Gutiérrez-Tarango M D, Berber A
Pediatrics Service of "Pensiones Civiles del Estado de Chihuahua", Chihuahua City, Chihuahua.
Chest. 2001 Jun;119(6):1742-8. doi: 10.1378/chest.119.6.1742.
Acute respiratory tract infections (ARTIs) are among the main causes of morbidity and mortality in children. The bacterial extract OM-85 BV (bronchovaxom) has shown protective effect for ARTIs on children. We report a double-blind, placebo-controlled, parallel, prospective clinical trial to assess the safety and efficacy of two courses of OM-85 BV in the prevention of ARTIs in susceptible children during 12 months.
Fifty-four susceptible children from 1 to 12 years of age living in the metropolitan area of Chihuahua City were selected. They were randomized to receive either OM-85 BV or placebo (one capsule a day for 10 days a month for 3 consecutive months) at the beginning of the trial and 6 months later with the same schedule. Patients were followed up for 12 months, including the administration period. The trial began in July 1997 and ended in April 1999.
The number (mean +/- SD) of ARTIs was 5.04 +/- 1.99 (median, 5.0) in the OM-85 BV group vs 8.0 +/- 2.55 (median, 8.0) in the placebo group, with a mean difference of - 2.96 (95% confidence interval [CI], - 4.22 to - 1.7). The number of antibiotic courses was 2.46 +/- 2.08 (median, 1.5) in the treatment group vs 4.46 +/- 2.08 (median, 4.0) in the control group, a difference of - 2.0 (95% CI, - 3.14 to - 0.86). The total duration of ARTIs was 35.23 +/- 17.64 days (median, 30.5 days) in the OM-85 BV group vs 60.75 +/- 25.44 days (median, 55.0 days) in the placebo group, ie, a difference of - 25.52 days (95% CI, - 37.56 to - 13.47 days), p < 0.001 by Student's t test and Mann-Whitney U test for all the items. Four patients in the OM-85 BV group had five adverse events. Only one episode of skin rash was related to the medication intake. Six patients in the control group had six adverse events.
OM-85 BV had a preventive effect on ARTI in the susceptible children for 12 months with an important reduction on the antibiotic requirements and the number of days of suffering ARTIs.
急性呼吸道感染（ARTIs）是儿童发病和死亡的主要原因之一。细菌提取物OM-85 BV（泛福舒）已显示出对儿童ARTIs的保护作用。我们报告一项双盲、安慰剂对照、平行、前瞻性临床试验，以评估两个疗程的OM-85 BV在12个月内预防易感儿童ARTIs的安全性和有效性。
选取了居住在奇瓦瓦市大都市区的54名1至12岁的易感儿童。在试验开始时及6个月后，他们被随机分为接受OM-85 BV或安慰剂治疗（每月连续10天，每天1粒胶囊，共3个月），治疗方案相同。对患者进行了12个月的随访，包括给药期。该试验于1997年7月开始，1999年4月结束。
OM-85 BV组ARTIs的数量（均值±标准差）为5.04±1.99（中位数为5.0），而安慰剂组为8.0±2.55（中位数为8.0），平均差值为-2.96（95%置信区间[CI]，-4.22至-1.7）。治疗组抗生素疗程数为2.46±2.08（中位数为1.5），对照组为4.46±2.08（中位数为4.0），差值为-2.0（95%CI，-3.14至-0.86）。OM-85 BV组ARTIs的总持续时间为35.23±17.64天（中位数为30.5天），安慰剂组为60.75±25.44天（中位数为55.0天），即差值为-25.52天（95%CI，-37.56至-13.47天），所有项目经学生t检验和曼-惠特尼U检验，p<0.001。OM-85 BV组有4名患者出现5次不良事件。仅1例皮疹发作与药物摄入有关。对照组有6名患者出现6次不良事件。
OM-85 BV对易感儿童的ARTIs有预防作用，持续12个月，可显著减少抗生素需求及ARTIs患病天数。
