用于预防囊性纤维化患者感染铜绿假单胞菌的疫苗。
Vaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosis.
作者信息
Johansen Helle Krogh, Gøtzsche Peter C
机构信息
The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 3343, Copenhagen, Denmark, DK 2100.
出版信息
Cochrane Database Syst Rev. 2015 Aug 23;2015(8):CD001399. doi: 10.1002/14651858.CD001399.pub4.
BACKGROUND
Chronic pulmonary infection in cystic fibrosis results in progressive lung damage. Once colonisation of the lungs with Pseudomonas aeruginosa occurs, it is almost impossible to eradicate. Vaccines, aimed at reducing infection with Pseudomonas aeruginosa, have been developed. This is an update of a previously published review.
OBJECTIVES
To assess the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register using the terms vaccines AND pseudomonas (last search 30 March 2015). We previously searched PubMed using the terms vaccin* AND cystic fibrosis (last search 30 May 2013).
SELECTION CRITERIA
Randomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis.
DATA COLLECTION AND ANALYSIS
The authors independently selected trials, assessed them and extracted data.
MAIN RESULTS
Six trials were identified. Two trials were excluded since they were not randomised and one old, small trial because it was not possible to assess whether is was randomised. The three included trials comprised 483, 476 and 37 patients, respectively. No data have been published from one of the large trials, but the company stated in a press release that the trial failed to confirm the results from an earlier study and that further clinical development was suspended. In the other large trial, relative risk for chronic infection was 0.91 (95% confidence interval 0.55 to 1.49), and in the small trial, the risk was also close to one. In the large trial, one patient was reported to have died in the observation period. In that trial, 227 adverse events (4 severe) were registered in the vaccine group and 91 (1 severe) in the control group. In this large trial of a vaccine developed against flagella antigens, antibody titres against the epitopes contained in the vaccine were higher in the vaccine group compared to the placebo group (P < 0.0001).
AUTHORS' CONCLUSIONS: Vaccines against Pseudomonas aeruginosa cannot be recommended.
背景
囊性纤维化中的慢性肺部感染会导致进行性肺损伤。一旦肺部被铜绿假单胞菌定植，几乎不可能根除。已经开发出旨在减少铜绿假单胞菌感染的疫苗。这是对先前发表的综述的更新。
目的
评估针对囊性纤维化患者接种抗铜绿假单胞菌疫苗的有效性。
检索方法
我们使用检索词“疫苗 AND 铜绿假单胞菌”检索了Cochrane囊性纤维化和遗传疾病小组试验注册库（最后检索时间为2015年3月30日）。我们之前使用检索词“疫苗* AND 囊性纤维化”检索了PubMed（最后检索时间为2013年5月30日）。
选择标准
比较抗铜绿假单胞菌疫苗（口服、胃肠外或鼻内）与对照疫苗或未在囊性纤维化患者中进行干预的随机试验（已发表或未发表）。
数据收集与分析
作者独立选择试验、评估试验并提取数据。
主要结果
共识别出6项试验。两项试验因未随机分组而被排除，一项老旧的小型试验因无法评估其是否随机分组而被排除。纳入的三项试验分别包含483例、476例和37例患者。其中一项大型试验未发表数据，但该公司在一份新闻稿中表示，该试验未能证实早期研究的结果，因此暂停了进一步的临床开发。在另一项大型试验中，慢性感染的相对风险为0.91（95%置信区间0.55至1.49），在小型试验中，风险也接近1。在大型试验中，有1例患者在观察期内死亡。在该试验中，疫苗组记录了227例不良事件（4例严重），对照组记录了91例（1例严重）。在这项针对鞭毛抗原开发的疫苗的大型试验中，疫苗组针对疫苗中所含表位的抗体滴度高于安慰剂组（P < 0.0001）。
作者结论
不推荐使用抗铜绿假单胞菌疫苗。
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