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楊旻鑫 以隨機分派試驗比較攝護腺動脈栓塞術及經尿道攝護腺刮除手術對攝護腺肥大病人治療效果 2021/8/3 下午 02:36:44 0
原 文 題  目 Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial
作  者 Dominik Abt, Gautier Mu¨llhaupt, Lukas Hechelhammer, Stefan Markart, Sabine Gu¨sewell, Hans-Peter Schmid, Livio Mordasini, Daniel S. Engeler
出  處 European urology
出版日期 2021 Feb 20
評 論

攝護腺肥大的標準手術治療一直是經尿道攝護腺刮除手術,雖然這是一項成熟且安全的手術,但一些共病較多的人仍然必須承擔手術帶來的風險。隨著血管攝影及導管技術的進步,放射科醫師漸漸嘗試透過栓塞攝護腺血管來使其壞死萎縮,治療攝護腺肥大。這項治療雖然看似微創、病人可以在局部麻醉下進行、並且不需在治療前停止抗凝血劑,但是許多研究報告指出栓塞後的攝護腺壞死過程可能帶來許多問題,包括一段時間攝護腺發炎腫脹帶來的疼痛及尿滯留、凋落的壞死組織阻塞…等。並且目前缺乏大型且證據力強的研究來支持,攝護腺栓塞的效果是否如同標準的手術治療這麼好。這篇研究難能可貴的地方在於,它使用證據等級最高的隨機分派試驗來比較攝護腺栓塞及標準手術(經尿道攝護腺刮除手術)的術後效果,並且在術後追蹤了長達兩年時間!!因此是一篇非常具有代表性的研究,難怪發表於如此高分期刊~

這篇研究最主要的結果告訴我們:在兩年追蹤期間,各項排尿指標皆是標準手術治療優於攝護腺栓塞。包括最大尿流速及殘尿量的改善、病人自覺排尿症狀(IPSS)及生活品質分數改善。甚至在接受攝護腺栓塞的病人中,有21%病人後續仍然接受了手術治療。

雖然攝護腺栓塞手術的治療效果不如預期,但它的確有較少的術後併發症。
特別是在輕度併發症明顯較少,在較嚴重的併發症上兩種治療則沒有明顯差異。

總結來說,攝護腺栓塞的確提供一些本身疾病非常嚴重、麻醉風險太高的病人新的治療選擇。但是有鑒於栓塞後的效果與手術治療的差距仍舊明顯,且根據本研究有五分之一病人後續仍須接受手術。因此仍建議以標準的攝護腺刮除手術,做為攝護腺肥大進階治療的首選。

abstract

Background: Prostatic artery embolisation (PAE) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (LUTS/BPO) still remains under investigation.

Objective: To compare the efficacy and safety of PAE and transurethral resection of the prostate (TURP) in the treatment of LUTS/BPO at 2 yr of follow-up. Design, setting, and participants: A randomised, open-label trial was conducted. There were 103 participants aged 40 yr with refractory LUTS/BPO. Intervention: PAE versus TURP. Outcome measurements and statistical analysis: International Prostate Symptoms Score (IPSS) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated. Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests.

Results and limitations: The mean reduction in IPSS after 2 yr was 9.21 points after PAE and 12.09 points after TURP (difference of 2.88 [95% confidence interval 0.04–5.72]; p = 0.047). Superiority of TURP was also found for most other patient-reported outcomes except for erectile function. PAE was less effective than TURP regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of –6.33 [–10.12 to –2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31–240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70–31.38]; p = 0.005). Adverse events were less frequent after PAE than after TURP (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar. Ten patients (21%) who initially underwent PAE required TURP within 2 yr due to unsatisfy-ing clinical outcomes, which prevented further assessment of their outcomes and, therefore, represents a limitation of the study.

Conclusions: Inferior improvements in LUTS/BPO and a relevant re-treatment rate are found 2 yr after PAE compared with TURP. PAE is associated with fewer complications than TURP. The disadvantages of PAE regarding functional outcomes should be consid-ered for patient selection and counselling.

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