基于羟基喹啉的凝胶对子宫托相关性细菌性阴道病的影响：一项多中心随机对照试验。
The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial.
作者信息
Meriwether Kate V, Rogers Rebecca G, Craig Ellen, Peterson Sean D, Gutman Robert E, Iglesia Cheryl B
机构信息
Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM.
Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM.
出版信息
Am J Obstet Gynecol. 2015 Nov;213(5):729.e1-9. doi: 10.1016/j.ajog.2015.04.032. Epub 2015 Apr 30.
OBJECTIVE
Pessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan gel (Milex Pessaries, Cooper Surgical, Trumbull, CT) on BV prevalence among pessary users.
STUDY DESIGN
Women presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy use and underwent a BV BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan placed vaginally twice weekly or to standard pessary care without TrimoSan gel. Women returned 2 weeks and 3 months later for a repeat slide collection for Gram stain, BV BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary.
RESULTS
There were 184 women randomized after successful fitting (92 to the TrimoSan group), and 147 (79%) presented for 3-month follow up. Mean age was 56 ± 16 years; patients were mostly white (57%) or Hispanic (23%), and 36% were using hormone therapy. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan vs 26% no gel, P = .46) or 3 months (24% TrimoSan vs 23% no gel, P = .82), nor did they differ in BV by BV BLUE testing at 2 weeks (0% TrimoSan vs 4% no gel, P = .12) or 3 months (3% TrimoSan vs 0% no gel, P = .15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan vs 45% no gel, P = .98) or 3 months (42% TrimoSan vs 32% no gel, P = .30). The TrimoSan group was equally likely to want to continue their pessary use compared with the standard care group at 2 weeks (90% vs 86%, P = .64) and 3 months (63% vs 60%, P = .76).
CONCLUSION
TrimoSan gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use.
目的
子宫托是治疗盆底功能障碍女性的重要选择，但许多使用子宫托的女性会患细菌性阴道病（BV）。本研究旨在评估TrimoSan凝胶（Milex子宫托，Cooper Surgical公司，特朗布尔，康涅狄格州）对子宫托使用者BV患病率的影响。
研究设计
前来适配子宫托的女性完成了关于阴道症状和激素治疗使用情况的问卷调查，并接受了BV BLUE检测以及按照 Nugent标准进行的用于BV分析的涂片采集。子宫托适配后，女性被随机分为两组，一组接受标准子宫托护理，每周两次经阴道放置TrimoSan凝胶，另一组接受不使用TrimoSan凝胶的标准子宫托护理。女性在2周和3个月后返回，再次进行涂片采集以进行革兰氏染色、BV BLUE检测，并完成关于阴道症状以及继续使用子宫托意愿的问卷调查。
结果
成功适配后有184名女性被随机分组（92名进入TrimoSan组），147名（79%）参与了3个月的随访。平均年龄为56±16岁；患者大多为白人（57%）或西班牙裔（23%），36%正在使用激素治疗。根据 Nugent标准，两组在2周时的BV患病率无差异（TrimoSan组为20%，无凝胶组为26%，P = 0.46），在3个月时也无差异（TrimoSan组为24%，无凝胶组为23%，P = 0.82）；根据BV BLUE检测，两组在2周时的BV患病率也无差异（TrimoSan组为0%，无凝胶组为4%，P = 0.12），在3个月时同样无差异（TrimoSan组为3%，无凝胶组为0%，P = 0.15）。两组在2周时（TrimoSan组为44%，无凝胶组为45%，P = 0.98）和3个月时（TrimoSan组为42%，无凝胶组为32%，P = 0.30）至少出现一种阴道症状的患病率无差异。与标准护理组相比，TrimoSan组在2周时（90%对86%，P = 0.64）和3个月时（63%对60%，P = 0.76）继续使用子宫托的意愿相同。
结论
在使用子宫托的前3个月，TrimoSan凝胶不会降低BV患病率或阴道症状的发生率，也不会改变女性继续使用子宫托的可能性。
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