Cai Tommaso, Caola Iole, Tessarolo Francesco, Piccoli Federico, D'Elia Carolina, Caciagli Patrizio, Nollo Giandomenico, Malossini Gianni, Nesi Gabriella, Mazzoli Sandra, Bartoletti Riccardo
Department of Urology, Santa Chiara Regional Hospital, Largo Medaglie d'Oro, 9, Trento, Italy,
World J Urol. 2014 Aug;32(4):1007-14. doi: 10.1007/s00345-013-1173-5. Epub 2013 Oct 4.
Plants extracts are used in urology to manage urinary tract infections. We aimed to evaluate the efficacy of a preparation with solidago, orthosiphon, birch and cranberry extracts (CISTIMEV PLUS(®)) in reducing microbial colonization and biofilm development in patients with indwelling urinary catheters.
All consecutive outpatients attending our department between January and June 2010 for the substitution of indwelling catheters were considered for this single-blinded, randomized and controlled pilot study to test superiority of the preventative management (CISTIMEV PLUS(®), 1 tablet daily for 30 days) in respect to no treatment. A sample size of 10-40 participants per group was considered adequate. All patients underwent urine culture the same day of the catheter substitution and were then randomized into test group (n = 48) and control group (n = 35). Ultrastructural analysis was also performed. After 30 days, the catheter was replaced and the analysis repeated. The primary outcome was the rate of positive urinary culture at the end of the entire study period.
Ten patients abandoned the study. At 30 days, according to per-protocol analysis, the groups statistically differed regarding the rate of positive urine cultures: test group 10/43 and control group 16/30 (p = 0.013) (-30.1 % [95 % CI -51.94 to -8.21]). The most common isolated bacteria were Escherichia coli and Enterococcus faecalis.
The use of solidago, orthosiphon, birch and cranberry extracts resulted in a significant reduction of microbial colonization in patients with indwelling urinary catheters. Larger clinical trials are needed to demonstrate that the effects here reported are sufficient to reduce symptomatic catheter-associated urinary tract infections.
植物提取物被用于泌尿外科治疗尿路感染。我们旨在评估一种含有一枝黄花、猫须草、桦树和蔓越莓提取物的制剂(CISTIMEV PLUS(®))在减少留置导尿管患者的微生物定植和生物膜形成方面的疗效。
2010年1月至6月期间到我们科室更换留置导尿管的所有连续门诊患者被纳入这项单盲、随机对照试验性研究,以测试预防性治疗(CISTIMEV PLUS(®),每日1片,共30天)相对于不治疗的优越性。每组10 - 40名参与者的样本量被认为是足够的。所有患者在更换导尿管当天进行尿培养,然后随机分为试验组(n = 48)和对照组(n = 35)。还进行了超微结构分析。30天后,更换导尿管并重复分析。主要结局是整个研究期结束时尿培养阳性率。
10名患者退出研究。在30天时,根据符合方案分析,两组在尿培养阳性率方面有统计学差异:试验组10/43,对照组16/30(p = 0.013)(-30.1% [95% CI -51.94至 -8.21])。最常见的分离细菌是大肠埃希菌和粪肠球菌。
使用一枝黄花、猫须草、桦树和蔓越莓提取物可显著减少留置导尿管患者的微生物定植。需要更大规模的临床试验来证明此处报道的效果足以减少有症状的导管相关性尿路感染。