海南省贫困地区新生儿应用自毁型预充式乙型肝炎疫苗有效性和安全性研究  

Study on Effect and Safety on the Uniject^(TM) Hepatitis B Vaccine Among Newborn in the Poor Areas of Hainan Province.

作　　者：孙莲英[1] 曾昭长[1] 符振旺[1] 王春雷[1] 朱坚[1] 李文师 王经辉 符发清 曾雪霞[1] 陈少明[1] 邓海英[1] 

机构地区：[1]海南省疾病预防控制中心,海口570203 [2]保亭县疾病预防控制中心,海南保亭572300 [3]琼中县卫生防疫站,海南琼中572900 [4]五指山市卫生防疫站,海南五指山572200

出　　处：《中国计划免疫》2005年第5期371-374,共4页Chinese Journal of Vaccines and Immunization

基　　金：北京生物制品研究所国际合作项目(编号:GAT.770-790-01535-COT)

摘　　要：目的评价自毁型预充式乙型肝炎(乙肝)疫苗在冷链内外保存,对新生儿接种后的有效性和安全性,探讨提高贫困地区新生儿乙肝疫苗首针及时接种率的新模式。方法采用随机整群抽样方法抽查项目地区新生儿乙肝疫苗接种率,进行冷链内、外不同项目组间和项目实施前后接种率比较;同时采集静脉血用放射免疫(RIA)法检测乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc),比较不同免疫策略的免疫效果和安全性。结果项目干预策略实施后新生儿乙肝疫苗3针全程合格接种率、及时接种率较项目前分别提高了13.7、33.2个百分点,差异均有非常显著的统计学意义(χ2=22.66,P<0.01;χ2=107.18,P<0.01)。新生儿HBsAg阳性率从项目前的6.2%降到2.1%。完成3针乙肝疫苗全程接种后抗-HBs阳转率为95.8%,组间差异无显著的统计学意义(χ2=2.38,P>0.05);96.4%抗-HBs阳转儿童达到保护水平抗体(≥10mIU/ml),几何平均滴度(GMT)为1∶148。在常温下存放1个月内,疫苗随着存放时间的延长,抗体阳转率和GMT略有下降,但组间差异无显著的统计学意义(χ2=0.34,P>0.05)。两组均无严重不良反应发生,冷链内、外使用疫苗不良反应无差别,该疫苗与计划免疫其它疫苗联合免疫未增加不良反应。结论自毁型预充式乙肝疫苗对新生儿进行接种是安全有效的,在冷链外保存1个月内使用也是安全有效的,该疫苗的使用对提高边远贫困地区新生儿乙肝疫苗首针及时接种率效果显著。Objective To evaluate the usefulness and safeties of the Uniject^TM Hepatitis B vaccine stored outside cold chain among newborn and look for a new model to improve timeliness coverage of the first dose within 24 hours after birth in the poor areas. Methods The target children were divided into two groups; group Ⅰ was received the Uniject^TM Hepatitis B vaccine stored outside cold chain, group Ⅱ was received the Uniject^TM Hepatitis B vaccine stored inside cold chain. The PPS sampling method was applied to investigated the Hepatitis B coverage of the target children, and collected the blood samples at the same time. To determine HBsAg, HBsAB and HBcAb by Radio Immuno Assay （RIA）, and compare the efficacy of different immunity strategy between group Ⅰ and group Ⅱ. Results The results showed that the coverage of the full-dose and the timeliness first-dose of Hepatitis B vaccine have increased by 13.7 and 33.2 percentage point respectively after the study carried out, and they showed significant difference respectively comparing with before. （X^2= 22, 66, P 〈 0.01; X^2= 107.18, P 〈 0.01） ; the newborns＇ carting-rate of HBsAg had decreased from 6.2 % to 2.1% ; Anti-HBs positive rates were 95.8 %,group Ⅰ and group Ⅱ had no significant difference （ X^2 = 2.38, P 〉0.05）. 96.4% of Anti-HBs （ ＋ ） children attained to protective level （ 〉 10mlUs/mL）, GMT was 1 ： 148; Anti-HBs positive rates and the GMT were slightly decreasing along with store-time extension outside cold chain within one month, but it has on significant difference（ X^2= 0.34, P 〉0.05）. The difference of side-effect rate between two groups was not significant, the sideeffect rate that the Uniject^TM Hepatitis B vaccine associated immunity with the other EPI vaccine was similar to single immunity. Conclusion It was safe and effective for the newborn received the Uniject^TM hepatitis B vaccine stored outside cold chain. The strategy of the study improved the timeliness coverage of the first-dose Hepatitis B v

关 键 词：新生儿 自毁型预充式乙肝疫苗 有效性 安全性 

分 类 号：R186[医药卫生—流行病学] R512.62[医药卫生—公共卫生与预防医学]