Alcaraz Antonio, Castro-Díaz David, Gacci Mauro, Salonia Andrea, Ficarra Vincenzo, Carballido-Rodríguez Joaquín, Rodríguez-Antolín Alfredo, Medina-Polo José, Fernández-Gómez Jesús M, Cózar-Olmo José M, Búcar-Terrades Santiago, Pérez-León Noemí, Brenes-Bermúdez Francisco J, Molero-García José M, Fernández-Pro-Ledesma Antonio, Herdman Michael, Angulo Javier C, Manasanch José
Urology Department, Hospital Clínic, Universitat de Barcelona, IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), 08036 Barcelona, Spain.
Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain.
J Clin Med. 2022 Jun 22;11(13):3615. doi: 10.3390/jcm11133615.
The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.
这项亚组分析的目的是评估和比较两种联合治疗方法对伴有良性前列腺增生的中重度下尿路症状（LUTS/BPH）男性患者的疗效和耐受性。数据来自于在门诊泌尿外科诊所进行的一项真实世界、开放标签、前瞻性多中心研究。中重度LUTS/BPH男性患者接受了为期6个月的坦索罗辛（TAM）联合白千层己烷提取物（HESr）或5α还原酶抑制剂（5ARI）的治疗。分别使用国际前列腺症状评分（IPSS）和膀胱出口梗阻指数（BII）问卷来测量尿路症状和生活质量的变化。通过记录不良反应（AE）来评估治疗耐受性。两个研究组的患者使用迭代和倾向评分匹配方法进行匹配。经过迭代匹配后，136例患者的数据可用（n = 68例接受TAM + 5ARI治疗，n = 68例接受TAM + HESr治疗）。治疗6个月后，TAM + 5ARI组和TAM + HESr组的IPSS总分平均（标准差）分别提高了7.7（6.3）分和6.7（5.0）分（p = 0.272）；BII总分平均分别提高了3.1（2.9）分和2.9（2.4）分（p = 0.751）。同一组中分别有26.5%和10.3%的患者报告了AE，主要影响性功能（p < 0.027）。在真实世界环境中用于治疗中重度LUTS/BPH患者时，TAM + HESr进行6个月的治疗与TAM + 5ARI一样有效，但耐受性更好。
