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首页> 外文期刊>Drug Design, Development and Therapy >Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial
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Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial

机译：含有三种益生菌菌株的阴道药品的功效和安全性：多中心，随机，双盲和安慰剂对照试验

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Objective: The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. Patients and methods: The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4–6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag?, or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Results: Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (P<0.05) and Nugent score (P<0.05), and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05). Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at visit III, and 47.5% at visit IV. There was no serious adverse event related to inVag administration during the study. Conclusion: The probiotic inVag is safe for administration to sustainably restore the healthy vaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota.
机译：目的：本研究的主要目的是评估阴道施用益生菌乳酸杆菌是否会导致其在阴道中的定植和持久性，以及乳酸菌定植是否能促进pH值和Nugent评分的正常化和维持。患者和方法：该研究是一项多中心，随机，双盲和安慰剂对照试验。总共评估了376名妇女的资格，并签署了知情同意书。随机分为160名合格妇女，这些妇女的异常，也称为中间阴道微生物区系，Nugent评分为4–6，pH> 4.5，乳酸菌计数为零或低。每个参与者在研究过程中接受了四次检查。妇女被随机分配接受益生菌制剂inVag？或安慰剂（阴道连续7天服用一粒胶囊）。 inVag的产品包括益生菌菌株发酵乳杆菌57A，植物乳杆菌57B和加氏乳杆菌57C。在访问I，III和IV期间，我们进行了阴道拭子检查，以确定乳杆菌属细菌的存在与否，测量pH值并评估Nugent得分。药物安全性评估基于对不良事件的类型和发生情况的分析。结果：inVag的使用导致阴道pH（P <0.05）和Nugent评分（P <0.05）显着降低（访视之间），并且在访视I与访视III和IV之间显着增加了乳杆菌的丰度（ P ＜0.05）。分子分型显示在第三次访视时有82％的妇女服用inVag的乳杆菌菌株，在第四次访视中有47.5％的妇女存在这种菌株。在研究期间，没有与inVag给药相关的严重不良事件。结论：益生菌inVag可以安全地持续恢复健康的阴道微生物群，如阴道微生物群中乳酸菌的优势所证明的那样。

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