Nawrocki J D, Bell T J, Lawrence W T, Ward J P
Department of Urology, Eastbourne Hospitals NHS Trust, UK.
Br J Urol. 1997 Mar;79(3):389-93. doi: 10.1046/j.1464-410x.1997.21515.x.
To establish the short term clinical and urodynamic effect of transurethral microwave thermotherapy (TUMT) in men with symptomatic uncomplicated benign prostatic hyperplasia (BPH) using a randomized controlled trial comparing the treatment with both 'placebo-like' and untreated control groups.
The study comprised 120 symptomatic patients with BPH who were candidates for transurethral resection and TUMT. They were randomized to one of three groups: group 1 underwent a standard TUMT, group 2 underwent a simulated treatment identical to group 1 but with no emission of microwaves and group 3 received no treatment. The treatment of the first two groups was 'double-blind' and the heat experienced by the patients during treatment was simulated in both. Patients were assessed on entry to the study and 6 months after treatment using an identical protocol to measure the American Urological Association (AUA) symptom score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), minimum urethral opening pressure (Pmuo) and maximum detrusor pressure (Pdet max).
In the untreated group there were no clinically or statistically significant changes in the median AUA symptom score, Qmax, PVR, Pmuo and Pdet max. In group 1 the AUA score changed significantly, from 19 to 9.5, but the Qmax, PVR, Pmuo and Pdet max did not. In group 2, the AUA score also changed significantly, from 17.5 to 9.5, but Qmax, PVR, Pmuo and Pdet max did not.
The untreated control group showed no clinically relevant deterioration or improvement. The standard and simulated TUMT groups showed little clinically relevant improvement in 'objective' variables, while the clinically significant symptom improvement was of a similar magnitude in both groups.
采用随机对照试验，比较经尿道微波热疗（TUMT）与“安慰剂样”对照组及未治疗对照组，以确定其对有症状的单纯性良性前列腺增生（BPH）男性患者的短期临床及尿动力学效果。
该研究纳入120例有症状的BPH患者，这些患者均适合经尿道切除术和TUMT治疗。他们被随机分为三组：第一组接受标准TUMT治疗；第二组接受与第一组相同的模拟治疗，但不发射微波；第三组不接受治疗。前两组的治疗为“双盲”，且两组均模拟患者治疗过程中所经历的热量。在研究入组时及治疗6个月后，使用相同方案对患者进行评估，以测量美国泌尿外科学会（AUA）症状评分、最大尿流率（Qmax）、排尿后残余尿量（PVR）、最小尿道开口压力（Pmuo）和最大逼尿肌压力（Pdet max）。
在未治疗组中，AUA症状评分中位数、Qmax、PVR、Pmuo和Pdet max在临床及统计学上均无显著变化。在第一组中，AUA评分有显著变化，从19降至9.5，但Qmax、PVR、Pmuo和Pdet max无变化。在第二组中，AUA评分也有显著变化，从17.5降至9.5，但Qmax、PVR.Pmuo和Pdet max无变化。
未治疗的对照组未出现临床相关的恶化或改善。标准TUMT组和模拟TUMT组在“客观”变量方面几乎没有临床相关的改善，而两组在临床上显著的症状改善程度相似。
