Carmona-Ramírez M A, Alvárez-Gómez V, Berber A
Department of Occupational Medicine, Ford Motor Company, Cuautitlan Unity, Cuautitlan, Mexico.
J Int Med Res. 2002 May-Jun;30(3):325-9. doi: 10.1177/147323000203000316.
This study evaluated the safety and efficacy of the immunostimulatory agent OM-85 BV in 112 male car-factory workers who were highly susceptible to acute respiratory tract infections (ARTIs), each having experienced > or = 4 ARTIs during 1999. From January to March 2000, each worker received one capsule of OM-85 BV (7 mg) per day for 10 consecutive days each month. The patients were followed for a further 9 months. Mean number of ARTIs decreased from 8.2 +/- 2.1 per worker in 1999 to 5.3 +/- 2.9 in 2000; i.e. a difference of -2.9 (95% confidence intervals, -3.5 to -2.4). Similar effects were observed in men who had different job roles, and no adverse events were reported during drug administration. We concluded that OM-85 BV appears to be safe and effective in reducing the incidence of ARTIs in susceptible workers, although further double-blind, placebo-controlled clinical trials are required.
本研究评估了免疫刺激剂OM-85 BV对112名极易患急性呼吸道感染（ARTI）的男性汽车厂工人的安全性和有效性，这些工人在1999年每人都经历了≥4次急性呼吸道感染。在2000年1月至3月期间，每名工人每月连续10天每天服用一粒OM-85 BV胶囊（7毫克）。对患者进行了为期9个月的随访。急性呼吸道感染的平均次数从1999年每名工人8.2±2.1次降至2000年的5.3±2.9次；即差异为-2.9（95%置信区间，-3.5至-2.4）。在从事不同工作的男性中也观察到了类似效果，并且在给药期间未报告不良事件。我们得出结论，OM-85 BV似乎在降低易感工人急性呼吸道感染的发病率方面是安全有效的，尽管还需要进一步进行双盲、安慰剂对照的临床试验。
