经直肠温控微波热疗治疗良性前列腺增生症的疗效和安全性：一项前瞻性、开放标签、单中心、为期1年随访研究的结果

Efficacy and safety of intraprostatic temperature-controlled microwave thermotherapy in patients with benign prostatic hyperplasia: results of a prospective, open-label, single-center study with 1-year follow-up.

作者信息

Gravas Stavros, Laguna Maria Pilar, de la Rosette Jean J M C H

机构信息

Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

J Endourol. 2003 Aug;17(6):425-30. doi: 10.1089/089277903767923236.

DOI:10.1089/089277903767923236

PMID:12965071

Abstract

BACKGROUND AND PURPOSE

Different devices for transurethral microwave thermotherapy (TUMT) are currently available for the treatment of benign prostatic hyperplasia (BPH). We evaluated the efficacy and safety of the Prostalund Feedback Treatment (PLFT), which continuously records the intraprostatic temperature, and its impact on sexual function of the patients.

PATIENTS AND METHODS

A total of 41 patients with lower urinary tract symptoms attributed to BPH were entered in this prospective open-label, single-center study of PLFT. The initial evaluation was performed according to a standard protocol. At 3, 6, and 12 months, the International Prostate Symptom Score (IPSS), bother score, sexual function, and peak flow rate (Qmax) were recorded. In addition, determination of prostate volume by transrectal ultrasonography (TRUS) and measurement of residual urine volume were repeated at the 6- and 12-month visits. All adverse events were also recorded. Patients with IPSS of < or =7, > or =50% improvement in IPSS from baseline, a Qmax of > or =15 mL/sec, or > or =50% improvement in Qmax from baseline were judged responders to the treatment.

RESULTS

Thirty-three of the patients completed the 12-month visit. The response rate was 88% (29 of 33 patients). There was a statistically significant decrease in IPSS at the 12-month visit, the mean IPSS being 7.1 v 21.9 at baseline (P<0.001). The mean IPSS was 10.3 and 7.6 at the 3- and 6-months' follow-up, respectively. The bother score presented a similar improvement, with a decrease from a mean of 4.2 at baseline to a mean of 1.4 after 12 months (P<0.001). The mean Qmax improved from 8.4 mL/sec at baseline to 15.9 mL/sec, 19.2 mL/sec, and 17.8 mL/sec at 3, 6, and 12 months, respectively (P<0.001). The mean change in prostate volume, as determined by TRUS, was 16 mL at 6 months and 19 mL at 12 months (P<0.001). The procedure was well tolerated. The mean post-treatment catheterization time was 17.90 days. Bladder spasms and urinary tract infection were the most common adverse events. Coitus ability remained practically unchanged after treatment (from 71% to 74.3%), but the number of patients with ejaculation decreased (from 78% to 51.4%).

CONCLUSION

Our results indicate that PLFT is an effective and safe treatment for most patients with BPH.

摘要

背景与目的

目前有不同的经尿道微波热疗（TUMT）设备可用于治疗良性前列腺增生（BPH）。我们评估了能够持续记录前列腺内温度的Prostalund反馈治疗（PLFT）的疗效和安全性，以及其对患者性功能的影响。

患者与方法

本前瞻性开放标签单中心研究共纳入41例因BPH导致下尿路症状的患者接受PLFT治疗。初始评估按照标准方案进行。在3个月、6个月和12个月时，记录国际前列腺症状评分（IPSS）、困扰评分、性功能及最大尿流率（Qmax）。此外，在6个月和12个月随访时重复经直肠超声（TRUS）测定前列腺体积及测量残余尿量。记录所有不良事件。IPSS≤7分、IPSS较基线改善≥50%、Qmax≥15 mL/秒或Qmax较基线改善≥50%的患者被判定为治疗有效者。

结果

33例患者完成了12个月的随访。有效率为88%（33例患者中的29例）。12个月随访时IPSS有统计学显著下降，基线时平均IPSS为21.9分，12个月时为7.1分（P<0.001）。3个月和6个月随访时平均IPSS分别为10.3分和7.6分。困扰评分有类似改善，从基线时的平均4.2分降至12个月后的平均1.4分（P<0.001）。平均Qmax从基线时的8.4 mL/秒分别改善至3个月时的15.9 mL/秒、6个月时的19.2 mL/秒和12个月时的17.8 mL/秒（P<0.001）。经TRUS测定，前列腺体积的平均变化在6个月时为16 mL，12个月时为19 mL（P<0.001）。该治疗耐受性良好。治疗后平均导尿时间为17.90天。膀胱痉挛和尿路感染是最常见的不良事件。治疗后性交能力基本未变（从71%至74.3%），但射精患者数量减少（从78%至51.4%）。