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经尿道前列腺针刺消融术治疗症状性出口梗阻的安全性和有效性

Safety and efficacy of transurethral needle ablation of the prostate for symptomatic outlet obstruction.

作者信息

Rosario D J, Woo H, Potts K L, Cutinha P E, Hastie K J, Chapple C R

机构信息

Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.

出版信息

Br J Urol. 1997 Oct;80(4):579-86. doi: 10.1046/j.1464-410x.1997.00414.x.

Abstract

OBJECTIVES

To examine, in an observational study, the safety and efficacy of transurethral needle ablation (TUNA) of the prostate as a treatment for symptomatic benign prostatic enlargement.

PATIENTS AND METHODS

This prospective study included 71 symptomatic men with unequivocal obstruction on pressure-flow urodynamics. The variables measured at baseline and up to 12 months after treatment included the American Urological Association (AUA)-7 symptom index and an added quality-of-life question, the AUA BPH-Impact Index, a sexual function score, transrectal ultrasonography of the prostate, a frequency-volume chart, free-flow uroflowmetry, post-void residual urine volume (PVR) and pressure-flow urodynamics. Transurethral resection of the prostate (TURP) was offered if the symptoms failed to resolve at any time during the follow-up period. TUNA was performed under local anaesthetic and sedation in 63 (89%) men and as a day-case procedure in 10 (14%). Five patients were on warfarin which was not discontinued.

RESULTS

There were no serious treatment-related adverse events. Eight of the initial nine patients who were not routinely catheterized after treatment with TUNA developed acute urinary retention. Although some haematuria occurred in all patients, only one (1.4%) developed catheter blockage by clot. There were no problems with bleeding in those patients on warfarin at the time of treatment. The mean (95% confidence interval, CI) AUA-7 index fell from 23 (1.7) to 10.6 (1.8) (P < 0.001, Mann-Whitney U-test) at 12 months, 29 men (41%) had an AUA-7 index of < or = 7. The maximum (95% CI) urinary flow rate increased from 9.0 (0.8) to 11.3 (1.1) mL/s (P < 0.001) and this was accompanied by a small but significant reduction in PVR of 70 (14) mL to 35 (8) mL (P < 0.001 Mann-Whitney U-test). There was a significant reduction in both maximal voiding pressure and detrusor pressure at peak flow at 3 months (Mann-Whitney U-test, both P < 0.001) and at 12 months (P < 0.001, Wilcoxon matched-pairs signed-ranks test). However, 78% of the 45 men undergoing repeat pressure-flow studies at 12 months were unequivocally obstructed according to the Abrams-Griffiths nomogram. The mean (95% CI) prostatic volume fell from 49.0 (4.8) mL at baseline to 40.8 (4.9) mL at 3 months, but this change was not statistically significant (P = 0.011, Mann-Whitney U-test). Two men reported erectile dysfunction, one experienced ejaculatory problems and seven reported an improvement in erectile function after TUNA. During the study, 22 men (31%) underwent TURP.

CONCLUSIONS

TUNA is a safe treatment which can be performed as an out-patient procedure under local anaesthesia and sedation in the vast majority of patients. There was no evidence of serious adverse events and no significant adverse effect on sexual function. The symptomatic improvement was sustained at 12 months in most (54%) patients, with modest improvements in peak flow rate, PVR and voiding pressures, indicating that TUNA may result in prolonged symptomatic improvement in a proportion of patients suffering from bladder outlet obstruction. A randomized controlled study against established therapies is now essential to clearly delineate its place in the management of such patients.

摘要

目的

在一项观察性研究中,检验经尿道针刺消融术(TUNA)治疗有症状的良性前列腺增生的安全性和有效性。

患者与方法

这项前瞻性研究纳入了71名有症状且在压力 - 流率尿动力学检查中有明确梗阻的男性。在基线及治疗后长达12个月测量的变量包括美国泌尿外科学会(AUA)-7症状指数、一个额外的生活质量问题即AUA良性前列腺增生影响指数、性功能评分、经直肠前列腺超声检查、频率 - 尿量图表、自由流率尿流率测定、排尿后残余尿量(PVR)以及压力 - 流率尿动力学检查。如果在随访期间任何时候症状未缓解,则提供经尿道前列腺切除术(TURP)。63名(89%)男性在局部麻醉和镇静下进行TUNA,10名(14%)作为日间手术进行。5名患者正在服用华法林,未停药。

结果

没有与治疗相关的严重不良事件。最初9名TUNA治疗后未常规留置导尿管的患者中有8名发生急性尿潴留。虽然所有患者均出现一些血尿,但只有1名(1.4%)因血凝块导致导尿管堵塞。治疗时服用华法林的患者未出现出血问题。12个月时,平均(95%置信区间,CI)AUA - 7指数从23(1.7)降至10.6(1.8)(P < 0.001,Mann - Whitney U检验),29名男性(41%)的AUA - 7指数≤7。最大(95%CI)尿流率从9.0(0.8)增加到11.3(1.1)mL/s(P < 0.001),同时PVR从70(14)mL小幅但显著降至35(8)mL(P < 0.001,Mann - Whitney U检验)。3个月时和12个月时最大排尿压力和峰值流率时的逼尿肌压力均显著降低(Mann - Whitney U检验,均P < 0.001)以及12个月时(P < 0.001,Wilcoxon配对符号秩检验)。然而,根据Abrams - Griffiths列线图,在12个月时接受重复压力 - 流率研究的45名男性中有78%有明确梗阻。平均(95%CI)前列腺体积从基线时的49.0(4.8)mL降至3个月时的40.8(4.9)mL,但这种变化无统计学意义(P = 0.011,Mann - Whitney U检验)。两名男性报告勃起功能障碍,一名有射精问题,7名报告TUNA后勃起功能改善。研究期间,22名男性(31%)接受了TURP。

结论

TUNA是一种安全的治疗方法,绝大多数患者可在局部麻醉和镇静下作为门诊手术进行。没有严重不良事件的证据,对性功能也没有显著不良影响。大多数(54%)患者在12个月时症状改善持续存在,峰值流率、PVR和排尿压力有适度改善,表明TUNA可能使一部分膀胱出口梗阻患者的症状改善持续较长时间。现在有必要进行一项针对既定疗法的随机对照研究,以明确其在此类患者管理中的地位。

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