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输尿管支架症状问卷确定的输尿管支架类型对患者症状的影响:一项前瞻性、随机、对照研究。

The impact of ureteral stent type on patient symptoms as determined by the ureteral stent symptom questionnaire: a prospective, randomized, controlled study.

作者信息

Park Hyoung Keun, Paick Sung Hyun, Kim Hyeong Gon, Lho Yong Soo, Bae Sangrak

机构信息

1 Department of Urology, Konkuk University School of Medicine , Seoul, Republic of Korea.

出版信息

J Endourol. 2015 Mar;29(3):367-71. doi: 10.1089/end.2014.0294. Epub 2014 Oct 9.

DOI:10.1089/end.2014.0294
PMID:25153249
Abstract

PURPOSE

To minimize stent-related symptoms, the proximal part of the Polaris™ stent is composed of a firm material and its distal part is composed of a soft material. The aim of this study was to compare stent-related symptoms of Polaris and Percuflex® stents and to assess the impacts of these stents on quality of life.

PATIENTS AND METHODS

A total of 144 patients were randomized to a "test" group (Polaris; n=64) or a "conventional" group (Percuflex; n=80) at the time of ureteral stent insertion after ureteroscopic stone removal surgery. Stents were allocated using a randomization program. At 1 week postoperatively, patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire (USSQ), and patients were asked complete a 10 cm visual analogue scale (VAS). Mean scores for USSQ domains and mean VAS scores were compared.

RESULTS

Mean patient age was 50.3 years, and the male-to-female ratio was 1:0.85. No significant intergroup differences were found in the domain scores of urinary symptoms (P=0.58), pain (P=0.87), general health (P=0.20), work (P=0.24), sexual activity (P=0.64), or additional problems (P=0.24). In addition, VAS scores were nonsignificantly different (P=0.11). Analysis of USSQ item scores, however, revealed the test group had better results for "presence of pain," "frequency of pain killer use," "difficulties with respect to hard physical activity," "fatigue," "frequency of rest," "stent-related impact on work," "antibiotics use" than the conventional group except for "outpatient department visits".

CONCLUSION

Compared with the conventional Percuflex ureteral stent, the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms, pain, general health, sexual matters, or additional problems as determined by the USSQ or in VAS determined pain. Sub-analysis, however, showed that the Polaris has some advantages with respect to pain, physical activities, impact on work, and additional problems. Accordingly, the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent.

摘要

目的

为了将支架相关症状降至最低,北极星™支架的近端由硬质材料制成,远端由软质材料制成。本研究的目的是比较北极星支架和百可施®支架的支架相关症状,并评估这些支架对生活质量的影响。

患者与方法

总共144例患者在输尿管镜取石术后输尿管支架置入时被随机分为“试验”组(北极星支架;n = 64)或“传统”组(百可施支架;n = 80)。使用随机化程序分配支架。术后1周,使用输尿管支架症状问卷(USSQ)评估患者症状,并要求患者完成10厘米视觉模拟量表(VAS)。比较USSQ各领域的平均得分和VAS平均得分。

结果

患者平均年龄为50.3岁,男女比例为1:0.85。在尿路症状(P = 0.58)、疼痛(P = 0.87)、总体健康状况(P = 0.20)、工作(P = 0.24)、性活动(P = 0.64)或其他问题(P = 0.24)的领域得分方面,未发现组间有显著差异。此外,VAS得分差异无统计学意义(P = 0.11)。然而,对USSQ项目得分的分析显示,除“门诊就诊次数”外,试验组在“疼痛存在情况”、“使用止痛药频率”、“剧烈体力活动困难程度”、“疲劳”、“休息频率”、“支架对工作的影响”、“抗生素使用”方面的结果优于传统组。

结论

与传统的百可施输尿管支架相比,新型带软尾的北极星输尿管支架在排尿症状、疼痛、总体健康状况、性方面或其他问题(由USSQ确定)以及VAS确定的疼痛方面未显示出显著优势。然而,亚组分析表明,北极星支架在疼痛、体力活动、对工作的影响和其他问题方面具有一些优势。因此,发现软头北极星支架比传统的百可施支架具有一些临床优势。

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