Wagrell Lennart, Schelin Sonny, Nordling Jorgen, Richthoff Jonas, Magnusson Bo, Schain Moddy, Larson Thayne, Boyle Emmett, Duelund Jens, Kroyer Kurt, Ageheim Håkan, Mattiasson Anders
Department of Urology, Uppsala University Hospital, Uppsala, Sweden.
Urology. 2004 Oct;64(4):698-702. doi: 10.1016/j.urology.2004.05.030.
To compare, in a prospective randomized multicenter study, the efficacy and safety of transurethral microwave thermotherapy with ProstaLund Feedback Treatment (PLFT), using the CoreTherm device, with transurethral resection of the prostate (TURP) 36 months after treatment.
The study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to PLFT or TURP in a 2:1 ratio. The treatment outcome was evaluated on the basis of the International Prostate Symptom Score (IPSS), the quality-of-life question (QOL) of the IPSS, peak urinary flow rate (Qmax), urodynamics, and adverse events. The microwave power and treatment time were adjusted according to each patient's response to the supplied energy (ie, the intraprostatic temperature guided the PLFT).
Statistically significant improvements in both the TURP and the PLFT groups were observed for IPSS, QOL, and Qmax at 36 months. The average value for the PLFT group was 8.2, 1.2, and 11.9 mL/s for IPSS, QOL, and Qmax, respectively. The corresponding values for the TURP group were IPSS 5.0, QOL 1.0, and Qmax 13.5 mL/s. The difference in IPSS outcome was statistically significant; however, no statistically significant differences were found in QOL or Qmax between the two treatment groups. The degree of improvement was in the same range as that observed after 12 and 24 months for both groups. During the 12 to 36-month period, the most frequent adverse events in the TURP group were impotence (15%), micturition urgency (13%), and urethral disorder (8%); in the PLFT group, impotence (8%), prostate-specific antigen increase (5%), and hematuria (4%) were the most common.
The clinical outcome 3 years after microwave thermotherapy with PLFT was comparable to the results seen after TURP. The safety of PLFT compared favorably to that of TURP in this study.
在一项前瞻性随机多中心研究中，比较使用CoreTherm设备进行经尿道微波热疗联合前列腺 Lund 反馈治疗（PLFT）与经尿道前列腺切除术（TURP）治疗36个月后的疗效和安全性。
该研究在美国和斯堪的纳维亚的10个中心进行。总共154例良性前列腺增生患者按2:1的比例随机分为PLFT组或TURP组。根据国际前列腺症状评分（IPSS）、IPSS的生活质量问题（QOL）、最大尿流率（Qmax）、尿动力学和不良事件评估治疗结果。微波功率和治疗时间根据每位患者对所提供能量的反应进行调整（即前列腺内温度指导PLFT）。
在36个月时，TURP组和PLFT组的IPSS、QOL和Qmax均有统计学意义的改善。PLFT组IPSS、QOL和Qmax的平均值分别为8.2、1.2和11.9 mL/s。TURP组的相应值为IPSS 5.0、QOL 1.0和Qmax 13.5 mL/s。IPSS结果的差异有统计学意义；然而，两个治疗组在QOL或Qmax方面未发现统计学意义上的差异。两组改善程度与12个月和24个月后观察到的范围相同。在12至36个月期间，TURP组最常见的不良事件是阳痿（15%）、尿急（13%）和尿道疾病（8%）；在PLFT组，阳痿（8%）、前列腺特异性抗原升高（5%）和血尿（4%）最为常见。
PLFT微波热疗3年后的临床结果与TURP术后的结果相当。在本研究中，PLFT的安全性优于TURP。
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