PROSPECTIVE RANDOMIZED STUDY OF THRICE WEEKLY 6-MONTH AND 9-MONTH CHEMOTHERAPY FOR CERVICAL TUBERCULOUS LYMPHADENOPATHY

The aim of this study is to compare the efficacy of a thrice weekly 6- month regimen, 4S(3)H(3)R(3)Z(3)/2H(3)R(3) (which consists of an initi al 4 months of streptomycin (5), isoniazid (H), rifampicin (R), and py razinamide (Z) followed by 2 months of isoniazid and rifampicin), with a thrice weekly 9-month regimen, 4S(3)H(3)R(3)Z(3)/5H(3)R(3) (which c onsists of an initial 4 months of streptomycin, isoniazid, rifampicin, and pyrazinamide followed by 5 months of isoniazid and rifampicin), i n the treatment of cervical tuberculous lymphadenopathy. A total of 11 3 patients were recruited between August 1987 and December 1993. Twent y-two patients were excluded from the analysis because of defaulting t reatment or modification of regimen. Ninety-one patients were included in the analysis. Forty-three patients were given the 6-month regimen, and 48 patients were given the 9-month regimen. Two (5%) patients of the 6-month regimen and one (2%) patient of the 9-month regimen had pr imary failure after completion of treatment (relative risk, 2.23; 95% confidence interval, 0.21 to 23.76). Of the 88 patients who had initia l clinical remission after completion of treatment, the 5-year actuari al remission rates were 89% for the 6-month regimen and 90% for the 9- month regimen (Wilcoxon, p = 0.44). There were no significant differen ces of both primary failure rate and 5-year actuarial remission rate o f the two regimens. The 6-month regimen is recommended as the initial treatment of tuberculous lymphadenopathy.