de la Taille Alexandre, Chalret du Rieu Quentin, Dialla Olivia, Bardin Laurent
Département de chirurgie urologique, CHU de Henri-Mondor, Assistance Publique Hôpitaux de Paris, 94010 Créteil, France.
Direction médicale pharmaceutical dermato, consumer care France, péraudel, 17, avenue Jean Moulin, 81100 Castres, France.
Prog Urol. 2023 Feb;33(2):66-72. doi: 10.1016/j.purol.2022.09.018. Epub 2022 Oct 4.
The objective of this sub-analysis of the PERSAT study was to evaluate the efficacy of hexanic extract of S. Repens (HESr) and alpha-blockers (AB), at 6 months in patients with moderate to severe LUTS/BPH.
The PERSAT observational study was conducted in France by general practitioners on patients with BPH with an IPSS≥12 score. The primary endpoint was the percentage of responders (decrease in total IPSS score ≥ 3) at 6 months. Improvement in quality of life (IPSS-QoL) as well as patient satisfaction were also measured.
Of the 759 patients in the study, 324 treated with HESr and 309 with AB were reviewed at 6 months, with no change in treatment during follow-up. Characteristics at inclusion were globally similar with a mean IPSS of 18.2±4.9. The response rates at 6 months (IPSS-total decrease ≥ 3) were 93.7% and 94.8% for patients treated with HESr and AB, with a mean decrease in IPSS score of 10.1±5.6 points, which reached 13.6 and 14.8 points respectively, in severe patients (IPSS>19), without major difference between groups. More than 95% of HESr or AB patients reported a significant overall improvement in their LUTS/BPH. The most frequently reported adverse events with AB were ejaculation disorders (4.9%) and hypotension (4.2%) and with HESr digestive disorders (1.5%).
This sub-analysis of the PERSAT cohort reported the clinical efficacy of HESr and AB as a first-line treatment in the management of moderate or severe LUTS/BPH patients.
本项对PERSAT研究的亚组分析旨在评估蛇床子正己烷提取物（HESr）和α受体阻滞剂（AB）对中重度下尿路症状/良性前列腺增生（LUTS/BPH）患者6个月时的疗效。
PERSAT观察性研究由法国的全科医生针对国际前列腺症状评分（IPSS）≥12分的BPH患者开展。主要终点为6个月时的应答者百分比（总IPSS评分降低≥3分）。还对生活质量改善情况（IPSS-QoL）以及患者满意度进行了测量。
研究中的759例患者中，6个月时对324例接受HESr治疗的患者和309例接受AB治疗的患者进行了评估，随访期间治疗未改变。纳入时的特征总体相似，平均IPSS为18.2±4.9。接受HESr和AB治疗的患者6个月时的应答率（IPSS总分降低≥3分）分别为93.7%和94.8%，IPSS评分平均降低10.1±5.6分，在重度患者（IPSS>19）中分别达到13.6分和14.8分，两组间无显著差异。超过95%的HESr或AB患者报告其LUTS/BPH有显著总体改善。AB最常报告的不良事件为射精障碍（4.9%）和低血压（4.2%），HESr为消化系统疾病（1.5%）。
PERSAT队列的本亚组分析报告了HESr和AB作为中重度LUTS/BPH患者管理一线治疗的临床疗效。
