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鞘内注射透明质酸联合硫酸软骨素预防脊髓损伤后尿路感染。

Intravesical hyaluronic acid with chondroitin sulphate to prevent urinary tract infection after spinal cord injury.

机构信息

School of Biological Sciences, The University of Western Australia, Crawley, WA, Australia.

Perth Urology Clinic, Murdoch, WA, Australia.

出版信息

J Spinal Cord Med. 2023 Sep;46(5):830-836. doi: 10.1080/10790268.2022.2089816. Epub 2022 Jul 6.

Abstract

CONTEXT/OBJECTIVE: Prevention of urinary tract infection (UTI) after spinal cord injury is an important goal. Intravesical hyaluronic acid with chondroitin sulphate (HA+CS) has been effective in preventing UTI in other settings. We aimed to demonstrate safety and feasibility of a standard treatment course of 7 intravesical HA+CS instillations over 12 weeks, in patients with acute (Arm A) and chronic (Arm B) spinal cord injury (SCI).

DESIGN

Follow-up of adverse events, quality of life bladder management difficulty (BMD) and bladder complication (BC) -scores at baseline (Arm B only), 12 and 24 weeks, and symptomatic urinary tract infection (UTI).

RESULTS

Of 33 and 14 individuals screened, 2 and 8 participants were recruited to the study for Arm A and Arm B respectively. Of the 10 participants, 8 completed all 7 instillations. HA+CS commonly caused cloudy urine with urinary sediment which was mild and short-lived. In Arm B, a mean reduction in BMD and BC T-scores was observed from baseline (57.3 and 54.4 respectively), of 6.8 and 4.3 at 12 weeks and 1.6 and 2.8 at 24 weeks, respectively. Four participants with a history of frequent UTI in the prior 12 months did not have UTI in the 24 weeks of the study.

CONCLUSIONS

HA+CS was well tolerated. Recruitment was more difficult in early acute SCI; participants with chronic SCI were highly motivated to reduce UTI and manage self-administration without difficulty. Larger case-control or randomized controlled trials in patients with neurogenic bladder from SCI are warranted.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03945110.

摘要

背景/目的:预防脊髓损伤后的尿路感染(UTI)是一个重要目标。在其他情况下,腔内透明质酸联合硫酸软骨素(HA+CS)已被证明可有效预防 UTI。我们旨在证明在急性(A 组)和慢性(B 组)脊髓损伤(SCI)患者中,7 次腔内 HA+CS 灌注 12 周的标准治疗方案的安全性和可行性。

设计

在基线时(仅 B 组)、12 周和 24 周时,随访不良反应、生活质量膀胱管理困难(BMD)和膀胱并发症(BC)评分,并记录有症状的尿路感染(UTI)。

结果

在筛选的 33 人和 14 人中,分别有 2 人和 8 人入组 A 组和 B 组。在 10 名参与者中,有 8 人完成了所有 7 次灌注。HA+CS 常导致尿液混浊伴短暂的轻度尿沉渣。在 B 组中,从基线开始(分别为 57.3 和 54.4),12 周时 BMD 和 BC T 评分分别降低了 6.8 和 4.3,24 周时分别降低了 1.6 和 2.8。在过去 12 个月中有频繁 UTI 病史的 4 名参与者在研究的 24 周内未发生 UTI。

结论

HA+CS 具有良好的耐受性。在早期急性 SCI 中招募更为困难;慢性 SCI 患者有强烈的动机减少 UTI,并能轻松自我管理。需要在 SCI 引起的神经源性膀胱患者中进行更大的病例对照或随机对照试验。

试验注册

ClinicalTrials.gov 标识符:NCT03945110。

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