Ozkinay Erdinc, Terek Mustafa Cosan, Yayci Murat, Kaiser Renato, Grob Philipp, Tuncay Gungor
Department of Obstetrics and Gynecology, Ege University Faculty of Medicine, Izmir 35100, Turkey.
BJOG. 2005 Feb;112(2):234-40. doi: 10.1111/j.1471-0528.2004.00329.x.
To evaluate the effectiveness of live lactobacilli in combination with low dose oestriol for restoration of the vaginal flora after anti-infective treatment.
The study was designed as a single centre, randomised, placebo-controlled, double-blind clinical trial.
University Hospital.
Three hundred and sixty women out of 1750 were randomised.
Three hundred and sixty women with the complaints of vaginal infections (bacterial vaginosis, candidiasis, trichomoniasis or fluor vaginalis) were randomly assigned two to seven days after the end of the anti-infective therapy, to therapy with live lactobacilli in combination with low dose oestriol (study group, n= 240) or placebo (n= 120). The follow up visits occurred three to seven days and four to six weeks after the end of the restoration therapy.
The Normal Flora Index (NFI), which consists of numbers of lactobacilli, pathogenic microorganisms, leucocytes and vaginal pH, was used as the primary outcome of the study. Secondary outcomes included the total symptoms score, the degree of purity of the vaginal flora and the global assessment of the treatment by the investigator and the women.
During restoration therapy, the NFI increased significantly more in the study group than in the control group in both first and second control visits (P= 0.002 and P= 0.006, respectively). The degree of purity of the vaginal flora also increased significantly more in the study group compared with the control group (P < 0.0001 and P= 0.001, respectively). No serious adverse event was reported during restoration therapy.
Restoration of the vaginal flora can be significantly enhanced by the administration of live lactobacilli in combination with low dose oestriol.
评估活乳酸杆菌联合低剂量雌三醇在抗感染治疗后恢复阴道菌群的有效性。
该研究设计为单中心、随机、安慰剂对照、双盲临床试验。
大学医院。
从1750名女性中随机选取360名。
360名有阴道感染（细菌性阴道病、念珠菌病、滴虫病或外阴阴道炎）主诉的女性在抗感染治疗结束后2至7天被随机分配，接受活乳酸杆菌联合低剂量雌三醇治疗（研究组，n = 240）或安慰剂治疗（n = 120）。在恢复治疗结束后3至7天以及4至6周进行随访。
正常菌群指数（NFI），由乳酸杆菌数量、致病微生物、白细胞和阴道pH值组成，用作研究的主要观察指标。次要观察指标包括总症状评分、阴道菌群纯净度以及研究者和女性对治疗的整体评估。
在恢复治疗期间，研究组的NFI在首次和第二次对照访视中均比对照组显著增加更多（分别为P = 0.002和P = 0.006）。与对照组相比，研究组阴道菌群的纯净度也显著增加更多（分别为P < 0.0001和P = 0.001）。恢复治疗期间未报告严重不良事件。
给予活乳酸杆菌联合低剂量雌三醇可显著增强阴道菌群的恢复。
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