Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
BJOG. 2020 Jan;127(2):287-299. doi: 10.1111/1471-0528.15870. Epub 2019 Aug 8.
Vaginal probiotics claiming to cure and/or prevent bacterial and/or fungal vaginal dysbiosis are available on the market but, until recently, did not have to be approved as drugs for human use.
We evaluated the impact of vaginal probiotics on bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) cure and/or recurrence, as well as vaginal microbiota (VMB) composition and vaginal detection of probiotic strains.
We performed a systematic literature search in MEDLINE and Embase up to 15 January 2019.
There were no restrictions in probiotic strains/formulations, study populations, and designs. BV had to be diagnosed by Nugent or Ison-Hay Gram stain scoring, VVC by culture, wet mount or PCR, and VMB composition/detection by molecular techniques.
The authors independently extracted data.
All 22 vaginal probiotics evaluated in the 34 eligible studies contained Lactobacillus strains, and some contained additional active ingredients. The probiotics hold promise for BV cure and prevention, but much less so for VVC cure and prevention. No major safety concerns were reported in any of the studies. Vaginal detection of probiotic strains never lasted long beyond the dosing period, suggesting that they did not colonise the vagina. However, findings are not definitive because heterogeneity was high and the quality of most studies suboptimal.
Availability of vaginal probiotics for vaginal health indications will likely decline in 2020 because of regulatory changes. We urge the field to invest in clinical evidence-based product development and to conduct future trials more rigorously.
Lactobacilli-containing vaginal probiotics hold promise for bacterial vaginosis cure and prevention, but not for vulvovaginal candidiasis.
声称可治疗和/或预防细菌性和/或霉菌性阴道菌群失调的阴道益生菌已在市场上销售，但直到最近，它们还无需作为人类使用的药物获得批准。
我们评估了阴道益生菌对细菌性阴道病（BV）和外阴阴道念珠菌病（VVC）治愈和/或复发的影响，以及阴道微生物群（VMB）组成和阴道中益生菌菌株的检测。
我们对 MEDLINE 和 Embase 数据库进行了系统性文献检索，检索时间截至 2019 年 1 月 15 日。
对益生菌菌株/配方、研究人群和设计没有限制。BV 必须通过 Nugent 或 Ison-Hay Gram 染色评分、VVC 通过培养、湿片或 PCR、以及分子技术检测 VMB 组成/检测进行诊断。
作者独立提取数据。
在 34 项合格研究中评估的所有 22 种阴道益生菌均含有乳杆菌菌株，有些还含有其他活性成分。这些益生菌有望治疗和预防 BV，但对治疗和预防 VVC 的效果则差得多。在任何研究中都没有报告重大安全问题。阴道中益生菌菌株的检测结果在给药期后从未持续很长时间，这表明它们并未定植于阴道。但是，由于存在高度异质性和大多数研究质量欠佳，因此这些结果尚不确定。
由于监管变化，预计 2020 年用于阴道健康适应症的阴道益生菌将不再可用。我们敦促该领域投资于基于临床证据的产品开发，并更严格地开展未来的试验。
含乳杆菌的阴道益生菌有望治疗细菌性阴道病并预防其发生，但对治疗外阴阴道念珠菌病无效。
