Pediatric Infection and Vaccine

The Korean Society of Pediatric Infectious Diseases (대한소아감염학회)
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The Incidence Rate of Lymphadenitis after Bacille Calmette-Guérin (BCG) Vaccination

Bacille Calmette-Guérin (BCG) 백신 접종 후 림프절염의 발생 빈도

  • Kim, Jaehong (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Lee, Kyujin (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Kim, Jong-Hyun (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Kim, Seong Joon (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Lee, Soo Young (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Lee, Hye Jin (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Cho, Kyung Soon (Department of Pediatrics, School of Medicine, The Catholic University of Korea) ;
  • Kwon, Young Joo (Department of Pediatrics, Sungsae Hospital) ;
  • Lee, Byoung Chan (Department of Pediatrics, Sungsae Hospital) ;
  • Jo, Sang Min (Department of Pediatrics, Sungsae Hospital) ;
  • Ha, Jeong Hun (Dr. Ha Jeong Hun's Pediatric Clinic) ;
  • Lee, Yoon Kyung (Hanmaeum Pediatric Clinic) ;
  • Seung, So Jin (Hanmaeum Pediatric Clinic)
  • 김재홍 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이규진 (가톨릭대학교 의과대학 소아과학교실) ;
  • 김종현 (가톨릭대학교 의과대학 소아과학교실) ;
  • 김성준 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이수영 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이혜진 (가톨릭대학교 의과대학 소아과학교실) ;
  • 조경순 (가톨릭대학교 의과대학 소아과학교실) ;
  • 권영주 (성세병원 소아청소년과) ;
  • 이병찬 (성세병원 소아청소년과) ;
  • 조상민 (성세병원 소아청소년과) ;
  • 하정훈 (하정훈 소아청소년과) ;
  • 이윤경 (한마음 소아청소년과) ;
  • 승소진 (한마음 소아청소년과)
  • Received : 2015.10.27
  • Accepted : 2015.10.29
  • Published : 2016.04.25
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Abstract

Purpose: Bacille Calmette-$Gu{\acute{e}}rin$ (BCG) lymphadenitis is a relatively frequent local adverse reactions after BCG vaccination. Its incidence rate is usually <1%. However, this rate may be different according to BCG strain, vaccination method or skill, etc. In the Republic of Korea, two BCG strains are used: intradermal Danish-1331 or percutaneous Tokyo-172. We surveyed the incidence rates of BCG lymphadenitis. Methods: This survey was performed in total 25 centers (5 general hospitals, 20 private pediatric clinics). Immunized type of BCG strain in study subjects was verified by directly observing the scar. The occurrence of BCG lymphadenitis was asked to their parent. In cases of BCG lymphadenitis, location, diameter size, progression of suppuration, and treatment method were investigated, as well. Results: The total number of study subjects was 3,342. Among these, the subjects suitable for enrollment criteria (total 3,222; Tokyo strain 2,501, Danish strain 721) were analyzed. BCG lymphadenitis regardless of its size developed in each five of subjects per strains, therefore, its incidence rate was 0.20% in Tokyo and 0.69% in Danish strain, respectively (P=0.086). However, when applying the WHO criteria - the development of lymph node swelling with diameter 1.5 cm or more, the incidence rate of BCG lymphadenitis was 0.16% (4 cases) in Tokyo and 0.42% (3 cases) in Danish strain, respectively. Conclusions: The incidence rate of lymphadenitis in two BCG types, percutaneous Tokyo and intradermal Danish strain BCG, is 0.20% and 0.69%, respectively. Both rates are acceptable.

목적: BCG 접종 후의 비교적 흔한 이상반응인 국소 림프절염은 일반적으로 1% 미만에서 발생하는데 BCG 균주와 접종법 등에 따라 발생률이 다를 수 있다. 현재 우리나라에서는 Danish 균주 피내법과 Tokyo 균주 경피법의 BCG가 접종되고 있으며, 이에 대한 국소 림프절염의 발생률을 조사하였다. 방법: 총 25개의 의료기관(종합병원 5개소, 소아청소년과 의원 20개소)에서 조사가 이루어졌다. BCG 균주의 종류는 접종 부위의 반흔을 직접 확인하였고, BCG 접종 후 림프절염의 발생 여부는 보호자에게 직접 질문을 하여 확인하였다. 림프절염이 발생한 경우는 그 위치, 크기, 화농화 여부 및 경과, 치료법에 대해서도 조사하였다. 결과: 모두 3,342례에서 조사되었고, 이 중 기준에 적합한 대상자만을 분석하였는데 총 3,222례로 Tokyo 균주 경피법이 2,501례, Danish 균주 피내법이 721례이었다. 림프절의 크기를 고려하지 않을 때의 BCG 림프절염은 각 균주마다 5례에서 발생하여 그 발생률이 Tokyo 균주 경피법은 0.20%, Danish 균주 피내법에서는 0.69%이었다(P=0.086). 그러나 국제보건기구의 기준, 즉 림프절의 직경이 1.5 cm 이상일 때를 림프절염이 발생한 것으로 정의했을 때 Tokyo 균주 경피법은 0.16% (4례), Danish 균주 피내법에서는 0.42% (3례)이었다. 결론: 현재 국내에서 사용하고 있는 두 가지 BCG 균주, Tokyo 균주 경피법과 Danish 균주 피내법에 대한 림프절염 발생률은 각각 0.20%와 0.69%로 두 균주 모두 받아들여지는 수치이다.

Keywords

References

  1. World Health Organization. BCG vaccine: WHO position paper. Wkly Epidemiol Rec 2004;79:27-38.
  2. Milstien JB, Gibson JJ. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety. Bull World Health Organ 1990;68:93-108.
  3. The Korean Pediatric Society. BCG vaccine. In: Lee HJ, editor. Immunization guideline. 7th ed. Seoul: The Korean Pediatric Society; 2012:40-54.
  4. Lotte A, Wasz-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E. A bibliography of the complications of BCG vaccination. A comprehensive list of the world literature since the introduction of BCG up to July 1982, supplemented by over 100 personal communications. Adv Tuberc Res 1984;21:194-245.
  5. World Health Organization. Immunization safety surveillance. Guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Manila: Western Pacific Regional Office, WHO,1999.
  6. Talbot EA, Perkins MD, Silva SF, Frothingham R. Disseminated bacille Calmette-Guerin disease after vaccination: case report and review. Clin Infect Dis 1997;24:1139-46. https://doi.org/10.1086/513642
  7. Ustvedt HJ. Local reactions in BCG vaccination. Bull World Health Organ 1950;2:441-68.
  8. Goraya JS, Virdi VS. Bacille Calmette-Guerin lymphadenitis. Postgrad Med J 2002;78:327-9. https://doi.org/10.1136/pmj.78.920.327
  9. Mori T, Yamauchi Y, Shiozawa K. Lymph node swelling due to bacille Camette-Guerin vaccination with multipuncture method. Tuber Lung Dis 1996;77:269-73. https://doi.org/10.1016/S0962-8479(96)90012-X
  10. Daoud W. Control of an outbreak of BCG complications in Gaza. Respirology 2003;8:376-8. https://doi.org/10.1046/j.1440-1843.2003.00489.x
  11. Jeena PM, Chhagan MK, Topley J, Coovadia HM. Safety of the intradermal Copenhagen 1331 BCG vaccine in neonates in Durban, South Africa. Bull World Health Organ 2001;79:337-43.
  12. R Core Team (2015). R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. Available at: https://www.R-project.org/. Assessed 26 October 2015.
  13. Corbel MJ, Fruth U, Griffiths E, Knezevic I. Report on a WHO consultation on the characterisation of BCG strains, Imperial College, London 15-16 December 2003. Vaccine 2004;22:2675-80. https://doi.org/10.1016/j.vaccine.2004.01.050
  14. Smith KC, Orme IM, Starke JR. Tuberculosis vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia: Elsevier Inc, 2013:789-811.
  15. Fine PEM, Carneiro IAM, Milstien JB, Clements CJ. Issues relating to the use of BCG in immunization programmes: a discussion document. Geneva: WHO; 1999.
  16. Samileh N, Ahmad S, Farzaneh A, Shahnaz R, Lida F, Mohammad N. Immunity status in children with Bacille Calmette-Guerin adenitis. A prospective study in Tehran, Iran. Saudi Med J 2006;27:1719-24.
  17. Serour F, Mizrahi A, Somekh E, Feinberg J, Picard C, Casanova JL, et al. Analysis of the interleukin-12/interferongamma pathway in children with non-tuberculous mycobacterial cervical lymphadenitis. Eur J Pediatr 2007;166:835-41. https://doi.org/10.1007/s00431-006-0338-2
  18. Yeganeh M, Heidarzade M, Pourpak Z, Parvaneh N, Rezaei N, Gharagozlou M, et al. Severe combined immunodeficiency:a cohort of 40 patients. Pediatr Allergy Immunol 2008;19:303-6. https://doi.org/10.1111/j.1399-3038.2007.00647.x
  19. Lee PP, Chan KW, Jiang L, Chen T, Li C, Lee TL, et al. Susceptibility to mycobacterial infections in children with X-linked chronic granulomatous disease: a review of 17 patients living in a region endemic for tuberculosis. Pediatr Infect Dis J 2008;27:224-30. https://doi.org/10.1097/INF.0b013e31815b494c
  20. Nyerges G, Drinoczy M. Significance of the number of viable units in BCG vaccines. Dev Biol Stand 1986;58:331-6.
  21. Teulieres L, Diouf MA, Chaud P, Saint-Cyr A, Saliou P. Comparative trial of administration of half (0.05 mg) and quarter (0.025 mg) dose of intradermal Pasteur BCG on 291 infants from birth to 1 year in French Guyana. Vaccine 1991;9:521-4. https://doi.org/10.1016/0264-410X(91)90040-D
  22. Teo SS, Smeulders N, Shingadia DV. BCG vaccine-associated suppurative lymphadenitis. Vaccine 2005;23:2676-9. https://doi.org/10.1016/j.vaccine.2004.07.052
  23. Gheorghiu M. The present and future role of BCG vaccine in tuberculosis control. Biologicals 1990;18:135-41. https://doi.org/10.1016/1045-1056(90)90025-U
  24. Bolger T, O'Connell M, Menon A, Butler K. Complications associated with the bacille Calmette-Guerin vaccination in Ireland. Arch Dis Child 2006;91:594-7.
  25. World Health Organization. Expanded programme on immunization, biologicals unit: lymphadenitis associated with BCG immunization. Wkly Epidemiol Rec 1988;63:381-8.
  26. Baek HS, Chang JY, Moon SJ, Oh SH. Lymphadenitis following intradermal BCG vaccination. Korean J Pediatr 2006;49:46-50. https://doi.org/10.3345/kjp.2006.49.1.46
  27. Hwang JS, Choi YY, Ma JS, Hwang TJ. A clinical study on BCG lymphadenitis. Korean J Pediatr 1997;40:614-8.
  28. Lee JS, Sohn YM. Observation of response to PPD skin test and local side reactions at multiple inoculation sites after percutaneous inoculation with BCG Tokyo 172 strain. Korean J Pediatr Infect Dis 2000;7:201-10.
  29. Oh MH, Kim KH, Sim JG. The clinical study on conversion rate of Mantoux test, change of local lesion and complication after multipuncture BCG vaccination in neonates. Korean J Pediatr 1997;40:1120-30.
  30. Kim HJ, Oh SY, Lee JB. Comparison of each strains (Pasteur, Danish, Tokyo) of BCG efficacy using tuberculin test and adverse reactions. Korea Center for Diseases Control and Prevention, Osong, 2008.
  31. Goraya JS, Virdi VS. Treatment of Calmette-Guerin Bacillus adenitis: a metaanalysis. Pediatr Infect Dis J 2001;20:632-4. https://doi.org/10.1097/00006454-200106000-00020
  32. Banani SA, Alborzi A. Neddle aspiration for suppurative post-BCG adenitis. Arch Dis Child 1994;71:446-7. https://doi.org/10.1136/adc.71.5.446