Hengli(®) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Hengli(®) 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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恒力®中国A型肉毒毒素治疗膀胱过度活动症患者：一项多中心、前瞻性、随机、双盲、安慰剂对照试验
DOI：
10.3389/fphar.2022.840695
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发表时间：
2022
影响因子：
5.6
通讯作者：
Dong J
中科院分区：
文献类型：
--
作者：
Liao L;Liu Q;Cong H;Xu Z;Li E;Weng Z;Jiang H;Liu B;Huang X;Xia S;Wen W;Wu J;Shi G;Wang Y;Li P;Yu Y;Fang Z;Zheng J;Tian Y;Shang D;Li H;Huang Z;Zhou L;Xiao Y;Zhang Y;Wang J;Zhang X;Zhang P;Wang D;Zhang X;Xie K;Wang B;Ma L;Tian X;Chen L;Dong J
目的：评价恒利®中国A型肉毒毒素（BTX-A; 100 U）治疗膀胱过度活动症的有效性和安全性。 研究方法：本研究是一项在抗胆碱能药物治疗不充分的中国患者中进行的多中心、随机、双盲、安慰剂对照试验。合格的患者以2：1的比例随机接受逼尿肌内注射Hengli® BTX-A（n = 144）或安慰剂（n = 72）。主要终点是第6周每日排尿次数相对于基线的变化。次要疗效终点包括每日尿急和尿失禁（UI）发作的平均频率、尿急评分、每日平均排尿量、OABSS和QoL评分。 结果如下：在恒立® BTX-A组中，与安慰剂组相比，每24小时平均排尿次数的减少显著更大（3.28 vs. 1.43; p = 0.003）。此外，每日尿急发作次数、排尿量和OABSS评分均显着改善。排尿后残余尿量增加、排尿困难和尿路感染是恒立® BTX-A组的不良事件（AE）。大多数AE的严重程度为轻度或中度。BTX-A组1例患者在治疗期间开始清洁间歇性导管插入术（CIC）。 结论：恒立® BTX-A治疗耐受性良好，并导致抗胆碱能药物治疗不充分的中国患者的OAB症状显著改善。 临床试验注册：http：//www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml，标识符：CTR 20131190。
Objective: To evaluate the efficacy and safety of Hengli® 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® 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® 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® 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® BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, Identifier: CTR20131190.
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DOI：
10.1111/luts.12193
发表时间：
2019-01
期刊：
Lower urinary tract symptoms
影响因子：
--
作者：
Chuang YC;Liu SP;Lee KS;Liao L;Wang J;Yoo TK;Chu R;Sumarsono B
通讯作者：
Sumarsono B
DOI：
10.1124/jpet.110.169342
发表时间：
2010-09-01
影响因子：
3.5
作者：
Lawrence, Gary W.;Aoki, K. Roger;Dolly, J. Oliver
通讯作者：
Dolly, J. Oliver
影响因子：
6.6
作者：
Nitti, Victor W.;Ginsberg, David;Chapple, Christopher
通讯作者：
Chapple, Christopher
影响因子：
4.5
作者：
Irwin, DE;Milsom, I;Cardozo, L
通讯作者：
Cardozo, L
DOI：
10.1016/j.juro.2016.10.109
发表时间：
2017-02-01
期刊：
The Journal of urology
影响因子：
--
作者：
Nitti, Victor W;Dmochowski, Roger;Haag-Molkenteller, Cornelia
通讯作者：
Haag-Molkenteller, Cornelia