Pavia Maria, Bianco Aida, Nobile Carmelo G A, Marinelli Paolo, Angelillo Italo F
Department of Hygiene, Medical School, University of Catanzaro Magna Graecia, Catanzaro, Italy.
Pediatrics. 2009 Jun;123(6):e1103-10. doi: 10.1542/peds.2008-3422.
Pneumococcal conjugate bacterial vaccines that are able to prevent invasive disease and mucosal infections have been developed.
A meta-analysis of published data from trials on pneumococcal conjugate vaccine was performed to determine the efficacy in reducing the incidence of invasive disease caused by Streptococcus pneumoniae, pneumonia, and acute otitis media in healthy infants younger than 24 months.
A systematic search of the literature was conducted. Controlled clinical trials had to compare the protective efficacy of the pneumococcal conjugate vaccine in reducing the incidence of invasive disease caused by S pneumoniae, pneumonia, and acute otitis media in healthy infants with placebo or control vaccines. Information was extracted by using a standardized protocol.
The efficacy of pneumococcal conjugate vaccine in the reduction of invasive pneumococcal disease was 89% involving vaccine serotypes in both the intention-to-treat and per-protocol analyses and ranged from 63% to 74% for all serotypes. The efficacy to prevent acute otitis media sustained by vaccine serotypes was 55% in the intention-to-treat and 57% in the per-protocol analyses, whereas it was 29% to prevent otitis involving all serotypes in the per-protocol analysis. Finally, in the intention-to-treat and per-protocol analyses, the efficacy to prevent clinical pneumonia was 6% and 7%, respectively, whereas for the prevention of radiograph-confirmed pneumonia it was 29% and 32%, respectively.
The pneumococcal conjugate vaccine produces a significant effect regarding prevention of invasive pneumococcal disease. Results on prevention of otitis or pneumonia have been less striking, but considering the high burden of these diseases in infants, even a low efficacy has potential for tremendous impact on the health of infants in developing and industrialized countries.
已研发出能够预防侵袭性疾病和黏膜感染的肺炎球菌结合疫苗。
对已发表的肺炎球菌结合疫苗试验数据进行荟萃分析,以确定其在降低24个月以下健康婴儿由肺炎链球菌引起的侵袭性疾病、肺炎和急性中耳炎发病率方面的疗效。
对文献进行系统检索。对照临床试验必须比较肺炎球菌结合疫苗在降低健康婴儿由肺炎链球菌引起的侵袭性疾病、肺炎和急性中耳炎发病率方面与安慰剂或对照疫苗的保护效果。使用标准化方案提取信息。
在意向性分析和符合方案分析中,肺炎球菌结合疫苗对降低侵袭性肺炎球菌疾病的疗效,涉及疫苗血清型的为89%,所有血清型的疗效范围为63%至74%。在意向性分析中,疫苗血清型所致急性中耳炎的预防疗效为55%,符合方案分析中为57%,而在符合方案分析中,预防所有血清型所致中耳炎的疗效为29%。最后,在意向性分析和符合方案分析中,预防临床肺炎的疗效分别为6%和7%,而预防X线确诊肺炎的疗效分别为29%和32%。
肺炎球菌结合疫苗在预防侵袭性肺炎球菌疾病方面产生显著效果。预防中耳炎或肺炎的结果不太显著,但考虑到这些疾病在婴儿中的高负担,即使疗效较低也可能对发展中国家和工业化国家婴儿的健康产生巨大影响。