| Background:Globally, human group A rotavirus is the most common cause of severe diarrhea in children under 5 years of age. Vaccine is the best way to prevent children from suffering rotavirus diarrhea. By 2006, there have been two ORV(Oral Rotavirus Attenuated Live Vaccine)-RotarixTM and RotaTeqTM-used worldwide. Based on the two vaccines safety and effectiveness, the World Health Organization (WHO) recommended the inclusion of rotavirus vaccine in the national immunization programs of all countries in 2013 position paper about ORV. Before the ORV introduced in China, the policy makers need to understand the rotavirus diarrhea disease burden, including the incidence, outpatient visits rate, hospitalization rate, mortality and the cost.In addition, intussusception is always the most attention side effect after ORV large-scale use. The world’s first rotavirus vaccine (RotaShieldTM) went public in 1998, and was delisted from the market after a year as associated with intussusception. For the two new vaccines (RotarixTM and RotaTeqTM), post-marketing surveillance in some regions showed that they could also increase the risk of intussusception among the vaccinated children. So, it is essential to know the baseline data of the intussusception to evaluate the safety of the ORV before and after the ORV introduced in our country.In the present study, we evaluated the epidemiologic and economic burden of rotavirus diarrhea and baseline data of incidence of intussusception to provide data support for ORV widespread use in China.Methods:1. To evaluate the epidemiologic burden of rotavirus diarrhea under 5 years old, we reviewed the epidemiologic survey data about acute diarrhea.2. Direct medical cost, direct non-medical cost, and indirect cost survey were conducted based on the hospital to evaluate economic burden associated with rotavirus diarrhea, and extrapolated to regional cost estimates.3. Detailed information of children aged under 2 years hospitalized due to intussusception were retrospectively collected based on a hospital. The epidemiological characteristics and incidence for hospitalization due to intussusception data were analyzed.Results:1. The epidemiological burden study of rotavirus diarrhea in children under 5 years oldThe incidence of rotavirus diarrhea in children under 5 years old is about 0.11 (Q25-Q75:0.05-0.18) person per year. Each year, rotavirus causes approximately 12 million episodes,9.7 milliom clinic visits,0.59 million hospitalions, and 4,169 deaths.The corresponding outpatient visits rate is 128.5‰, hospitalization rate is 7.8‰, the mortality rate is 0.29‰. By 5 years of age, almost all children will have an episode of rotavirus diarrhea(1 in 1),1 in 2 will require a clinic visit,1 in 24 will require hospitalization, and approximately 1 in 3,411 will die.2. The economic burden study of rotavirus diarrhea in children under 5 years old in NanjingIn the present study, average total cost of outpatient were ￥970.41, including direct medical cost of ￥241.66, direct non-medical cost of ￥228.11, and indirect cost of ￥500.64. Average cost of inpatient were ￥7,867.92, including direct medical cost of ￥3,019.51, direct non-medical cost of ￥1144.76, and indirect cost of ￥3,461.75. Inpatient direct medical cost for the rotavirus-negative patients tended to be higher than that for the rotavirus-positive patients (￥4,133.61 VS ￥3,019.51). Only one diagnosis of rotavirus diarrhea inpatients in direct medical cost were belower than that of mergered other diagnosis inpatients (￥1,740.91 VS ￥3,839.79). The mean duration of hospital stay for the rotavirus-positive inpatients and only one diagnosis inpatients were shorter than that for rotavirus-negative inpatients (5.5d VS 6.5d) and for mergered other diagnosis inpatients (4.2d VS 6.5d) respectively. For outpatient, only 1.3% rotavirus diarrhea patients have insurance reimbursement, and the direct medical expenses reimbursement ratio was 39.3%. For inpatient,17.2% of rotavirus diarrhea inpatients have insurance reimbursement, and the direct medical expenses reimbursement ratio was 47.9%. The estimated total outpatient cost of rotavirus in Nanjing region were ￥70,986,431.28, including total direct medical cost of ￥17,677,663.03, total direct non-medical cost of ￥16,686,467.41, and total indirect cost of ￥36,622,300.84. The estimated total inpatient cost of rotavirus diarrhea in Nanjing region were ￥13,790,770.16, including total direct medical cost of ￥5,460,465.39, total direct non-medical cost of ￥2,070,157.16, and total indirect cost of ￥6,260,147.60.3. Epidemiological characteristics of intussusception hospitalizations among children under 2 years of age in SuzhouA total of 594 intussusception-related hospitalizations were identified over a period of more than 6 years among children under 2 years of age, with no death. The crude incidence for hospitalization due to intussusception was 57.3 (95% CI:52.8-62.1) per 100,000 in under-twos, and 100.6 (95% CI:92.1～109.8) per 100,000 in under-ones. The male-to-female ratio was 1.90:1.85.4%(507/594) of subjects were aged below one year, with 66.2% (393/594) aged 3 months to 8 months. The age distribution peaked in 5 to 8 months of age. The median age was 6.8 (QR=4.4) months, and increased trend of median age was observed from 6.3 (QR=4.2) months to 7.3 (QR=4.0) months from January 2007～August 2013. There was no significant seasonal variation except for a slight predominance of cases in the months from March to August (320/531,60.3%) between January 2007 and December 2012. Main symptoms or signs were vomiting (83.2%,494/594), abdominal mass (81.1%,482/594), and bloody stool (64.5%,383/594).The abdominal ultrasound (98.7%,586/594) was the most frequently used diagnostic approaches.86.2%(512/594) of patients were successfully treated by surgical intervention. The predominant sites for acute intussusception in infants under 2 years of age were ileo-colic (34.5%, 183/530), ileo-ileo (30.8%,163/530) or ileo-ileo-colic (27.9%,148/594).Conclusions:The disease burden of rotavirus diarrhea is heavy in children under 5 years old in China. Rotavirus diarrhea in children constitutes a considerable economic burden, and the insurance reimbursement ratio is low in Nanjing region. The ORV should be introduced and incorporated into the national children routine immunication system as soon as possible to reduce the epidemiologic and ecomonic burden of rotavirus diarrhea substantially. In addition, the incidence for hospitalization due to intussusception among children under 1 year of age is higher in Suzhou than the global average level. It is imperative to conduct the national intussusception sentinel surveillence study to provide base-line data to evaluate the incidence of intussusception and the new rotavirus vaccine safety in the ORV post-marketing era in China. |
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