Previously untreated 312 pulmonary tuberculosis patients were allocated at random to the following three regimens:
I: SM 1.0g three times weekly+PAS 10g daily+Isoniazid 0.3g daily
II: SM 0.5g three times weekly+PAS 10g daily+Isoniazid 0.3g daily
III: CPM (Capreomycin) 1.0g three times weekly+PAS 10g daily+Isoniazid 0.3g daily
103 cases were excluded due to various reasons shown in Table 1, and the remaining 209 cases were evaluated bacteriologically and roentgenographically, while 292 cases were used in the discussion of adverse reactions.
The background factors were presented in Table 5, and the proportion of multiple or multilocular cavity was higher and the amount of bacilli discharge was larger in the Group II than in the other two groups, but the difference was not statiscally significant.
The rate of sputum negative conversion in all cases at 6th month was about 95% each in the three groups, while in far advance cases, the rate was 95%, 93%, and 87% respectively. The rate of the appearance of drug resistant bacilli during the course of therapy was 15.2% in Group I, 5.6% in Group II and 10.7% in Group III, and the resistance to SM was lower in Group II than in Group I as demonstrated in Table 4.
No difference was found in the rate of improvement of X ray findings among the three groups.
Frequency of adverse reactions was 21.0% in Group I, 22.3% in Group II and 15.7% in Group III, and the rate of drop out due to adverse reactions was 8.0%, 5.8%, 6.7%, respectively, as shown in Table 6. The incidence of hearing impairment was highest in Group I, next Group II and lowest in Group III.
In conclusion, there is no significant difference in clinical efficacy between 1.0g SM regimen and 0.5g SM regimen as far as Japanese patients with average body weight of about 50kg were concerned and CPM seems to be almost of the same efficacy as of SM. As for hearing impairment, it was the order is highest in 1.0g SM, next 0.5g SM and lowest in CPM.
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