Effect of Lyophilized Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Vaginitis and Vaginosis with Disrupted Vaginal Microflora: A Multicenter, Randomized, Single-Blind, Active-Controlled Pilot Study
Effect of Lyophilized Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Vaginitis and Vaginosis with Disrupted Vaginal Microflora: A Multicenter, Randomized, Single-Blind, Active-Controlled Pilot Study
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DOI：
10.1159/000314016
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发表时间：
2010-01-01
影响因子：
2.1
通讯作者：
Graf, F.
中科院分区：
文献类型：
--
作者：
Donders, G. G. G.;Van Bulck, B.;Graf, F.
目的 评估冻干乳酸杆菌联合 0·03 mg 雌三醇与甲硝唑治疗细菌性阴道感染的疗效 设置 在比利时 3 个独立妇科诊所进行的多中心、随机、单盲、主动对照试点研究 方法 46 名 18 至 50 岁绝经前妇女，因细菌性阴道感染而阴道菌群遭到破坏（细菌性阴道病需氧性阴道炎）被包括在内，前提是阴道液的新鲜相差显微镜显示乳杆菌菌群为 2B 级或 3 级。患者被给予一个盲盒，其中装有 12 颗 Gynoflor (R)（研究药物）阴道片剂或 6 个含有 500 mg 甲硝唑（对照药物）的阴道栓剂。研究了八个功效变量，以评估进入时阴道菌群的状态，治疗结束后 3-7 天（对照 1）、4-6（对照 2）周和 4 个月 结果 在对照 1 时，乳酸菌组的综合变量与甲硝唑组的改善相同 在对照 2 时，乳酸菌制剂的结果略逊于甲硝唑组 在 4 个月时，由于数量较少而无法进行此分析，但两组之间的复发率和所需额外用药分析没有差异 结论 冻干乳酸菌与小剂量雌三醇合用，短期治疗细菌性阴道感染的效果与甲硝唑相当，但1个月后效果较差。需要进一步研究评估反复应用时乳酸菌的长期疗效。版权所有 (c) 2010 S Karger AG Basel
Objectives To evaluate the efficacy of lyophilized lactobacilli in combination with 0 03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections Setting Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium Methods Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3 Patients were given a blinded box with either 12 vaginal tablets of Gynoflor (R) (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication) Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3-7 days (control 1), 4-6 (control 2) weeks and 4 months after the end of therapy Results At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups Conclusion Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly Copyright (c) 2010 S Karger AG Basel