使用乙烯-乙烯醇（EVOH）共聚物进行前列腺动脉栓塞治疗良性前列腺增生：十二个月分析
Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis.
作者信息
Sédat Jacques, Fontas Eric, Arnoffi Paolo, Stranieri Giuseppe, Colomb Frederic, Chau Yves
机构信息
Service d'Interventionnel Neurologique et Général, CHU de Nice, Hôpital Pasteur 2, 30 Voie Romaine, Nice, France.
DRCI, CHU de Nice, Hôpital de Cimiez, 4 Avenue Reine Victoria, Grand Hôtel, BP 1179, 06003, Nice, France.
出版信息
Cardiovasc Intervent Radiol. 2025 Aug 13. doi: 10.1007/s00270-025-04164-x.
PURPOSE
Our goal was to evaluate the feasibility, safety, and outcomes at 12 months of prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer in patients with benign prostatic hyperplasia-related lower urinary tract symptoms.
MATERIALS AND METHODS
This was a single-centre prospective study from November 2023 to November 2024 registered in clinical trials (IDRCB, 2021-AO29-56-35). Twelve consecutive patients were included. Inclusion criteria were an IPSS > 18 or a QoL score > 2, and prostate volume > 40 mL. Exclusion criteria were prostate cancer, advanced atherosclerosis. Outcomes were assessed at 12 months using the International Prostate Symptoms Score and associated quality-of-life score, prostate volume, and post-void residual volume. The overall evolution was analysed using a mixed-effects model with repeated measures.
RESULTS
Bilateral injection was performed in all patients. No patients experienced major adverse events. Compared to baseline, statistically significant improvements were observed at 12 months for the IPSS (9.3 ± 7.8 vs. 17.9 ± 5.8; P = 0.03), IPSS-QoL (2.1 ± 1.9 vs. 4.8 ± 1.1; P = 0.01). No statistically significant improvements were observed at 12 months for post-void residual volume (41.5 ± 54.96 vs. 57.3 ± 61.3; P = 0.9) and prostate volume (82.7 ± 46.6 mL vs. 89.2 ± 34.1 mL; P = 0.6).
CONCLUSIONS
Prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer is safe. This method provides good outcomes at 12 months, but no effect on the prostate volume and post-void residual volume. It deserves further evaluation in randomised trials with longer follow-up.
TRIAL REGISTRATION
This study was performed according to Good Clinical Practice requirements and the Helsinki Declaration and registered on Clinical Trials.gov (Trial registration: IDRCB, 2021-AO29-56-35. Registered 27 May 2022, http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 ).
目的
我们的目标是评估使用乙烯-乙烯醇共聚物进行前列腺动脉栓塞术治疗良性前列腺增生相关下尿路症状患者的可行性、安全性及12个月时的治疗效果。
材料与方法
这是一项于2023年11月至2024年11月在临床试验注册中心（IDRCB，2021-AO29-56-35）登记的单中心前瞻性研究。纳入连续12例患者。纳入标准为国际前列腺症状评分（IPSS）>18或生活质量评分>2，且前列腺体积>40 mL。排除标准为前列腺癌、晚期动脉粥样硬化。在12个月时使用国际前列腺症状评分及相关生活质量评分、前列腺体积和排尿后残余尿量评估治疗效果。使用重复测量的混合效应模型分析总体变化情况。
结果
所有患者均进行了双侧注射。无患者发生重大不良事件。与基线相比，12个月时IPSS（9.3±7.8 vs. 17.9±5.8；P = 0.03）、IPSS-生活质量评分（2.1±1.9 vs. 4.8±1.1；P = 0.01）有统计学意义的改善。12个月时排尿后残余尿量（41.5±54.96 vs. 57.3±61.3；P = 0.9）和前列腺体积（82.7±46.6 mL vs. 89.2±34.1 mL；P = 0.6）无统计学意义的改善。
结论
使用乙烯-乙烯醇共聚物进行前列腺动脉栓塞术是安全的。该方法在12个月时效果良好，但对前列腺体积和排尿后残余尿量无影响。值得在随访时间更长的随机试验中进一步评估。
试验注册
本研究按照良好临床实践要求和《赫尔辛基宣言》进行，并在ClinicalTrials.gov上注册（试验注册号：IDRCB，2021-AO29-56-35。于2022年5月27日注册，http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 ）
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