ICMR-National Institute of Epidemiology, Chennai, Tamil Nadu, India.
The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Indian J Pediatr. 2021 Mar;88(Suppl 1):124-130. doi: 10.1007/s12098-020-03597-1. Epub 2021 Jan 20.
High burden of rotavirus associated diarrhea has been documented among Indian children. The phased introduction of an indigenous rotavirus vaccine 'ROTAVAC' in India's national immunization programme began in 2017. Phase-III trial showed the vaccine to have a low-intussusception-risk profile. However, evaluation of post-licensure trends of intussusception is necessary to assess potential vaccine-associated intussusception risk. This study's objective was to describe the epidemiology of intussusception hospitalizations in children under two years of age in Tamil Nadu and Puducherry following ROTAVAC introduction.
A cross-sectional surveillance was established in six hospitals in Tamil Nadu and Puducherry. Children under two years of age with intussusception fulfilling Brighton Collaboration's criteria for level 1 diagnostic certainty were enrolled. Patient and disease characteristics were captured using a standardized questionnaire. Descriptive and inferential statistical analyses were performed using Stata Version 13.
Overall, 287 cases were enrolled and had a median age of seven months. Frequently presenting symptoms were vomiting (78%), abdominal pain (76%), and blood in stool (71%). Abdominal ultrasonography or radiography confirmed diagnosis in 65% of cases and managed by nonoperative measures. Remaining 35% of cases were diagnosed and managed with surgery. Over 98% of the cases had positive treatment outcomes. Age less than five months (OR = 4.36), and hospitalization at a state government health facility (OR = 5.01) were significant predictors for children to receive surgical management.
The present study documents the epidemiology of intussusceptions immediately after the rollout of rotavirus vaccine in Tamil Nadu and Puducherry. No appreciable increase in intussusception hospitalizations was seen in the study hospitals after vaccine introduction.
印度儿童的轮状病毒相关腹泻负担很高。印度国家免疫计划于 2017 年开始分阶段引入本土轮状病毒疫苗“ROTAVAC”。III 期试验表明该疫苗具有低肠套叠风险特征。然而，评估疫苗上市后的肠套叠趋势对于评估潜在的疫苗相关肠套叠风险是必要的。本研究的目的是描述 ROTAVAC 引入后泰米尔纳德邦和普杜切里两岁以下儿童肠套叠住院的流行病学情况。
在泰米尔纳德邦和普杜切里的六家医院建立了一项横断面监测。符合布莱顿合作组织一级诊断确定性标准的 2 岁以下肠套叠患儿入选。使用标准化问卷收集患者和疾病特征。使用 Stata 版本 13 进行描述性和推断性统计分析。
共有 287 例患儿入选，中位年龄为 7 个月。常出现的症状是呕吐（78%）、腹痛（76%）和大便带血（71%）。65%的病例通过腹部超声或 X 线检查确诊并通过非手术治疗进行管理。其余 35%的病例通过手术进行诊断和治疗。98%以上的病例有积极的治疗结果。年龄小于 5 个月（OR=4.36）和在州政府卫生机构住院（OR=5.01）是儿童接受手术治疗的显著预测因素。
本研究记录了 ROTAVAC 在泰米尔纳德邦和普杜切里推出后轮状病毒疫苗接种后的肠套叠流行病学情况。疫苗引入后，研究医院的肠套叠住院人数没有明显增加。
