결핵성경부림프절염의항결핵제치료기간에관한연구 : 6 개월과 12 개월요법의무작위임상대조연구

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1 KISEP Head and Neck Korean J Otolaryngol 2004;47: 결핵성경부림프절염의항결핵제치료기간에관한연구 : 6 개월과 12 개월요법의무작위임상대조연구 고려대학교의과대학이비인후 - 두경부외과학교실, 1 내과학교실, 2 예방의학교실 3 임기정 1 권윤환 1 백승국 1 우정수 1 권순영 1 정광윤 1 박대원 2 손장욱 2 김민자 2 천병철 3 Duration of Chemothrapy for Tuberculous Cervical Lymphadenitis:A Randomized Controlled Study on Six Months versus Twelve Months Chemotherapy Gi Jung Im, MD 1, Yoon Hwan Kwon, MD 1, Seung Kuk Baek, MD 1, Jeong Su Woo, MD 1, Soon Young Kwon, MD 1, Kwang-Yoon Jung, MD 1, Dae Won Park, MD 2, Jang Wook Sohn, MD 2, Min Ja Kim, MD 2 and Byung Chul Cheon, MD 3 1 Department of Otolaryngology Head and Neck Surgery, 2 Internal Medicine and 3 Preventive Medicine, Korea University College of Medicine, Seoul, Korea ABSTRACT Background and Objectives:Tuberculous cervical lymphadenitis is one of the most common extrapulmonary manifestations of tuberculosis. Foreign guidelines recommend a six-month short course chemotherapy for tuberculous peripheral lymphadenitis as an initial standard regimen. However, there have been some debates about the duration of chemotherapy in South Korea. The aim of this study is to determine the reasonable duration of chemotherapy for tuberculous cervical lymphadenitis in a randomized controlled study. Subjects and Method:We analyzed clinical outcome of 80 patients with tuberculous cervical lymphadenitis treated at Korea University Medical Center from April 1998 to November All patients were randomized in two groups by treatment regimens. All patients were given antituberculous chemotherapy for 6 or 12 months, starting with isoniazid H, rifampicin R, ethambutol E and pyrazinamide P for 2 months, then continuing with isoniazid, rifampicin and ethambutol for the remaining 4 months or 10 months, respectively. Results:Forty-seven patients were given a 12-month regimen 2 HERZ/10 HRE, and 43 patients 91.5% were cured. Thirty-three patients were given a 6-month regimen 2 HERZ/ 4 HRE, and 20 patients 60.6% were cured. The cure rate of the 12-month regimen appeared significantly higher than that of the 6-month. In both groups, no recurrence was found during the follow up period up to 12 months. Conclusion:The 12-month regimen could be recommended as a reasonable chemotherapy regimen for tuberculous cervical lymphadenitis in South Korea. Single lymph node excisional biopsy is an important diagnostic method. but, it has no additional benefits of treatment. (Korean J Otolaryngol 2004;47:258-62) KEY WORDS:Tuberculosis Lymphadenitis Chemotherapy Clinical protocols

2 임기정외 Table 1. Drugs and dosages for treatment of tuberculous cervical lymphadenitis Drug Isoniazid Daily dosage 300 mg Rifampicin 450 mg below 50 kg 600 mg above 50 kg Pyrazinamide 2-month initial phase 1500 mg Ethambutol 2-month initial phase* 800 mg below 50 kg 1200 mg above 50 kg Continuation phase 800 mg In case of higher dosages above 20 mg/kg/day, ethambutol should be reduced after a 2-month initial phase of chemotherapy 259

3 결핵성경부림프절염 Table 2. Basal characteristics of patients enrolled in this study 6 month regimen 12 month regimen Number of patients MaleFemale %85% %68% p value 0.08 Mean/Median age 39.2 / / Abscess/Sinus formation 05 15% 06 13% 0.75 Neck dissection 01 03% 03 06% 0.64 Excisional biopsy 24 73% 37 79% 0.54 Table 3. Treatment results at the time of chemotherapy completion Result Favorable Doubtful Unfavorable Total 6 month % % % month % % % 47 Table 4. Cure rate of the 6 and 12 month regimen, which is determined at 1 year after the completion of chemotherapy Result Cure* Failure Total 6 month % % month % % 47 Cure rate of the 12-month regimen appeared significantly higher than that of the 6-month p Korean J Otolaryngol 2004;47:258-62

4 임기정외 Table 5. The effect of excisional biopsy on cure rate Cure rate 6 month 12 month 12 / / 37 Excisional biopsy 50.0% 83.8% p=0.241* p=0.317* 2 / 9 10 / 10 Excisional biopsy 22.2% 100.0% Single lymph node excisional biopsy has no additional benefits on cure rate 261

5 결핵성경부림프절염 REFERENCES 1) Joint Tuberculosis Committee of the British Thoracic Society. Chemotherapy and management of tuberculosis in the United Kindom: Recommendations Thorax 1998;53: ) Bass JB, Farer LS, Hopewell PC, Obrien R, Jacobs RF, Ruben F, et al. Treatment of tuberculosis and tuberculosis infection in adults and children, American Thoracic Society and the Centers for Disease Control and Prevention. Am J Respir Crit Care Med 1994;149: ) Campbell IA, Ormerod LP, Friend JA, Jenkins PA, Prescott RJ. Six months versus nine months chemotherapy for tuberculosis of lymph nodes: Final results. Respir Med 1993;87: ) Van Loenhout-Rooyackers JH, Laheij RJ, Richter C, Verbee AL. Shortening the duration of treatment for cervical tuberculous lymphadenitis. Eur Respir J 2000;15: ) Chi C, Lee JS. A clinical study of the treatment of tuberculous cervical lymphadenitis. J Korean Surg Soc 1999;56: ) Awad MA. Mycobacterial infection of the head and neck: Presentation and diagnosis. Laryngoscope 2001;111: ) Kanlikama M, Gokalp A. Management of mycobacterial cervical lymphadenitis. World J Surg 1997;21: ) Baek CH, Kim SI, Ko YH, Chu KC. Polymerase chain reaction detection of mycobacterium tuberculosis from fine-needle aspirate for the diagnosis of cervical tuberculous lymphadenitis. Laryngoscope 2000;110: ) Kim YJ, Sung KJ, Kang MJ, Kim MS. CT manifestation of cervical tuberculous lymphadenitis. Korean J Radiol 1992;28: ) Park MR, Kim CS, Seo JY, Seo JY, Son HD, Rheu NS, et al. Clinical investigation of cervical tuberculous lymphadenitis. Tbc Resp Dis 1997;44: ) Shin KS, Sue JC, Ko DS, Kim GH, Jeong SS, Kim JO, et al. Prospective study for treatment method of cervical tuberculous lymphadenitis. Tbc Resp Dis 1998;46: ) Ord RJ, Matz GJ. Tuberculous cervical lymphadenitis. Arch Otolaryngol 1974:99; ) Lee HS, Jeong JH, Tae K, Park CW, Hong DK. Surgical treatment of tuberculous cervical abscess. Korean J Otolaryngol 2000;43: Korean J Otolaryngol 2004;47:258-62