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A controlled clinical trial of oral short-course regimens in the treatment of sputum-positive pulmonary tuberculosis. Tuberculosis Research Centre.
Int J Tuberc Lung Dis 1997; 1(6):509-17IJ

Abstract

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 was randomly allocated to one of three regimens. I (2EHRZ7/6EH7): 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 (2EHRZ2/4EHR2): 6-month twice-weekly regimen with the same four drugs for 2 months, followed by EHR for 4 months. III (2HRZ2/4HR2): 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.

Pub Type(s)

Clinical Trial
Controlled Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9487448

Citation

"A Controlled Clinical Trial of Oral Short-course Regimens in the Treatment of Sputum-positive Pulmonary Tuberculosis. Tuberculosis Research Centre." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 1, no. 6, 1997, pp. 509-17.
A controlled clinical trial of oral short-course regimens in the treatment of sputum-positive pulmonary tuberculosis. Tuberculosis Research Centre. Int J Tuberc Lung Dis. 1997;1(6):509-17.
(1997). A controlled clinical trial of oral short-course regimens in the treatment of sputum-positive pulmonary tuberculosis. Tuberculosis Research Centre. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 1(6), pp. 509-17.
A Controlled Clinical Trial of Oral Short-course Regimens in the Treatment of Sputum-positive Pulmonary Tuberculosis. Tuberculosis Research Centre. Int J Tuberc Lung Dis. 1997;1(6):509-17. PubMed PMID: 9487448.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A controlled clinical trial of oral short-course regimens in the treatment of sputum-positive pulmonary tuberculosis. Tuberculosis Research Centre. PY - 1998/3/6/pubmed PY - 1998/3/6/medline PY - 1998/3/6/entrez SP - 509 EP - 17 JF - The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease JO - Int. J. Tuberc. Lung Dis. VL - 1 IS - 6 N2 - 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 was randomly allocated to one of three regimens. I (2EHRZ7/6EH7): 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 (2EHRZ2/4EHR2): 6-month twice-weekly regimen with the same four drugs for 2 months, followed by EHR for 4 months. III (2HRZ2/4HR2): 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. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/9487448/A_controlled_clinical_trial_of_oral_short_course_regimens_in_the_treatment_of_sputum_positive_pulmonary_tuberculosis__Tuberculosis_Research_Centre_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=1&issue=6&spage=509&aulast= DB - PRIME DP - Unbound Medicine ER -