经膀胱内给予透明质酸和硫酸软骨素预防复发性尿路感染：一项安慰剂对照随机试验。

Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial.

机构信息

Urology Unit, Magna Graecia University of Catanzaro, Catanzaro, Italy.

出版信息

Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.

DOI:10.1016/j.eururo.2010.12.039

PMID:21272992

Abstract

BACKGROUND

Urinary tract infection (UTI) is a prevalent condition in women during their lifetime with a high rate of recurrence within 3-6 mo.

OBJECTIVES

Our aim was to investigate the efficacy and tolerability of the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) in female patients with a history of recurrent UTI.

DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective, randomised, double-blind, placebo-controlled study comparing the intravesical instillation of HA-CS with placebo in women with recurrent UTI.

INTERVENTION

Participants were randomised to receive 50 ml of sterile sodium HA 1.6% and CS 2.0% solution (IALURIL(®)) weekly for 4 wk and then monthly for 5 mo.

MEASUREMENTS

The primary end point of the study was defined as the mean number of UTI per patient per year. Participants were evaluated addressing UTI status/urinary symptoms and with a general health-related quality-of-life (QoL) questionnaire at baseline and after 3, 6, 9, and 12 mo.

RESULTS AND LIMITATIONS

In the intention-to-treat analysis, 57 women were randomly allocated to HA-CS (n=28) or placebo (n=29). The UTI rate per patient per year at the end of the study (12 mo) (mean±SD: -86.6%±47.6 vs -9.6%±24.6; mean difference: 77%; 95% confidence interval, 72.3-80.8; p=0.0002) and the mean time to UTI recurrence (52.7±33.4 vs 185.2±78.7 d; p<0.001) were significantly reduced after treatment with HA-CS compared with placebo. Overall urinary symptoms and QoL measured by questionnaires significantly improved compared with placebo (Pelvic Pain and Urgency/Frequency questionnaire symptom score: 14.53±4.32 vs 9.88±6.77; p=0.004; SF-36 QoL score: 78.6±6.44 vs 53.1±4.72; p<0.001). No serious adverse event was reported.

CONCLUSIONS

Compared with placebo, HA-CS intravesical instillations significantly reduced UTI rate without severe side effects while improving symptoms and QoL over a 12-mo period in patients with recurrent UTI.

TRIAL REGISTRATION

ISRCTN 76354426.

摘要

背景

尿路感染（UTI）是女性一生中常见的疾病，其在 3-6 个月内的复发率很高。

目的

我们旨在研究腔内给予透明质酸（HA）和硫酸软骨素（CS）联合治疗复发性 UTI 女性患者的疗效和耐受性。

设计、设置和参与者：我们进行了一项前瞻性、随机、双盲、安慰剂对照研究，比较了复发性 UTI 女性患者腔内给予 HA-CS 与安慰剂的效果。

干预

参与者被随机分配接受每周 50ml 无菌 HA 1.6%和 CS 2.0%溶液（IALURIL®），持续 4 周，然后每月持续 5 个月。

测量

该研究的主要终点定义为每位患者每年的 UTI 平均次数。在基线时和 3、6、9 和 12 个月时，参与者通过评估 UTI 状态/尿症状和一般健康相关生活质量（QoL）问卷进行评估。

结果和局限性

在意向治疗分析中，57 名女性被随机分配至 HA-CS（n=28）或安慰剂（n=29）。在研究结束时（12 个月），每位患者每年的 UTI 发生率（年率）（均值±SD：-86.6%±47.6 比-9.6%±24.6；均值差：77%；95%置信区间，72.3-80.8；p=0.0002）和 UTI 复发的平均时间（52.7±33.4 比 185.2±78.7d；p<0.001）在 HA-CS 治疗后明显低于安慰剂。与安慰剂相比，整体尿症状和通过问卷测量的 QoL 显著改善（盆腔疼痛和尿急/频数问卷症状评分：14.53±4.32 比 9.88±6.77；p=0.004；SF-36 QoL 评分：78.6±6.44 比 53.1±4.72；p<0.001）。未报告严重不良事件。