Source of Support: None, Conflict of Interest: None
A total of 212 smear positive patients suffering from pulmonary tuberculosis were randomly allocated to two anti-tuberculous drug regimens. Ten out of 107 (9.3%) patients on drug regimen 1 (2 SHR/6 TH) developed hepatitis as compared to 13 out of 105 (12.3%) patients on drug regimen II (2 SHRZ/6 TH). Onset of anorexia during therapy was always specific of hepatitis. Clinical jaundice developed in four and eight patients respectively (p>0.05). The hepatitis was of severe type (ALT >125 units) in two and four patients respectively (p>0.05). Thus, the risk of hepatitis is not significantly increased by addition of pyrazinamide to rifampicin-isoniazid combination. However, withdrawal of drugs should be effected immediately if a patient on these drugs develops anorexia.