Wang Mao Qiang, Zhang Jin Long, Xin Hai Nan, Yuan Kai, Yan Jieyu, Wang Yan, Zhang Guo Dong, Fu Jin Xin
Department of Interventional Radiology, Chinese PLA General Hospital, Beijing 100853, P.R. China.
Department of Interventional Radiology, Chinese PLA General Hospital, Beijing 100853, P.R. China.
J Vasc Interv Radiol. 2018 Dec;29(12):1694-1702. doi: 10.1016/j.jvir.2018.06.019. Epub 2018 Oct 5.
To evaluate the safety and efficacy of prostatic artery embolization (PAE) using the combination of 50-μm and 100-μm polyvinyl alcohol (PVA) particles versus 100-μm PVA particles alone in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH).
Over a 5-year period, 120 patients treated with PAE for lower urinary tract symptoms (LUTS) secondary to BPH were randomized to undergo embolization with 50-μm plus 100-μm PVA particles (group A) or 100-μm PVA particles alone (group B). Mean follow-up time was 34 months (range, 12-57 mo). There were no differences between groups regarding baseline data. Primary outcome measurements included change in International Prostate Symptom Score (IPSS) and incidence of adverse events. Secondary outcome measurements included procedure-associated pain, prostate ischemia measured on magnetic resonance (MR) imaging 1 week after PAE, and changes over time in quality of life (QOL) questionnaire, peak urinary flow rate (Q), postvoid residual (PVR) volume, prostate volume (PV), prostate-specific antigen (PSA) level, and International Index of Erectile Function (IIEF) were evaluated. Recurrence of LUTS following PAE was defined as relief of LUTS temporally but increased IPSS ≥ 8 or QOL score ≥ 3 or decrease in Q to < 7 mL/s.
Mean follow-up periods were 35 months ± 22 in group A and 33 months ± 25 in group B (P = .629). No differences between groups regarding procedural details, pain scores, or adverse events were noted (P > .05). At 24 month of follow-up, patients in group A had a greater decrease in mean IPSS (18.7 ± 12.5 vs 14.8 ± 13.5), QOL score (3.7 ± 1.5 vs 2.4 ± 1.8), Q (10.5 mL ± 9.5 vs 6.8 mL ± 5.0), PVR (92.0 mL ± 75.0 vs 60.0 mL ± 55.0), and PV (37.0 mL ± 19.5 vs 25.5 mL ± 15.0) compared with patients in group B (P < .05 for all). Mean ratios of prostate ischemic volume at 1 week after PAE were 70% ± 20 in group A and 41% ± 25 in group B (P = .021); mean PSA levels at 24 hour after PAE were 92.5 ng/mL ± 55.0 in group A and 77.5 ng/mL ± 45.0 in group B (P = .031); LUTS recurrence rates were 3.6% in group A and 14.6% in group B (P = .024). The mean IIEF-5 was not significantly different from baseline in either group.
PAE with 50-μm plus 100-μm PVA particles resulted in greater improvement in clinical and imaging outcomes and no significant differences in adverse events compared with 100-μm PVA particles alone.
评估使用50μm和100μm聚乙烯醇（PVA）颗粒联合与单独使用100μm PVA颗粒进行前列腺动脉栓塞术（PAE）治疗有症状良性前列腺增生（BPH）患者的安全性和有效性。
在5年期间，120例因BPH继发下尿路症状（LUTS）接受PAE治疗的患者被随机分为接受50μm加100μm PVA颗粒栓塞（A组）或仅接受100μm PVA颗粒栓塞（B组）。平均随访时间为34个月（范围12 - 57个月）。两组基线数据无差异。主要结局指标包括国际前列腺症状评分（IPSS）的变化和不良事件发生率。次要结局指标包括与手术相关的疼痛、PAE术后1周磁共振（MR）成像测量的前列腺缺血情况，以及生活质量（QOL）问卷、最大尿流率（Q）、排尿后残余尿量（PVR）、前列腺体积（PV）、前列腺特异性抗原（PSA）水平和国际勃起功能指数（IIEF）随时间的变化。PAE后LUTS复发定义为LUTS暂时缓解但IPSS增加≥8或QOL评分≥3或Q降至<7 mL/s。
A组平均随访期为35个月±22，B组为33个月±25（P = 0.629）。两组在手术细节、疼痛评分或不良事件方面无差异（P>0.05）。在随访24个月时，与B组患者相比，A组患者的平均IPSS（18.7±12.5对14.8±13.5）、QOL评分（3.7±1.5对2.4±1.8）、Q（10.5 mL±9.5对6.8 mL±5.0）、PVR（92.0 mL±75.0对60.0 mL±55.0）和PV（37.0 mL±19.5对25.5 mL±15.0）下降幅度更大（所有P<0.05）。PAE术后1周前列腺缺血体积的平均比例A组为70%±20，B组为41%±25（P = 0.021）；PAE术后24小时平均PSA水平A组为92.5 ng/mL±55.0，B组为77.5 ng/mL±45.0（P = 0.031）；LUTS复发率A组为3.6%，B组为14.6%（P = 0.024）。两组平均IIEF - 5与基线相比无显著差异。
与单独使用100μm PVA颗粒相比，使用50μm加100μm PVA颗粒进行PAE在临床和影像学结局方面有更大改善，且不良事件无显著差异。
