만성 B형 간염 소아청소년 환자에서의 라미부딘 치료 효과
Therapeutic Efficacy of Lamivudine in Children and Adolescents with Chronic Hepatitis B
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목적: 만성 B형 간염으로 치료가 필요하였던 소아청소년 중 lamivudine을 투여하면서 전향적으로 관찰한 자료를 검토하여 약제에 대한 치료 효과를 파악하고자 하였다. 방법: 2003년 6월 1일부터 2015년 10월 30일까지 가톨릭대학교 성빈센트병원 소아청소년과를 방문하여 만성 B형 간염의 첫 치료로 lamivudine (3 mg/kg, 최대 100 mg)을 3개월 이상 투여한 55명을 대상으로 하였다. 약제 투여 후 1개월, 3개월째, 이후는 매 3개월마다 B형 간염 바이러스(hepatitis B virus [HBV]) 표지자, HBV-DNA, 간기능을 추적하였다. 치료 중단은 alanine aminotransferase (ALT) 정상, HBeAg 음성 및 anti-HBe 양성 결과가 처음 발견된 시기로부터 12개월 후로 정하였다. 결과: 연구군은 남자가 31명(56.4%), 여자가 24명(43.6%)이었고, 약제의 첫 투여 연령은 평균 8.1세, 투여기간은 평균 23.4개월이었다. ALT 정상화는 98.2% (54/55), HBeAg 양성에서 anti-HBe 양성으로의 혈청 전환은 70.6% (36/51), HBsAg 소실은 10.9% (6/55)에서 이루어졌는데 모두 7세 미만 연령이었다. 약제 투여 6개월 시 HBV-DNA <2,000 IU/mL 바이러스 반응은 78.7% (37/47)이었고, 약제 중단 12개월 후에도 바이러스 반응이 유지되는 경우는 87.2% (34/39)이었다. Lamivudine 약제 내성이 발현된 경우는 16.4% (9/55)이었다. 결론: 만성 B형 간염을 가진 국내 소아청소년에 대한 lamivudine의 치료 효과는 유사한 외국 연구 결과에 비해 더 우수하였다. 새로 권고되고 있는 다른 항바이러스제 치료에 대한 국내에서의 지속적인 연구도 필요할 것으로 판단된다.
Abstract
Purpose: This prospective study aimed to investigate the therapeutic efficacy of lamivudine in children with chronic hepatitis B virus (HBV) infection. Methods: During July 2003 through October 2015, children with chronic hepatitis B who visited our institution were included in this study. Fifty-five patients, who received first-line treatment of lamivudine (3 mg/kg, 100 mg maximum) for over three months, were enrolled. After initiating lamivudine, alanine aminotransferase (ALT), HBV-DNA, and HBV markers were followed up at 1 month, 3 months, and every 3 months, thereafter. The treatment endpoint was determined as 1) normalization of ALT, 2) HBeAg seroconversion, and 3) anti-HBe positivity for twelve consecutive months. Results: Thirty-one male (56.4%) and 24 female (43.6%) patients were included. The mean age at treatment initiation was 8.1 years. The mean duration of treatment was 23.4 months. ALT normalization was found in 98.2% (54 of 55). Anti-HBe seroconversion was found in 70.6% (36/51). Loss of HBsAg was found in 10.9% (6/55). All biochemical responses occurred under age seven. The rate of virologic response (defined as HBV-DNA <2,000 IU/mL) at six months after treatment initiation was 78.7% (37/47). At twelve months after reaching treatment endpoint, 87.2% (34/39) maintained their virologic response. Resistance to lamivudine was found in 16.4% (9/55). Conclusions: Lamivudine treatment in Korean pediatric patients with chronic hepatitis B showed better outcomes compared with other studies that implemented similar protocols in foreign populations. Further studies are needed to investigate the efficacy of newly recommended antiviral drugs on the Korean pediatric population.
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