CPM+1321TH+CS,KM+1321TH+CSおよびKM+1314TH+CS併用療法の臨床的研究
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Retreatment cases with positive culture who had not been treated previously with secondary drugs were allocated randomly to the following three treatment groups.<BR>I. CPM 1 g daily for 60 days and thereafter twice weekly+1 3 21 TH 0.5g daily+CS 0.5 g daily<BR>II. KM 2g twice weekly+1321 TH 0.5g daily +CS 0.5g daily<BR>III. KM 2g twice weekly-1-1314 TH 0.5g daily+CS 0.5g d aily After the exclusion of ineligible cases, there remained 30 cases in group I, 26 cases in group II and 26 cases in group III (Tables 1 and 2). Background factors of these groups and their comparability are shown in Fig.1. Out of the total 82 cases, 50 cases (61.0%) were far advanced tuberculosis by the NTA classification and 38 cases (46.3%) had two or more cavities. Many cases dropped out from the trial because of the side effects (Tables 3 and 4 ). As the bacteriologic status of the dropped-out cases was nearly equal to that of the total cases in each three group, the negative conversion rate was not biased by the exclusion of the droppedout cases. As shown in Table 5 and Fig.2, the negative conversion rate was 64.3% in group I, 60.9% in group II and 45.5% in group III by three months treatment, and 78.3%, 68.5%and 70.6%, respectively, by 6 months treatment. No significant difference was found in the negative conversion rate of these three groups. The rate of radiological improvement of the three groups are shown in Fig.3 and Table 6. No statistically significant difference was found in the rate of improvement of non-cavitary basic lesions as well as cavitary lesions. Side effects were observed am o ng cases including culture negative cases before treatment.. Number of cases examined, average duration of treatment and frequency of each side effect is shown in Table 8. Out of 96 cases treated with CS, 14 cases (14.6%) showed psychotic reaction. Incidence of gastroenteric disturbances was less in 1321 TH group than in 1314 TH group. From the data mentioned above, the authors concluded as follows:<BR>1. Combined therapy with CPM+1321 TH+CS, KM+1321 TH+CS o r KM+1314TH+CS is the effective regimen for re-treatment cases of pulmonary tuberculosis.<BR>2. No significant difference of clinical effect was observ e d among these three regimens.<BR>3. The incidence of the side effects in the treatment with secondary drugs was high, and the authors considered that the endeavor to reduce the side effects, for example the use of 1321 TH, was very important in the treatment with secondary drugs.
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