Fedson David S
Sergy Haut, France.
Hum Vaccin Immunother. 2014;10(1):47-51. doi: 10.4161/hv.26422. Epub 2013 Sep 12.
Hollingsworth and Isturiz (1) have raised several questions about our earlier review of the use of pneumococcal conjugate (PCV) or polysaccharide (PPV) vaccine for older adults (i.e., ≥65 y of age). (2) They begin by citing two metaanalyses published in 2009 and 2013 that concluded that prevention of pneumococcal pneumonia could not be demonstrated for PPV. (3)(,) (4) They overlook my earlier review of five metaanalyses that was published in 2004. (5) This review showed that the study populations in prospective trials of PPV were often not representative of the populations of elderly and high-risk adults for whom PPV is recommended. Furthermore, the five metaanalyses often omitted clinical trials that should have been evaluated, included trials that should have been omitted, and frequently miscounted the numbers of subjects and outcome events in the individual clinical trials. More important, retrospective sample size calculations showed that none of the five metaanalyses included an adequate number of person years of observation to rule out false-negative results. The numbers speak for themselves and cannot be ignored. Simply put, metaanalyses of the PPV clinical trials will never tell us whether the vaccine prevents pneumococcal pneumonia or all-cause pneumonia in elderly and high-risk adults, and consequently they must be regarded as inconclusive and uninformative. Since 2004, only one small prospective clinical trial of PPV has been published (reviewed in 6). Nothing new has been added to our knowledge of PPV efficacy by the more recent metaanalyses. (3)(,) (4) Epidemiologists have reminded us that the lack of evidence of PPV efficacy is not evidence of its absence. The conclusions of our earlier review still stand. (5.)
霍林斯沃思和伊斯图里兹(1)针对我们之前关于老年人(即年龄≥65岁)使用肺炎球菌结合疫苗(PCV)或多糖疫苗(PPV)的综述提出了几个问题。(2)他们首先引用了2009年和2013年发表的两项荟萃分析,这两项分析得出结论,无法证明PPV可预防肺炎球菌肺炎。(3)(,)(4)他们忽略了我在2004年发表的对五项荟萃分析的早期综述。(5)该综述表明,PPV前瞻性试验中的研究人群往往不能代表推荐使用PPV的老年和高危成年人群体。此外,这五项荟萃分析常常遗漏了本应评估的临床试验,纳入了本应排除的试验,并且经常错误计算各个临床试验中的受试者数量和结局事件数量。更重要的是,回顾性样本量计算表明,这五项荟萃分析中没有一项纳入足够的人年观察数来排除假阴性结果。数据不言自明,不容忽视。简而言之,PPV临床试验的荟萃分析永远无法告诉我们该疫苗是否能预防老年和高危成年人的肺炎球菌肺炎或全因性肺炎,因此必须将其视为无定论且无参考价值的。自2004年以来,仅发表了一项关于PPV的小型前瞻性临床试验(在6中进行了综述)。最近的荟萃分析并未为我们对PPV疗效的认识增添新内容。(3)(,)(4)流行病学家提醒我们,缺乏PPV疗效的证据并不证明其无效。我们早期综述的结论仍然成立。(5)