450 pulmonary tuberculosis patients were allocated at random to the following two kinds of regimens:
1 g of SM and 2 g of KM (Kanamycin) were administered twice weekly, while O.3 g of INH, 10g of PAS, 1 g of EB (Ethambutol), 0.5 g of TH (Ethionamide) and 0.5 g of CS (Cycloserine)were administered daily.
If sputum was p ositive at 4 or 5 months, SHP was switched to the combination of KM, TH, CS and EB at 7 months and SHPE to the combination of KM, TH and CS.
After excluding the subjects who failed to meet the criterion for accepta n ce to the trial or dropped out in the first two months of therapy, 148 SHP cases and 140 SHPE cases were analysed for clinical efficacy, while all 450 cases were utilized in discussing toxicity.
The rate of sputum conversion at 6 months was 94.9% in SHP and 96.9% in SHPE. The rate for far advanced cases was 91.2% and 94.2%, respectively. In the 7th series of our study, the superiority of the combined regimen of SM, INH, PAS and PZA over the ordinary triple drug regimen was established. The difference between PZA and EB in enhancing clinical efficacey of triple drug regimen, is not easy to understand, as EB is believed to be more potent than PZA. Simultaneous comparison is a necessary prerequisite for determining the relative merits of different regimens.
A planned and e a rly switching to entirely new regimen consisting of secondary drugs in. original treatment results in 100% conversion at the end of 12 months.
As the frequency of adverse reaction and especially the inc i d ence of drop out due to side effect are greater in SHPE than SHP, it seems reasonable to start the initial treatment with ordinary triple drug regimen and later switch to the combination of secondary drugs whenever necessary.

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Retreatment cases who had not been treated previously by at least any two drugs amongethionamide (T), cycloserine (C), and pyrazinamide (P) were accepted to the trial and they were allocated to the following four regimens so as to have a combination of ethambutol (E)and two unused drugs.
(1) T 0.5 g daily + E 0.5 g daily H-E 1.0 g daily
(2) C 0.5 g daily + E 1.0 g daily P 1.5 g daily
(3) T 0.5 daily + E 1.0 g daily + P 1.5 g daily (4) T 0.5 g daily + C 0.5 g daily + P 1.5 g daily + E 1.0 g daily After the exclusion of ineligible cases, there remained 6 0 cases in (1), 63 cases in (2), 58cases in (3) and 51 cases in (4), but as for the evaluation of clinical efficacy, only the subjects who had been treated by the allocated regimen for more than 3 months were analysed: 40 cases in (1), 52 cases in (2), 42 cases in (3) and 33 cases in (4). The number of excluded cases at the start of trial and the number of withdrawn cases during the trial are indicated in Tables 1 and 2. Comparability among the four treatment groups are shown in Figs.1 and 2. The rate of culture conversion is higher in the regimens which contain both E and T (regimen (1) and (3)) than the regimen which contains only E (regimen (2)) in the case of triple drug combination and the four drug regimen (regimen (4)) is not advantageous over the three drug regimens (regimen (1) and (3)) as shown in Fig.3. It is noteworthy that about 90% of the failure cases in initial and re-treatment can be converted to negative by the simultaneous use of E and T. As for rad i o graphic response, the rate of regression is slight as shown in Figs.4, 5 and 6, for almost all subjects had very long history of chemotherapy. The order of improvement is different from the rate of sputum conversion and the four drug regimen (4) stands the first in this respect.

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In the previous reports, the authors made analysis on the factors influencing the results of chemotherapy and came to the following conclusion;
1) radiological improvement was different by age, the type of pulmonary lesion, the regimen of chemotherapy and the presence of previous chemotherapy.
2) radiological aggravation after the cessation of chemotherapy was different by age, the maximal size and the type of lesion.
In the present report, the authors made further analysis on the factors influencing radiological improvement during chemotherapy and aggravation after the cessation of chemotherapy on 2902 cases of pulmonary tuberculosis conducted at out-patient clinics of Japan Antituberculosis Association. Among 2902 cases, 2117 were original treatment cases and 785 were retreatment cases, and the follow-up period after the cessation of chemotherapy was the following; 0-1 year 619, 1.1-2 years 683, 2.1-3years 561, 3.1-5 years 759 and longer than 5 years 280.
When analysis was made on one factor, comparison was made among cases with the same back ground factors regarding other factors. The results were the following:
Among original treatment cases.
1) Comparing radiological improvement by the regimen of chemotherapy, no significant difference was found between SM INH. PAS group and INH. PAS group both in cases with infiltrative caseous type lesion (B type) and that with intermediate type between infiltrative caseous and fibrocaseous typelesions (CB type).
2) No significant difference was found in radiological aggravation after the cessation of chemotherapy between SM INH PAS group and INH. PAS group.
3) Radiological aggravation after the cessation of chemotherapy was significantly higher among cases treated for less than 1 year than among cases, treated for 1 year or longer. Among retreatment cases.
1) Regarding rad iological improvement during: chemotherapy.
a) Observing by the type of pulmonary lesion at the beginning of treatment, the rate wash igher among B type lesion than among CB type lesion.
b) No significant difference was found by the extent of lesions, and the regimen of chemotherapy.
c) Comparing by the exercise status during chemotherapy, no significant differnce was found between cases continued on work and cases kept. bed rest. d) Comparing by age, the rate was higher among oases younger than 30 years or over.
2) Regarding radiological aggravation after the cessation of chemotherapy.
a) Observing by the type of lesions at the end of treatment, the rate was higher among cases with CB type lesion than among cases with fibrocaseoustype lesion (CC type).
b) The rate was higher among cases younger than 30 years than among cases 30 years or over.
c) Comparing by the duration of chemotherapy, the rate was higher among cases treated for less than 18 months.
d) Comparing by the maximal size of lesion at the end of treatment, the rate was higher among cases with lesions less than 1 cm.
e) No significant difference was found by the regimen of chemotherapy.
3) No significant difference was found in radioogical. aggravation after the cessation of chemothepapy by original treatment cases and retreatment cases.

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298 pulmonary tuberculosis patients who were discharging bacilli continuously regardless previous long term chemotherapy were treated for 6 months by kanamycin, ethionamide and/or pyrazinamide in single, double or triple drug regimen. Besides 221 patients had been exempted from the trial due to various reasons mentioned in Fig.1. The assignment of the drug was not at random but a drug or a combination of drugs which had not been prescribed previously were allocated to individual patient. Streptomycin, isoniazid or its derivatives, PAS or sulfonamide which had been proved to be of no effect was also administered to the most of patients simultaneously with the drugs to be assessed. The regimens used were indicated in Table 2. The analysis of the background foctors reveale d that the triple drug regimens were slightly advantageous over other kinds of regimens (Fig.1 and 2). Table 3, Fig.3, 4, 10 and 11 indicate that the more the number of the sensitive drugs administered simultaneously increase, the higher is the clinical efficacy of the regimen as to the rate of sputum conversion, the rate of reappearance of bacilli after the consecutive negative three months, and the rate of regression of cavitary and noncavitary lesion. The triple drug regimen, especially the combination of kanamycin, ethi o namide and cycloserine was the most potent among the regimens assessed in the present trial. The relationship between the rate of drug resistance, doubtful drug resistance and sensitivity on the one hand and a trend of the change in the number of bacilli discharged on the other was demonstrated in Fig.6, 7 and 8. The effect of the accompanying drugs on the appearance of resistance to kanamycin, ethionamide and cycloserine was analysed in Fig.9.

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