A controlled clinical trial of oral short-course regimens in the treatment of sputum-positive pulmonary tuberculosis.
Tuberculosis Research Centre.
International Journal of Tuberculosis and Lung Disease; 1997; 1; 509-517.
Setting : The Tuberculosis Research Centre, Chennai, and its unit at Madurai, South India.
Objective : To design oral short-course regimens for the treatment of sputum-positive pulmonary tuberculosis that could be more easily implemented under field conditions.
Design : A total of 1203 patients were randomly allocated to one of three regimens.
I. (2EHRZ 7 /6EH 1 ): 8-month daily regimen of ethambutol (E), isoniazid (H), rifampicin (R) and pyrazinamide (Z) for 2 months, followed by E and H for 6 months.
II. (2EHRZ 2 / 4EHR 2 ): 6-month twice-weekly regimen with the same four drugs for 2 months, followed by EHR for 4 months.
III.(2HRZ 2 /4HR 2 ): similar to Reg.II, but without ethambutol.
In Reg. I, drugs were given completely unsupervised. Regs. II and III were either completely or partially supervised.
Results : Drug-susceptible group: At the end of treatment, 3.6% of 305 patients in Reg. I, 0.4% of 263 in Reg. II and 9.3% of 257 in Reg. III had an unfavourable bacteriological response. By 24 months after start of treatment, 5% of 290 in Reg. I, 11% of 258 in Reg. II and 10% of 229 in Reg. III had a bacteriological relapse requiring treatment. Giving the twice-weekly regimens partly unsupervised did not influence the response to treatment, emergence of drug resistance or relapse rates.
Isoniazid resistant group : Unfavourable response and relapse with Reg. I (94 patients) was 17% and 8%, with Reg. II (59 patients) 20% and 25%, and with Reg. III (74 patients) 62% and 15%, respectively.
Conclusion : A fully unsupervised ethambutol-containing regimen given daily for 8 months (Reg. I) was found to be very effective even in the presence of isoniazid-resistant bacilli. With the ethambutol-containing twice-weekly regimen, the response at the end of treatment was near 100%, but the relapse rate was high (11%). The non-ethambutol twice-weekly regimen was not satisfactory. All three regimens failed in the presence of bacilli resistant to rifampicin and isoniazid.
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