BCG 접종 후 이상반응 발생의 일부 위험요인에 관한 환자-대조군 연구

Abstract

[한글]

BCG 백신 접종은 발병력이 높은 인형 결핵균에 감염되기 전에 약독균을 접종하여 결핵에 대한 방어수단을 구축하는 것이나, BCG를 생균으로 접종하여 피접종자가 충분한 면역력을 유도할 때까지 균이 피접종자의 체내에 생존하고 있어 경미한 이상반응을 피할 수는 없다.본 연구는 2004년 1월 1일부터 2005년 12월 31일 사이에 BCG를 접종한 자 중 BCG 이상반응 진료비 지원을 신청한 자(BCG 이상반응이 발생한자)를 환자군(408명)으로 하고, 환자군과 같은 날 같은 보건소에서 접종하였으나 BCG 이상반응이 발생하지 않은자(1,242명)을 대조군으로 하였다. BCG 접종 후 이상반응의 발생 실태 및 특징을 파악하고, 접종 시기, 성별, 지역 등의 정보를 활용하여 이상반응 발생에 영향을 미치는 요익을 분석하였다.단변량 분석(Chi-Square Test)결과 성별에 따라 BCG 이상반응 발생을 비교하면, 환자군은 남자 254명(62.3%)이고, 여자 154명(37.7%)이며, 대조군은 남자 641명(51.6%), 여자 601명(48.4%)으로 성별에 따라 BCG 이상반응 발생은 통계적으로 유의하였다(p-value= 0.0002). 지역에 따라 BCG 이상반응 발생을 비교하면, 환자군은 대도시(특별시 또는 광역시)에 거주하는 비율이 35.3%(144명), 기타도시(도)에 거주하는 비율이 64.7%(264명)이며, 대조군은 대도시(특별시 또는 광역시)에 거주하는 비율이 23.2%(288명), 기타도시(도)에 거주하는 비율이 76.8%(954명)으로 지역에 따라 BCG 이상반응 발생은 통계적으로 유의하였다(p-value=<.0001). BCG를 접종하는 시기에 따라 BCG 이상반응 발생을 살펴보면, 환자군은 출생 후 30일 이내에 접종한 자는 292명(71.6%)이고, 31일에서 365일 내에 접종한 자는 113명(27.7%)이고, 출생 후 366일 이후에 접종받은 자는 3명(0.7%)이며, 대조군은 출생 후 30일 이내에 접종한 자는 775명(62.4%)이고, 31일에서 365일 내에 접종한 자는 465명(37.4%)이고, 출생 후 366일 이후에 접종받은 자는 2명(0.2%)으로 접종시기에 따라 BCG 이상반응 발생은 통계적으로 유의하였다(p-value=0.0008).다변량 분석(로지스틱 회귀분석)결과 이상반응 발생에 영향을 미치는 요인은 접종시기(p-value=0.0010), 성별(p-value=0.0001), 지역(p-value=<.0001)으로 나타났으며, 접종 시기는 출생 후 30일 이내에 접종이 출생 후 31일 이후 접종에 비해 BCG 이상반응이 발생할 확률이 0.66배 (odds ratio 0.66(95% C.I., 0.515-0.845)), 남자가 여자에 비해서 BCG 이상반응이 발생할 확률이 1.57배 (odds ratio 1.568(95% C.I., 1.244-1.977)), 지역은 기타도시에서 접종한자가 대도시에서 접종한자에 비해 BCG 이상반응이 발생할 확률이 0.57배 (odds ratio 0.565(95% C.I., 0.515-0.845))로 나타났다.본 연구 결과로부터 접종 시기, 성별, 지역이 BCG 이상반응 발생에 영향을 미치는 요인으로 조사되었다.

[영문]The objective of BCG vaccination is to structure the means of defense against the tuberculosis before one is infected to mycobacterium tuberculosis which has high possibility of outbreak by vaccinating the microbe; however, once BCG vaccination is done with live bacilli, it cannot be avoid from a minor adverse event because bacilli still exist in the vaccinated person until the person becomes immuned from tuberculosis.This study set the people applied for the treatment cost for the BCG adverse event(the people with BCG adverse event) as the patient group (408 people) and set the people without BCG adverse event who also had the vaccination on the same date at the public health center as the control group (1242 people) among the people who had the BCG vaccination from January, 1st, 2004 to December 31st, 2005. It examined the actual condition and characteristics of the adverse event after the BCG vaccination, and analyzed the factors that affect the onset of adverse event using the information such as vaccination period, gender, and region.As a result of univariate anlaysis (test of independence), comparing the occurrence of the BCG adverse event according to the gender, the patient group( people with the occurrence) was 254 persons for men (15.4%) and 154 persons for women (9.3%), and the control group (people without the occurrence) was 641 persons for men (38.8%) and 601 persons for women (36.4%). Comparing the occurrence of the BCG adverse event according to the region, the patient group who resides in large cities (special cities or metropolitan cities) was 144 persons (8.7%) and the control group who resides in large cities was 288 persons (17.5%); and the patient group who resides in other cities (province) was 264 persons (16.0%) and the control group who resides in other cities were 954 persons (57.8%). Looking into the occurrence of the BCG adverse event according to the period of time of the BCG vaccination, the people with the occurrence of the BCG adverse event after the vaccination within 30 days after the birth was 292 persons (17.7%) and the people without the occurrence was 775 persons (47.0%), among the people who had vaccination between 31~365 days, the people with the occurrence of the BCG adverse event was 113 persons (6.8%) and the people without the occurrence was 465 persons (28.2%), and among the people who had vaccination after 366 days or more from the birth, the people with the occurrence of the BCG adverse event was 3 persons (0.2%) and the people without the occurrence was 2 persons (0.1%) , which was statistically significant.As a result of multivariable analysis (logistic regression analysis), for the vaccination period, the odds ratio that BCG adverse event occurred was shown as 0.66 (95% C.I., 0.515-0.845) for the vaccination after 31 days from the birth compared to the vaccination within 30 days after the birth; for gender, the odds ratio was shown as 1.568 (95% C.I., 1.244-1.977) for men with the occurrence of the BCG adverse event compared to that of women; and for region, the odds ratio that the BCG adverse event would occur among the people who had vaccination in other cities compared to the people who had vaccination in large city was shown as 0.565 (95% C.I., 0.441-0.723). which is statistically significant.From the result of this research, the vaccination period, gender, and region were indicated as the factors that affect the occurrence of the BCG adverse event.