The aim was to evaluate the clinical efficacy of 23-valent PCPV among COPD immunocompetent patients by use of a population-based intervention in our health-area (South Area of Seville).
A randomized, controlled trial, in which COPD patients (FEV1</=65%) were randomized to receive or not, PCPV. 600 patients were incorporated; 4 were missing during follow-up. 596 patients (mean age: 65.8±9.7 years) were finally included: 298 with PCPV and 298 without PCPV. End-point was pneumococcal pneumonia and pneumonia of any etiology. Pneumonia was diagnosed when the patient had symptoms of a lower respiratory tract infection and evidence of a new infiltrate on a chest radiograph. Pneumococcal pneumonia was considered by isolation of Streptococcus pneumoniae in blood, pleural fluid or bronchial samples. No intervention was made in the regular clinic or hospital care given to the patients by their physicians. All patients were followed for development of radiologically confirmed pneumonia, during a median period of 30 months (range 3-36 months). Conventional Statistical Analyses and Kaplan-Meier survival curves were performed with SPSS for windows (ver 11.5).
Forty-one episodes of pneumonia were observed among patients who received pneumococcal vaccine and 42 episodes among those who did not. Nineteen of these 83 pneumonias were of known to be caused by agents different from streptococcus pneumoniae or with negative pneumococcal urinary antigen test; there were 64 pneumonic episodes caused by S pneumoniae or unknown germen: 30 (10.07%) among vaccinated-patients and 34 (11.4%) among non-vaccinated-patients. There were only four episodes of documented pneumococcal pneumonia and all of them were found among non-vaccinated patients (1.34%, Fisher test, p=0.062). Kaplan-Meier curves were slightly better for vaccinated patients although without statistical significance (p=0.3, Log Rank test).
We do not find statistical differences in the incidence of pneumococcal and unknown etiology pneumonias between immunocompetent COPD patients with or without PCPV.
Although we failed to prove statistical results, we recommend the use of PCPV in COPD patients due to we do not find pneumococcal pneumonia among vaccinated patients.
N. Reyes, SEPAR and SAS