To evaluate the immunogenicity, safety, and dosage of a new inactivated hepatitis A vaccine administered to young adults Methods One hundred and four normal adult volunteers, seronegative for hepatitis A virus and...
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To evaluate the immunogenicity, safety, and dosage of a new inactivated hepatitis A vaccine administered to young adults Methods One hundred and four normal adult volunteers, seronegative for hepatitis A virus and hepatitis B surface antigen, were randomly assigned to one of three groups The high dose group received a primary dose of 1000 units of the new vaccine, the low dose group received a primary dose of 500 units of the same vaccine, and the Havrix group received a primary dose of 1440 enzyme linked immunosorbent assay units of Havrix, a licensed inactivated hepatitis A vaccine All groups received a booster dose of the same vaccine 6 months after the primary dose Local and systemic adverse reactions, seroconversion rates, and geometric mean titers of hepatitis A virus antibodies were measured in all three groups Results Local and systemic reaction types and rates were similar in all three groups after primary and booster doses, although local reactions were more frequent in the Havrix group following the primary dose No serious adverse reactions occurred One month after the primary dose, the seroconversion rate was 87 5% in the high dose group, 70 0% in the low dose group, and 50.0% in the Havrix group ( P =0.001, versus the high dose group) At month 6 (before administration of the booster dose), seroconversion rates were 96 9% in the high dose group, 65 0% in the low dose group ( P =0 0029), and 68 8% in the Havrix group ( P =0 007) All subjects in all groups seroconverted by one month after receipt of the booster dose Geometric mean titers were similar in all three groups at month 1, but were higher in the high dose group (264 mIU/ml) than those in the Havrix group (135 mIU/ml) at month 6 ( P =0 0013) One month after the booster dose, geometric mean titers in the high dose group (2747 mIU/ml) were higher than those in the low dose group (1657 mIU/ml) ( P =0 0223) or in the Havrix group (1316 mIU/ml)
目的探讨和评价适合中国农村地区的子宫颈癌筛查方案。方法本研究依托中国2015年卫生行业科研专项"适合中国农村地区的子宫颈癌筛查技术与示范研究"建立筛查人群队列,收集卫生经济学和流行病学参数,采用Treeage Pro 2011软件...
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目的探讨和评价适合中国农村地区的子宫颈癌筛查方案。方法本研究依托中国2015年卫生行业科研专项"适合中国农村地区的子宫颈癌筛查技术与示范研究"建立筛查人群队列,收集卫生经济学和流行病学参数,采用Treeage Pro 2011软件建立未筛查组模型和筛查组模型。通过将现场调查获得的人群筛查、诊断、治疗的相关临床资料和成本数据代入模型,以模拟中国农村妇女在采用不同筛查方案干预后子宫颈癌的发生、发展,并预测20年后的筛查效果[包括累积发病率、累积发病风险、挽救的生命年和质量调整生命年(QALY)、收益]和相应的成本费用,并进行卫生经济学评价(包括成本效果分析、成本效用分析、成本效益分析)。子宫颈癌筛查方法有5种,包括醋酸或碘染色后肉眼观察(VIA/VILI)法、HPV快速筛查技术(careHPV)、液基薄层细胞学检查(TCT)、careHPV+TCT、careHPV+VIA/VILI,筛查间隔时间有3个,包括1年1次、3年1次和5年1次,共15种子宫颈癌筛查方案。结果与未筛查组相比,15种子宫颈癌筛查方案可降低累积发病风险22.65%~51.76%。在同一筛查间隔时间,careHPV分别与TCT、VIA/VILI法比较,降低的累积发病风险、挽救的生命年、增加的QALY、收益均较高。15种子宫颈癌筛查方案的成本效果比为(0.44~3.24)万元/生命年,成本效用比为(0.15~1.01)万元/QALY,效益成本比为7.73~59.10。增量成本效果分析显示,优势方案有VIA/VILI法5年1次、VIA/VILI法3年1次、care HPV检测5年1次、careHPV检测3年1次和careHPV检测1年1次。结论VIA/VILI法筛查经济有效,careHPV成本稍高但效果更好。对于我国农村地区建议选择careHPV检测5年1次的筛查方案。本研究为确定适合中国农村地区的子宫颈癌筛查方法提供了依据。
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