The main objectives of this study is to evaluate whether the 9-month chemotherapy with rifampicin and isoniazid, supplemented with streptomycin, ethambutol or pyrazina mide, might show the same relapse rate as reported in many publications, even if the ma jority of patients consisting of far advanced disease with huge cavities.
A total of 124 patients were allocated at random to the following four regimens: 9 RHE and 1 RHES/8 RHE, each with 39 cases, from January, 1976 to November, 1978 ; 9 RHS with 14 cases and 2 RHZE/7 RHZ with 32 cases, from November, 1978 to August, 1982. 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 0.3-0.6g, SM and EB 1.0g, and PZA 1.5g.
After excluding patients who did not meet the protocol requirements, 91 patients remained for the final analysis (Table 1).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.
The background factors of Group A are shown in Fig.1.They all had cavities and were all far advanced cases.Eighty-four percent of them had a cavity of more than 4 cm in size and among them 12 percent with cavity size 8 cm or more.The conversion rate at 8 weeks was 18-68 %, an average of 41% (Table 2).The rate was much lower compared with our former study with RHE (60 %) and with results in many other publications.In thisconnection, it is interesting to note that the conversion rate changes with the more thebacilli count at the onset of chemotherapy (Fig.2).Seventy-three percent and 75 % of cavities in Groups A and B, respectively, remainedopen at the end of chemotherapy (Table 4).In Group A, there was no bacteriological relapseamong 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 beingless than 5 cm, and the original cavities had completely disappeared when the treatmentwas completed (Table 7).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 diabetesmellitus and the administration of rifampicin was interrupted for forty days in the thirdcase.There was no relapse in cases treated with the regimen of RHZE (Tables 7, 8&9).Thirty-five percent of the patients suffered from side-effects, 10.5% being liverdysfunction, determined solely by the elevation of transaminase (Table 5).Although theincidence of side-effects was quite high, they were all transitory and disappeared when thedrugs concerned were discontinued.Most of these cases could be re-treated successfully ifboth RFP and INH are could be used.In our study, the combined use of RFP and INH wastried in 32 cases and they all succeeded in completing the 9-month chemotherapy.Out ofthese cases, 2 cases relapsed including one diabetic.Conclusion.
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