Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Catholic Integrative Medicine Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Investig Clin Urol. 2023 Jan;64(1):20-30. doi: 10.4111/icu.20220290.
To evaluate the efficacy and safety of in men with moderate lower urinary tract symptoms (LUTS).
A total of 135 subjects with International Prostate Symptom Score (IPSS) of 8-19 were randomized in 2 centers from June 2018 to April 2019. Patients were assigned into one of the three groups: a low-dose group (LG, 1,000 mg ), a high-dose group (HG, 2,000 mg ) or a placebo group (PG). The primary endpoint was the change of IPSS at the end of treatment from baseline. Secondary end points included the changes of prostate specific antigen, testosterone, dihydrotestosterone, maximum urinary flow rate (Qmax), postvoid residual volume (PVR) and International Index of Erectile Function-5 (IIEF-5), with drug safety.
113 patients were able to finish the study. Compared to the PG, total IPSS in the LG and the HG was significantly improved at 6 weeks and 12 weeks. For IPSS subscores, LG showed improvements in all except for urgency and quality of life at 6 weeks. HG showed improvements in incomplete emptying and frequency at 6 weeks and 12 weeks along with improvements in intermittency, straining, and quality of life at 12 weeks. For IIEF-5 subscores, orgasmic function and overall satisfaction improved in HG when compared to PG at 12 weeks. Lastly, increase of Qmax and decrease of PVR was observed at 6 weeks in LG.
12-week treatment with has a therapeutic effect and is well tolerated in patients with LUTS.
评估 在中度下尿路症状（LUTS）男性患者中的疗效和安全性。
2018 年 6 月至 2019 年 4 月，在 2 个中心共纳入 135 例国际前列腺症状评分（IPSS）为 8-19 分的患者。患者被随机分为三组：低剂量组（LG，1000mg）、高剂量组（HG，2000mg）或安慰剂组（PG）。主要终点为治疗结束时与基线相比 IPSS 的变化。次要终点包括前列腺特异性抗原、睾酮、二氢睾酮、最大尿流率（Qmax）、剩余尿量（PVR）和国际勃起功能指数-5（IIEF-5）的变化，并评估药物安全性。
113 例患者完成了研究。与 PG 相比，LG 和 HG 在治疗 6 周和 12 周时总 IPSS 显著改善。对于 IPSS 亚评分，LG 在 6 周时除了急迫性和生活质量外，所有评分均改善；HG 在 6 周和 12 周时改善了不完全排空和频率，12 周时改善了间断性、费力和生活质量。对于 IIEF-5 亚评分，HG 在 12 周时与 PG 相比，性高潮功能和总体满意度改善。最后，LG 在 6 周时观察到 Qmax 增加和 PVR 减少。
12 周治疗 可有效治疗 LUTS 患者，且耐受性良好。
