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随机临床试验:复发性外阴阴道念珠菌病女性患者中益生菌和乳铁蛋白作为维持治疗的疗效。

Randomised clinical trial in women with Recurrent Vulvovaginal Candidiasis: Efficacy of probiotics and lactoferrin as maintenance treatment.

机构信息

Giellepi S.p.A. Health Science, Lissone (MB), Italy.

National Centre for Innovative Technologies in Public Health, National Institute of Health, Rome, Italy.

出版信息

Mycoses. 2019 Apr;62(4):328-335. doi: 10.1111/myc.12883. Epub 2019 Feb 20.

Abstract

BACKGROUND

Vulvovaginal candidiasis (VVC) is a recurrent vaginal condition in childbearing women.

OBJECTIVES

The aim of this study was to assess the efficacy of an oral formulation containing Lactobacillus acidophilus GLA-14, Lactobacillus rhamnosus HN001 and bovine lactoferrin on symptoms and recurrence of VVC as adjuvant therapy to topical clotrimazole.

PATIENTS/METHODS: Forty-eight women positive for C. albicans, symptoms of VVC and documented history of recurrences were randomised into 2 groups receiving verum or placebo (2 capsules/day for 5 days followed by 1 capsule/day for additional 10 days) as adjuvant treatment to clotrimazole (induction phase) followed by a maintenance cycle of 6 months (1 capsule/day verum or placebo for 10 consecutive days each month). Symptoms, overall cure rate and recurrence rate were assessed.

RESULTS

After clotrimazole therapy, a significant improvement of symptoms was shown in both groups. However, only women treated with probiotics and lactoferrin showed a significant improvement of itching and discharge at 3 and 6 months. During the six-month follow-up, recurrences were significantly less in the intervention group vs placebo (33.3% vs 91.7% after 3 months and 29.2% vs 100% after 6 months).

CONCLUSIONS

The results show that the investigated lactobacilli mixture in combination with lactoferrin represents a safe and effective adjuvant approach for reducing symptoms and recurrences of RVVC.

摘要

背景

外阴阴道假丝酵母菌病(VVC)是育龄妇女中反复发作的阴道疾病。

目的

本研究旨在评估含有嗜酸乳杆菌 GLA-14、鼠李糖乳杆菌 HN001 和牛乳铁蛋白的口服制剂作为克霉唑局部辅助治疗对 VVC 症状和复发的疗效。

患者/方法:48 名 C. albicans 阳性、VVC 症状和复发病史记录的妇女被随机分为 2 组,分别接受真药或安慰剂(每天 2 粒,连用 5 天,然后每天 1 粒,再连用 10 天)作为克霉唑(诱导期)的辅助治疗,随后进行 6 个月的维持治疗周期(真药或安慰剂每天 1 粒,连续 10 天,每月 1 次)。评估症状、总治愈率和复发率。

结果

在克霉唑治疗后,两组的症状均显著改善。然而,只有接受益生菌和乳铁蛋白治疗的妇女在 3 个月和 6 个月时瘙痒和分泌物明显改善。在 6 个月的随访中,干预组的复发率明显低于安慰剂组(3 个月后分别为 33.3%和 91.7%,6 个月后分别为 29.2%和 100%)。

结论

结果表明,所研究的乳杆菌混合物联合乳铁蛋白是一种安全有效的辅助治疗方法,可减少 RVVC 的症状和复发。

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