口服益生菌预防孕期复发性外阴阴道感染——多中心双盲随机安慰剂对照试验
Oral Probiotics to Prevent Recurrent Vulvovaginal Infections During Pregnancy-Multicenter Double-Blind, Randomized, Placebo-Controlled Trial.
作者信息
Nachum Zohar, Suleiman Abeer, Colodner Raul, Battino Shlomo, Wattad Malak, Kuzmin Olga, Yefet Enav
机构信息
Department of Obstetrics & Gynecology, Emek Medical Center, Afula 1834111, Israel.
Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa 3478403, Israel.
出版信息
Nutrients. 2025 Jan 27;17(3):460. doi: 10.3390/nu17030460.
: During pregnancy, vulvovaginal infections (VVIs), including abnormal vaginal flora (AVF), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC), are associated with serious complications and discomfort. We aimed to elucidate the effectiveness of oral probiotics in secondary prevention of VVIs in pregnant women. : A multicenter prospective randomized, double-blind, placebo-controlled trial was conducted at three medical centers between 2016 and 2021. Women who complained of vaginal symptoms with positive smear for AVF/BV and/or candida were treated with antibiotics or an antimycotic agent, respectively. After confirmation of VVI eradiation by repeated vaginal smear, the women were divided into a research group, receiving two capsules/day of oral probiotic formula containing , , () , , and (>6 × 10 CFU/capsule), and a control group, receiving a placebo (two capsules/day) until delivery. At least once a month or following complaints, a vaginal smear was taken to assess vaginal microbiota. If VVIs were found, they were treated with antibiotics/antimycotics, and eradication was assessed by a repeated vaginal smear. Lactobacilli vaginal colonization, including the specific strains from the probiotic capsules, were detected using the matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI TOF-MS). The primary outcome was the rate of women who developed VVI during the study period until delivery. : Twenty-three and twenty-four women were analyzed in the probiotic and placebo cohorts, respectively. There was no difference in the rate of any VVI between the probiotic and placebo cohorts (16 (67%) versus 11 (48%), respectively; = 0.19), time until first infection or pregnancy outcomes. The lactobacilli strains that colonized the vagina were similar at baseline and following probiotic or placebo administration. No woman was detected with vaginal colonization of the strains from the capsule, although the probiotics were taken for about 4 months. : The oral probiotic product tested in this study did not reduce the recurrence rate of VVIs in pregnant women following eradication.
在孕期,外阴阴道感染(VVIs),包括异常阴道菌群(AVF)、细菌性阴道病(BV)和外阴阴道念珠菌病(VVC),与严重并发症及不适相关。我们旨在阐明口服益生菌在孕妇VVIs二级预防中的有效性。
2016年至2021年期间,在三个医疗中心进行了一项多中心前瞻性随机、双盲、安慰剂对照试验。主诉有阴道症状且AVF/BV涂片阳性和/或念珠菌阳性的女性,分别接受抗生素或抗真菌药物治疗。经重复阴道涂片确认VVI根除后,将这些女性分为研究组,每天服用两粒含嗜酸乳杆菌、双歧杆菌、鼠李糖乳杆菌(嗜酸乳杆菌 、双歧杆菌 、鼠李糖乳杆菌(>6×10⁸CFU/胶囊)的口服益生菌配方胶囊,以及对照组,每天服用一粒安慰剂直至分娩。每月至少一次或在出现不适后,进行阴道涂片以评估阴道微生物群。如果发现VVIs,则用抗生素/抗真菌药物治疗,并通过重复阴道涂片评估根除情况。使用基质辅助激光解吸/电离飞行时间质谱(MALDI TOF-MS)检测阴道中乳酸杆菌的定植情况,包括来自益生菌胶囊的特定菌株。主要结局是在研究期间直至分娩时发生VVI的女性比例。
益生菌组和安慰剂组分别分析了23名和24名女性。益生菌组和安慰剂组之间任何VVI的发生率、首次感染时间或妊娠结局均无差异(分别为16例(67%)和11例(48%);P = 0.19)。在基线时以及服用益生菌或安慰剂后,定植于阴道的乳酸杆菌菌株相似。尽管服用益生菌约4个月,但未检测到任何女性阴道中有来自胶囊的菌株定植。
本研究中测试的口服益生菌产品并未降低孕妇根除VVIs后的复发率。