锯叶棕果实提取物软胶囊治疗良性前列腺增生的有效性和安全性分析

Efficacy and safety of Saw Palmetto Extract Capsules in the treatment of benign prostatic hyperplasia

目的:探讨锯叶棕果实提取物软胶囊治疗良性前列腺增生(BPH)的有效性和安全性。方法:采用多中心、开放性临床研究,对临床和实验室确诊的165例BPH患者给予锯叶棕果实提取物软胶囊口服1粒/次(160 mg),1次/d,6周后及12周试验结束时比较患者治疗前后的疗效。主要疗效指标:IPSS评分、前列腺体积、残余尿量;次要疗效指标:尿流率、生活质量评分(QOL)。结果:治疗6周后,患者的国际前列腺症状评分(IPSS)和QOL较前有所改善,治疗12周后,患者的IPSS评分、QOL评分、尿流率、残余尿较治疗前均有明显改善。研究过程中有1例不良事件发生。结论:锯叶棕果实提取物软胶囊治疗BPH是有效和安全的。

Objective： To assess the efficacy and safety of Saw Palmetto Extract Capsules in the treatment of benign prostatic hyperplasia（ BPH）. Methods： We conducted a multi-centered open clinical study on 165 BPH patients treated with Saw Palmetto Extract Capsules at a dose of 160 mg qd for 12 weeks. At the baseline and after 6 and 12 weeks of medication,we compared the International Prostate Symptom Scores（ IPSS）,prostate volume,postvoid residual urine volume,urinary flow rate,quality of life scores（ QOL）,and adverse events between the two groups of patients. Results： Compared with the baseline,both IPSS and QOL were improved after 6 weeks of medication,and at 12 weeks,significant improvement was found in IPSS,QOL,urinary flow rate,and postvoid residual urine. Mild stomachache occurred in 1 case,which necessitated no treatment. Conclusion： Saw Palmetto Extract Capsules were safe and effective for the treatment of BPH.