Winthrop University Hospital, Mineola, New York, USA.
Urology. 2010 Oct;76(4):841-5. doi: 10.1016/j.urology.2010.01.068.
To determine the safety, tolerability, maximal tolerated dose, and efficacy of a concentrated cranberry liquid blend, UTI-STAT with Proantinox, in female patients with a history of recurrent urinary tract infections (rUTIs).
The study agent was administered orally at 15, 30, 45, 60, and 75 mL daily for 12 weeks to women with a history of 2.78 ± 0.73 rUTIs <6 months. Blood and urine samples were collected at baseline and weeks 4 and 12. The women took daily doses of the agent. The primary endpoints were the safety, tolerability, and maximal tolerated dose. The secondary endpoints were the efficacy with regard to rUTI and quality-of-life (QOL) symptoms.
A total of 28 subjects were included in the study. Of these 28 women, the data from 23 were analyzable. The average age was 46.5 ± 12.8 years. The maximal tolerated dose of UTI-STAT was 75 mL/d, and the recommended dose was set at 60 mL/d. The secondary endpoints demonstrated that only 2 (9.1%) of 23 reported a rUTI, a markedly better rate than the historical data. At 12 weeks, the reduction in worry about rUTIs and increased QOL with regard to the physical functioning domain and role limitations from physical health domain, as measured by the Medical Outcomes Study short-form 36-item questionnaire, were significant (P = .0097). A lower American Urological Association Symptom Index indicating greater QOL was also significant (P = .045).
The novel concentrated cranberry liquid blend showed a good safety profile and tolerability in both pre- and postmenopausal women with history of rUTIs. The secondary endpoints demonstrated its effectiveness in reducing the incidence of rUTI and increasing QOL. Given this evidence, supplementation might be beneficial in the prevention of rUTIs in this population.
确定浓缩蔓越莓液混合制剂 UTI-STAT 联合 Proantinox 在有复发性尿路感染(rUTI)病史的女性患者中的安全性、耐受性、最大耐受剂量和疗效。
该研究将有 2.78±0.73 次<6 个月 rUTI 病史的女性患者随机分为 5 组,每天口服 15、30、45、60 和 75 mL 研究药物,共 12 周。于基线、第 4 周和第 12 周采集血样和尿样。患者每日服用研究药物。主要终点为安全性、耐受性和最大耐受剂量。次要终点为 rUTI 和生活质量(QOL)症状的疗效。
共有 28 名女性患者纳入研究,其中 23 名女性的数据可分析。这些女性的平均年龄为 46.5±12.8 岁。UTI-STAT 的最大耐受剂量为 75 mL/d,推荐剂量为 60 mL/d。次要终点显示,23 名患者中仅有 2 名(9.1%)报告 rUTI,明显优于历史数据。12 周时,与基线相比,使用 Medical Outcomes Study 短表 36 项问卷评估的 rUTI 担忧减少,生理功能领域和生理健康领域所致角色受限的 QOL 提高,差异均有统计学意义(P=0.0097)。较低的美国泌尿外科学会症状指数表明 QOL 更高,差异也有统计学意义(P=0.045)。
新型浓缩蔓越莓液混合制剂在有 rUTI 病史的绝经前和绝经后女性中显示出良好的安全性和耐受性。次要终点显示其在降低 rUTI 发生率和提高 QOL 方面的有效性。鉴于这些证据,该制剂可能有益于该人群 rUTI 的预防。