Wijsmuller G
Bull World Health Organ. 1971;45(5):633-48.
A total of 1183 patients in a mental hospital who had 10 years earlier participated in a study of isoniazid prophylaxis were given 2 tests, one containing a standard dose of a reference tuberculin, the other containing one of 3 concentrations of a preparation of tuberculin for assay. Combinations were assigned at random to groups that were selected to be as similar as possible with respect to age, sex, previous reaction to tuberculin, and history of isoniazid or placebo medication. The report discusses the problem of characterizing the new preparation in relation to the standard on the basis of limited information, as collected in a population that had acquired sensitivity to tuberculin, not only by infections with Mycobacterium tuberculosis but also by infections with non-tuberculous mycobacteria. After various analytical approaches were rejected, a method was developed that classifies subjects on the basis of the sum of the reactions to the reference and the assay preparations in both the infected and the non-infected, and in which the difference between the three sets of tests is used to calculate the potency ratio between the two groups.
一家精神病院里共有1183名患者，他们在10年前参与了一项异烟肼预防研究，这些患者接受了两项检测，一项含有标准剂量的参考结核菌素，另一项含有三种浓度的用于检测的结核菌素制剂中的一种。组合被随机分配到各个组，这些组在年龄、性别、先前对结核菌素的反应以及异烟肼或安慰剂用药史方面被选择得尽可能相似。该报告讨论了在有限信息的基础上，根据在不仅因结核分枝杆菌感染，还因非结核分枝杆菌感染而对结核菌素产生敏感性的人群中收集的数据，将新制剂与标准制剂进行特征描述的问题。在各种分析方法被排除后，开发出了一种方法，该方法根据感染组和未感染组对参考制剂和检测制剂反应的总和对受试者进行分类，并利用三组检测之间的差异来计算两组之间的效价比。
