Huang Yongmei, Merkatz Ruth B, Hillier Sharon L, Roberts Kevin, Blithe Diana L, Sitruk-Ware Régine, Creinin Mitchell D
Population Council, Center for Biomedical Research, New York, United States of America.
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and the Magee-Womens Research Institute, Pittsburgh, United States of America.
PLoS One. 2015 Aug 12;10(8):e0134460. doi: 10.1371/journal.pone.0134460. eCollection 2015.
A contraceptive vaginal ring (CVR) containing Nestorone® (NES) and ethinyl estradiol (EE) that is reusable for 1- year (13 cycles) is under development. This study assessed effects of this investigational CVR on the incidence of vaginal infections and change in vaginal microflora.
There were 120 women enrolled into a NES/EE CVR Phase III trial and a microbiology sub-study for up to 1- year of cyclic product use. Gynecological examinations were conducted at baseline, the first week of cycle 6 and last week of cycle 13 (or during early discontinuation visits). Vaginal swabs were obtained for wet mount microscopy, Gram stain and culture. The CVR was removed from the vagina at the last study visit and cultured. Semi-quantitative cultures for Lactobacillus, Gardnerella vaginalis, Enterococcus faecalis, Staphylococcus aureus, Escherichia coli, anaerobic gram negative rods (GNRs), Candida albicans and other yeasts were performed on vaginal and CVR samples. Vaginal infections were documented throughout the study.
Over 1- year of use, 3.3% of subjects were clinically diagnosed with bacterial vaginosis, 15.0% with vulvovaginal candidiasis, and 0.8% with trichomoniasis. The detection rate of these three infections did not change significantly from baseline to either Cycle 6 or 13. Nugent scores remained stable. H2O2-positive Lactobacillus dominated vaginal flora with a non-significant prevalence increase from 76.7% at baseline to 82.7% at cycle 6 and 90.2% at cycle 13, and a median concentration of 107 colony forming units (cfu) per gram. Although anaerobic GNRs prevalence increased significantly, the median concentration decreased slightly (104 to 103cfu per gram). There were no significant changes in frequency or concentrations of other pathogens. High levels of agreement between vaginal and ring surface microbiota were observed.
Sustained use of the NES/EE CVR did not increase the risk of vaginal infection and was not disruptive to the vaginal ecosystem.
ClinicalTrials.gov NCT00263341, NCT00455156.
一种含有内美通（NES）和炔雌醇（EE）的可重复使用一年（13个周期）的避孕阴道环（CVR）正在研发中。本研究评估了这种试验性CVR对阴道感染发生率和阴道微生物群变化的影响。
120名女性参加了NES/EE CVR III期试验和微生物学子研究，使用周期产品长达一年。在基线、第6周期的第一周和第13周期的最后一周（或在早期停药访视期间）进行妇科检查。采集阴道拭子进行湿片显微镜检查、革兰氏染色和培养。在最后一次研究访视时从阴道取出CVR并进行培养。对阴道和CVR样本进行乳酸杆菌、阴道加德纳菌、粪肠球菌、金黄色葡萄球菌、大肠杆菌、厌氧革兰氏阴性杆菌（GNRs）、白色念珠菌和其他酵母菌的半定量培养。在整个研究过程中记录阴道感染情况。
在一年的使用期内，3.3%的受试者临床诊断为细菌性阴道病，15.0%为外阴阴道念珠菌病，0.8%为滴虫病。这三种感染的检出率从基线到第6周期或第13周期均无显著变化。 Nugent评分保持稳定。过氧化氢阳性乳酸杆菌主导阴道菌群，其患病率从基线时的76.7%无显著增加至第6周期时的82.7%和第13周期时的90.2%，中位浓度为每克107菌落形成单位（cfu）。虽然厌氧GNRs的患病率显著增加，但其中位浓度略有下降（从每克104降至103 cfu）。其他病原体的频率或浓度没有显著变化。观察到阴道和环表面微生物群之间有高度一致性。
持续使用NES/EE CVR不会增加阴道感染风险，也不会破坏阴道生态系统。
ClinicalTrials.gov NCT00263341，NCT00455156。
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