曲司氯铵治疗膀胱过度活动症的多中心临床研究
吴士良，孙培红，杨勇，段继宏
(1北京大学第一医院，北京 100034; 2北京大学人民医院，北京 100044;3上海华山医院，上海200040)
[摘 要] 目的: 评价曲司氯铵治疗膀胱过度活动症的有效性和安全性。 方法: 以盐酸奥昔布宁为对照，采用随机双盲双模拟多中心临床试验设计，对144例(顺睦利组72例，奥昔布宁组72例)膀胱过度活动症患者进行研究，服药方法每次顺睦利20mg或奥昔布宁5mg,bid。 结果:治疗6周后，试验组(n=69)和对照组(n=64) 24小h平均排尿次数减少、尿失禁患者的平均尿失禁次数减少以及平均每次尿量增加比较无统计学差异(p>0.05)。试验组患者不良事件的总发生率47.2%，其中主要不良事件口干发生率为23.6%;而奥昔布宁组不良事件的总发生率为76.4%，口干发生率为68.1%，不良事件总发生率及口干发生率在两组间均有明显统计学差异(P<0.001)。结论：顺睦利是治疗膀胱过度活动症的有效药物，其疗效与奥昔布宁等效，但其不良反应明显低于奥昔布宁。
, http://www.100md.com
【关键词】 膀胱过度活动症；曲司氯铵；奥昔布宁
Clinical trial of the efficacy and safety of Trospium chloride in the Treatment of Overactive Bladder
WU Shiliang, SUN Peihong, YANG Yong, et al
( Beijing University First Hospital, Beijing 100034)
【Abstract】 OBJECTIVE: To evaluate the efficacy and safety of Trospium in patients with an overactive bladder. METHODS: A double-blind double-dummy randomized controlled multicenter clinical trial was designed. 144 patients with bladder overactivity were enrolled, Patients received either Trospium (20mg twice daily) or oxybutynin (5mg twice daily). Results: After 6 weeks' treatment, the mean decrease of frequency of micturition, the mean decrease of incontinence episodes among those with incontinence and the volume increase of every micturition were statistically equivalent in those receiving Trospium (n=69) and oxybutynin (n=64). In the Trospium group, the total incidence of adverse event was 47.2% and the incidence of dry mouth, the most common adverse, was 23.6%. While in the oxybutynin group, the incidences were 76.4% and 58.1%, respectively. The incidences of adverse events and dryness were significantly lower in those on Trospium than in those on oxybutynin. Conclusions: Trospium 20mg twice daily had the equivalent efficacy on patients with overactive bladder as compared to oxybutynin 5mg twice daily, and the side-effects of Trospium were lower than oxybutynin.
, http://www.100md.com
【Key words】 Overactive bladder; Trospium; Oxybutynin
【参考文献】
1. Colling J. An update on the AHCPR guideline implementation. Nurse Practice Forum,1994;5(3):134-137.
2. 段继宏，杨勇，吴士良，等. 北京地区尿失禁发病率的调查. 北京医科大学学报, 2000;32:74-75.
3. Yarker YE, Guo KL, Fitton A. Oxybutynin: a review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in detrusor instability. Drugs Aging, 1995;6:243-262.
4. Abrams P, Freeman R, Anderstrom C, et al. Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. Br J Urol,1998;81:801-810.
5. Wein AJ. Pharmacology of incontinence. Urol Clin North AM, 1995;22(3):557-578., http://www.100md.com
(1北京大学第一医院，北京 100034; 2北京大学人民医院，北京 100044;3上海华山医院，上海200040)
[摘 要] 目的: 评价曲司氯铵治疗膀胱过度活动症的有效性和安全性。 方法: 以盐酸奥昔布宁为对照，采用随机双盲双模拟多中心临床试验设计，对144例(顺睦利组72例，奥昔布宁组72例)膀胱过度活动症患者进行研究，服药方法每次顺睦利20mg或奥昔布宁5mg,bid。 结果:治疗6周后，试验组(n=69)和对照组(n=64) 24小h平均排尿次数减少、尿失禁患者的平均尿失禁次数减少以及平均每次尿量增加比较无统计学差异(p>0.05)。试验组患者不良事件的总发生率47.2%，其中主要不良事件口干发生率为23.6%;而奥昔布宁组不良事件的总发生率为76.4%，口干发生率为68.1%，不良事件总发生率及口干发生率在两组间均有明显统计学差异(P<0.001)。结论：顺睦利是治疗膀胱过度活动症的有效药物，其疗效与奥昔布宁等效，但其不良反应明显低于奥昔布宁。
, http://www.100md.com
【关键词】 膀胱过度活动症；曲司氯铵；奥昔布宁
Clinical trial of the efficacy and safety of Trospium chloride in the Treatment of Overactive Bladder
WU Shiliang, SUN Peihong, YANG Yong, et al
( Beijing University First Hospital, Beijing 100034)
【Abstract】 OBJECTIVE: To evaluate the efficacy and safety of Trospium in patients with an overactive bladder. METHODS: A double-blind double-dummy randomized controlled multicenter clinical trial was designed. 144 patients with bladder overactivity were enrolled, Patients received either Trospium (20mg twice daily) or oxybutynin (5mg twice daily). Results: After 6 weeks' treatment, the mean decrease of frequency of micturition, the mean decrease of incontinence episodes among those with incontinence and the volume increase of every micturition were statistically equivalent in those receiving Trospium (n=69) and oxybutynin (n=64). In the Trospium group, the total incidence of adverse event was 47.2% and the incidence of dry mouth, the most common adverse, was 23.6%. While in the oxybutynin group, the incidences were 76.4% and 58.1%, respectively. The incidences of adverse events and dryness were significantly lower in those on Trospium than in those on oxybutynin. Conclusions: Trospium 20mg twice daily had the equivalent efficacy on patients with overactive bladder as compared to oxybutynin 5mg twice daily, and the side-effects of Trospium were lower than oxybutynin.
, http://www.100md.com
【Key words】 Overactive bladder; Trospium; Oxybutynin
【参考文献】
1. Colling J. An update on the AHCPR guideline implementation. Nurse Practice Forum,1994;5(3):134-137.
2. 段继宏，杨勇，吴士良，等. 北京地区尿失禁发病率的调查. 北京医科大学学报, 2000;32:74-75.
3. Yarker YE, Guo KL, Fitton A. Oxybutynin: a review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in detrusor instability. Drugs Aging, 1995;6:243-262.
4. Abrams P, Freeman R, Anderstrom C, et al. Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. Br J Urol,1998;81:801-810.
5. Wein AJ. Pharmacology of incontinence. Urol Clin North AM, 1995;22(3):557-578., http://www.100md.com