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Hengli(R) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

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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 [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 [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 [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
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关键词: botulinum toxin type A Hengli(R) overactive bladder randomized controlled trial China

摘要:
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.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 药学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 药学
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出版当年[2020]版:
Q1 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q1 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2020版] 出版当年五年平均[2016-2020] 出版前一年[2019版] 出版后一年[2021版]

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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
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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
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