y Efficacy and Safety of Serenoa repens Extract Among Patients with Benign Prostatic Hyperplasia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
机构：[1]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[2]Hubei Institute of Urology, Wuhan, China[3]Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat- Sen University, Guangzhou, China中山大学附属第二医院[4]Department of Urology, Peking University First Hospital, Beijing, China[5]Department of Urology, Beijing Tongren Hospital Capital Medical University, Beijing, China首都医科大学附属同仁医院[6]Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China江苏省人民医院[7]Department of Urology, Peking University Third Hospital, Beijing, China[8]Department of Urology, The First Hospital of Shanxi Medical University, China[9]Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China[10]Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, China广东省中医院[11]Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China[12]Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China中山大学附属第一医院[13]Department of Urology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China[14]Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China[15]Department of Urology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China[16]Department of Urology, The Second Affiliated Hospital of Tianjin Medical University, Tianjin, China[17]Department of Urology, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[18]Department of Urology, The First Hospital, Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[19]Department of Urology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China[20]Department of Urology, Ningbo First Hospital, Ningbo, China[21]Department of anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院
OBJECTIVE To evaluate the efficacy and safety of Serenoa repens among patients with benign prostatic hyperplasia (lower urinary tract symptoms/benign prostatic hyperplasia [LUTS/BPH]) in China. METHODS We conducted a double blind, placebo-controlled study of 354 patients with LUTS/BPH from 19 institutions, to evaluate the efficacy and safety of Serenoa repens. Participants were randomly assigned (1:1) into the Serenoa repens extract (320 mg) or placebo groups for 24 weeks. Primary efficacy parameters were changes in International Prostate Symptom Score and peak urinary flow from baseline to each assessment. Secondary efficacy parameters included improvement of storage symptom and voiding symptom scores, prostate volume, urinary frequency, and total prostate-specific antigen level. Other parameters assessed were quality of life score, a four-item male sexual function questionnaire score, and International Index of Erectile Function score across the consecutive double-blind visits. RESULTS Statistically significant improvement in the peak urinary flow, International Prostate Symptom Score, scores of storage symptoms and voiding symptoms, quality of life score, four-item male sexual function questionnaire score, and International Index of Erectile Function score were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05). Two (1.18%) of 169 patients in the placebo group and 3 (1.89) of 159 patients in the Serenoa repens extract group experienced 1 or more adverse events. CONCLUSION The Serenoa repens extract was effective, safe, well-tolerated, and clinically and statistically superior to placebo in the target LUTS/BPH population. (C) 2019 Elsevier Inc.
第一作者机构：[1]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China[2]Hubei Institute of Urology, Wuhan, China[3]Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat- Sen University, Guangzhou, China[4]Department of Urology, Peking University First Hospital, Beijing, China[5]Department of Urology, Beijing Tongren Hospital Capital Medical University, Beijing, China[6]Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China[7]Department of Urology, Peking University Third Hospital, Beijing, China[8]Department of Urology, The First Hospital of Shanxi Medical University, China[9]Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China[10]Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, China[11]Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China[12]Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China[13]Department of Urology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China[14]Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China[15]Department of Urology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China[16]Department of Urology, The Second Affiliated Hospital of Tianjin Medical University, Tianjin, China[17]Department of Urology, West China Hospital, Sichuan University, Chengdu, China[18]Department of Urology, The First Hospital, Zhejiang University, Hangzhou, China[19]Department of Urology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China[20]Department of Urology, Ningbo First Hospital, Ningbo, China[21]Department of anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
通讯作者：
通讯机构：[1]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China[2]Hubei Institute of Urology, Wuhan, China[3]Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat- Sen University, Guangzhou, China[4]Department of Urology, Peking University First Hospital, Beijing, China[5]Department of Urology, Beijing Tongren Hospital Capital Medical University, Beijing, China[6]Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China[7]Department of Urology, Peking University Third Hospital, Beijing, China[8]Department of Urology, The First Hospital of Shanxi Medical University, China[9]Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China[10]Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, China[11]Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China[12]Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China[13]Department of Urology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China[14]Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China[15]Department of Urology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China[16]Department of Urology, The Second Affiliated Hospital of Tianjin Medical University, Tianjin, China[17]Department of Urology, West China Hospital, Sichuan University, Chengdu, China[18]Department of Urology, The First Hospital, Zhejiang University, Hangzhou, China[19]Department of Urology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China[20]Department of Urology, Ningbo First Hospital, Ningbo, China[21]Department of anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China[*1]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
推荐引用方式(GB/T 7714)：
Ye Zhangqun,Huang Jian,Zhou Liqun,et al.y Efficacy and Safety of Serenoa repens Extract Among Patients with Benign Prostatic Hyperplasia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial[J].UROLOGY.2019,129:172-179.doi:10.1016/j.urology.2019.02.030.
APA：
Ye, Zhangqun,Huang, Jian,Zhou, Liqun,Chen, Shan,Wang, Zengjun...&Zeng, Xiaoyong.(2019).y Efficacy and Safety of Serenoa repens Extract Among Patients with Benign Prostatic Hyperplasia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.UROLOGY,129,
MLA：
Ye, Zhangqun,et al."y Efficacy and Safety of Serenoa repens Extract Among Patients with Benign Prostatic Hyperplasia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial".UROLOGY 129.(2019):172-179
