Madhi Shabir A, Kohler Mariane, Kuwanda Locadiah, Cutland Clare, Klugman Keith P
University of the Witwatersrand/Medical Research Council/National Institute of Communicable Diseases-Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa.
Pediatr Infect Dis J. 2006 Jan;25(1):30-6. doi: 10.1097/01.inf.0000195787.99199.4a.
This study explored whether C-reactive protein (CRP) and/or procalcitonin levels were useful to measure vaccine efficacy (VE) and impact against the burden of pneumonia of a 9-valent pneumococcal conjugate vaccine (PCV), compared with chest radiograph-confirmed alveolar consolidation (CXR-AC) as an outcome. Sera obtained from children participating in a phase 3 PCV efficacy trial who were hospitalized for treatment of clinically diagnosed lower respiratory tract infection (C-LRTI) were retrospectively analyzed for CRP and procalcitonin measurements.
For non-human immunodeficiency virus (HIV)-infected children, the VE estimates for C-LRTI with CRP levels of > or =40 mg/dL (VE 26.3%; P = 0.003) or CRP levels of > or =120 mg/dL (VE 41.0%; P = 0.003) were 1.7-fold (P = 0.002) and 2.7-fold (P < 0.0001) greater, respectively, than that for CXR-AC (VE 15.1%; P= 0.15). The sensitivity of CXR-AC as an outcome to detect the burden of pneumonia prevented by PCV was 44% (95% confidence interval, 36-55%) in comparison with C-LRTI with CRP levels of > or =40 mg/dL and 73% (95% confidence interval, 58-92%) in comparison with C-LRTI with CRP levels of > or =120 mg/dL. CRP also helped to measure the PCV efficacy for children with C-LRTI but the absence of CXR-AC, for whom the outcome of C-LRTI with CRP levels of > or =40 mg/dL (VE 31.5%; P = 0.007) increased the VE estimate 19.8-fold (P < 0.0001) in comparison with C-LRTI alone (VE 1.6%; P = 0.78) and 3.2-fold (P = 0.005) in comparison with WHO-defined severe pneumonia (VE 10.0%; P = 0.17). Although there was a significant correlation between CRP and procalcitonin levels (Spearman's rho = 0.45; P < 0.0001), the use of procalcitonin levels did not improve either the specificity or sensitivity of measuring the effect of PCV against pneumonia for non-HIV-infected children. The observations were similar for HIV-infected children.
CRP levels of > or =40 mg/dL provide a better measure than chest radiographs to assess the effect of PCV in preventing pneumonia.
本研究探讨了与胸部X线片确诊的肺泡实变（CXR-AC）这一结果相比，C反应蛋白（CRP）和/或降钙素原水平是否有助于衡量9价肺炎球菌结合疫苗（PCV）的疫苗效力（VE）及其对肺炎负担的影响。对参与3期PCV效力试验、因临床诊断为下呼吸道感染（C-LRTI）住院治疗的儿童所获血清进行回顾性分析，以测量CRP和降钙素原。
对于未感染人类免疫缺陷病毒（HIV）的儿童，CRP水平≥40mg/dL时C-LRTI的VE估计值（VE 26.3%；P = 0.003）或CRP水平≥120mg/dL时C-LRTI的VE估计值（VE 41.0%；P = 0.003）分别比CXR-AC的VE估计值（VE 15.1%；P = 0.15）高1.7倍（P = 0.002）和2.7倍（P < 0.0001）。与CRP水平≥40mg/dL的C-LRTI相比，CXR-AC作为检测PCV预防肺炎负担的结果的敏感性为44%（95%置信区间，36 - 55%），与CRP水平≥120mg/dL的C-LRTI相比为73%（95%置信区间，58 - 92%）。CRP也有助于衡量C-LRTI但无CXR-AC的儿童的PCV效力，对于这些儿童，CRP水平≥40mg/dL的C-LRTI的结果（VE 31.5%；P = 0.007）与单独的C-LRTI（VE 1.6%；P = 0.78）相比，VE估计值提高了19.8倍（P < 0.0001），与世界卫生组织定义的重症肺炎（VE 10.0%；P = 0.17）相比提高了3.2倍（P = 0.005）。尽管CRP和降钙素原水平之间存在显著相关性（Spearman秩相关系数 = 0.45；P < 0.0001），但对于未感染HIV的儿童，使用降钙素原水平并未提高测量PCV对肺炎效果的特异性或敏感性。对于感染HIV的儿童，观察结果相似。
CRP水平≥40mg/dL比胸部X线片能更好地评估PCV预防肺炎的效果。
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