A Controlled Trial of 3-Month, 4-Month, and 6-Month Regimens of Chemotherapy for Sputum-smear-negative Pulmonary Tuberculosis: Results at 5 Years

Hong Kong Chest Service, Tuberculosis Research Centre, British Medical Research Council

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Abstract

Of 1,710 Chinese patients with radiologically active pulmonary tuberculosis but with sputum negative for acid-fast bacilli on four or more initial microscopic examinations who were studied for 5 yr, 592 (35%) had one or more initial sputum cultures positive for Mycobacterium tuberculosis. These 592 patients were randomly allocated to receive streptomycin, isoniazid, rifampin, and pyrazinamide daily for 4 months or 3 times a week for either 4 or 6 months. The remaining 1,118 patients with all their initial cultures negative were randomly allocated to receive the same four drugs daily for 3 months or 3 times a week for either 3 or 4 months. There were no bacteriologic failures during chemotherapy, and the relapse rates for the 4-month regimens during the 5 yr were 2% in 293 patients with drug-susceptible cultures initially (95% confidence limits, 1 to 5%); 8% in 59 patients with cultures resistant to isoniazid, streptomycin, or both drugs, but susceptible to rifampin initially; and 4% in 325 patients with all their cultures negative initially (95% confidence limits, 1 to 7%). The combined relapse rate for the 3-month regimens was 7% in 709 patients with all their cultures negative initially (95% confidence limits, 5 to 9%). In Hong Kong, 4 months of chemotherapy is now used routinely in the treatment of patients with smear-negative pulmonary tuberculosis, whether their initial sputum cultures are positive or negative.
Original languageEnglish
Pages (from-to)871-876
Number of pages6
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume139
Issue number4
DOIs
Publication statusPublished - 1 Apr 1989

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Sputum
Pulmonary Tuberculosis
Drug Therapy
Isoniazid
Streptomycin
Rifampin
Pharmaceutical Preparations
Pyrazinamide
Recurrence
Hong Kong
Mycobacterium tuberculosis
Bacillus
Acids

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A Controlled Trial of 3-Month, 4-Month, and 6-Month Regimens of Chemotherapy for Sputum-smear-negative Pulmonary Tuberculosis: Results at 5 Years. / Hong Kong Chest Service; Tuberculosis Research Centre; British Medical Research Council.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 139, No. 4, 01.04.1989, p. 871-876.

Research output: Contribution to journalArticle

Hong Kong Chest Service ; Tuberculosis Research Centre ; British Medical Research Council. / A Controlled Trial of 3-Month, 4-Month, and 6-Month Regimens of Chemotherapy for Sputum-smear-negative Pulmonary Tuberculosis: Results at 5 Years. In: American Journal of Respiratory and Critical Care Medicine. 1989 ; Vol. 139, No. 4. pp. 871-876.
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abstract = "Of 1,710 Chinese patients with radiologically active pulmonary tuberculosis but with sputum negative for acid-fast bacilli on four or more initial microscopic examinations who were studied for 5 yr, 592 (35{\%}) had one or more initial sputum cultures positive for Mycobacterium tuberculosis. These 592 patients were randomly allocated to receive streptomycin, isoniazid, rifampin, and pyrazinamide daily for 4 months or 3 times a week for either 4 or 6 months. The remaining 1,118 patients with all their initial cultures negative were randomly allocated to receive the same four drugs daily for 3 months or 3 times a week for either 3 or 4 months. There were no bacteriologic failures during chemotherapy, and the relapse rates for the 4-month regimens during the 5 yr were 2{\%} in 293 patients with drug-susceptible cultures initially (95{\%} confidence limits, 1 to 5{\%}); 8{\%} in 59 patients with cultures resistant to isoniazid, streptomycin, or both drugs, but susceptible to rifampin initially; and 4{\%} in 325 patients with all their cultures negative initially (95{\%} confidence limits, 1 to 7{\%}). The combined relapse rate for the 3-month regimens was 7{\%} in 709 patients with all their cultures negative initially (95{\%} confidence limits, 5 to 9{\%}). In Hong Kong, 4 months of chemotherapy is now used routinely in the treatment of patients with smear-negative pulmonary tuberculosis, whether their initial sputum cultures are positive or negative.",
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AB - Of 1,710 Chinese patients with radiologically active pulmonary tuberculosis but with sputum negative for acid-fast bacilli on four or more initial microscopic examinations who were studied for 5 yr, 592 (35%) had one or more initial sputum cultures positive for Mycobacterium tuberculosis. These 592 patients were randomly allocated to receive streptomycin, isoniazid, rifampin, and pyrazinamide daily for 4 months or 3 times a week for either 4 or 6 months. The remaining 1,118 patients with all their initial cultures negative were randomly allocated to receive the same four drugs daily for 3 months or 3 times a week for either 3 or 4 months. There were no bacteriologic failures during chemotherapy, and the relapse rates for the 4-month regimens during the 5 yr were 2% in 293 patients with drug-susceptible cultures initially (95% confidence limits, 1 to 5%); 8% in 59 patients with cultures resistant to isoniazid, streptomycin, or both drugs, but susceptible to rifampin initially; and 4% in 325 patients with all their cultures negative initially (95% confidence limits, 1 to 7%). The combined relapse rate for the 3-month regimens was 7% in 709 patients with all their cultures negative initially (95% confidence limits, 5 to 9%). In Hong Kong, 4 months of chemotherapy is now used routinely in the treatment of patients with smear-negative pulmonary tuberculosis, whether their initial sputum cultures are positive or negative.

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