Hengli(R) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
单位:[1]Capital Med Univ, Sch Rehabil Med, China Rehabil Res Ctr, Dept Urol, Beijing, Peoples R China[2]Shandong Univ, Cheeloo Coll Med, Jinan, Peoples R China[3]Univ Hlth & Rehabil Sci, Qingdao, Peoples R China[4]Zhejiang Prov Peoples Hosp, Dept Urol, Hangzhou, Peoples R China[5]Wenzhou Med Univ, Dept Urol, Affiliated Hosp 1, Wenzhou, Peoples R China[6]Zhejiang Univ, Dept Urol, Sch Med, Affiliated Hosp 1, Hangzhou, Peoples R China浙江大学医学院附属第一医院[7]Shanghai First Peoples Hosp, Dept Urol, Shanghai, Peoples R China[8]Shanghai Fifth Peoples Hosp, Dept Urol, Shanghai, Peoples R China[9]Ningxia Med Univ, Dept Urol, Gen Hosp, Xining, Peoples R China[10]Fudan Univ, Huashan Hosp, Dept Urol, Shanghai, Peoples R China[11]Capital Med Univ, Beijing Friendship Hosp, Dept Urol, Beijing, Peoples R China首都医科大学附属北京友谊医院[12]Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Urol, Beijing, Peoples R China[13]Peking Univ First Hosp, Dept Urol, Beijing, Peoples R China[14]Beijing Hosp, Dept Urol, Beijing, Peoples R China[15]Capital Med Univ, Beijing Chaoyang Hosp, Dept Urol, Beijing, Peoples R China北京朝阳医院[16]Shanxi Med Univ, Dept Urol, Hosp 1, Taiyuan, Peoples R China[17]Guangzhou First Peoples Hosp, Dept Urol, Guangzhou, Peoples R China[18]Peking Univ Third Hosp, Dept Urol, Beijing, Peoples R China[19]Peoples Liberat Army Gen Hosp, Dept Urol, Med Ctr 5, Beijing, Peoples R China
Objective: To evaluate the efficacy and safety of Hengli(R) Chinese botulinum toxin type A (BTX-A; 100 U) in Chinese patients with overactive bladder.Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial in Chinese patients who were inadequately managed with anticholinergic medications. Eligible patients were randomized 2:1 to receive intradetrusor injections of Hengli(R) BTX-A (n = 144) or placebo (n = 72). The primary endpoint was the change in the number of daily micturition episodes at week 6 from baseline. The secondary efficacy endpoints included the average frequency of urgency and urinary incontinence (UI) episodes per day, urgency score, average micturition volume per day, OABSS, and QoL score.Results: In the Hengli(R) BTX-A group, there was a significantly greater reduction in the average number of micturition episodes per 24 h compared with the placebo group (3.28 vs. 1.43; p = 0.003). Moreover, there was a significantly greater improvement in the daily number of urgency episodes, micturition volume and OABSS score. An increased post-void residual urine volume, dysuria, and urinary tract infection represented adverse events (AEs) in the Hengli(R) BTX-A group. Most AEs were mild or moderate in severity. One patient in the BTX-A group initiated clean intermittent catheterization (CIC) during treatment.Conclusion: Hengli(R) BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics.
基金:
National Natural Science Foundation of China [81870523]
第一作者单位:[1]Capital Med Univ, Sch Rehabil Med, China Rehabil Res Ctr, Dept Urol, Beijing, Peoples R China[2]Shandong Univ, Cheeloo Coll Med, Jinan, Peoples R China[3]Univ Hlth & Rehabil Sci, Qingdao, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Capital Med Univ, Sch Rehabil Med, China Rehabil Res Ctr, Dept Urol, Beijing, Peoples R China[2]Shandong Univ, Cheeloo Coll Med, Jinan, Peoples R China[3]Univ Hlth & Rehabil Sci, Qingdao, Peoples R China
推荐引用方式(GB/T 7714):
Liao Limin,Liu Qinggang,Cong Huiling,et al.Hengli(R) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial[J].FRONTIERS in PHARMACOLOGY.2022,13:doi:10.3389/fphar.2022.840695.
APA:
Liao, Limin,Liu, Qinggang,Cong, Huiling,Xu, Zhihui,Li, Enhui...&Dong, Jinkai.(2022).Hengli(R) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.FRONTIERS in PHARMACOLOGY,13,
MLA:
Liao, Limin,et al."Hengli(R) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial".FRONTIERS in PHARMACOLOGY 13.(2022)