Evaluation of the effectiveness of correction of vagina dysbiosis with the use of vaginal prebiotic complex in women with risk factors of spontaneous premature birth

V. Pyrohova, O. Laba
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Abstract

Dysbiotic changes in microbial ecosystem of the female lower genital tract are risk factors for spontaneous abortions, spontaneous preterm births, intra-amniotic infection, postpartum endometritis, and adverse perinatal outcomes. However, the opinions about the expediency of antimicrobial therapy in women with bacterial vaginosis and a history of preterm birth are controversial, and discussions and the search for an effective method of treatment are still continuing. Treatment of dysbiosis of the vaginal microbiota requires a complex approach for not only the pathogen elimination, but also for the restoring of the normal vaginal biotope. The objective: to evaluate the effectiveness of correction of dysbiotic disorders of the vaginal microbiota in women with risk factors for premature birth using the prebiotic topical therapy.Materials and methods. The studied cohort included 105 women with risk factors for premature birth. I group included 38 women at the stage of pregnancy planning, II group – 39 pregnant women, III group – 28 pregnant women from the moment of their first visit to the female consultation for pregnancy monitor. The control group included 20 conditionally healthy pregnant women at the same gestational age. The patients of the I and II groups after diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis, or aerobic vaginitis received etiotropic topical therapy in accordance with the recommendations of the Centers for Disease Control and Prevention and International Union against sexually transmitted infections. Bacterial vaginosis was treated by clindamycin cream (2 %) once a day for 7 days; aerobic vaginitis – vaginal tablets which contain 10 mg of dequalinium chloride for 6 days; candida vaginitis – fenticonazole 600 mg in one vaginal capsule once followed by topical application of a prebiotic complex (oligosaccharide, sodium hyaluronate, xylitol, vitamins, lactose) for 10 days. Then pH balance and normocenosis of the vagina were supported by the use of one vaginal capsule of the prebiotic complex per week till the 22nd week of gestation. The pregnant women in the III group with similar pathologies received only classical antimicrobial therapy with antibiotics and/or antifungal drugs.The assessment of the vaginal microbiota was carried out at the time of the patients inclusion in the study and at the 17–19 weeks of gestation by determination of the vaginal pH and using molecular biological and bacterioscopic methods. Results. The effectiveness of BV and mixed vaginitis therapy in all groups was high, the frequency of BV detection after treatment decreased from 28.9 % to 2.6 % in the I group and from 32.1 % to 3.6 % – in the III group.In the I and II groups, in which the patients received complex treatment with the prebiotic complex, the quantity of women with normocenosis of the vagina increased significantly (from 39.5 % to 89.5 % in the I group; from 35.9 % to 89.7 % in the II group), the frequency of the intermediate state of the vaginal microbiota decreased twice (from 13.2 % to 7.9 % in the I group and from 15.4 % to 7.7 % in the II group). In patients of the III group, the incidence of normocenosis increased slightly (from 32.1 % to 39.3 %), but the rate of pregnant women with an intermediate state of vaginal microbiota increased significantly (from 14.3 % to 46.4 %), which is a threat to the recurrence of dysbiotic processes.Conclusions. The topical use of the prebiotic complex, which contains oligosaccharide, sodium hyaluronate, xylitol, vitamins and lactose, is effective in the management of symptoms and pathogenic load in uncomplicated vaginal infection, which is manifested by a decrease in the prevalence of intermediate states of the microbiota and a steady increase in normocenosis. The complex therapy with antibiotics/antifungal agents with a vaginal prebiotic complex provides an effective restoration of the vaginal flora to the state of normocenosis compared to treatment with antibiotics/antifungal agents only.
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有自然早产危险因素的妇女使用阴道益生元复合物纠正阴道生态失调的有效性评价
女性下生殖道微生物生态系统的不良变化是自然流产、自然早产、羊膜内感染、产后子宫内膜炎和围产期不良结局的危险因素。然而,对于有早产史的细菌性阴道病妇女是否应使用抗菌药物治疗存在争议,讨论和寻找有效的治疗方法仍在继续。阴道菌群失调的治疗需要一个复杂的方法,不仅要消除病原体,而且要恢复正常的阴道菌群。目的:评估使用益生元局部治疗对有早产危险因素的妇女阴道微生物群失调的纠正效果。材料和方法。研究队列包括105名有早产危险因素的妇女。I组包括38名处于妊娠计划阶段的妇女,II组- 39名孕妇,III组- 28名孕妇从第一次就诊到女性咨询妊娠监护。对照组包括20名相同胎龄的条件健康孕妇。诊断为细菌性阴道病(BV)、外阴阴道念珠菌病或有氧阴道炎的I组和II组患者按照疾病控制和预防中心和国际反性传播感染联盟的建议接受致病因局部治疗。细菌性阴道病用克林霉素乳膏(2%)治疗,每日1次,连用7天;有氧阴道炎-阴道片,含10毫克氯去qualinium,可服用6天;念珠菌阴道炎-一次服用芬替康唑600毫克阴道胶囊,然后局部应用益生元复合物(低聚糖,透明质酸钠,木糖醇,维生素,乳糖)10天。然后通过每周服用一粒益生元复合物阴道胶囊来维持阴道的pH平衡和正常生育,直至妊娠22周。III组病理相似的孕妇仅接受抗生素和/或抗真菌药物的经典抗菌治疗。在患者纳入研究时和妊娠17-19周时,通过测定阴道pH值并使用分子生物学和细菌学方法对阴道微生物群进行评估。结果。BV和混合治疗阴道炎在所有组中的有效性都很高,治疗后BV检出率在I组从28.9%下降到2.6%,在III组从32.1%下降到3.6%。在I组和II组中,患者接受益生元复合物的综合治疗,阴道正常病变的女性数量显著增加(I组从39.5%增加到89.5%;从II组的35.9%降至89.7%),阴道微生物群中间状态的频率下降了两倍(I组从13.2%降至7.9%,II组从15.4%降至7.7%)。在III组患者中,正常妊娠的发生率略有增加(从32.1%增加到39.3%),但阴道微生物群处于中间状态的孕妇的发生率显著增加(从14.3%增加到46.4%),这是对生态不良过程复发的威胁。局部使用含有低聚糖、透明质酸钠、木糖醇、维生素和乳糖的益生元复合物,可有效控制无并发症阴道感染的症状和致病负荷,表现为微生物群中间状态的患病率下降,正常菌群的患病率稳步上升。与仅使用抗生素/抗真菌药物治疗相比,抗生素/抗真菌药物与阴道益生元复合物的复合治疗可有效地将阴道菌群恢复到正常状态。
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