目的：基于支付方角度，就七价肺炎球菌结合疫苗（PCV7）纳入深圳市城市免疫规划（City Immunization Program, CIP）与否两种情况，对2岁以下儿童注射疫苗在全人群获得的免疫效果和成本效果进行实证研究。方法：疾病负担数据取自深圳市三甲医院2010年肺炎链球菌性疾病患者的电子病历；流行病学病学数据来自台湾健保局肺炎链球菌性疾病法定上报系统；疫苗效果数据来自国内外公开发表的临床试验文献；最后根据接种方案及结果构建的决策树模型和深圳市人口学数据模拟运算，评估实施接种政策后的免疫效果和成本效果。结果：当PCV7未纳入深圳CIP作为二类疫苗使用时，由于较低的接种率和较高的接种价格，结果不具备成本效果优势；当PCV7纳入深圳CIP作为一类疫苗使用时，预测CIP的3+1接种策略每年共可预防36594人患肺炎链球菌性脑膜炎、肺炎链球菌性菌血症、全因肺炎和全因中耳炎，并可避免162人死亡，共获得2223个生命年和2004个质量调整生命年，平均每获得一个质量调整生命年的成本为11.8万元。结论： PCV7纳入深圳CIP后，能大幅降低儿童及成人肺炎球菌相关疾病及死亡。根据WHO对药物经济学评价的推荐意见，其介于我国1倍至3倍的人均GDP 间，认为具有成本效果优势。%Objective: To evaluate the potential clinical and economic benefits of introducing a public financed City Immunization Program (CIP) to pay for the 7-valent pneumococcal conjugate vaccine (PCV7). Methods: Disease burden data was gained from the patients’electronic record of streptococcus pneumoniae disease in tertiary hospital in 2010. Epidemic disease data was obtained from Taiwan National Health Insurance legal reportiog systerm of streptococcus pneumociae was taken from the preliminary results summarized at home and abroad. The Vaccine efficacy for PCV7 was consistent with that reported in the results from the Northern California Kaiser Permanente pivotal efficacy trial. A five percent discount rate was applied to calculate both costs and life years. Results:Currently, being not in the CIP, the Category II vaccine is not cost-effective due to the high market unit price and low penetration rate. However, a publicly financed CIP would prevent 36 594 cases of invasive pneumococcal disease (IPD) , pneumonia and Otitis media and 162 pneumococcal deaths if indirect effects were considered comparing to no vaccination. From a payer’s perspective, a PCV7 CIP would achieve an ICER of RMB 118, 000 per QALY versus no vaccination, and dominant versus Category II. Conclusion: Infant PCV7 vaccination in CIP is expected to lead to a substantial reduction in the incidence of all clinical presentation of pneumococcal disease in both children and adults. With reference to the WHO’s threshold for cost-effectiveness, universal infant vaccination with PCV7 is a highly cost-effective intervention from a public payer’s perspective.
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