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口服 TM13 和 LG55 可以恢复细菌性阴道病患者的阴道健康。

Orally administrated TM13 and LG55 can restore the vaginal health of patients recovering from bacterial vaginosis.

机构信息

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, China.

BGI-Shenzhen, Shenzhen, China.

出版信息

Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023.

Abstract

UNLABELLED

Bacterial vaginosis (BV) is a common infection of the lower genital tract with a vaginal microbiome dysbiosis caused by decreasing of lactobacilli. Previous studies suggested that supplementation with live may benefit the recovery of BV, however, the outcomes vary in people from different regions. Herein, we aim to evaluate the effectiveness of oral Chinese-origin with adjuvant metronidazole (MET) on treating Chinese BV patients. In total, 67 Chinese women with BV were enrolled in this parallel controlled trial and randomly assigned to two study groups: a control group treated with MET vaginal suppositories for 7 days and a probiotic group treated with oral TM13 and LG55 as an adjuvant to MET for 30 days. By comparing the participants with Nugent Scores ≥ 7 and < 7 on days 14, 30, and 90, we found that oral administration of probiotics did not improve BV cure rates (72.73% and 84.00% at day 14, 57.14% and 60.00% at day 30, 32.14% and 48.39% at day 90 for probiotic and control group respectively). However, the probiotics were effective in restoring vaginal health after cure by showing higher proportion of participants with Nugent Scores < 4 in the probiotic group compared to the control group (87.50% and 71.43% on day 14, 93.75% and 88.89% on day 30, and 77.78% and 66.67% on day 90). The relative abundance of the probiotic strains was significantly increased in the intestinal microbiome of the probiotic group compared to the control group at day 14, but no significance was detected after 30 and 90 days. Also, the probiotics were not detected in vaginal microbiome, suggesting that TM13 and LG55 mainly acted through the intestine. A higher abundance of at baseline was significantly associated with long-term cure failure of BV and greatly contributed to the enrichment of the lipid IVA synthesis pathway, which could aggravate inflammation response. To sum up, TM13 and LG55 can restore the vaginal health of patients recovering from BV, and individualized intervention mode should be developed to restore the vaginal health of patients recovering from BV.

CLINICAL TRIAL REGISTRATION

https://classic.clinicaltrials.gov/ct2/show/, identifier NCT04771728.

摘要

未加说明

细菌性阴道病(BV)是一种常见的下生殖道感染,其特征是阴道微生物群失调,导致乳杆菌减少。先前的研究表明,补充活菌可能有益于 BV 的恢复,但不同地区人群的结果存在差异。在此,我们旨在评估口服中国来源的 与辅助甲硝唑(MET)治疗中国 BV 患者的有效性。总共有 67 名中国 BV 患者参加了这项平行对照试验,并随机分为两组:对照组接受 MET 阴道栓剂治疗 7 天,益生菌组接受口服 TM13 和 LG55 作为 MET 的辅助治疗 30 天。通过比较第 14、30 和 90 天 Nugent 评分≥7 和<7 的参与者,我们发现口服益生菌并不能提高 BV 治愈率(第 14 天为 72.73%和 84.00%,第 30 天为 57.14%和 60.00%,第 90 天为 32.14%和 48.39%,分别为益生菌组和对照组)。然而,益生菌在治愈后恢复阴道健康方面是有效的,因为与对照组相比,益生菌组有更高比例的参与者 Nugent 评分<4(第 14 天为 87.50%和 71.43%,第 30 天为 93.75%和 88.89%,第 90 天为 77.78%和 66.67%)。与对照组相比,益生菌组肠道微生物组中益生菌株的相对丰度在第 14 天显著增加,但在第 30 和 90 天没有检测到差异。此外,在阴道微生物组中未检测到益生菌,表明 TM13 和 LG55 主要通过肠道起作用。基线时较高的 丰度与 BV 长期治疗失败显著相关,并极大地促进了脂 IVA 合成途径的富集,这可能加重炎症反应。总之, TM13 和 LG55 可以恢复 BV 康复患者的阴道健康,应开发个体化干预模式来恢复 BV 康复患者的阴道健康。

临床试验注册

https://classic.clinicaltrials.gov/ct2/show/,标识符 NCT04771728。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00e9/10415204/3ec452e64186/fimmu-14-1125239-g001.jpg

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