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Park, Hong, Oh, Lim, Lee, Koh, Kim, Kim, Kim, and Shim: Comparison of Effectiveness and Adverse Reactions between Isoniazid 300 mg and 400 mg in Korean Patients with Pulmonary Tuberculosis
Original Article
Tuberculosis and Respiratory Diseases

Tuberculosis and Respiratory Diseases 2006; 60(1): 44-48.

Published online: 31 January 2006

DOI: https://doi.org/10.4046/trd.2006.60.1.44

Comparison of Effectiveness and Adverse Reactions between Isoniazid 300 mg and 400 mg in Korean Patients with Pulmonary Tuberculosis

I-Nae Park, M.D., Sang-Bum Hong, M.D., Yeon-Mok Oh, M.D., Chae-Man Lim, M.D., Sang Do Lee, M.D., Younsuck Koh, M.D., Woo Sung Kim, M.D., Dong Soon Kim, M.D., Won Dong Kim, M.D., Tae Sun Shim, M.D.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

Address for correspondence: Tae Sun Shim, M.D., Division of Pulmonary and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, 388-1 Pungnap-2dong, Songpa-gu, Seoul 138-736, Korea. Phone: 82-2-3010-3892, Fax: 82-2-3010-6968, shimts@amc.seoul.kr

Received 2 November 2005       Accepted 19 December 2005

Copyright © 2006 The Korean Academy of Tuberculosis and Respiratory Diseases

Abstract

Background

Isoniazid (INH) is one of the most effective anti-tuberculosis (TB) drugs. In Korea, the dose of INH normally used in patients over 50 kg is 400 mg/day, which differs from the dose recommended by other countries. Indeed, the metabolism of INH shows ethnic variations, and Koreans are predominantly rapid acetylators. However, two reports suggested 300 mg of INH might be sufficient to reach an ideal peak level in Korean patients over 50 kg. Therefore, the aim of this study was to compare the effectiveness and adverse reactions between INH 300 mg and 400 mg in Korean TB patients.

Method

Patients who were culture-positive, susceptible to all 1st-line drugs, initially on HREZ, and weighed over 50 kg were selected from patients with pulmonary TB between April 2003 and March 2005. The treatment results and adverse reactions in the INH 300 mg and 400 mg group were compared. Since April 2004, most TB patients at Asan Medical Center were administered INH 300 mg irrespective of the body weight.

Results

The study included 123 patients in the 300 mg INH group and 128 in the 400 mg INH group. There were no significant differences between the groups in terms of age, gender, weight, history of TB treatment, initial smear strength, and frequency of cavitary lesions. There was no difference in the treatment duration between the groups. One hundred eleven (90%) patients in the INH 300 mg group and 102 (80%) in the INH 400 mg group completed treatment (p>0.05). There were no differences in the frequency of modification of the initial regimen between groups due to any adverse reactions (300 mg : 9.0%, 400 mg : 13.7%) and hepatotoxicity (300 mg : 2.7% ; 400 mg : 7.8%).

Conclusion

Considering treatment results and adverse reactions of two groups, 300mg of INH may be sufficient for treating Korean TB patients. Further studies comparing the frequency of relapse will be needed.

Keywords: Tuberculosis, Isoniazid, Acetylator phenotype, Treatmenrt

Figures and Tables

Table 1
Baseline characteristics of the eligibles
trd-60-44-i001

TB: tuberculosis.

Table 2
The Comparison of treatment results and adverse reactions between INH 300 mg and 400 mg groups
trd-60-44-i002

* The number of denominaotr means just number of cured or treatment-completed patients.

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