2015 - 2017年湖北省口服轮状病毒减毒活疫苗安全性监测分析

目的 分析湖北省2015 - 2017年口服轮状病毒减毒活疫苗（oral live attenuated rotavirus vaccine,ORV）疑似预防接种异常反应（adverse Events following Immunization, AEFI）的发生特征,评价ORV预防接种的安全性。方法 通过中国AEFI信息管理系统,收集湖北省2015 - 2017年接种ORV发生的AEFI个案数据,采用描述流行病学方法进行分析。结果 湖北省2015 - 2017年接种ORV发生AEFI 223例（33.82/10万剂）,未报告肠套叠等严重AEFI病例,其中一般反应、异常反应分别为197例（29.88/10万剂）和20例（3.03/10万剂次）。一般反应主要表现为发热（25.63/10万剂）和胃肠道反应（9.71/10万剂）,异常反应主要为过敏性皮疹（2.12/10万剂）和荨麻疹（0.91/10万剂）。发病年龄集中在2岁以下,其中51.57%发生在＜1岁,35.43%发生在1~2岁;各剂次中,首剂接种后发生186例（83.41%）、第2剂30例（13.45%）、第3剂7例(3.14%);66.37%的病例发生在接种当天;17.04%发生在接种后1 d;4.48%发生在接种后2 d,0.45%发生在接种后3 d及以上;联合接种时92.04%为一般反应;98.21%病例治愈或好转,无后遗症和死亡病例报告。结论 口服轮状病毒减毒活疫苗具有良好的安全性。     

2011—2012年新疆哨点医院轮状病毒流行分析

目的对620例婴幼儿腹泻患者的粪便标本进行A组轮状病毒抗原检测,了解其流行规律。方法用酶联免疫吸附试验(ELLISA)抗原检测法对≤5岁住院腹泻患儿粪便标本进行检测并对结果进行分析。结果在620例标本中检测到轮状病毒阳性286例,阳性率为46.13%;6~23月龄婴幼儿轮状病毒发病率最高,其次为0~5月龄;轮状病毒腹泻发病的高峰期为9月至次年2月。结论新疆轮状病毒感染高发季节是秋冬季,2岁以下儿童是感染的高发年龄段,疫苗接种的适用对象应重点为2岁以内婴幼儿     

婴幼儿轮状病毒感染性腹泻流行特征及免疫状况研究

目的:掌握婴幼儿轮状病毒感染性腹泻流行特征及轮状病毒疫苗免疫状况,为制定防控对策提供依据.方法:以常山县人民医院报告的婴幼儿(0～3岁儿童)其他感染性腹泻的病例为研究对象,所有病例采用酶联免疫吸附试验法进行轮状病毒抗原检测,分析轮状病毒检出率、描述轮状病毒感染性腹泻病流行特征.并探讨免疫接种与轮状病毒感染性腹泻发病关联.结果:婴幼儿轮状病毒感染性腹泻发病率1.19％,婴幼儿其他感染性腹泻病人中轮状病毒检出率34.01％,11月至次年4月为轮状病毒检出率高峰时段;1～岁年龄组检出率最高.婴幼儿感染性腹泻病例轮状病毒疫苗接种率为38.54％,免疫接种一剂次者占98.69％.研究对象轮状病毒疫苗接种与轮状病毒感染性腹泻发病存在统计学关联(x2=14.76,P＜0.001);6～12月龄阶段接种轮状疫苗与发病的关联也有统计学意义(x2=10.75,P＜0.001).结论:常山县轮状病毒感染性腹泻病具有明显季节性和人群特征,与温州王金文、丽水丁友法等研究结果一致.婴幼儿轮状病毒疫苗接种对婴幼儿轮状病毒感染性腹泻有较好保护作用,婴幼儿在6～12月龄阶段接种轮状病毒疫苗保护效果最佳.     

5岁以下儿童轮状病毒腹泻流行特征和经济负担评价分析

目的了解轮状病毒在5岁以下门诊和住院腹泻儿童中的流行特征,探索建立轮状病毒腹泻经济负担的评价方法,为轮状病毒疫苗的使用和成本效益评价提供背景资料。方法收集甘肃省2012年8月-2013年7月2个轮状病毒哨点医院门诊和住院的5岁以下腹泻就诊儿童的个案信息和粪便标本,进行轮状病毒腹泻流行特征分析,对所有标本统一使用酶联免疫吸附试验方法检测轮状病毒,资料采用SPSS17．0进行数据分析。结果共调查5岁以下腹泻就诊儿童734例．轮状病毒阳性率为41．69％,其中门诊病例的轮状病毒阳性率为30．99％,住院病例的轮状病毒阳性率为46．07％,门诊和住院轮状病毒腹泻儿童的发病年龄主要集中在2岁以下,分别占门诊和住院腹泻儿童的92．42％和97．92％,其中6月龄组的婴幼儿比例最高。分别占fq诊和住院腹泻儿童的54．55％和55．42％,粪便性状主要以水样便为主,占85．80％,其次为稀便,占81．27％。5岁以下轮状病毒腹泻儿童人次均门诊直接医疗费用375．42元,人次均住院直接医疗费用2053．91元．人次均门诊直接非医疗费用47．92元,人次均住院直接非医疗费用180．13元。人次均门诊间接费用270．45元,人次均住院间接费用721．20元。结论2岁以下婴幼儿是轮状病毒腹泻的高友人群,针对轮状病毒腹泻对儿童健康造成的危害和经济负担．需采取措施控制轮状病毒腹泻的发病水平。     

杭州地区腹泻患儿轮状病毒感染流行病学特征分析

【目的】 探讨杭州地区腹泻儿童感染A组轮状病毒的流行病学特征,指导临床防治。 【方法】 对2007-2011年门诊和住院的急性腹泻儿童的大便进行轮状病毒抗原检测,并采用统计方法分析流行病学特征。 【结果】 杭州地区2007-2011年腹泻儿童A组轮状病毒平均阳性率为29.25%。阳性率从2007年的39.42%下降到2011年的19.61%,其中每年11-12月份为儿童轮状病毒感染高峰期;且以6~18月的患儿感染率最高。腹泻儿童中门诊轮状病毒阳性率为32.28%,住院儿童的阳性率为20.70%。 【结论】 杭州地区儿童A组轮状病毒感染率低于全国平均水平,而且有逐年下降趋势。在今后应加快安全高效的轮状病毒疫苗的开发,从根本上解决儿童轮状病毒的危害。     

长春市2005~2013年小儿轮状病毒腹泻流行病学研究

目的:了解长春市小儿轮状病毒腹泻流行病学特征。方法:在长春市儿童医院收集5岁以下住院腹泻患儿粪便标本和临床资料,对粪便标本采用ELISA方法进行轮状病毒检测,用反转录PCR方法进行G血清型和P基因型分析。结果:长春市2005~2013年小儿腹泻轮状病毒阳性检出率为53.33%(2098/3934),2005~2010年逐年下降,2011年开始上升;轮状病毒性腹泻每年10月到次年2月为感染高发季节;轮状病毒感染以G3型为主(51.83%)是流行优势株,但G3型呈下降趋势,G9型有上升趋势;P血清型以P[8]型为主;发病年龄97.54%集中在0~24月龄婴幼儿,高发年龄段为7~12月龄婴儿,男∶女为1.83∶1;主要临床表现是腹泻、呕吐和发热。结论:轮状病毒是长春市小儿腹泻的主要病原,G分类是G3型,P分类是P[8]型,并且呈现超常多样性。长期监测轮状病毒性腹泻病原变化对于预防病毒性腹泻和疫苗研发有重要意义。     

盐城市<3岁儿童家长口服轮状病毒疫苗接种意愿调查

目的了解盐城地区儿童家长对口服轮状病毒疫苗(ORV)认知度和接种意愿,分析影响因素。方法随机抽取预防接种综合服务管理信息系统中未接种ORV、年龄3岁儿童的家长,采用统一设计问卷进行调查。结果有效调查儿童家长932人,表示愿意接种ORV占79.1%。听说过ORV的愿意选择接种的占86.3%,未听说过而愿意选择接种的占73.7%,差异有统计学意义(χ~2=21.79,P0.01)。愿意接种原因前3位依次为能保护小孩不得病(77.9%)、接种门诊医生建议(37.9%)、轮状病毒感染严重(36.8%);拒绝接种原因前3位依次为担心疫苗安全性(53.8%)、没听说过ORV(50.3%)、担心疫苗预防效果(44.6%)。多因素logistic回归分析结果显示,农村户籍、高收入、听说过轮状病毒儿童家长更易愿意接种ORV(P值均0.05)。结论应加强非免疫规划疫苗的宣传力度,提高接种率,降低疫苗针对疾病的发病率。     

轮状病毒疫苗

1背景1·1流行病学轮状病毒是世界上引起<5岁儿童重症腹泻的首位病原,每年轮状病毒感染引起2 500万门诊病例和200万住院病例。在发展中国家,3/4的儿童在<12月龄就会发生轮状病毒初次感染,而在发达国家初次感染通常延迟至2~5岁。重症轮状病毒胃肠炎的发生主要限于6~24月龄儿童。据估计,2004年约有52·7万(47·5万~58万)死亡病例,主要发生在低收入国家。虽然初次感染的临床症状最明显,轮状病毒的再感染也十分普遍。在温带地区,轮状病毒胃肠炎的典型发病高峰是在冬季,而在热带地区轮状病毒感染是全年发生,无明显的发病高峰季节,可能的原因是被…     

婴幼儿轮状病毒腹泻发病危险因素1：2配对病例对照研究

WHO估计全球每年有453 000例5岁以下儿童因感染轮状病毒（RV）腹泻而死亡，大部分发生在发展中国家[1]；亚洲5岁以下儿童腹泻中RV检出率高达55.0%，我国住院腹泻患儿RV检出率为46.0%，门诊为29.0%[2]；RV可通过受污染的手和物品以及呼吸道进行传播[3]。为此本研究于2007-2008年对甘肃省5岁以下儿童RV腹泻患病的危险因素开展1：2配对病例对照研究。     

广州地区儿童腹泻轮状病毒的流行病学研究

目的了解广州地区儿童腹泻中轮状病毒(RV)感染的情况,为临床诊断和治疗提供可靠实验数据。方法收集某院2010年1月至2012年12月住院和门诊的腹泻儿童粪便标本1 878,采用免疫层析双抗体夹心法进行A组轮状病毒(RV)抗原检测,并比较分析检测数据。结果 1 878例腹泻标本中[年龄范围在(1.99±2.37)岁],有616例RV结果阳性,阳性率为32.80%;其中0~1岁组腹泻患儿童阳性率可达36.21%(构成比69.48%),其次为1~2岁年龄组腹泻儿童占31.92%(构成比15.91%),2~3岁年龄组腹泻儿童占33.74%(构成比9.09%),可见0~3岁年龄段腹泻儿童(构成比共占94.48%)年龄段为高发期。以每年秋冬季节10、11、12和1月份(4个月构成比为82.46%)为发病高峰。结论轮状病毒是本地区儿童腹泻(0~14岁)的主要病原,0~3岁儿童是轮状病毒的易感人群,以秋冬季节10、11、12和1月份为流行高峰。     

婴幼儿轮状病毒腹泻发病危险因素的病例对照研究

目的探讨5岁以下婴幼儿轮状病毒（RV）腹泻发病的危硷因素,为该病的预防控制提供科学依据。方法选择深圳某街道2007年10月—2009年12月,5岁以下的RV实验室确诊病例166例作为病例组,按照1∶1匹配随机选择同期未出现呕吐或腹泻症状,且与确诊病例同一或相邻楼层、相同性别、相同月龄段者作为对照。自行设计问卷,由统一培训的调查员对儿童家长进行面访调查,收集相关信息。采用EPI INFO 3.3软件建立数据库,然后使用SPSS 13.0软件包进行统计分析。结果 166例病例中,腹泻占98.80%（164/166）,发热（≥37.5℃）的占55.42%（92/166）,呕吐的占48.80%（81/166）。曾口服RV疫苗的56例病例中,服苗14 d内发病的占32.14%（18/56）,服苗超过1年后发病的占58.93%（33/56）。单因素条件logistic回归分析结果显示,接触过呕吐（腹泻）病人和到过某医院门诊部的是危险因素,口服RV疫苗、母乳喂养和喂孩子之前洗手是保护因素（均P〈0.05）。口服RV疫苗的疫苗效力（VE）=（1-0.57）×100%=43%。多因素条件logistic回归分析结果显示,接触过呕吐（腹泻）病人是危险因素,口服RV疫苗每年二三次和喂孩子之前洗手是保护因素（均P〈0.05）[1]。口服RV疫苗2次/a的VE=（1-0.48）×100%=52%;口服RV疫苗3次/a的VE=（1-0.35）×100%=65%。结论腹泻、发热、呕吐是轮状病毒感染主要的症状;口服RV疫苗需要经过2周后方可产生抗体,免疫力只能维持1 a;避免接触呕吐（腹泻）病人,每年口服RV疫苗二三次和喂孩子之前洗手等可减少感染RV。     

2006年婴幼儿腹泻轮状病毒监测分析

目的监测乌鲁木齐地区婴幼儿腹泻轮状病毒（RV）感染情况和流行特点。方法 2006年1月至12月,采集门诊或住院≤5岁婴幼儿腹泻样本248例,用酶免法（ELISA）筛查RV,用RT-PCR方法对RV阳性毒株进行G基因型分型。采用SPSS13.0统计软件,数据处理用χ2检验。P〈0.05表示统计学差异有统计学意义。结果 248例腹泻样本,检出RV 133例,阳性率为53.6%。RV感染对象主要为24月以内婴幼儿,占94.7%,发病高峰在8~9月份。对125份RV阳性毒株进行G基因型分型,结果显示：G1型（46.4%）为最流行毒株,其次为G3型（17.6%）、G9型（7.2%）和G2型（4.0%）,混合感染占14.4%,不能分型占10.4%。结论轮状病毒是乌鲁木齐地区婴幼儿腹泻的主要病原,2006年G1和G3型为主要流行基因型。     

口服轮状病毒活疫苗的社区应用效果评价

目的探讨口服轮状病毒活疫苗在社区卫生服务中的应用效果,以提高预防接种率,促进社区卫生服务疾病预防工作。方法将在社区健康服务中心建立健康档案的2000名6月龄～3周岁的儿童随机分成服苗组和对照组,进行轮状病毒腹泻的发病情况比较。结果服苗组发病率为2.1%,同期对照组的发病率为8.4%,两者差异有统计学意义(P0.01),且服苗组的发病程度明显低于对照组。结论口服轮状病毒活疫苗预防儿童轮状病毒腹泻效果显著。     

Evaluating the first introduction of rotavirus vaccine in Thailand: Moving from evidence to policy

BackgroundWe assessed the effectiveness and possible impact of introducing rotavirus vaccine into the routine immunization program.MethodsTwo provinces were selected for an observational study, one where vaccine was introduced and another where vaccine was not available. In these areas, two sub-studies were linked. The prospective cohort study enrolled children 2 month old and followed them to the age of 18 months to detect all diarrhea episodes. The hospital surveillance study enrolled all children up to age 5 hospitalized with diarrhea whose fecal samples were tested for rotavirus. Rates of rotavirus hospitalizations in older children who had not been vaccinated in both settings provided data to determine whether immunization had an indirect herd effect. The key endpoints for the study were both vaccine effectiveness (VE) based upon hospitalized rotavirus diarrhea and herd protection.FindingsFrom the cohort study, the overall VE for hospitalized rotavirus diarrhea was 88% (95%CI 76–94). Data from hospital surveillance indicated that for 2 consecutive years, the seasonal peak of rotavirus admissions was no longer present in the vaccinated area. Herd protection was observed among older children born before the rotavirus vaccine program was introduced, who experienced a 40–69% reduction in admission for rotavirus.ConclusionsRotavirus vaccine was highly effective in preventing diarrheal hospitalizations and in conferring herd protection among older children who had not been vaccinated.     

三个监测点医院2001-2004年婴幼儿轮状病毒腹泻监测

目的 了解3个监测点医院2001年8月至2004年7月住院的5岁以下婴幼儿轮状病毒腹泻流行状况。方法 以医院为基础的哨点监测,监测对象为5岁以下腹泻住院患儿。收集患儿的临床资料和粪便标本并进行轮状病毒检测和分型。结果 共检测3121份腹泻患儿的粪便标本,轮状病毒检出率为51%。94%的轮状病毒腹泻发生在2岁以下儿童。G3型为流行优势株,占69．9%,其次为G1型6．6%、G2型2．9%、G9型2．2%、G4型0．3%。P[8]型为最常见的P基因型。最常见的P-G组合型是P[8]G3,占64．0%,还有其他7种不常见的P-G组合的毒株类型。结论 轮状病毒是3个监测点医院住院腹泻患儿的主要病原,P[8]G3型为主要流行株。     

The effect of rotavirus immunization on rotavirus gastroenteritis hospitalization rates in military dependents

We conducted a retrospective review of all U.S. military dependents less than 5 years old hospitalized with rotavirus-associated gastroenteritis from July 2003 to June 2009. The two post-vaccine seasons showed a significant reduction of 62.4% (95% CI, 58.6-65.8, P < 0.001) in rotavirus gastroenteritis hospitalization rate compared to the three pre-vaccine seasons. Infants less than 12 months old showed the greatest reduction in incidence at 75.3%. A substantial decrease was also seen in unvaccinated children as well. Vaccine efficacy against hospitalization was 86.0% (95% CI, 77.7-91.3) after just a single dose. The overwhelming majority of children hospitalized for rotavirus since the introduction of the vaccine (ranging from 91.8 to 100% per season) had not received any of the rotavirus vaccine series.     

2006-2010四川地区婴幼儿腹泻轮状病毒监测

目的了解四川地区哨点医院轮状病毒腹泻流行状况和特点,为疫苗研制和疫情控制提供科学依据。方法四川监测点(成都市儿童医院)监测对象为5岁以下腹泻的门诊和住院患儿,收集2006-2010年患儿的粪便标本进行轮状病毒检测和分型,使用ELISA进行病毒检测,RT-PCR进行病毒分型。结果 972例腹泻患儿送检标本中检测到353株轮状病毒抗原阳性,阳性率为36.3%,6月龄-2岁幼儿是轮状病毒感染的高发年龄段,轮状病毒腹泻发病的高峰季节是10-12月份。结论轮状病毒是四川地区哨点医院婴幼儿腹泻的重要病原,毒株流行型别显示一定的规律性和多样性。     

Rotavirus vaccines and vaccination in Latin America.

Worldwide, rotaviruses account for more than 125 million cases of infantile gastroenteritis and nearly 1 million deaths per year, mainly in developing countries. Rather than other control measures, vaccination is most likely to have a major impact on rotavirus disease incidence. The peak incidence of rotavirus diarrhea occurs between 6 and 24 months of age. In developing countries, however, cases are not uncommon among children younger than 6 months. G serotypes 1 to 4 are responsible for most disease, but there are indications that in Brazil that G type 5 is of emerging epidemiological importance. Both homotypic and heterotypic responses are elicited during natural rotavirus infection, and the immunological response at the intestinal mucosal surface is probably the more consistent predictor of clinical immunity. With the primary objective of protecting children against life-threatening dehydrating diarrhea, many approaches to rotavirus vaccine development have been attempted. One vaccine, the tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV), was given licensing approval in the United States of America, introduced to the market, and later withdrawn. A number of studies have found better efficacy of RRV-TV in developed countries than in developing ones. Field trials with a 4 x 10(4) plaque-forming units (PFU) preparation of RRV-TV have been carried out in two countries in Latin America, Brazil and Peru. Those trials yielded protective efficacy rates against all rotavirus diarrhea ranging from 18% to 35%. Data from a large catchment trial in Venezuela with a higher RRV-TV dose, of 4 x 10(5) PFU/dose, indicated an efficacy rate of 48% against all rotavirus diarrhea and 88% against severe rotavirus diarrhea. It appears that breast-feeding does not compromise the efficacy of RRV-TV if three doses of the vaccine are administered. Similarly, possible interference of oral poliovirus vaccine with the "take" of the rotavirus vaccine can be overcome by giving three doses of the rotavirus vaccine or by using a higher-titer formulation of it. Wild enteroviruses, however, may cause primary rotavirus vaccine failure in developing countries. Studies in Peru with RRV-TV have shown a trend towards higher vaccine efficacy rates against "pure" (rotavirus-only) diarrheal episodes. Economic analyses made in the United States indicate that a vaccine that costs less than US$ 9 per dose would lead to a net savings in medical costs. To date, however, cost-benefit studies have not been done in developing countries. In the future, it is possible that some Latin American countries might adapt their polio production facilities to the preparation of rotavirus vaccines for human use. A year after RRV-TV was licensed for vaccination of infants in the United States, the occurrence of intussusception as an adverse event led to the vaccine's withdrawal from the market. The implications of that action, particularly for Latin America, will be addressed in this article, including the need to explore alternative rotavirus candidate vaccines, particularly through the conduct of parallel clinical trials in both developed and developing countries.     

Effectiveness of Lanzhou lamb rotavirus vaccine against rotavirus gastroenteritis requiring hospitalization: a matched case-control study

We sought to determine the vaccine effectiveness (VE) of Lanzhou lamb rotavirus (LLR) vaccine against rotavirus gastroenteritis in children <5 requiring hospitalization. Children hospitalized 2002–2004 with rotavirus gastroenteritis were matched by gender, age and community to 838 controls. VE was calculated for one or more doses of LLR vaccine with 95% confidence intervals (CI). For one dose versus zero doses, LLR vaccine VE was 73.3% (95% CI, range 61.2–81.6%). VE of one dose versus zero doses was higher in children 12–23 months than in children 2–11 months (80.9% versus 60.0%). We found one dose moderately effective in preventing rotavirus gastroenteritis requiring hospitalization.