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口服益生菌鼠李糖乳杆菌GR-1和罗伊氏乳杆菌RC-14增强甲硝唑治疗细菌性阴道病的疗效:随机、双盲、安慰剂对照试验

Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial.

作者信息

Anukam Kingsley, Osazuwa Emmanuel, Ahonkhai Ijeoma, Ngwu Michael, Osemene Gibson, Bruce Andrew W, Reid Gregor

机构信息

Department of Pharmaceutical Microbiology, Faculty of Pharmacy, University of Benin, Nigeria.

出版信息

Microbes Infect. 2006 May;8(6):1450-4. doi: 10.1016/j.micinf.2006.01.003. Epub 2006 Mar 29.

Abstract

This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis (BV) by presence of vaginal irritation, discharge and 'fishy' odor, and Nugent criteria and detection of sialidase enzyme. The subjects were treated with oral metronidazole (500 mg) twice daily from days 1 to 7, and randomized to receive oral Lactobacillus rhamnosus GR-1 (1 x 10(9)) and Lactobacillus reuteri RC-14 (1 x 10(9)) or placebo twice daily from days 1 to 30. Primary outcome was cure of BV as determined by normal Nugent score, negative sialidase test and no symptoms or signs of BV at day 30. A total of 106 subjects returned for 30-day follow-up, of which 88% were cured in the antibiotic/probiotic group compared to 40% in the antibiotic/placebo group (p<0.001). Of the remaining subjects, 30% subjects in the placebo group and none in the probiotic group had BV, while 30% in the placebo and 12% in the probiotic group fell into the intermediate category based upon Nugent score, sialidase result and clinical findings. High counts of Lactobacillus sp. (>10(5) CFU/ml) were recovered from the vagina of 96% probiotic-treated subjects compared to 53% controls at day 30. In summary, this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women.

摘要

本研究纳入了125名绝经前女性,她们因出现阴道刺激、分泌物和“鱼腥味”,以及根据 Nugent 标准和唾液酸酶检测被诊断为细菌性阴道病(BV)。受试者在第1至7天每天口服甲硝唑(500毫克)两次,并随机分为两组,从第1至30天每天两次接受口服鼠李糖乳杆菌GR-1(1×10⁹)和罗伊氏乳杆菌RC-14(1×10⁹)或安慰剂。主要结局是根据Nugent评分正常、唾液酸酶检测阴性以及在第30天无BV症状或体征来确定BV治愈。共有106名受试者返回进行30天随访,其中抗生素/益生菌组88%治愈,而抗生素/安慰剂组为40%(p<0.001)。在其余受试者中,安慰剂组30%的受试者患有BV,益生菌组无受试者患有BV,而根据Nugent评分、唾液酸酶结果和临床发现,安慰剂组30%、益生菌组12%属于中间类别。在第30天,96%接受益生菌治疗的受试者阴道中分离出高计数的乳酸杆菌属(>10⁵CFU/ml),而对照组为53%。总之,本研究表明乳酸杆菌和抗生素在根除非洲黑人女性的BV方面有效。

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