Alfageme I, Vazquez R, Reyes N, Muñoz J, Fernández A, Hernandez M, Merino M, Perez J, Lima J
Pneumology Section, Valme University Hospital, 41014 Seville, Spain.
Thorax. 2006 Mar;61(3):189-95. doi: 10.1136/thx.2005.043323. Epub 2005 Oct 14.
A study was undertaken to evaluate the clinical efficacy of the 23-valent pneumococcal polysaccharide vaccine (PPV) in immunocompetent patients with chronic obstructive pulmonary disease (COPD).
A randomised controlled trial was carried out in 596 patients with COPD of mean (SD) age 65.8 (9.7) years, 298 of whom received PPV. The main outcome was radiographically proven community acquired pneumonia (CAP) of pneumococcal or unknown aetiology after a mean period of 979 days (range 20-1454).
There were 58 first episodes of CAP caused by pneumococcus or of unknown aetiology, 25 in the intervention group and 33 in the non-intervention group. Kaplan-Meier survival curves for CAP did not show significant differences between the intervention and non-intervention arms (log rank test = 1.15, p = 0.28) in the whole group of patients. The efficacy of PPV in all patients was 24% (95% CI -24 to 54; p = 0.333). In the subgroup aged <65 years the efficacy of PPV was 76% (95% CI 20 to 93; p = 0.013), while in those with severe functional obstruction (forced expiratory volume in 1 second <40%) it was 48% (95% CI -7 to 80; p = 0.076). In younger patients with severe airflow obstruction the efficacy was 91% (95% CI 35 to 99; p = 0.002). There were only five cases of non-bacteraemic pneumococcal CAP, all in the non-intervention group (log rank test = 5.03; p = 0.025). Multivariate analysis gave a hazard ratio for unknown and pneumococcal CAP in the vaccinated group, adjusted for age, of 0.20 (95% CI 0.06 to 0.68; p = 0.01).
PPV is effective in preventing CAP in patients with COPD aged less than 65 years and in those with severe airflow obstruction. No differences were found among the other groups of patients with COPD.
开展了一项研究以评估23价肺炎球菌多糖疫苗（PPV）在免疫功能正常的慢性阻塞性肺疾病（COPD）患者中的临床疗效。
对596例平均（标准差）年龄为65.8（9.7）岁的COPD患者进行了一项随机对照试验，其中298例接受了PPV。主要结局是在平均979天（范围20 - 1454天）后经影像学证实的肺炎球菌或病因不明的社区获得性肺炎（CAP）。
共有58例由肺炎球菌或病因不明引起的CAP首发病例，干预组25例，非干预组33例。在整个患者组中，CAP的Kaplan - Meier生存曲线在干预组和非干预组之间未显示出显著差异（对数秩检验 = 1.15，p = 0.28）。PPV在所有患者中的疗效为24%（95%置信区间 - 24至54；p = 0.333）。在年龄小于65岁的亚组中，PPV的疗效为76%（95%置信区间20至93；p = 0.013），而在严重功能障碍（1秒用力呼气量<40%）的患者中为48%（95%置信区间 - 7至80；p = 0.076）。在年轻且有严重气流阻塞的患者中，疗效为91%（95%置信区间35至99；p = 0.002）。仅5例非菌血症性肺炎球菌CAP病例，均在非干预组（对数秩检验 = 5.03；p = 0.025）。多因素分析得出，在调整年龄后，接种疫苗组中病因不明和肺炎球菌性CAP的风险比为0.20（95%置信区间0.06至0.68；p = 0.01）。
PPV对预防年龄小于65岁的COPD患者以及有严重气流阻塞的患者的CAP有效。在其他COPD患者组中未发现差异。
