Long-term results of short course chemotherapy of pulmonary tuberculosis. Second study-B: results at 6 years after the end of 4-9 month chemotherapy of pulmonary tuberculosis

Baba, H.; Shinkai, A.; Izuchi, R.; Azuma, Y.

Kekkaku 62(10): 511-520

1987


ISSN/ISBN: 0022-9776
PMID: 3444194
Document Number: 299902
The main objective of this study was to evaluate whether the 9-month chemotherapy with rifampicin and isoniazid, supplemented with streptomycin, ethambutol or pyrazinamide, might show the same relapse rate as reported in many publications, even in the majority of patients with huge cavities. Conditions of the admittance to the trial were as follows: Patients should be admitted to our hospital, be aged 15 years old or more, have pulmonary tuberculosis with huge cavities, be smear positive, and be previously untreated or treated for less than 15 days. Drug daily dosage was RFP 450 mg in all patients, INH 0.3-0.6 g, SM and EB 1.0 g, and PZA 1.5 g. After excluding patients who did not meet the protocol requirements, 91 patients remained for the final analysis. They were divided into two groups, A and B, according to whether they satisfied the following conditions (A) or not (B): i) Sensitive to all drugs used; ii) treatment was completed as scheduled or, if not, RFP was not interrupted for longer than 2 weeks, and iii) no complications with diabetes mellitus or tuberculous empyema. Seventy-three percent and 75% of cavities in Groups A and B, respectively, remained open at the end of chemotherapy. In Group A, there was no bacteriological relapse among 58 patients up to 5 years after the end of treatment, after which, one case relapsed. This patient had two cavities at the onset of chemotherapy, the size of the largest one being less than 5 cm, and the original cavities had completely disappeared when the treatment was completed. In Group B, 3 bacteriological relapses were observed, occurring at 3 months, 5 months, and 2 years after the end of chemotherapy. Two of them were complicated with diabetes mellitus and the administration of rifampicin was interrupted for forty days in the third case. There was no relapse in cases treated with the regimen of RHZE. Thirty-five percent of the patients suffered from side-effects. Although the incidence of side-effects was quite high, they were all transitory and disappeared when the drugs concerned were discontinued. Most of the cases could be re-treated successfully if both RFP and INH are could be used. In our study, the combined use of RFP and INH was tried in 32 cases and they all succeeded in completing the 9-month chemotherapy. Out of these cases, 2 cases relapsed including one diabetic. Nine month chemotherapy with RFP and INH supplemented with SM, EM or PZA was very effective even though patients had very advanced diseases with huge cavities. The RHZE regimen was particularly effective and there was not a single case of relapse in 25 patients treated with this regimen. Side-effects occurred fairly frequently but they were all transitory.

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