提高边远农村地区乙型肝炎疫苗首针及时接种率策略研究

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目的探索在中国经济发展滞后、交通不便的农村地区提高新生儿乙型肝炎(乙肝)疫苗首针(HepB1)及时接种率的策略。方法在中国湘西北3个国家扶贫开发县,将住院分娩率较低的乡随机分为3个组,1组用瓶装乙肝疫苗、自毁型注射器(Auto-Disable Syringe,AD注射器)按常规冷链要求接种;2组用瓶装疫苗、AD注射器,疫苗按常规冷链运输到村卫生室,村医按每月计划出生婴儿数领取HepB置于室温保存,待婴儿出生后24h内为婴儿接种;3组用Uniject预充式HepB,按常规冷链运输至村卫生室,疫苗置室温按第2组要求保存、使用。所有瓶装HepB和HB-Uniject疫苗都将贴上疫苗温度指示标签(vaccine vial monitor,VVM),以检测疫苗暴露于热源的程度和时间。结果研究基线和终期调查显示,1组儿童HepB1及时接种率由8.0%提高到57.9%;2组由11.3%提高至67.8%;3组由6.8%提高到77.3%。不同策略组儿童的HepB1及时接种率差异有显著的统计学意义。住院分娩的儿童,各种策略在提高HepB1及时接种率方面无明显差异。在家出生的儿童,1组儿童HepB1及时接种率从研究实施前的2.4%提高到实施后的25.2%,2组从2.5%提高到51.8%,3组从0.6%提高到66.7%。在24h内接种HepB1并完成3针接种1个月以上的儿童中,各组乙肝病毒表面抗体(抗-HBs)阳转率为95.5%~96.1%,冷链内外,使用AD和Uniject注射器差异均无显著的统计学意义。抗-HBs阳转的儿童中,90%产生了保护水平[≥10毫国际单位/毫升(mIU/ml)]的抗体,抗体几何平均浓度(GMC)为77mIU/ml~84mIU/ml,三组之间差异无显著的统计学意义。结论冷链外存放HepB的策略可以提高儿童,特别是在家出生的儿童HepB1及时接种率,对儿童产生保护性抗体无影响。Uniject注射器培训容易,使用简单,携带方便,尤其是上门接种时十分方便。更容易接种完整剂量的疫苗,还可以节省接种时间,在一定程度上提高HepB1及时接种率。 Objective To explore strategies to improve timely vaccination rate of hepatitis B (Hepatitis B) vaccine in rural areas with lagging economic development and inaccessible transportation in China. Methods Three rural poverty alleviation and development counties in northwestern Hunan Province were divided into three groups at random. The groups were randomly divided into three groups: hepatitis B vaccine, Auto-Disable Syringe (AD) Chain vaccination; 2 bottles of vaccine, AD syringes, the vaccine by conventional cold chain transport to village clinics, village doctors according to the monthly plan to receive HepB number of births placed at room temperature to be infants 24h after birth for the baby vaccination; Three groups were pre-filled with Uniject HepB, according to the conventional cold chain transport to the village clinics, vaccines room temperature according to the requirements of the second group to save, use. All bottles of HepB and HB-Uniject will be labeled with a vaccine vial monitor (VVM) to determine the extent and timing of vaccine exposure to heat. Results Baseline and final surveys showed that the timely vaccination rate of HepB1 increased from 8.0% to 57.9% in group 1, from 11.3% to 67.8% in group 1 and from 6.8% to 77.3% in group 3, respectively. HepB1 vaccination rate in different strategies group had significant difference statistically. Children in hospital delivery, various strategies in improving timely vaccination rate of HepB1 no significant difference. Children born at home, 1 group of children HepB1 timely vaccination rate from the pre-study 2.4% to 25.2% after the implementation of the two groups increased from 2.5% to 51.8%, 3 groups increased from 0.6% to 66.7%. Among children vaccinated with HepB1 for more than one month and 3 months after inoculation for more than 1 month, the seroconversion rates of hepatitis B virus surface antibody (anti-HBs) in each group were 95.5% -96.1%, both in AD and Uniject syringes No significant statistical significance. Ninety percent of antibodies raised levels of protection [≥ 10 milli-IU / ml (mlI) / ml) in anti-HBs positive children with antibody mean geometric mean concentrations (GMC) of 77 mIU / ml to 84 mIU / No significant difference between the statistical significance. Conclusion The strategy of HepB storage outside the cold chain can increase the timely vaccination rate of HepB1 in children, especially those born at home, and has no effect on protective antibodies in children. Uniject syringes are easy to train, easy to use and easy to carry, especially when in-field vaccination. Easier inoculation of a complete dose of vaccine, but also can save vaccination time, to a certain extent, improve HepB1 timely vaccination rate.
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