Prospective Concurrent Controlled Trial Of 23-valent Pneumococcal Polysaccharide Vaccine In Prevention Of Lower Respiratory Tract Infections The Elderly In The Community

Objective To evaluate the efficacy, safety and cost-benefit of 23-valent pneumococcal polysaccharide vaccine in prevention of lower respiratory tract infections (LRTIs) in the elderly in the community. Method 600 elderly were non-randomly, concurrently, equally divided into experimental group and control group. Data were collected, including name, sex, age, smoking, exercise, family income per capita in a month, living condition, if inoculated influenza vaccine, if taken health care drugs, kinds of diseases and LRTIs in the last 3 months. The elderly of experimental group were followed up 2 weeks to understand side effect after vaccinated 23-valent pneumococcal polysaccharide vaccine. During a 1-year follow-up period, it would be observed on incidence and degree of LRTIs, usage rate and kinds of antibiotics, hospitalization rate and hospitalization time of two groups of LRTIs. At the same time, direct medical cost would be also known. Statistical analysis was made using SPSS 12.0 or SAS 8.1 software to calculate chi-squared -test, t-test and multinomial logistic regression. Results 23-valent pneumococcal polysaccharide vaccine was protective factor in LRTIs, usage of antibiotics and hospitalization in this study. With increase of times of LRTIs, usage of antibiotics and hospitaliztion, protective ability of vaccine gradually increased (RR and 95%CI of LRTIs: 0.236,0.146-0.383; 0.259, 0.135-0.498; 0.155, 0.048-0.502; RR and 95%CI of usage, of antibiotics: 0.256, 0.158-0.256; 0.213, 0.106-0.427; 0.199, 0.061-0.653; RR and 95%CI of hospitalization: 0.284, 0.130-0.617; 0.161, 0.032-0.812). Compared with control group, incidence of LRTIs, usage rate of antibiotics, hospitalization rate and degree of LRTIs of experimental group all reduced sharply and were significant. Overall vaccine efficacies in LRTIs, usage of antibiotics and hospitalization were 69.7%, 72.6%, 65.9% respectively and these differences between the two groups were significant. Stratified analysis showed that 23-valent pneumococcal polysaccharide vaccine reduced incidence of LRTIs, usage rate of antibiotics, hospitalization rate and degree of LRTIs of the experimental group in which the elderly have chronic lung diseases and Coronary heart disease and these differences between the two groups also were significant. Though vaccine was protective factor in LRTIs, usage rate of antibiotics of the elderly who had Diabetes Mellitus, Hypertension and inoculated influenza vaccine, it was not significant in hospitalization. But vaccine could not reduce incidence of LRTIs, usage rate of antibiotics, hospitalization rate and degree of LRTIs of the experimental group in which the elderly were healthy. 91 elderly had side effects, including 80 local reactions in inject site, 14 systemic reactions, and 2 both. All adverse reactions were mild and relieved by local stupe or rest in 1~3 days. Vaccine cost was Y62850.5. Benefit of vaccine was Y129322.15. Benefit-cost ratio was 2.06. Net benefit was Y66471.65. Conclusions Incidence of LRTIs, usage rate of antibiotics, hospitalization rate and degree of LRTIs of the elderly in the community, especial who had chronic lung diseases and Coronary heart disease, decreased in vaccinated 23-valent pneumococcal polysaccharide vaccine than in unvaccinated elderly. This kind of vaccine had not only safety but alsocost-benefit.