Clinical efficacy of anti-pneumococcal vaccination in patients with COPD
Clinical efficacy of anti-pneumococcal vaccination in patients with COPD
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DOI：
10.1136/thx.2005.043323
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发表时间：
2006-03-01
期刊：
影响因子：
10
通讯作者：
Lima, J
中科院分区：
文献类型：
--
作者：
Alfageme, I;Vazquez, R;Lima, J
背景资料：为评价23价肺炎球菌多糖疫苗（PPV）对免疫功能正常的慢性阻塞性肺疾病（COPD）患者的临床疗效，对596例COPD患者进行了随机对照试验，平均年龄65.8（9.7）岁，其中298例接受PPV治疗。主要结局是平均979天（范围20 - 1454天）后，经放射学证实的肺炎球菌或病因不明的社区获得性肺炎（CAP）。结果：共有58例由肺炎球菌或病因不明的CAP首次发作，其中干预组25例，非干预组33例。CAP的Kaplan-Meier生存曲线显示，在整个患者组中，干预组和非干预组之间无显著差异（对数秩检验= 1.15，p = 0.28）。PPV在所有患者中的疗效为24%（95% CI - 224至54; p = 0.333）。在年龄65岁的亚组中，PPV的有效性为76%（95% CI 20 - 93; p = 0.013），而在重度功能性阻塞（1秒用力呼气量< 40%）的患者中，PPV的有效性为48%（95% CI - 7 - 80; p = 0.076）。在严重气流阻塞的年轻患者中，疗效为91%（95% CI 35 - 99; p = 0.002）。只有5例非菌血症性肺炎球菌CAP，均在非干预组（对数秩检验= 5.03; p = 0.025）。多变量分析表明，接种组中未知和肺炎球菌CAP的风险比为0.20（95%CI 0.06至0.68; p = 0.01）。结论：PPV可有效预防年龄小于65岁的COPD患者和严重气流阻塞患者的CAP。其他COPD患者组间无差异。
Background: 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).Methods: 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).Results: 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 - 224 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).Conclusions: 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.