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一项比较双极等离子体动力学与单极经尿道前列腺切除术的前瞻性随机试验的四年结果

Four-year outcome of a prospective randomised trial comparing bipolar plasmakinetic and monopolar transurethral resection of the prostate.

作者信息

Autorino Riccardo, Damiano Rocco, Di Lorenzo Giuseppe, Quarto Giuseppe, Perdonà Sisto, D'Armiento Massimo, De Sio Marco

机构信息

Clinica Urologica, Seconda Università degli Studi, Napoli, Italy.

出版信息

Eur Urol. 2009 Apr;55(4):922-9. doi: 10.1016/j.eururo.2009.01.028. Epub 2009 Jan 24.

Abstract

BACKGROUND

No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP).

OBJECTIVE

To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP.

DESIGN, SETTING, AND PARTICIPANTS: Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age > 50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) > or = 18, and maximal flow rate (Q(max)) < or = 15 ml/s. Exclusion criteria were prostate volume < 30 cm(3), documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity > 500 ml.

INTERVENTION

Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique.

MEASUREMENTS

Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded.

RESULTS AND LIMITATIONS

The number of dropouts was not statistically significantly different in the two groups (p=0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q(max), and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 (p=0.58); mean Q(max) 19.8 ml/s and 21.2 ml/s (p=0.44), and mean PVR volume 42 ml and 45 ml (p=0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications (p=0.15). The major study limitation was the small sample size.

CONCLUSIONS

This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.

摘要

背景

关于双极经尿道前列腺切除术(TURP)的中期疗效尚无数据发表。

目的

评估一项前瞻性随机试验中双极TURP与标准单极TURP比较的4年结果。

设计、地点和参与者:70例有症状的良性前列腺增生患者纳入了该三级医疗机构的前瞻性随机对照试验。纳入标准为年龄>50岁、身体状况良好、尿潴留、国际前列腺症状评分(IPSS)≥18且最大尿流率(Q(max))≤15 ml/s。排除标准为前列腺体积<30 cm³、有记录或怀疑有前列腺癌、神经源性膀胱、膀胱结石或憩室、尿道狭窄以及最大膀胱容量>500 ml。

干预

患者接受由同一位外科医生采用相同手术技术进行的标准或双极等离子体动力TURP。

测量

在1年、2年、3年和4年时通过比较尿流率、IPSS和估计的排尿后残余(PVR)尿量来评估治疗效果。中期并发症也予以记录。

结果和局限性

两组的失访人数在统计学上无显著差异(p = 0.2)。与基线值相比,两组在4年时IPSS、生活质量评分、Q(max)和PVR均保持显著改善。双极和单极TURP在4年时的主要结局变量为平均IPSS分别为6.9和6.4(p = 0.58);平均Q(max)分别为19.8 ml/s和21.2 ml/s(p = 0.44),平均PVR尿量分别为42 ml和45 ml(p = 0.3)。总体而言,32例患者中有2例(6.2%)和31例患者中有3例(9.6%)因晚期并发症需要再次手术(p = 0.15)。主要研究局限性是样本量小。

结论

本研究是对先前发表试验的二次中期分析。我们的4年数据证实了我们最初关于双极等离子体动力TURP疗效和安全性的阳性发现。需要更大规模、设计良好的研究来证实这些发现。

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