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一项关于由硬质和软质聚合物制成的输尿管支架的前瞻性随机单盲比较研究。

A prospective randomized single-blind comparison of ureteral stents composed of firm and soft polymer.

作者信息

Joshi H B, Chitale S V, Nagarajan M, Irving S O, Browning A J, Biyani C S, Burgess N A

机构信息

Department of Urology, Norfolk and Norwich University Hospital, NHS Trust, Colney Lane, Norwich NR4 7UY, UK.

出版信息

J Urol. 2005 Dec;174(6):2303-6. doi: 10.1097/01.ju.0000181815.63998.5f.

Abstract

PURPOSE

Ureteral stents are composed of different polymers and it is unclear if stent composition influences patient comfort. We compared the impact of stents composed of firm and soft polymer on patient health related quality of life.

MATERIALS AND METHODS

A total of 130 patients requiring insertion of ureteral stents during the treatment of urinary calculi were randomized to receive a stent composed of firm (Percuflex, group 1) or soft (Contour, group 2) polymer. Patients were asked to complete the Ureteric Stent Symptoms Questionnaire, a validated instrument, at weeks 1 and 4 with the stent in situ and 4 weeks after its removal, this served as the main outcome measure. Additional assessments included difficulty in stent insertion and the need for early stent removal.

RESULTS

There were 78 men and 38 women in total (61 in group 1 and 55 in group 2) with a mean age of 51 years (range 22 to 79) and no difference in age between the 2 groups (p = 0.9). Comparison of the results of the Ureteric Stent Symptoms Questionnaire survey at weeks 1 and 4 with stent in situ revealed no significant differences in the domain scores of urinary symptoms (p = 0.9 and p = 0.8), pain (p = 0.8 and p = 0.6) and general health (p = 0.6 and p = 0.4). Similarly, there were no differences in the number of days with reduced activities, work performance (p = 0.7) and sexual dysfunction between the 2 groups. A similar number of patients (8 and 7 in groups 1 and 2, respectively) required stent removal earlier than planned due to stent related symptoms.

CONCLUSIONS

This randomized study showed no difference in the impact on patient quality of life between ureteral stents composed of firm or soft polymer.

摘要

目的

输尿管支架由不同的聚合物组成,目前尚不清楚支架组成是否会影响患者舒适度。我们比较了由硬质聚合物和软质聚合物制成的支架对患者健康相关生活质量的影响。

材料与方法

共有130例在尿路结石治疗期间需要插入输尿管支架的患者被随机分为两组,分别接受由硬质聚合物(Percuflex,第1组)或软质聚合物(Contour,第2组)制成的支架。要求患者在支架置入第1周和第4周以及取出支架4周后完成输尿管支架症状问卷,这是一种经过验证的工具,作为主要结局指标。额外的评估包括支架插入难度和早期取出支架的必要性。

结果

总共有78名男性和38名女性(第1组61名,第2组55名),平均年龄51岁(范围22至79岁),两组年龄无差异(p = 0.9)。比较输尿管支架症状问卷在支架置入第1周和第4周时的调查结果,发现尿路症状(p = 0.9和p = 0.8)、疼痛(p = 0.8和p = 0.6)和总体健康状况(p = 0.6和p = 0.4)的领域得分无显著差异。同样,两组在活动减少天数、工作表现(p = 0.7)和性功能方面也没有差异。两组中因支架相关症状需要比计划更早取出支架的患者数量相似(第1组和第2组分别为8例和7例)。

结论

这项随机研究表明,由硬质或软质聚合物制成的输尿管支架对患者生活质量的影响没有差异。

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