| 夏国良,龚健,王继杰,孟宗达,贾志远,曹惠霖,刘崇柏.重组乙型肝炎疫苗阻断乙型肝炎病毒母婴传播方案的保护效果评价[J].中华流行病学杂志,2003,24(5):362-364,365 |
| 重组乙型肝炎疫苗阻断乙型肝炎病毒母婴传播方案的保护效果评价 |
| Efficacy of recombinant hepatitis B vaccine and low-dose hepatitis B immune globulin in preventing mother-infant transmission of hepatitis B virus infection |
| 收稿日期:2002-11-28 出版日期:2014-09-18 |
| DOI： |
| 中文关键词: 疫苗 乙型肝炎免疫球蛋白 母婴传播 |
| 英文关键词: Vaccine Hepatitis B immune globulin Mother-infant transmission |
| 基金项目:国家“九五”科技攻关资助项目( 969060302) |
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| 中文摘要: |
| 目的评价国产重组乙型肝炎(乙肝)疫苗及其与中效价乙肝免疫球蛋白(HBIG)联合应用母婴阻断方案的保护效果。方法在广西等3个地区,对乙肝病毒双阳性母亲新生儿,应用重组乙肝疫苗和重组乙肝疫苗加50IUHBIG两种母婴阻断方案免疫新生儿,共随访单纯重组乙肝疫苗母婴阻断儿289例,重组乙肝疫苗加HBIG阻断儿186例。结果单纯重组乙肝疫苗的母婴阻断效果为87.8%(95%CI:83.6～91.9),重组乙肝疫苗加HBIG的阻断效果为91.2%(95%CI:86.7～95.6),重组(酵母)乙肝疫苗和重组(CHO细胞)乙肝疫苗间(P=0.7072)、两种母婴阻断方案间(P=0.2955)及各地免疫人群间(P=0.9987)的母婴阻断效果差异均无显著统计学意义。两种母婴阻断方案免疫新生儿间抗HBs的阳转率(P=0.3188)和抗体滴度(GMT)间(P=0.8925)差异均无显著统计学意义,首剂免疫后1年,抗HBs阳性率在单纯重组乙肝疫苗组和重组乙肝疫苗加HBIG组分别为91.1%和93.5%,GMT分别为153mIU/ml和164mIU/ml,以后逐年显著下降(线性趋势检验χ2=60.47,P=0.0001),至免疫后第4年,阳性率分别降为65.0%和66.6%,GMT仅为第一年的1/3。结论重组乙肝疫苗加中效价HBIG的母婴阻断效果可达90%以上, 明显优于常规剂量的血源疫苗。中国现行重组乙肝疫苗抗-HBs的免疫检测技术方法有待改进 |
| 英文摘要: |
| Objective To determine the efficacy of recombinant hepatitis B (rHB)vaccine and low-dose hepatitis B immune globulin (HBIG)in the prevention of mother-infant transmission of hepatitis B virus (HBV)infection.Methods rHB vaccine was administered to two groups of healthy neonates born to mothers with both hepatitis B surface antigen and e antigen positive in Guangxi,Hunan and Hebei province.Two hundred eighty-nine subjects were included in active immunization group, receiving triple doses of rHB vaccine given i.m.at 0,1 and 6 month intervals;while 186 subjectsreceiving 50 IU HBIG at birth with triple doses of rHB vaccine in the low-dose HBIG group.Results Efficacy of active immunization alone was 87.8%(95%CI:83.6-91.9).Efficacy of rHB vaccine and HBIG was 91.2%(95%CI:86.7-95.6).No significant differences in efficacy by type of rHB vaccine (P =0.7072),immunoprophylaxis programs (P = 0.2955) and regions of living (P =0.9987) were noticed.Seroprotection rates (anti-HBs ≥10 mIU/ml)were detected in 91.1% and 93.5% in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients,with geometric mean titer (GM T)of 153 mIU/ml and 164 mIU/ml at 1 year of age,respectively.Anti-rHBs decreased significantly with years after vaccination(χ2=60.47,P =0.0001).Seroprotection rates of anti-rHBs antibodies decreased to 65.0% and 66.6% at 4 years of age in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients,with GM T of 55 mIU/ml and 56 mIU/ ml,respectively .Conclusion These results suggested that the effectiveness of rHB vaccine plus low-dose HBIG was much better than only active plasma-derived vaccine;however,methods used for anti-rHBs assay need to be evaluated and verified. |
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