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比较益生菌和氟康唑对治疗和复发性外阴阴道念珠菌病的效果:一项三盲随机对照试验。

Comparing the Effect of Probiotic and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis: a Triple-Blinded Randomized Controlled Trial.

机构信息

Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.

Department of Food Science and Technology, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Probiotics Antimicrob Proteins. 2023 Oct;15(5):1436-1446. doi: 10.1007/s12602-022-09997-3. Epub 2022 Oct 5.

Abstract

Vaginitis is a common problem in women. Candida albicans is responsible for more than 85% of vaginal fungal infections. The aim of this study was to compare the effects of probiotic and fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). This triple-blinded randomized controlled trial was conducted on 80 married women, aged 18-49 years, with VVC, as confirmed by clinical and laboratory diagnosis. The participants were allocated into two groups using blocked randomization method. The fluconazole-treated group received a single dose of fluconazole (150 mg) supplemented with 30 placebo capsules of probiotic, and the probiotic-treated group got 30 probiotic capsules containing 1 × 10 CFU/g LA-5 with 1 fluconazole placebo capsule. The samples were taken from patients to evaluate the vaginal pH and microbiological tests before, 30-35 days, and 60-65 days after starting the treatment. The signs and symptoms were assessed before the intervention and the first and second follow-ups. Chi-square, Fisher's exact, independent t, and ANCOVA tests were then used for data analysis. There was no statistically significant difference between the two groups (p = 0.127) in the frequency of negative culture 30-35 days after starting the treatment, but the frequency of negative culture 60-65 days after starting treatment in the fluconazole group was significantly higher than that of the probiotic group (p = 0.016). The abnormal discharge and vulvovaginal erythema in the first and second follow-ups and also pruritus in the second follow-up in the fluconazole group were significantly lower than those in the probiotic group (p < 0.05). There was, however, no statistically significant difference in burning, frequent urination, dysuria, and dyspareunia between the groups (p > 0.05). Lactobacillus acidophilus supplementation had an effect similar to that of fluconazole in treating most symptoms of VVC, but it was less effective than the latter in preventing recurrence. Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20110826007418N5. Date of registration: 3 March 2021; URL: https://en.irct.ir/trial/50819 ; Date of first registration: 10 March 2021.

摘要

阴道炎是女性常见的问题。白色念珠菌是导致阴道真菌感染的 85%以上的原因。本研究旨在比较益生菌和氟康唑对治疗和复发外阴阴道念珠菌病(VVC)的影响。这项三盲随机对照试验纳入了 80 名年龄在 18-49 岁之间的已婚妇女,她们患有 VVC,这是通过临床和实验室诊断来确认的。参与者采用分组随机方法分为两组。氟康唑治疗组给予单剂量氟康唑(150mg),并补充 30 粒安慰剂益生菌,益生菌治疗组给予 30 粒含有 1×10 CFU/g LA-5 的益生菌胶囊,同时给予 1 粒氟康唑安慰剂胶囊。在开始治疗前、30-35 天和 60-65 天后,从患者身上取样评估阴道 pH 值和微生物学检查。在干预前以及第一次和第二次随访时评估体征和症状。然后使用卡方检验、Fisher 确切检验、独立 t 检验和协方差分析进行数据分析。治疗开始后 30-35 天,两组之间的阴性培养频率(p=0.127)无统计学差异,但氟康唑组治疗开始后 60-65 天的阴性培养频率明显高于益生菌组(p=0.016)。氟康唑组在第一次和第二次随访时的异常分泌物和外阴阴道红斑,以及第二次随访时的瘙痒均明显低于益生菌组(p<0.05)。然而,两组之间的烧灼感、尿频、尿痛和性交痛无统计学差异(p>0.05)。补充嗜酸乳杆菌在治疗 VVC 的大多数症状方面与氟康唑的效果相似,但在预防复发方面不如后者有效。试验注册:伊朗临床试验注册中心(IRCT):IRCT20110826007418N5。注册日期:2021 年 3 月 3 日;网址:https://en.irct.ir/trial/50819;首次注册日期:2021 年 3 月 10 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b76/9534588/ef89531cef24/12602_2022_9997_Fig1_HTML.jpg

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