细菌免疫疗法在降低儿童反复上呼吸道感染方面非常有效：一项前瞻性观察研究。

Bacterial immunotherapy is highly effective in reducing recurrent upper respiratory tract infections in children: a prospective observational study.

机构信息

Department of Otorhinolaryngology, San Jorge Hospital, Avenida de Martínez de Velasco 36, 22004, Huesca, Spain.

School of Medicine, University of Zaragoza, Calle de Pedro Cerbuna 12, 50009, Saragossa, Spain.

出版信息

Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4519-4530. doi: 10.1007/s00405-023-08035-4. Epub 2023 May 30.

DOI:10.1007/s00405-023-08035-4

PMID:37254001

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10477114/

Abstract

PURPOSE

Whilst immunotherapy is an appealing option as it could reduce the burden of recurrent pediatric respiratory tract infections (RTI), there is limited evidence on its effectiveness and more research was requested in order to better understand this therapeutic modality.

METHODS

We performed a prospective cohort study involving 57 subjects to assess the safety and effectiveness a 3-month regimen of either typified or patient-specific bacterial lysates could have in reducing the number of RTIs in children aged 0 to 11 years with histories of recurrent episodes.

RESULTS

After a 6-month follow-up, the number of RTIs and school absenteeism dropped sharply and significantly, from an adjusted mean (standard error) of 0.6 (0.04) episodes/month to 0.1 (0.03) episodes/month (74.7% reduction, P < 0.001), and from an adjusted mean score of 4.6 (1.06) points to 0.0 (0.01) points over 10 (99.5% reduction, P < 0.001), respectively. There was also a significant decrease in the severity of symptoms. No adverse reactions were observed.

CONCLUSION

The use of the study product is associated with a decreased risk of recurrent RTIs in children, with a very favorable safety profile that warrants further investigation in randomized clinical trials.

摘要

目的

免疫疗法作为一种有吸引力的选择，因为它可以减轻儿童反复发生的呼吸道感染（RTI）的负担，但关于其有效性的证据有限，需要更多的研究来更好地了解这种治疗方式。

方法

我们进行了一项前瞻性队列研究，涉及 57 名受试者，以评估标准化或个体化细菌裂解物 3 个月疗程对减少有反复发作史的 0 至 11 岁儿童 RTI 次数的安全性和有效性。

结果

经过 6 个月的随访，RTI 次数和缺课率明显且显著下降，从调整后的平均（标准误差）每月 0.6（0.04）次降至每月 0.1（0.03）次（74.7%减少，P<0.001），从调整后的平均得分 4.6（1.06）分降至 0.0（0.01）分（99.5%减少，P<0.001）。症状的严重程度也有显著下降。未观察到不良反应。