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关于口服 L. plantarum P17630 产品在复发性外阴阴道念珠菌病(RVVC)病史女性中的新证据:一项随机双盲安慰剂对照研究。

New evidence on oral L. plantarum P17630 product in women with history of recurrent vulvovaginal candidiasis (RVVC): a randomized double-blind placebo-controlled study.

机构信息

University of Medicine and Pharmacy Carol Davila Bucharest, Elias University Hospital, Bucharest, Romania.

出版信息

Eur Rev Med Pharmacol Sci. 2018 Jan;22(1):262-267. doi: 10.26355/eurrev_201801_14128.

Abstract

OBJECTIVE

To evaluate activity and tolerability of an oral product containing the specific probiotic strain Lactobacillus plantarum P17630 on vaginal colonization of lactic acid bacteria.

PATIENTS AND METHODS

L. plantarum P17630 (5x109 CFU/capsule) or placebo were formulated in capsules and administrated orally to a total of 93 women with a history of recurrent vulvovaginal candidiasis over a period of 3 treatment cycles (15 days/cycle) separated by 15-day wash-out intervals. Vulvovaginal examinations and vaginal mycological culture, including Nugent score and Lactobacillary grade (LBG), were assessed at baseline, at day 45 and at day 90 (end of the study).

RESULTS

Probiotic intake significantly improved lactobacilli colonization on vaginal epithelial cells. The results demonstrated a significant difference in LBG score when comparing day 0 to day 45 (p=0.000016) and to day 90 (p=0.001415) in women treated with L. plantarum P17630. No evidence of improvement in LBG score was recorded in women who received placebo (p<0.005). The increased lactobacilli adhesion was associated with the improvement of clinical signs such as redness, swelling, and discharge.

CONCLUSIONS

This study demonstrates that the administration of oral probiotic Lactobacillus plantarum P17630 improves vagina colonization of acid lactic bacteria (an increase of vaginal LBG score) and suggests the use of this oral product to successfully prevent episodes of vulvovaginal candidiasis. The clinical study described in this article is registered in the ISRCTN registry with trial registration ID ISRCTN12669692.

摘要

目的

评估含有特定益生菌菌株植物乳杆菌 P17630 的口服产品对阴道内乳酸菌定植的活性和耐受性。

患者和方法

将植物乳杆菌 P17630(5x109 CFU/胶囊)或安慰剂制成胶囊,共 93 名有复发性外阴阴道假丝酵母菌病病史的女性连续服用 3 个治疗周期(每个周期 15 天),每个周期之间有 15 天的洗脱间隔期。在基线、第 45 天和第 90 天(研究结束时)进行外阴阴道检查和阴道真菌培养,包括 Nugent 评分和乳杆菌分级(LBG)。

结果

益生菌摄入显著改善了阴道上皮细胞中的乳酸菌定植。结果显示,与第 0 天相比,L. plantarum P17630 治疗组在第 45 天(p=0.000016)和第 90 天(p=0.001415)时 LBG 评分有显著差异。接受安慰剂的女性 LBG 评分无改善(p<0.005)。乳酸杆菌黏附的增加与临床体征的改善相关,如发红、肿胀和分泌物。

结论

本研究表明,口服益生菌植物乳杆菌 P17630 可改善阴道内乳酸菌定植(阴道 LBG 评分增加),并提示使用该口服产品成功预防外阴阴道假丝酵母菌病发作。本文描述的临床研究已在 ISRCTN 注册中心注册,注册号为 ISRCTN12669692。

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