Xyloglucan plus Gelose Combination versus Placebo as Adjuvant Therapy to First-Line Antimicrobials for Uncomplicated Urinary Tract Infection in Adults
Xyloglucan plus Gelose Combination versus Placebo as Adjuvant Therapy to First-Line Antimicrobials for Uncomplicated Urinary Tract Infection in Adults
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DOI：
10.1159/000497106
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发表时间：
2019-01-01
影响因子：
1.6
通讯作者：
Edu, Antoine
中科院分区：
文献类型：
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作者：
Costache, Radu Cristian;Novac, Bogdan;Edu, Antoine
背景资料：含有木葡聚糖-琼脂糖-芙蓉-葡聚糖（以下称为木葡聚糖+琼脂糖）的医疗器械可作为粘膜屏障保护剂和尿酸化剂。研究了该器械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。患者和方法：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（n = 20）或安慰剂（n = 20）与抗菌剂（例如，例如，在一个实施例中，环丙沙星）给药5天，然后单独给药5天，然后在研究的第30天开始，每月给药15天，持续2个月。结果：木葡聚糖+琼脂糖组和安慰剂组的不良事件（AE）频率分别为5%和45%。所有AE均与研究产品无关。木葡聚糖+琼脂糖将尿培养阳性（定义为细菌计数≥ 10（3）CFU/mL）从基线时的100%患者降低至第11天的0%，到第76天有3例患者（15%）复发。安慰剂的相应结果是，基线时100%的尿培养阳性患者在第11天降至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尿急的频率（均p < 0.05），所有患者的症状在第90天消退。结论：木葡聚糖+琼脂糖医疗器械是安全的，耐受性良好，并减少了无并发症UTI成人的细菌学和症状参数。(c)2019 S. Karger AG，巴塞尔
Background: 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. Patients and Methods: 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. Results: 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 >= 10(3) 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. Conclusions: The xyloglucan + gelose medical device was safe, well tolerated, and it reduced bacteriological and symptomatic parameters in adults with uncomplicated UTI. (c) 2019 S. Karger AG, Basel