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经会阴激光消融术经皮治疗良性前列腺增生:一项可行性研究。回顾性多中心研究的 6 个月和 12 个月结果。

Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study.

机构信息

Department of Diagnostic Imaging and Interventional Radiology, Regina Apostolorum Hospital, Via San Francesco 50, 00041 Albano Laziale, Rome, Italy.

Department of Diagnostic and Interventional Radiology, ASST Bergamoest, via Paderno 21, 24068, Seriate, Italy.

出版信息

Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11.

Abstract

PURPOSE

To investigate the effectiveness and safety of SoracteLite™-transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up.

METHODS

Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLite TPLA treatment. Secondary end-point was the assessment of complications.

RESULTS

Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P < 0.001), PVR from 89.5 ± 84.6 to 27.2 ± 44.5 ml (P < 0.001), Qmax from 8.0 ± 3.8 to 14.3 ± 3.9 ml/s (P < 0.001), QoL from 4.5 ± 1.1 to 1.8 ± 1.0 (P < 0.001), volume from 75.0 ± 32.4 to 60.3 ± 24.5 ml (P < 0.001). At 12 months, IPSS improved from 22.5 ± 4.5 to 7.0 ± 2.9 (P < 0.001), PVR from 71.7 ± 93.9 to 17.8 ± 51.0 ml (P < 0.001), Qmax from 8.6 ± 5.2 to 15.0 ± 4.0 ml/s (P < 0.001), QoL from 4.2 ± 0.6 to 1.6 ± 0.9 (P < 0.001), volume from 87.9 ± 31.6 to 58.8 ± 22.9 ml (P < 0.001). 7/160 (4.3%) grade I and 1/160 (0.6%) grade III complication occurred.

CONCLUSIONS

SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months.

摘要

目的

研究 SoracteLite™经会阴经皮激光消融(TPLA)在治疗有症状的良性前列腺增生(BPH)患者中的有效性和安全性,随访时间为 6 个月和 12 个月。

方法

在四个中心,在局部麻醉下对有 BPH 症状的患者进行 TPLA。在超声引导下,将多达四个 21G 的施源器插入前列腺组织中。每次治疗均使用二极管激光,波长为 1064nm,根据前列腺体积改变照明时间。本研究的主要终点为 SoracteLite TPLA 治疗后 6 个月和 12 个月时国际前列腺症状评分(IPSS)、前列腺体积、残余尿量(PVR)、最大尿流率(Qmax)、生活质量(QoL)的变化。次要终点为并发症评估。

结果

对至少有 6 个月随访的 160 例(平均年龄 69.8±9.6 岁)和至少有 12 个月随访的 83 例(平均年龄 67.9±8.7 岁)患者的数据进行了分析。6 个月时,IPSS 从 22.5±5.1 分降至 7.7±3.3 分(P<0.001),PVR 从 89.5±84.6ml 降至 27.2±44.5ml(P<0.001),Qmax 从 8.0±3.8ml/s 升至 14.3±3.9ml/s(P<0.001),QoL 从 4.5±1.1 分降至 1.8±1.0 分(P<0.001),前列腺体积从 75.0±32.4ml 降至 60.3±24.5ml(P<0.001)。12 个月时,IPSS 从 22.5±4.5 分降至 7.0±2.9 分(P<0.001),PVR 从 71.7±93.9ml 降至 17.8±51.0ml(P<0.001),Qmax 从 8.6±5.2ml/s 升至 15.0±4.0ml/s(P<0.001),QoL 从 4.2±0.6 分降至 1.6±0.9 分(P<0.001),前列腺体积从 87.9±31.6ml 降至 58.8±22.9ml(P<0.001)。160 例患者中发生 7 例(4.3%)1 级并发症,1 例(0.6%)3 级并发症。

结论

SoracteLite™TPLA 可显著改善 IPSS、Qol、Qmax、PVR 和前列腺体积,在 6 个月和 12 个月时均有改善。

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