Prevention of invasive pneumococcal diseases: beyond cultures.

Prevention of invasive pneumococcal diseases: beyond cultures.
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侵袭性肺炎球菌疾病的预防:超越文化。

DOI:
10.1016/s2213-2600(14)70143-2
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发表时间:
2014
期刊:
The Lancet. Respiratory medicine
影响因子:
--
通讯作者:
Griffin,MarieR
Griffin,MarieR
中科院分区:
--
文献类型:
--
作者:
Grijalva,CarlosG;Griffin,MarieR

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尽管疫苗有效性传统上被报告为疾病发生率的相对量度(例如90%的有效性),但考虑预防疾病的绝对估计值对于疫苗接种效果的完整评估是必要的。1,2这对于终点定义敏感性较低的研究尤其相关。在这些情况下,需要一个特定的终点定义来估计相对疗效,但需要使用敏感的定义和估计率差异进行额外的分析,以了解疾病预防的负担,培养证实的侵袭性肺炎球菌疾病是目前的标准和最具体的终点随机对照研究,评估肺炎球菌疫苗在预防侵袭性疾病的疗效。重要的是,培养有助于确定肺炎球菌血清型和抗生素敏感性的特征。然而,肺炎球菌培养的敏感性较低,3并且仅基于培养结果的发病率估计低估了真实的疾病负担。相比之下,缺乏培养确认的侵袭性疾病的相容性发作的鉴定可能更敏感,并且可以更好地捕获肺炎球菌疾病的负担。然而,这种识别疑似侵袭性肺炎球菌疾病的方法特异性较低,包括一些假病例,并导致研究终点的错误分类。
Although vaccine efficacy is traditionally reported as a relative measure of disease incidence (eg 90% efficacy), the consideration of absolute estimates of disease prevented is necessary for a complete assessment of vaccination effects. 1, 2 This is particularly relevant for studies in which the endpoint definition has a low sensitivity. In these situations, a specific endpoint definition is needed to estimate relative efficacy, but additional analyses using a sensitive definition and estimates of rate differences are needed to understand the burden of disease prevented.Culture-confirmed invasive pneumococcal disease is the current standard and most specific endpoint for randomized controlled studies that evaluate the efficacy of pneumococcal vaccines in preventing invasive disease. Importantly, cultures help identify pneumococcal serotypes and characterize patterns of antibiotic susceptibility. However, pneumococcal cultures have low sensitivity, 3 and incidence estimates based on culture results alone underestimate the real disease burden. In contrast, the identification of compatible episodes of invasive disease that lack culture confirmation can be more sensitive and could better capture the burden of pneumococcal disease. Nevertheless, this approach to identify suspected invasive pneumococcal disease is less specific, includes some false cases and leads to misclassification of study endpoints.
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