目的:将前列腺动脉栓塞术(PAE)与坦索罗辛和杜他雄胺联合治疗作为阻塞性良性前列腺增生(BPH)的潜在一线治疗方法在未治疗的患者中进行比较。一项随机可控试验(P-EASYADVANCE)。
方法:共39例前列腺增大的男性,中重度下尿路症状(LUTS)和阻塞/模棱两可的尿动力学研究(UDS),以前没有接受过BPH治疗的人,随机接受坦索罗辛和度他雄胺(药物)或PAE联合药物治疗。后续UDS,国际前列腺症状评分(IPSS)在干预后的短期至中期间隔进行尿流测定和超声检查,并与基线进行比较.
结果:药物治疗组和PAE治疗组具有相似的基线特征,包括前列腺体积(分别为87.8和85.4毫升),最大尿流率(Qmax;6.5和6.6mL/s,分别),IPSS(分别为19.5和21)和阻塞的UDS(79%和74%,分别)。两种干预措施均从基线改善了排尿和膀胱流出道梗阻,与药物治疗(28%)相比,PAE后通畅的患者更多(63%)(P=0.03)。PAE患者的前列腺大小明显减少(P<0.001),不完全排空(P=0.002),总IPSS(P=0.032),Qmax(P=0.006)和生活质量(P=0.001)。射精改变,勃起功能障碍和恶心在药物组中更为常见。
结论:前列腺动脉栓塞术在减少尿路梗阻方面比联合药物治疗更有效。以前未接受过治疗的BPH患者的前列腺体积减小和LUTS改善。这是第一个比较PAE和联合药物治疗的随机对照研究,专门治疗初治患者,并提高了PAE作为BPH替代早期治疗选择的潜力。计划进行进一步的随机比较试验,以进一步验证PAE在缓解阻塞性BPH中的作用。
OBJECTIVE: To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first-line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment-naïve patients in the \'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial\' (P-EASY ADVANCE).
METHODS: A total of 39 men with enlarged prostates, moderate-severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow-up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short- to medium-term intervals following interventions and compared to baseline.
RESULTS: The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P < 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group.
CONCLUSIONS: Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment-naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.