Blute M L, Tomera K M, Hellerstein D K, McKiel C F, Lynch J H, Regan J B, Sankey N E
Department of Urology, Mayo Clinic, Rochester, Minnesota 55905.
J Urol. 1993 Nov;150(5 Pt 2):1591-6. doi: 10.1016/s0022-5347(17)35852-4.
The primary objective of the study was to determine the safety and efficacy of transurethral microwave thermotherapy for the treatment of symptomatic benign prostatic hyperplasia. From March to August 1991, 150 patients were entered into a multi-site study and treated with transurethral microwave thermotherapy under a Food and Drug Administration approved protocol. Only patients with symmetrical trilobar or bilobar prostatic hypertrophy, peak flow rate of less than 15 cc per second (on 2 voided volumes of 150 cc or greater) and a total Madsen symptom score of more than 8 were treated. Transurethral microwave thermotherapy was performed with a 20F catheter and 1,296 MHz. microwave antenna for 60 minutes. The mean power achieved for this single session was 32.1 watts, with a mean power at maximum urethral temperature of 41.1 watts. Mean urethral temperature was 44.3C and the mean rectal temperature was 42.2C. The rectal and urethral temperatures were continuously monitored. Mean peak urinary flow rates, Madsen symptom score, post-void residual volume and improvement in motivating symptom to seek treatment were measured at 6 weeks, and 3, 6 and 12 months. Mean peak urinary flow rates improved 33% at 12 months (p < 0.0001). Overall, the mean Madsen symptom score improved 61% (p < 0.0001). The obstructive score and the irritative score improved 67% and 43%, respectively. Of 17 patients 12 (71%) reported improvement in weak stream when that was the motivating symptom to seek treatment. Of 28 men 18 (64%) reported improvement in nocturia, while 11 of 30 (37%) reported improvement in daytime frequency and 12 of 17 (71%) reported improvement in urgency. There was no statistically significant difference in post-void residual volume at 12 months from baseline. The treatment was well tolerated by all patients, and side effects were considered mild and transitory. Our study demonstrates the safety, effectiveness, patient tolerability and durability of transurethral microwave thermotherapy.
该研究的主要目的是确定经尿道微波热疗治疗症状性良性前列腺增生的安全性和有效性。1991年3月至8月，150名患者进入一项多中心研究，并根据美国食品药品监督管理局批准的方案接受经尿道微波热疗。仅对患有对称性三叶或双叶前列腺肥大、峰值尿流率低于每秒15毫升（在两次排尿量为150毫升或更多时）且Madsen症状总评分超过8分的患者进行治疗。经尿道微波热疗使用20F导管和1296兆赫的微波天线进行60分钟。该单次治疗达到的平均功率为32.1瓦，尿道最高温度时的平均功率为41.1瓦。平均尿道温度为44.3摄氏度，平均直肠温度为42.2摄氏度。持续监测直肠和尿道温度。在6周以及3、6和12个月时测量平均峰值尿流率、Madsen症状评分、排尿后残余尿量以及促使患者寻求治疗的症状改善情况。12个月时平均峰值尿流率提高了33%（p<0.0001）。总体而言，Madsen症状平均评分提高了61%（p<0.0001）。梗阻评分和刺激评分分别提高了67%和43%。在因尿流变弱而寻求治疗的17名患者中，12名（71%）报告尿流变弱情况有所改善。在28名男性中，18名（64%）报告夜尿症有所改善，而在30名中有11名（37%）报告日间尿频有所改善，在17名中有12名（71%）报告尿急有所改善。12个月时排尿后残余尿量与基线相比无统计学显著差异。所有患者对该治疗耐受性良好，且副作用被认为轻微且短暂。我们的研究证明了经尿道微波热疗的安全性、有效性、患者耐受性和持久性。
