翁沥通草药与托特罗定联合使用在治疗女性膀胱过度活动症方面可能比单独使用托特罗定效果更好：一项随机安慰剂对照前瞻性试验。
The combination of herbal medicine Weng-li-tong with Tolterodine may be better than Tolterodine alone in the treatment of overactive bladder in women: a randomized placebo-controlled prospective trial.
作者信息
Xiao Dong-Dong, Lv Jian-Wei, Xie Xin, Jin Xing-Wei, Lu Mu-Jun, Shao Yuan
机构信息
Department of Urology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Zhi-zao-ju Road, Shanghai, 200011, China.
Department of Urology and Andrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shan-dong Road, Shanghai, 200001, Peoples Republic of China.
出版信息
BMC Urol. 2016 Aug 8;16(1):49. doi: 10.1186/s12894-016-0167-1.
BACKGROUND
To assess the efficacy and safety of the herbal medicine, Weng-li-tong (WLT) as monotherapy or combined with tolterodine in women with overactive bladder (OAB).
METHODS
A prospective, randomized, single-blind multi-center trial was performed which included 182 OAB patients treated with either placebo (n = 26), WLT (n = 52), tolterodine (n = 52) or WLT plus tolterodine (n = 52). The overactive bladder symptom score (OABSS) and micturition behavior were measured to evaluate treatment efficacy.
RESULTS
In total, 146 patients [placebo (n = 23), WLT (n = 39), tolterodine (n = 41) and WLT plus tolterodine (n = 43)] completed 8 weeks of treatment. Compared to those treated with placebo, patients in three intervention groups showed significant improvements in the OABSS, voiding frequency, average voided volume and urgency incontinence. WLT had a slower onset than tolterodine or combination therapy in reducing urgency incontinence. Compared with tolterodine, WLT had a weaker effect in improving OABSS (P = 0.022) and daily voiding frequency (P = 0.034). The combination therapy had better efficacy than WLT or tolterodine alone in improving the OABSS, voiding frequency and voided volume. No significant differences in the changes in quality of life scores were observed among the three intervention groups. Residual urine increased significantly in tolterodine group (P = 0.004), but not in combination group. WLT resulted in fewer adverse effects than tolterodine such as dry mouth (P = 0.002), weak stream (P = 0.002) and less residual urine (P < 0.001).
CONCLUSIONS
WLT could improve OAB symptoms in women, while it had slower onset and weaker efficacy but fewer adverse effects than tolterodine. The combination of WLT and tolterodine was more efficacious than tolterodine alone in improving OAB symptoms.
TRIAL REGISTRATION
Chinese Clinical Trial Registry [ ChiCTR-IPR-14005626 ]. Date of registration: 7 December 2014.
背景
评估中药翁沥通（WLT）单药治疗或联合托特罗定治疗女性膀胱过度活动症（OAB）的疗效和安全性。
方法
进行了一项前瞻性、随机、单盲多中心试验，纳入182例OAB患者，分别接受安慰剂治疗（n = 26）、WLT治疗（n = 52）、托特罗定治疗（n = 52）或WLT联合托特罗定治疗（n = 52）。通过测量膀胱过度活动症症状评分（OABSS）和排尿行为来评估治疗效果。
结果
共有146例患者[安慰剂组（n = 23）、WLT组（n = 39）、托特罗定组（n = 41）和WLT联合托特罗定组（n = 43）]完成了8周治疗。与安慰剂组相比，三个干预组患者的OABSS、排尿频率、平均排尿量和急迫性尿失禁均有显著改善。在减轻急迫性尿失禁方面，WLT起效比托特罗定或联合治疗慢。与托特罗定相比，WLT在改善OABSS（P = 0.022）和每日排尿频率（P = 0.034）方面效果较弱。联合治疗在改善OABSS、排尿频率和排尿量方面比单独使用WLT或托特罗定疗效更好。三个干预组在生活质量评分变化方面无显著差异。托特罗定组残余尿量显著增加（P = 0.004），联合治疗组则无。WLT导致的口干（P = 0.002）、尿流无力（P = 0.002）等不良反应比托特罗定少，残余尿量也更少（P < 0.001）。
结论
WLT可改善女性OAB症状，但其起效较慢，疗效较弱，但不良反应比托特罗定少。WLT与托特罗定联合治疗在改善OAB症状方面比单独使用托特罗定更有效。
试验注册
中国临床试验注册中心[ChiCTR-IPR-14005626]。注册日期：2014年12月7日。
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