Melbourne School of Population Health, University of Melbourne, Australia.
Clin Infect Dis. 2013 Mar;56(6):777-86. doi: 10.1093/cid/cis1030. Epub 2012 Dec 12.
Bacterial vaginosis (BV) recurrence posttreatment is common. Our aim was to determine if behaviors were associated with BV recurrence in women in a randomized controlled trial (RCT).
Symptomatic 18- to 50-year-old females with BV (≥3 Amsel criteria and Nugent score [NS] = 4-10) were enrolled in a 3-arm randomized double-blind RCT Melbourne Sexual Health Centre, Australia, in 2009-2010. All 450 participants received oral metronidazole (7 days) and were equally randomized to vaginal clindamycin, lactobacillus-vaginal probiotic or vaginal placebo. At 1, 2, 3, and 6 months, participants self-collected vaginal smears and completed questionnaires. Primary endpoint was NS = 7-10. Cox regression was used to estimate hazard ratios (HRs) for risk of BV recurrence associated with baseline and longitudinal characteristics.
Four hundred four (90%) women with postrandomization data contributed to analyses. Cumulative 6-month BV recurrence was 28% (95% confidence interval [CI], 24%-33%) and not associated with treatment. After stratifying for treatment and adjusting for age and sex frequency, recurrence was associated with having the same pre-/posttreatment sexual partner (adjusted HR [AHR] = 1.9; 95% CI, 1.2-3.0), inconsistent condom use (AHR = 1.9; 95% CI, 1.0-3.3), and being non-Australian (AHR = 1.5; 95% CI, 1.0-2.1), and halved with use of an estrogen-containing contraceptive (AHR = 0.5; 95% CI, .3-.8).
Risk of BV recurrence was increased with the same pre-/posttreatment sexual partner and inconsistent condom use, and halved with use of estrogen-containing contraceptives. Behavioral and contraceptive practices may modify the effectiveness of BV treatment.
ACTRN12607000350426.
细菌性阴道病（BV）治疗后复发较为常见。本研究旨在通过随机对照试验（RCT）确定女性患者的行为因素与 BV 复发的相关性。
2009-2010 年，澳大利亚墨尔本性健康中心入组了符合条件的 18-50 岁、有症状的 BV 患者（≥3 项 Amsel 标准和 Nugent 评分[NS]为 4-10），并进行了 3 组随机双盲 RCT。所有 450 名参与者均接受了 7 天的口服甲硝唑治疗，并随机分为阴道克林霉素组、阴道乳酸杆菌阴道益生菌组和阴道安慰剂组。在第 1、2、3 和 6 个月时，参与者自行采集阴道涂片并完成问卷调查。主要终点为 NS = 7-10。使用 Cox 回归估计与基线和纵向特征相关的 BV 复发风险的风险比（HR）。
404 名（90%）有随机后数据的女性参与了分析。6 个月时的累积 BV 复发率为 28%（95%置信区间[CI]，24%-33%），与治疗无关。在对治疗进行分层并调整年龄和性交频率后，复发与具有相同的治疗前/后性伴侣（调整后的 HR [AHR] = 1.9；95%CI，1.2-3.0）、不坚持使用安全套（AHR = 1.9；95%CI，1.0-3.3）和非澳大利亚人（AHR = 1.5；95%CI，1.0-2.1）相关，而使用含有雌激素的避孕药可将风险减半（AHR = 0.5；95%CI，0.3-0.8）。
与治疗前/后性伴侣相同和不坚持使用安全套与 BV 复发风险增加相关，而使用含有雌激素的避孕药可将风险减半。行为和避孕措施可能会影响 BV 治疗的效果。
ACTRN12607000350426。
