Prevots D R, Sutter R W, Strebel P M, Weibel R E, Cochi S L
National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga.
Arch Pediatr Adolesc Med. 1994 May;148(5):479-85. doi: 10.1001/archpedi.1994.02170050037007.
Although the risk of vaccine-associated paralytic poliomyelitis (VAPP) has remained relatively constant during the past 30 years, estimates of VAPP depend largely on the completeness of reporting to the existing passive surveillance system. The National Vaccine Injury Compensation Program constitutes an alternative system for reporting VAPP, and data available from this system permitted us to evaluate the completeness of the national poliomyelitis surveillance system.
We compared cases of paralytic poliomyelitis reported to the national surveillance system (maintained by the Centers for Disease Control and Prevention, Atlanta, Ga) with cases recommended for compensation by the National Vaccine Injury Compensation Program, Rockville, Md, and we calculated the observed completeness of reporting to the national system for 1980 through 1991. A capture-recapture method was also used to estimate completeness of reporting, ie, to account for cases potentially missed by both systems. In addition, we reviewed the epidemiology and updated the risk of VAPP based on the most current information on cases of VAPP.
From 1980 through 1991, 105 cases of paralytic poliomyelitis were identified by the Centers for Disease Control and Prevention and National Vaccine Injury Compensation Program systems, 98 (93%) of which were VAPP (average, 8.2 cases per year). The observed completeness of reporting to the Centers for Disease Control and Prevention was 94%, and the estimated completeness of reporting (capture-recapture method) was 81%. The overall risk of VAPP was one case per 2.5 million doses of oral poliovirus vaccine distributed. In the sensitivity analysis, the risk estimates of VAPP remained relatively stable throughout a wide range of assumptions regarding underreporting and specificity of the case definition for paralytic poliomyelitis.
The risk of VAPP remains virtually unchanged from previous estimates despite the inclusion of previously unidentified VAPP cases. Despite the potential for both underreporting and misclassification of cases, our risk estimates were relatively insensitive to either of these biases. Since both of these biases were in opposite directions, and both probably occurred with low frequency, the risk estimates provided in this report appear valid and approximate the "true" risk of VAPP in the United States.
尽管在过去30年中,疫苗相关麻痹型脊髓灰质炎(VAPP)的风险一直相对稳定,但VAPP的估计很大程度上取决于向现有被动监测系统报告的完整性。国家疫苗伤害赔偿计划构成了报告VAPP的另一种系统,该系统提供的数据使我们能够评估国家脊髓灰质炎监测系统的完整性。
我们将向国家监测系统(由佐治亚州亚特兰大疾病控制和预防中心维护)报告的麻痹型脊髓灰质炎病例与马里兰州罗克维尔国家疫苗伤害赔偿计划建议赔偿的病例进行比较,并计算了1980年至1991年向国家系统报告的观察到的完整性。还使用了捕获-再捕获方法来估计报告的完整性,即考虑两个系统可能遗漏的病例。此外,我们回顾了流行病学情况,并根据VAPP病例的最新信息更新了VAPP的风险。
1980年至1991年期间,疾病控制和预防中心及国家疫苗伤害赔偿计划系统共识别出105例麻痹型脊髓灰质炎病例,其中98例(93%)为VAPP(平均每年8.2例)。向疾病控制和预防中心报告的观察到的完整性为94%,估计的报告完整性(捕获-再捕获方法)为81%。VAPP的总体风险为每分发250万剂口服脊髓灰质炎病毒疫苗中有1例。在敏感性分析中,在关于麻痹型脊髓灰质炎病例漏报和病例定义特异性的广泛假设范围内,VAPP的风险估计值保持相对稳定。
尽管纳入了先前未识别的VAPP病例,但VAPP的风险与先前估计基本保持不变。尽管存在病例漏报和错误分类的可能性,但我们的风险估计对这两种偏差中的任何一种都相对不敏感。由于这两种偏差方向相反,且可能都很少发生,本报告提供的风险估计似乎是有效的,并且接近美国VAPP的“真实”风险。