Association Between Pentavalent Rotavirus Vaccine and Severe Rotavirus Diarrhea Among Children in Nicaragua
Association Between Pentavalent Rotavirus Vaccine and Severe Rotavirus Diarrhea Among Children in Nicaragua
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DOI：
10.1001/jama.2009.756
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发表时间：
2009-06-03
影响因子：
120.7
通讯作者：
Parashar, Umesh
中科院分区：
文献类型：
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作者：
Patel, Manish;Pedreira, Cristina;Parashar, Umesh
五价轮状病毒疫苗（RV 5）是一种口服减毒活疫苗，主要在芬兰和美国进行的一项试验中预防了98%的严重轮状病毒腹泻。尼加拉瓜介绍了RV 5在2006年，提供了第一次机会，以评估疫苗接种和轮状病毒disease in a developing countries.Objective之间的关联评估RV 5疫苗接种和随后的轮状病毒腹泻需要过夜入院或静脉hydration.Design，设置，和参与者病例对照评价在尼加拉瓜4家医院从2007年6月至2008年6月。病例为年龄符合接受RV 5的儿童，他们因实验室确认的轮状病毒腹泻而入院或需要静脉补液。对于每个病例（n=285），1至3个邻居（n=840）和医院（n=690）controlsed.Main结果测量主要结果是RV 5和轮状病毒腹泻需要过夜入院或在急诊室静脉补液的关联。次要分析进一步将疾病分类为重度和极重度。我们计算了病例组与对照组疫苗接种的匹配比值比。结果在285例轮状病毒感染病例中，265例（93%）需要住院治疗，251例（88%）接受静脉补液治疗。在88%的病例中鉴定出单一轮状病毒株（G2 P [ 4]）。在病例和对照组中，分别有18%和12%未接种疫苗，12%和15%接受了1剂RV 5，15%和17%接受了2剂，55%和57%接受了3剂。接种3剂疫苗与需要过夜住院或静脉补液的轮状病毒腹泻风险较低相关（比值比[OR]，0.54; 95%置信区间[CI]，0.36-0.82）。在285例轮状病毒病例中，191例（67%）为重度，54例（19%）为非常重度。RV 5疫苗接种后，观察到重度（OR，0.42; 95% CI，0.26-0.70）和极重度轮状病毒腹泻（OR，0.23; 95% CI，0.08-0.61）的风险逐渐降低。因此，3剂RV 5对需要住院或静脉补液治疗的轮状病毒病的有效性为46%。（95% CI，18%-64%）;对重度轮状病毒腹泻，58%（95% CI，30%-74%）;和非常严重的轮状病毒腹泻，77%（95%可信区间，39%-92%）结论在尼加拉瓜，接种RV 5疫苗与2岁以下儿童严重轮状病毒腹泻的风险降低相关，但程度低于工业化国家临床试验的结果。国家美国医学会杂志2009;301（21）：2243-2251 www.jama.com
Context Pentavalent rotavirus vaccine (RV5), a live, oral attenuated vaccine, prevented 98% of severe rotavirus diarrhea in a trial conducted mainly in Finland and the United States. Nicaragua introduced RV5 in 2006, providing the first opportunity to assess the association between vaccination and rotavirus disease in a developing country.Objective To assess the association between RV5 vaccination and subsequent rotavirus diarrhea requiring overnight admission or intravenous hydration.Design, Setting, and Participants Case-control evaluation in 4 hospitals in Nicaragua from June 2007 to June 2008. Cases were children age-eligible to receive RV5 who were admitted or required intravenous hydration for laboratory-confirmed rotavirus diarrhea. For each case (n=285), 1 to 3 neighborhood (n=840) and hospital (n=690) controls were selected.Main Outcome Measures Primary outcome was the association of RV5 and rotavirus diarrhea requiring overnight admission or intravenous hydration in the emergency department. Secondary analysis further classified disease as severe and very severe. We computed the matched odds ratio of vaccination in cases vs controls. Vaccine effectiveness was estimated using the formula 1-matched odds ratio x 100%.Results Of the 285 rotavirus cases, 265 (93%) required hospitalization; 251 (88%) received intravenous hydration. A single rotavirus strain (G2P[ 4]) was identified in 88% of the cases. Among cases and controls, respectively, 18% and 12% were unvaccinated, 12% and 15% received 1 dose of RV5, 15% and 17% received 2 doses, and 55% and 57% received 3 doses. Vaccination with 3 doses was associated with a lower risk of rotavirus diarrhea requiring overnight admission or intravenous hydration (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.36-0.82). Of the 285 rotavirus cases, 191 (67%) were severe and 54 (19%) were very severe. A progressively lower risk of severe (OR, 0.42; 95% CI, 0.26-0.70) and very severe rotavirus diarrhea (OR, 0.23; 95% CI, 0.08-0.61) was observed after RV5 vaccination. Thus, effectiveness of 3 doses of RV5 against rotavirus disease requiring admission or treatment with intravenous hydration was 46% (95% CI, 18%-64%); against severe rotavirus diarrhea, 58% ( 95% CI, 30%-74%); and against very severe rotavirus diarrhea, 77% (95% CI, 39%-92%).Conclusion Vaccination with RV5 was associated with a lower risk of severe rotavirus diarrhea in children younger than 2 years in Nicaragua but to a lesser extent than that seen in clinical trials in industrialized countries. JAMA. 2009;301(21):2243-2251 www.jama.com