During 39 months period from October, 1975 to December, 1978, 520 patients withpulmonary tuberculosis were randomly allocated to four drugregimens-3RHS/3RHS2, 2RHES/4RHE, 2RHZS/4RHZ, 2RHZE/4RHZ-with each group consisting of 130 cases.
Patients eligible for the trial had to satisfy the following criteria:
i) Admission to our hospital,
ii) No previous treatment, or treatment for less than 15 days.
iii) Smear test was positive for tubercie bacilli.
iv) Aged 15 years or more,
v) Size of cavity less than 5 cm.
Seventy six cases were subsequently excluded and 444 remained for the follow up studies.
We have previously reported that the bacteriological relapse rated uring 3 years after the end of chemotherapy for the pyrazinamide groups was 2% and that for the other groups was 10%. On that occasion, we included cases which were resistant to the drugs and or who had complications such as empyema, diabetes mellitus. In this study, we divided the 444 cases into two main groups, A and B (Table 2), with the focus of interest being placed on Group A without drug resistance and complications.
The conversion ratesat 8 weeks and relapses during the first 2 years and 6 years after the chemotherapy was terminated are shown in Tables 3 and 8 respectively. All cases converted to negative after 5 months, and 98% after 3 months. As to relapse, 69% occurred within one year and 85% with in 2 years. After 2 years, two relapses occurred, one at 51 months from the RHS group and the other at 65 months from the RHZS group.
If we consider only the relapses which occurred during the first two vears. then 4 out of 176 (2.3%) patients from the pyrazinamide groups with 95% confidence limits being 0.6-5.8%, and 7 out of 165 (4.2%) patients from the groups without pyrazinamide relapsed. Although the PZA groups showed lower relapse rate than the other groups, the difference was not significant. However, the superiority of the PZA groups was strikingly shown in Group B (Table 9).
The contribution of SM in the prevention of relapse appears to be doubtful as all the relapses occurred in the SM sensitive patients and not in the SM-resistant patients. Moreover, the interruption or termination of SM therapy in the early stages of treatment had no effect on the occurrence of relapse.
The resistance pattern of tubercle bacilli at the time of relapse was exactly the same as pretreatment status, except for one case which was on the borderline between resistant and sensitive.
The factors which significantly affected the occurrence of relapse were:
i) Severity of the illness,
ii) Negative culture at 8 weeks,
iii) A remaining cavity at the end of chemotherapy.
As to other factors such as sex, age, cavity size at the beginning of chemotherapy, no relation with relapse could be found.
Finally, confining to slight cases (moderatels advanced or minimum by NTA classification) inclnding A and B groups, the bacteriological relapse rate during 6 years after the end of chemotherapy was 0.6% (1 out of 161 patients) for the PZA groups with 95% confidence limits being 0.02-3.5%, and 5.9% (9 out of 152) for the groups without PZA with, the confidence limits being 2.7-11.2%.
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