Newly diagnosed moderately or far advanced culture-positive pulmonary tuberculosis in patients, 243 in number, were allocated at random to the following two regimens:
ST (Standard): SM 1.0g twice weekly+INH 0.3g daily+PAS 10g daily
Out of 243 cases, 59 were excluded due to various reasons. The remaining 184 cases (“IM”: 93 cases and “ST”: 91 cases) were analysed as to their clinical efficacy, while 225 cases were utilized for the analysis of adverse reactions. The back-ground factors were almost similer in both groups. Number of far advanced cases were 66 (71.0%) in IM and 70 (76.9%) in ST.
Drop-out cases during the first 6 months were 10 in “IM” and 13 in “ST”, and in the second 6 months they were 12 in “IM”and 32 in “ST”. As the difference in the drop-out cases during the second 6 months was statistically significant, the data in the second 6 months could not be comparable between the two groups.
The rate of negative conversion of tubercle bacilli by culture for all cases at 6 months was 100% in FEW j and 96.1% in “ST”, and for far advanced cases 100% and 94.8%, respectively. The rates of TM j at 3 and 4 months were significantly higher than the rates of “ST”. On the contrary, the rates of smear negativity of “IM” were lower than that of “ST” at each month. In “IM”, the rates of smear negativity were lower than those of culture negativity.
Two bacteriologic relapse cases were observed in the second 6 months in “IM”, and the organismus in one case were resistant to both SM and INH. It seems that the administration of INH and rifampicin only for 6 months is not safe enough to prevent the bacteriological relapse.
Daily use of SM 0.75g for 2 months was safety and effective.