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首页> 外文期刊>BMC Women s Health >Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial
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Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial

机译：口服益生菌补充标准抗生素治疗细菌性阴道病和有氧性阴道炎的研究：一项随机，双盲，安慰剂对照试验

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This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag?) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV). Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5–6 (I, II, II bis – if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10?days; during follow up, patients took one capsule daily for 10?days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n?=?285; placebo, n?=?293) 18–50-year-old women who were randomised. BV/AV was confirmed microbiologically in 241 (probiotic, n?=?118; placebo, n?=?123) participants, who continued the trial. Data from 154 (probiotic, n?=?73; placebo, n?=?81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n?=?22; placebo, n?=?15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51?% (p?
机译：进行了这项多中心，随机，双盲，安慰剂对照试验，以确定是否使用包含三种乳酸菌菌株的口服益生菌制剂（prOVag？）以及标准甲硝唑治疗和靶向抗生素治疗（继甲硝唑治疗失败之后）可以降低细菌性阴道病（BV）和有氧性阴道炎（AV）的复发率。在波兰的私人妇科诊所，有反复出现BV / AV病史和当前症状的患者被随机分配接受甲硝唑和益生菌或安慰剂，并在II和III-V访视时每月进行评估。研究访问的总数为5–6（I，II，II之二–如果适用，III，IV，V）。一个益生菌或安慰剂胶囊每天两次服用甲硝唑/靶向抗生素，持续10天;在随访过程中，患者每天在月经周围10天服用一粒胶囊。每次访视时进行临床检查和阴道擦拭。主要结局为临床或微生物BV / AV复发和益生菌安全性。次要结果是阴道微生物群的阴道pH值，Nugent评分和乳酸杆菌计数。安全性分析是在随机分组的578名（益生菌，n = 285;安慰剂，n = 293）中进行的。 BV / AV在241名参与者中进行了微生物学确认（益生菌，n = 118）;安慰剂，n = 123），他们继续进行了试验。分析来自完成研究的154位（益生菌，n = 73;安慰剂，n = 81）的数据，以确定prOVag的疗效。其他分析包括接受靶向抗生素和益生菌或安慰剂的37名（益生菌，n = 22;安慰剂，n = 15）参与者。与安慰剂相比，prOVag使BV / AV症状的临床复发时间延长了51％（p <0.05）。 AV复发最多延迟了76％（p <0.05）。在标准治疗后，使用益生菌还可以降低并维持较低的阴道pH和Nugent评分，并增加阴道乳酸菌计数。这项研究表明，口服益生菌可延长BV / AV复发患者的缓解期，并改善其临床和微生物学参数。 NCT01993524; 2013年11月20日。

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