Tuberc Respir Dis.  1986 Mar;33(1):9-18. 10.4046/trd.1986.33.1.9.

Comparison of 9-month and 6-month Short Course Regimens for Sputum Microscopy Positive Pulmonary Tuberculosis Patients under Programme Conditions

Abstract

Under the existing conditions of the National Tuberculosis Control Programme(NTP), the current nine-month regimen(9HER) comprising daily isoniazid 400 mg, ethambutol 800 mg and rifampicin 450mg was compared with a six-month regimen (2 HERZ/4HER), in which daily pyrazinamide 1. 5 gm was supplemented for the initial two months. A total of 673 pulmonary tuberculosis patients with positive sputum microscopy were registered and randomly allocated to each regimen(351 9HER and 322 2HERZ/4HER) at 13 Health Centres in Chungchongbuk.do Province from October 1983 through December 1984. 18 patients were excluded from main analyses, due to pretreatment conditions. Seventy-five(22.0%) of 351 9HER patients, and 57 (18.7%) of 322 2HERZ/4HER patients have dropped out prematurely due to various reasons. 266 patients finished their nine-month chemotherapy: 255(95.9%) achieved negative conversion, 4( 1. 5%) failed, and 7(2.6%) were not available for lack of the follow-up examinations during treatment. 257 finished their six-month chemotherapy: 248(96.5%) achieved negative conversion, 1(0.4%) failed, and 8(3.1%) were unknown. There was no significant difference between the negative conversion rates of the two regimens at the end of the chemotherapy (t=0.38). However, the negative conversion rate at the time of two months after chemotherapy was significantly higher is 6 months regimen than that of a 9 months: 80.5% vz 73.3% (p<0.05). There was no evidence that shows the increase of untoward reactions, owing to the supplement of pyrazinamide in the six-month regimen. The results of chemotherapy by the end of treatment demonstrates that the six-month regimen is as effective as the current nine-month regimen under existing programme conditions. Follow-up investigations for relapse rates of the chemotherapy are in progress.

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