Trotta Francesco, Da Cas Roberto, Bella Antonino, Santuccio Carmela, Salmaso Stefania
Pharmacovigilance Office, Italian Medicines Agency (AIFA), Via del Tritone 181, Rome, 00187, Italy.
National Centre for Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health, Viale Regina Elena 299, Rome, 00161, Italy.
Ital J Pediatr. 2016 Sep 27;42(1):89. doi: 10.1186/s13052-016-0298-8.
Study to investigate the intussusception incidence background in the pediatric population and its temporal trend in Italy.
A cross-sectional study was conducted on the pediatric population aged 0 to 15 years, in the period 1 January 2002 to 31 December 2012. Intussusception cases were identified using the national hospital discharge database. The annual intussusception incidence, the incidence rate ratios (IRRs) and the related 95 % confidence Intervals (CI) were calculated.
The overall intussusception incidence rate was 21 per 100,000 children aged ≤15 years, and was higher among boys than girls. The highest intussusception incidence rate occurred in infants <1 year of age (39 per 100,000 infants). Among infants, incidence varied with the geographical area, with higher rates in the central Italy (50 per 100,000 infants). The annual incidence rates in infants were stable since 2004 and up to 2012, ranging from 40.1 and 33.0 per 100,000 infants. Similar stable patterns were observed when conducting the analysis on children over 1 year of age.
This study provided the intussusception incidence background in Italy in different pediatric ages, including infants, over an 11-year period. This information is essential in post-marketing safety surveillance, to continuously monitor the benefit/risk profile of rotavirus vaccinations.
开展研究以调查意大利儿科人群肠套叠的发病情况背景及其时间趋势。
于2002年1月1日至2012年12月31日期间,对0至15岁的儿科人群进行了一项横断面研究。使用国家医院出院数据库识别肠套叠病例。计算了年度肠套叠发病率、发病率比(IRR)及相关的95%置信区间(CI)。
≤15岁儿童的总体肠套叠发病率为每100,000名儿童中有21例,男孩的发病率高于女孩。肠套叠发病率最高的是<1岁的婴儿(每100,000名婴儿中有39例)。在婴儿中,发病率因地理区域而异,意大利中部地区的发病率较高(每100,000名婴儿中有50例)。自2004年至2012年,婴儿的年发病率稳定,范围为每100,000名婴儿中有40.1例至33.0例。对1岁以上儿童进行分析时也观察到了类似的稳定模式。
本研究提供了意大利11年间不同儿科年龄段(包括婴儿)的肠套叠发病情况背景。该信息对于上市后安全性监测至关重要,有助于持续监测轮状病毒疫苗的效益/风险状况。