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与坦索罗辛单药治疗相比,索利那新与坦索罗辛联合使用可减少良性前列腺增生和膀胱过度活动症患者的前列腺体积和血管形成:一项随机试点研究的结果。

Combination of solifenacin with tamsulosin reduces prostate volume and vascularity as opposed to tamsulosin monotherapy in patients with benign prostate enlargement and overactive bladder symptoms: Results from a randomized pilot study.

作者信息

Sakalis Vasileios, Sfiggas Vasileios, Vouros Ioannis, Salpiggidis George, Papathanasiou Athanasios, Apostolidis Apostolos

机构信息

Department of Urology, Hippokration Hospital, Thessaloniki, Greece.

2nd Department of Urology, Papageorgiou General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.

出版信息

Int J Urol. 2018 Aug;25(8):737-745. doi: 10.1111/iju.13721. Epub 2018 Jul 15.

DOI:10.1111/iju.13721
PMID:30008188
Abstract

OBJECTIVES

To identify the potential influence of antimuscarinics on morphometric parameters of the prostate in patients with benign prostatic enlargement and overactive bladder.

METHODS

Non-neurological patients with prostate volume >30 mL, predominately storage lower urinary tract symptoms, three or more urgency episodes per 24 h, maximum flow rate ≥10 mL/s and post-void residual ≤100 mL were recruited for this study. They were randomized to receive either tamsulosin or tamsulosin + solifenacin. Patients were submitted to transrectal and transvesical ultrasonography, pressure-flow study and prostate-specific antigen test, and completed the International Prostate Symptom Score, bladder diary and overactive bladder questionnaire at induction and at 6 months. End-study changes in morphometric prostate parameters (total prostate and adenoma volumes, prostate vascularity), as measured by transrectal ultrasound, were the principal outcomes.

RESULTS

A reduction in total prostate volume (mean -9.5%) was noted in the combination group, as opposed to an increase in the monotherapy group (+9.2%; P < 0.001). Similar changes were reflected in adenoma volume (monotherapy +17.4% vs combination -12.5%, P = 0.001) and in prostate vascularity (monotherapy +149.3% vs combination -19.8%, P = 0.001). Both treatment regimens improved the International Prostate Symptom Score (P = 0.001); monotherapy improved the voiding subscale (P = 0.01) more, whereas combination therapy improved the storage subscale (P = 0.024). Cystometric capacity improved in the combination group (P < 0.001). Post-void residual was increased in the combination group (+34.79%), as opposed to a decrease in the monotherapy group (-17.05%; P = 0.001).

CONCLUSIONS

The results of this pilot study suggest that solifenacin might affect morphometric properties of the prostate, decreasing total prostate and adenoma volume, as well as vascularity. A molecular effect of antimuscarinics on the prostate, in parallel with their expected bladder effect, warrants further investigation.

摘要

目的

确定抗毒蕈碱药物对良性前列腺增生和膀胱过度活动症患者前列腺形态学参数的潜在影响。

方法

本研究招募了前列腺体积>30 mL、以下尿路储尿期症状为主、每24小时尿急发作3次或更多、最大尿流率≥10 mL/s且排尿后残余尿量≤100 mL的非神经学患者。他们被随机分为接受坦索罗辛或坦索罗辛+索利那新治疗。患者接受经直肠和经膀胱超声检查、压力-流率研究及前列腺特异性抗原检测,并在入组时和6个月时完成国际前列腺症状评分、膀胱日记和膀胱过度活动症问卷。经直肠超声测量的前列腺形态学参数(前列腺总体积和腺瘤体积、前列腺血管情况)的研究结束时变化为主要结局。

结果

联合治疗组前列腺总体积减少(平均-9.5%),而单药治疗组增加(+9.2%;P<0.001)。腺瘤体积(单药治疗组+17.4% vs联合治疗组-12.5%,P=0.001)和前列腺血管情况(单药治疗组+149.3% vs联合治疗组-19.8%,P=0.001)也有类似变化。两种治疗方案均改善了国际前列腺症状评分(P=0.001);单药治疗对排尿子量表的改善更大(P=0.01),而联合治疗对储尿子量表的改善更大(P=0.024)。联合治疗组膀胱测压容量增加(P<0.001)。联合治疗组排尿后残余尿量增加(+34.79%),而单药治疗组减少(-17.05%;P=0.001)。

结论

这项初步研究的结果表明,索利那新可能会影响前列腺的形态学特性,减少前列腺总体积和腺瘤体积以及血管情况。抗毒蕈碱药物对前列腺的分子效应,与其预期的膀胱效应并行,值得进一步研究。

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