使用OM-85对复发性上呼吸道感染儿童进行免疫刺激：一项双盲、安慰剂对照的多中心研究。

Immunostimulation with OM-85 in children with recurrent infections of the upper respiratory tract: a double-blind, placebo-controlled multicenter study.

作者信息

Schaad Urs B, Mütterlein Ralph, Goffin Heidi

机构信息

University Children's Hospital of Basel, PO Box CH-4005, Basel, Switzerland.

出版信息

Chest. 2002 Dec;122(6):2042-9. doi: 10.1378/chest.122.6.2042.

DOI:10.1378/chest.122.6.2042

PMID:12475845

Abstract

OBJECTIVE

Recurrent upper respiratory tract infections (URTIs) are common illnesses in young children. As the immunoactive bacterial extract OM-85 has been shown to prevent these infections in both adults and children, the aim of the present trial was to investigate further its efficacy and safety in infection-prone children.

METHODS

This is a randomized, double-blind, placebo-controlled, multicenter study with OM-85 in 232 patients aged 36 to 96 months with recurrent URTIs. Treatment was one capsule daily during month 1 and during 10 days in months 3 to 5. URTI was defined by the presence of at least two of the following: rhinitis, pharyngitis, cough, hoarseness, temperature > or = 38.5 degrees C, or URTI-related prescription of an antibiotic.

RESULTS

OM-85-treated patients had a lower rate of URTIs (p < 0.05). The cumulated difference in URTIs between the two groups reached - 0.40 URTIs per patient in 6 months, corresponding to a 16% reduction in the active-treatment group with respect to placebo. The largest difference was observed in the patients having had three or more URTIs during the study period; odds ratios for three or more URTIs were 0.51 (95% confidence interval, 0.29 to 0.91) and 0.65 (95% confidence interval, 0.37 to 1.11) after 5 months and 6 months, respectively. The difference between OM-85 and placebo was independent of age but was more important in patients reporting a larger number of URTIs in the previous year. Patients' global assessment showed improvement in comparison to the previous season in the majority of the cases (OM-85, 78.4% of cases; placebo, 75.5%); however, there were more cases reporting worsening with placebo (6.4% vs 0.9%; p = 0.05).

CONCLUSIONS

OM-85 treatment significantly reduced the rate of URTIs, particularly in children with a history of frequent URTIs. Safety and tolerance of test medication were good, comparable to placebo.

摘要

目的

复发性上呼吸道感染（URTIs）是幼儿常见疾病。鉴于免疫活性细菌提取物OM - 85已被证明可预防成人和儿童的这些感染，本试验旨在进一步研究其在易感染儿童中的疗效和安全性。

方法

这是一项随机、双盲、安慰剂对照、多中心研究，对232名年龄在36至96个月的复发性URTIs患儿使用OM - 85进行研究。第1个月每日服用1粒胶囊，第3至5个月服用10天。URTIs定义为至少出现以下两种情况：鼻炎、咽炎、咳嗽、声音嘶哑、体温≥38.5℃或因URTIs开具抗生素处方。

结果

接受OM - 85治疗的患者URTIs发生率较低（p < 0.05）。两组之间URTIs的累积差异在6个月时达到每位患者-0.40次URTIs，相当于活性治疗组相对于安慰剂组减少了16%。在研究期间发生三次或更多次URTIs的患者中观察到最大差异；在5个月和6个月后，三次或更多次URTIs的优势比分别为0.51（95%置信区间，0.29至0.91）和0.65（95%置信区间，0.37至1.11）。OM - 85与安慰剂之间的差异与年龄无关，但在前一年报告URTIs次数较多的患者中差异更显著。患者的总体评估显示，与上一季节相比，大多数病例有所改善（OM - 85组为78.4%的病例；安慰剂组为75.5%）；然而，安慰剂组报告病情恶化的病例更多（6.4%对0.9%；p = 0.05）。