二次抗結核剤の副作用発現頻度とCMI型第9次国療化研B研究第二部

第9次国療化研B研究第二部

抄録

On the occasion of 9-B Series of the CSUCT Study, the relationship between incidence of complaints or clinical symptoms on the one hand and Cornell Medical Index (CMI) of the subjects on the other was investigated.
In the investigation, Form a (Fig.1) was filled up by physicians in charge and Form b (Fig.2) by patients themselves. As for the group A patients (84 cases), both Form a and b were utilized, while as for the group B patients (107 cases), only Form a was filled up as shown in Fig.3.
The frequency of I, II, III and IV levels of CMI in A and B group was indicated in Table
1. High coincidence between the two groups was confirmed.
The incidence of complaints before the start of the trial classified by CMI is demonstrated in Fig.4 and the incidence one month after the start of treatment in Fig.5. There is a definite trend that the number of complaints or symptoms increased in the order of I, II, III and IV levels.
The incidence of symptoms complained by the patients (Form a) and those confirmed by the physicians(Form b)are compared in Figs.6, 7 and 8. A remarkable discrepancy is revealed in subjects on II, III and IV levels, especially during chemotherapy.
In Figs.9 and 10, the frequency and duration of in d ividual symptom classified by CMI is indicated.
In conclusion, random allocation of subjects or stratification of them by CMI is a necessary prerequisite for toxicity study, as marked difference was observed in the incidence rate of complaints and symptoms among the patients of I, II, III and IV levels of CMI during drug therapy.