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国产血源性乙型肝炎疫苗接种后九年效果评价 |
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徐慧文 左弘 庄贵华 王学良 刘蓬勃
孔令斌 张建营 李东升 隋秀芬 徐经武
【摘要】 目的 观察乙型肝炎疫苗接种后9年效果。方法 对9年前经随机、双盲、有安慰剂对照严格设计的，曾完成疫苗全程接种的疫苗组126名、安慰剂组135名5～9岁儿童进行随访并采血，询问发病情况，检测乙型肝炎3项指标(HBsAg、抗-HBc和抗-HBs)。对抗体下降原因进行多因素分析。结果 经9年观察，失访率控制在4%～19%。第九年(T108)疫苗组抗体阳性率和GMT仍显著高于安慰剂组，分别为65.3%、5.47和28.2%、1.46。但与第六年(T72)相比，疫苗组两指标均明显下降。对4、6、9年抗体下降原因做多因素分析均显示，T12抗体滴度高低是抗体是否能持续存在的重要因素，自然加强可能也起一定作用。9年中，T108时安慰剂组发生1例临床乙型肝炎病人，疫苗组无病例；对HBV感染的保护率为81.4%，对HBsAg阳转的保护率为84.6%。与第六年相比基本相同。结论 乙肝疫苗接种后9年效果仍是完好的，无需复种。
【关键词】 肝炎，乙型 疫苗 肝炎抗体
Evaluation of the Effectiveness Nine Years after Primary Immunization with Local Produced Plasma-derived Hepatitis B Vaccine Xu Huiwen, Zuo Hong, Zhuang Guihua, et al. Department of Epidemiology, Xi′an Medical University, Xi′an 710061
【Abstract】 Objective To observe the effectiveness of hepatitis B vaccine nine years after primary immunization. Methods A randomized, controlled and double-blinded trial was designed with 126 children primarily immunized with local produced plasma-derived hepatitis B vaccine nine years ago and 135 placebo-control children aged five to nine years. All the children were followed-up, their blood samples collected and their disease occurrence examined. Their hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBc) and antibody against hepatitis B surface antigen (anti-HBs) were tested. Causes of lowering in their antibodies were analyzed with multivariate methods. Results During the nine-year follow-up, 4% to 19% of the study subjects dropped out. In the ninth year after immunization (T108), anti-HBs positive rate in the vaccinees and their geometric mean titer (GMT) (65.3% and 5.47, respectively) were still significantly higher than those in the placebo-controls (28.3% and 1.46, respectively), but significantly lower than those in the 6th year after immunization (T72). Multivariate analysis for the causes of lowering in the antibody during the 4th, 6th [1] [2] [3] 下一页
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