Single-center retrospective study on high-frequency irreversible electroporation focal therapy for prostate cancer
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摘要: 目的 评价高频不可逆电穿孔(high-frequency irreversible electroporation,H-FIRE)局灶治疗局限性前列腺癌(prostate cancer,PCa)的安全性和短期内性功能保护及肿瘤控制效果。方法 收集上海市东方医院2022年9月1日—2024年4月1日期间,初始治疗方法为H-FIRE手术的PCa患者的信息,记录基线时性功能问卷结果、围术期不良事件、术后性功能问卷结果、术后总前列腺特异性抗原(total prostate-specific antigen,tPSA)、术后6个月活检穿刺及复发的结果,随后对术前术后结果进行比较。结果 共纳入77例患者,随访达到术后6个月的患者有44例(57.1%),此部分患者6个月时测定平均tPSA水平为(3.33±2.76) ng/mL,相较于术前的(9.42±5.34) ng/mL,平均下降了6.09 ng/mL,差异有统计学意义(P < 0.000 1)。24例(54.5%,24/44)患者术后6个月进行了前列腺穿刺活检复查,其中5例(20.8%,5/24)穿刺结果提示复发,5例复发患者均选择二次H-FIRE手术。术后有6例(7.8%,6/77)患者因尿管拔除较早导致出院后出现急性尿潴留,于门诊再次行留置导尿操作,并于1周后拔除;围术期未观察到其他Clavien-DindoⅡ级并发症。54例(70.1%,54/77)患者高质量地完成了术前及术后1个月的功能问卷调查,此部分患者基线时尿垫使用率为0,术后1个月时1例(1.9%,1/54)患者使用尿垫。术后1个月及6个月时,患者国际前列腺症状评分(IPSS)、生活质量指数(QOL)与基线相比差异无统计学意义。术后1个月国际勃起功能指数(IIEF-5)评分相较于基线略微降低,差异有统计学意义(P=0.016 9),但于术后6个月逐渐回归基线水平。结论 H-FIRE治疗PCa在短期肿瘤控制方面表现良好,短期内可能有轻微的性功能方面的消极影响,但仍可以有效地保护患者的泌尿功能和生活质量,降低围术期并发症的发生概率。Abstract: Objective To evaluate the safety, short-term sexual function preservation, and tumor control effects of high-frequency irreversible electroporation(H-FIRE) in the treatment of localized prostate cancer(PCa).Methods Data were collected from patients who underwent initial treatment with H-FIRE at Shanghai East Hospital from September 1st 2022 to April 1st 2024. Information on baseline sexual function questionnaire results, perioperative adverse events, postoperative sexual function questionnaire results, postoperative tPSA levels, postoperative 6-month biopsy results, and recurrence outcomes were recorded and compared before and after the procedure.Results A total of 77 patients were included. Among them, 44 patients(57.1%) were completed the 6-month follow-up, with a statistically significant decrease in average tPSA levels from(9.42±5.34) ng/mL before surgery to (3.33±2.76) ng/mL after surgery(P < 0.000 1). Twenty-four patients(54.5%, 24/44) underwent prostate biopsy at 6 months postoperatively, with 5 patients(20.8%, 5/24) showing signs of recurrence and subsequently choosing a second H-FIRE surgery. Six patients(7.8%, 6/77) experienced early postoperative urinary retention due to premature catheter removal, necessitating outpatient catheterization and removal after one week. No other Clavien-Dindo grade Ⅱ complications were observed perioperatively. Fifty-four patients(70.1%, 54/77) were completed the preoperative and 1-month postoperative functional questionnaire assessments, with one patient(1.9%, 1/54) using pads at 1 month postoperatively compared to none at baseline. There was no statistically significant difference in the International Prostate Symptom Score(IPSS), Quality of Life(QOL) index, or IIEF-5 score at 1 and 6 months postoperatively compared to baseline, except for a slight decrease in the IIEF-5 score at 1 month(P=0.016 9), which gradually returned to baseline by 6 months postoperatively.Conclusion H-FIRE for prostate cancer demonstrates good short-term tumor control outcomes with a slight negative impact on sexual function in the short term, while effectively preserving urinary function and quality of life and reducing the risk of perioperative complications.
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表 1 77患者基线数据
例(%), X±S,M(Q1,Q3) 项目 结果 年龄/岁 68.6±8.7 tPSA/(ng/L) 8.5±4.8 ISUP分级 1组 29(37.6) 2组 22(28.6) 3组 21(27.3) 4组 5(6.5) MRI PI-RADS评分 1~2分 25(32.5) 3~5分 52(67.5) IPSS评分/分 8(6,14) IIEF-5评分/分 7(1.5,14.5) QOL评分/分 1(1,2) 尿垫使用情况 0(0) 表 2 术后随访数据
例(%),X±S,M(Q1,Q3) 项目 结果 围术期结果(77例) 并发症 出现并发症患者数 15(19.5) 不良事件数 21(27.3) Clavien-Dindo分级 Ⅰ级 14 Ⅱ级 7 Ⅲ级 0 事件类型 尿中白细胞异常 10 尿潴留 6 长时间肉眼血尿 4 尿路感染 1 术后1个月随访结果(54例) IPSS评分/分 8(6,13) IIEF-5评分/分 7(2,13) QOL评分/分 1(1,2) 尿垫使用情况 1(1.9) 术后6个月随访结果(44例) tPSA/(ng/L) 3.33±2.76 IPSS评分/分 8(6,12) IIEF-5评分/分 6(0,15) QOL评分/分 1(1,2) 术后6个月活检(24例) 有临床意义的PCa 5(20.8) -
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