Division of Pediatric Infectious Diseases, University Children's Hospital, Basel, Switzerland.
World J Pediatr. 2010 Feb;6(1):5-12. doi: 10.1007/s12519-010-0001-x. Epub 2010 Feb 9.
This study was conducted to assess the efficacy of OM-85 BV (Broncho-Vaxom) in the prevention of pediatric recurrent respiratory tract infections (RTIs). Available evidence suggests that defining recurrent RTIs as >or=3 infections per fall-winter semester is both medically and epidemiologically justified. Therefore, this criterion was chosen as a primary endpoint.
Trials were identified through consultation of bibliographic databases and other channels. Eleven non-blinded studies plus one dealing with primary prevention were excluded and eight randomized controlled trials were included in the meta-analysis. The data were compared at 6 months, which represented the end of most studies. The complete database was examined according to the guidelines of the Cochrane collaboration.
The mean age of children and the number of RTIs in the preceding year were comparable at admission. Of the patients in the OM-85 BV treated population (n=435), 32% had recurrent RTIs (that is, >or=3 RTIs/6 months) vs. 58.2% in the placebo treated population (n=416; P<0.001). Sensitivity analysis showed that this was not driven by any particular trial. The results of this review were also positive for the active treatment regarding the secondary variables, which were represented by the number of patients with at least one RTI and the mean number of RTIs.
This meta-analysis shows, as observed in several individual trials, that the population treated with OM-85 BV had significantly and consistently fewer cases of recurrent RTIs. The data suggest that the effect is greater in patients at increased risk of recurrent RTIs.
本研究旨在评估 OM-85BV（Broncho-Vaxom）在预防儿科反复呼吸道感染（RTI）中的疗效。现有证据表明，将秋季-冬季学期反复 RTI 定义为>或=3 次感染在医学和流行病学上都是合理的。因此，该标准被选为主要终点。
通过查阅文献数据库和其他渠道，确定了试验。排除了 11 项非盲研究和 1 项涉及初级预防的研究，共纳入 8 项随机对照试验进行荟萃分析。数据在 6 个月时进行比较，这代表了大多数研究的结束时间。根据 Cochrane 协作组的指南，对完整数据库进行了检查。
入院时，儿童的平均年龄和前一年 RTI 的数量相当。在 OM-85BV 治疗组（n=435）中，有 32%的患者（即>或=3 次 RTI/6 个月）发生反复 RTI，而安慰剂治疗组（n=416）为 58.2%（P<0.001）。敏感性分析表明，这不是任何特定试验造成的。对于次要变量（表现为至少有一次 RTI 的患者人数和 RTI 的平均次数），该研究对活性治疗的结果也是阳性的。
本荟萃分析显示，如在几项单独的试验中观察到的那样，接受 OM-85BV 治疗的人群反复 RTI 的病例明显且一致减少。数据表明，在反复 RTI 风险增加的患者中，效果更大。
