A pilot study on the combined therapy of granulocyte-macrophage colony-stimulating factor and hepatitis B vaccine on chronic hepatitis B virus carrier children  

粒细胞-巨噬细胞集落刺激因子联合乙肝疫苗治疗宫内乙型肝炎病毒感染慢性携带儿童的研究(英文)

作　　者：王建设[1] 朱启镕[1] 张婷[1] 俞蕙[1] 

机构地区：[1]复旦大学附属儿童医院传染科,上海200032

出　　处：《Chinese Medical Journal》2002年第12期1824-1828,共5页中华医学杂志（英文版）

基　　金：ThisstudywassupportedbyagrantfromtheNationalPublicHealthMinistry (No97030223)andagrantfromtheNationalNaturalScienceFoundationofChina (No 39670 667)

摘　　要：Objective To observe the efficacy of treating intrauterine infected chronic hepatitis B virus (HBV) carrier children with a combination of granulocyte macrophage colony stimulating factor (GM CSF) or hepatitis B immunoglobulin (HBIG) plus recombinant hepatitis B vaccine (rHBvac) Methods A total of 27 chronic HBV infected children, who were born to HBV carrier mothers and received hepatitis B immunoprophylaxis at birth, were randomized into 2 groups: one receiving a combined therapy of 50 μg of GM CSF plus 10 μg of rHBvac injected intramuscularly at the same location (GM CSF group, 14 children) or 200 IU HBIG and 10 μg rHBvac in different muscles (HBIG group, 13 children) on a monthly four dose schedule HBV DNA quantification and other HBV serological markers were tested before and after the four dose therapy Results Twelve children in each group completed the study Of them, 3 children in the GM CSF group and 4 in the HBIG group had elevated serum alanine transaminase (ALT) before the trial, and then 2 in each group became ALT normal after the treatment Before the therapy, hepatitis B e antigen (HBeAg) positivity was found in nine children in the GM CSF group and 10 in the HBIG group One from each group had an HBeAg/anti HBe seroconversion after the treatment The quantity of HBV DNA was significantly lower after the treatment ( P =0 023) in GM CSF group, but was not significantly reduced in HBIG group No subjects were found to be negative for hepatitis B surface antigen (HBsAg) after the treatment, and no serious adverse events occurred in either group Conclusion Combined GM CSF and rHBvac therapy inhibit HBV replication in carrier children who were not protected after treatment with immunoprophylaxis目的　初步观察重组粒细胞 巨噬细胞集落刺激因子 (GM CSF)或乙型肝炎免疫球蛋白 (HBIG)联合酵母重组乙型肝炎疫苗 (rHBvac)对宫内感染呈慢性乙型肝炎病毒 (HBV)携带儿童的治疗作用。方法　母亲为慢性HBV携带者、出生时乙型肝炎表面抗原 (HBsAg)阳性、经乙型肝炎疫苗免疫仍发展为慢性HBV的无症状儿童 2 7名随机分为两组。Ⅰ组 (n =14)使用GM CSF 5 0 μg和rHBvac 10 μg同一部位肌肉注射 ,每月一次 ,共四次 ;Ⅱ组 (n =13)HBIG 2 0 0IU和rHBvac 10 μg不同部位肌肉注射 ,每月一次 ,共四次。治疗结束后一月定量复查HBV DNA及其他HBV标记。结果　两组各有 12名儿童完成研究。治疗前丙氨酸转氨酶 (ALT)异常Ⅰ组 3例 ,Ⅱ组 4例 ,治疗后各有两例恢复正常 ;治疗前乙型肝炎e抗原 (HBeAg)阳性Ⅰ组 9例 ,Ⅱ组 10例 ,治疗后各 1例发生HBeAg/抗 HBe血清转换HBV DNA定量 ,治疗后和治疗前相比 ,Ⅰ组有显著下降 (符号秩和检验P =0 0 2 3) ,Ⅱ组变化不明显。两组中均无HBsAg转阴病例。未出现严重副作用。结论　GM CSF联合乙肝疫苗对乙肝疫苗免疫失败的慢性HBV携带儿童有一定治疗作用 ,其作用可能通过增加 1型细胞因子分泌实现。

关 键 词：recombinant hepatitis B vaccine  ·granulocyte  macrophage colony  stimulating factor  ·  chronic   hepatitis B 

分 类 号：R725.1[医药卫生—儿科]