Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO.
Division of Infectious Diseases, Department of Internal Medicine.
Urogynecology (Phila). 2023 Mar 1;29(3):367-377. doi: 10.1097/SPV.0000000000001270. Epub 2022 Oct 15.
Further research is needed to determine whether d-mannose plus vaginal estrogen therapy (VET) is beneficial over VET alone for recurrent urinary tract infection (rUTI) prevention.
The aim of this study was to evaluate d-mannose efficacy for rUTI prevention in postmenopausal women using VET.
We conducted a randomized controlled trial comparing d-mannose (2 g/d) with control. Participants were required to have a history of uncomplicated rUTIs and to remain on VET throughout the trial. They were followed up 90 days for incident UTIs. Cumulative UTI incidences were calculated by the Kaplan-Meier method and compared by Cox proportional hazards regression. For the planned interim analysis, P < 0.001 was considered statistically significant. Futility analysis was performed by generating post hoc conditional power for multiple scenarios.
We evaluated 545 patients for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these women, 213 had culture-proven rUTIs, 71 were eligible, 57 enrolled, 44 began their planned 90-day study period, and 32 completed the study. At interim analysis, the overall cumulative UTI incidence was 46.6%; 41.1% in the treatment arm (median time to first UTI, 24 days) and 50.4% in the control arm (median, 21 days); hazard ratio, 0.76; 99.9% confidence interval, 0.15-3.97. d-Mannose was well tolerated with high participant adherence. Futility analysis suggested the study lacked power to detect the planned (25%) or observed (9%) difference as statistically significant; the study was halted before conclusion.
d-Mannose is a well-tolerated nutraceutical, but further research is needed to determine whether d-mannose in combination with VET has a significant, beneficial effect beyond VET alone in postmenopausal women with rUTIs.
需要进一步研究来确定 D-甘露糖联合阴道雌激素治疗（VET）是否优于单独使用 VET 预防复发性尿路感染（rUTI）。
本研究旨在评估 D-甘露糖预防接受 VET 的绝经后妇女 rUTI 的疗效。
我们进行了一项随机对照试验，比较了 D-甘露糖（2g/d）与对照。参与者需要有单纯性 rUTI 病史，并在整个试验过程中继续接受 VET。他们在 90 天内接受尿路感染事件随访。累积尿路感染发生率采用 Kaplan-Meier 法计算，并通过 Cox 比例风险回归进行比较。对于计划的中期分析，P<0.001 被认为具有统计学意义。通过对多种情况进行事后条件功效分析进行了无效性分析。
我们于 2018 年 3 月 1 日至 2020 年 1 月 18 日评估了 545 例因频发/复发性尿路感染就诊的患者。这些女性中，213 例有培养证实的 rUTI，71 例符合条件，57 例入组，44 例开始计划的 90 天研究期，32 例完成研究。中期分析时，总体累积尿路感染发生率为 46.6%；治疗组为 41.1%（首次尿路感染中位时间 24 天），对照组为 50.4%（中位时间 21 天）；风险比，0.76；99.9%置信区间，0.15-3.97。D-甘露糖耐受性良好，参与者依从性高。无效性分析表明，该研究缺乏检测计划（25%）或观察（9%）差异的统计学意义的效力；研究在得出结论之前停止。
D-甘露糖是一种耐受性良好的营养保健品，但需要进一步研究来确定 D-甘露糖联合 VET 是否对接受 VET 的 rUTI 绝经后妇女具有比单独使用 VET 更显著、有益的效果。
