是评估临床试验结果的一种有效的统计方法，并且它不意味着对数据分布类型有任何假设。
