Costache Radu Cristian, Novac Bogdan, Bardan Tiberiu Razvan, Agapie Dorin Nicolae, Edu Antoine
Department of Urology, "Dr. C. I. Parhon" Clinical Hospital, Iasi, Romania.
Department of Urology, "Pius Brinzeu" County Emergency Clinical Hospital, Timisoara, Romania.
Urol Int. 2019;102(4):468-475. doi: 10.1159/000497106. Epub 2019 Mar 19.
A medical device containing xyloglucan-gelose-hibiscus-propolis (referred to hereafter as xyloglucan + gelose) acts as a mucosal barrier protector and urinary acidifier. The safety and efficacy of this device were investigated as adjuvant therapy to first-line antimicrobials for treatment of uncomplicated urinary tract infection (UTI) in adults.
In this multicentre, randomised, parallel group, double-blind, phase IV study, xyloglucan + gelose (n = 20) or placebo (n = 20) were administered orally in combination with an antimicrobial agent (e.g., ciprofloxacin) for 5 days, then alone for 5 days, then beginning on Day 30 of the study for 15 days per month for 2 months.
Frequency of adverse events (AEs) was 5 and 45% in the xyloglucan + gelose and placebo groups respectively. All AEs were unrelated to study products. Xyloglucan + gelose reduced uroculture positivity (defined as a bacterial count ≥103 CFU/mL) from 100% of patients at baseline to 0% at Day 11, with recurrence in 3 patients (15%) by Day 76. Corresponding results with placebo were 100% uroculture positive patients at baseline reduced to 45% at Day 11, with recurrence in 14 patients (70%) by Day 76. Xyloglucan + gelose significantly reduced the frequency of urinary incontinence and urgency of micturition compared with placebo (both p < 0.05), with symptom resolution in all patients by Day 90.
The xyloglucan + gelose medical device was safe, well tolerated, and it reduced bacteriological and symptomatic parameters in adults with uncomplicated UTI.
一种含有木葡聚糖 - 琼脂糖 - 木槿 - 蜂胶（以下简称木葡聚糖 + 琼脂糖）的医疗设备可作为黏膜屏障保护剂和尿液酸化剂。本研究调查了该设备作为一线抗菌药物辅助治疗成人单纯性尿路感染（UTI）的安全性和有效性。
在这项多中心、随机、平行组、双盲、IV期研究中，木葡聚糖 + 琼脂糖组（n = 20）或安慰剂组（n = 20）口服给药，与抗菌药物（如环丙沙星）联合使用5天，然后单独使用5天，然后从研究第30天开始，每月服用15天，共2个月。
木葡聚糖 + 琼脂糖组和安慰剂组的不良事件（AE）发生率分别为5%和45%。所有不良事件均与研究产品无关。木葡聚糖 + 琼脂糖使尿培养阳性率（定义为细菌计数≥103 CFU/mL）从基线时的100%降至第11天的0%，到第76天有3例患者（15%）复发。安慰剂组相应结果为基线时尿培养阳性患者100%降至第11天的45%，到第76天有14例患者（70%）复发。与安慰剂相比，木葡聚糖 + 琼脂糖显著降低了尿失禁和排尿急迫的频率（均p < 0.05），到第90天所有患者症状均得到缓解。
木葡聚糖 + 琼脂糖医疗设备安全、耐受性良好，可降低成人单纯性UTI的细菌学和症状学参数。
