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A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis.一项评估1.3%甲硝唑阴道凝胶治疗细菌性阴道病安全性和有效性的3期、多中心、随机、双盲、赋形剂对照研究。
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Composition of the vaginal microbiota in women of reproductive age--sensitive and specific molecular diagnosis of bacterial vaginosis is possible?育龄妇女阴道微生物组构成——细菌性阴道病的敏感和特异分子诊断是否可行?
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Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples.细菌性阴道病与女性向男性 HIV-1 传播风险增加相关:非洲夫妇中的前瞻性队列分析。
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A comparative study of oral single dose of metronidazole, tinidazole, secnidazole and ornidazole in bacterial vaginosis.口服单次剂量甲硝唑、替硝唑、塞克硝唑和奥硝唑治疗细菌性阴道病的比较研究。
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Efficacy of the Mentha crispa in the treatment of women with Trichomonas vaginalis infection.薄荷叶治疗阴道毛滴虫感染女性的疗效。
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Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis.早孕期应用克林霉素治疗异常阴道菌群预防自发性早产的系统评价和荟萃分析。
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Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole.细菌性阴道病的治疗:一项比较塞克硝唑和甲硝唑的多中心、双盲、双模拟、随机III期研究。
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与甲硝唑、替硝唑和克林霉素相比,细菌性阴道病(BV)相关细菌对塞克硝唑的敏感性。

Susceptibility of bacterial vaginosis (BV)-associated bacteria to secnidazole compared to metronidazole, tinidazole and clindamycin.

作者信息

Petrina Melinda A B, Cosentino Lisa A, Rabe Lorna K, Hillier Sharon L

机构信息

Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA 15213, USA.

Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA 15213, USA; University of Pittsburgh, Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA 15213, USA.

出版信息

Anaerobe. 2017 Oct;47:115-119. doi: 10.1016/j.anaerobe.2017.05.005. Epub 2017 May 15.

DOI:10.1016/j.anaerobe.2017.05.005
PMID:28522362
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5623164/
Abstract

Secnidazole, a 5-nitroimidazole with a longer half-life, is structurally related to metronidazole and tinidazole. For treatment of bacterial vaginosis (BV), secnidazole is a suitable single-dose oral drug having a longer serum half-life than metronidazole. The objective of this study was to evaluate the antimicrobial susceptibility of vaginal isolates of facultative and anaerobic bacteria to secnidazole, metronidazole, tinidazole and clindamycin. A total of 605 unique BV-related bacteria and 108 isolates of lactobacilli recovered from the human vagina of US women during the years 2009-2015 were tested for antimicrobial susceptibility by the agar dilution CLSI reference method to determine the minimal inhibitory concentration (MIC). The MIC (μg/mL) for secnidazole was similar to metronidazole and tinidazole for Anaerococcus tetradius (secnidazole: MIC 2; metronidazole: MIC 2; tinidazole: MIC 4), Atopobium vaginae (32; >128; 128), Bacteroides species (2; 2; 2), Finegoldia magna (2; 2; 4), Gardnerella vaginalis (128; 64; 32), Mageeibacillus indolicus (2; 2; 2), Megasphaera-like bacteria (0.5; 0.25; 0.5), Mobiluncus curtisii (128; >128; >128) and Mobiluncus mulieris (>128; >128; >128), Peptoniphilus lacrimalis (4; 4; 4) and Peptoniphilus harei (2; 2; 4), Porphyromonas species (0.25; 0.5; 0.25), Prevotella bivia (8; 8; 8), Prevotella amnii (2; 1; 2) and Prevotella timonensis (2; 2; 2). In this evaluation, 14 (40%) of 35 P. bivia, 5 (14%) of 35 P. amnii and 21 (58%) of 36 P. timonensis isolates were resistant to clindamycin with MIC values of >128 μg/mL. Secnidazole, like metronidazole, was superior to clindamycin for Prevotella spp., Bacteroides spp., Peptoniphilus spp., Anaerococcus tetradius and Finegoldia magna. Clindamycin had greater activity against Atopobium vaginae, Gardnerella vaginalis and Mobiluncus spp. compared to the nitroimidazoles. All 27 Lactobacillus crispatus, 26 (96%) of 27 L. jensenii, 5 (19%) of 27 L. gasseri and 18 (67%) of 27 L. iners isolates were susceptible to clindamycin (MIC ≤2) while the MIC for all lactobacilli tested was >128 μg/mL for secnidazole, metronidazole and tinidazole. Secnidazole has similar in vitro activity against the range of microorganisms associated with BV compared to metronidazole or tinidazole. Further, secnidazole spares lactobacilli, a characteristic which is desirable in drugs used to treat bacterial vaginosis.

摘要

塞克硝唑是一种半衰期较长的5-硝基咪唑类药物,在结构上与甲硝唑和替硝唑相关。对于细菌性阴道病(BV)的治疗,塞克硝唑是一种合适的单剂量口服药物,其血清半衰期比甲硝唑长。本研究的目的是评估兼性厌氧菌和厌氧菌的阴道分离株对塞克硝唑、甲硝唑、替硝唑和克林霉素的抗菌敏感性。通过琼脂稀释CLSI参考方法对2009年至2015年期间从美国女性阴道中分离出的605株独特的BV相关细菌和108株乳酸杆菌进行抗菌敏感性测试,以确定最低抑菌浓度(MIC)。塞克硝唑的MIC(μg/mL)与甲硝唑和替硝唑对以下细菌的MIC相似:四联厌氧球菌(塞克硝唑:MIC 2;甲硝唑:MIC 2;替硝唑:MIC 4)、阴道阿托波菌(32;>128;128)、拟杆菌属(2;2;2)、巨大芬戈尔德菌(2;2;4)、阴道加德纳菌(128;64;32)、产吲哚马吉杆菌(2;2;2)、巨球形菌属样细菌(0.5;0.25;0.5)、柯氏动弯杆菌(128;>128;>I28)和穆氏动弯杆菌(>128;>128;>128)、泪栖胨球菌(4;4;4)和哈氏胨球菌(2;2;4)、卟啉单胞菌属(0.25;0.5;0.25)、二路普雷沃菌(8;8;8)、羊膜普雷沃菌(2;1;2)和蒂莫内斯普雷沃菌(2;2;2)。在本次评估中,35株二路普雷沃菌中的14株(40%)、35株羊膜普雷沃菌中的5株(14%)和36株蒂莫内斯普雷沃菌中的21株(58%)对克林霉素耐药,MIC值>128 μg/mL。与甲硝唑一样,塞克硝唑对普雷沃菌属、拟杆菌属、胨球菌属、四联厌氧球菌和巨大芬戈尔德菌的抗菌活性优于克林霉素。与硝基咪唑类药物相比,克林霉素对阴道阿托波菌、阴道加德纳菌和动弯杆菌属的活性更强。所有27株卷曲乳酸杆菌、27株詹氏乳酸杆菌中的26株(96%)、27株加氏乳酸杆菌中的5株(19%)和27株惰性乳酸杆菌中的18株(67%)对克林霉素敏感(MIC≤2),而所有测试乳酸杆菌对塞克硝唑、甲硝唑和替硝唑的MIC均>128 μg/mL。与甲硝唑或替硝唑相比,塞克硝唑对与BV相关的一系列微生物具有相似的体外活性。此外,塞克硝唑对乳酸杆菌无影响,这是用于治疗细菌性阴道病的药物所期望的特性。