琥珀酸索利那新治疗膀胱过度活动症的疗效和安全性

The efficacy and safety of solifenacin vesicare therapy in patients with overactive bladder

目的对琥珀酸索利那新治疗膀胱过度活动症(OAB)的疗效和安全性进行评估。方法将76例确诊为OAB病程超过3个月的患者采用随机、双盲法分为2组:对照组38例,给予托特罗定2mgbid,早晚口服;实验组38例,给予琥珀酸索利那新5mgqd,早饭后口服。2组疗程均为8周。2组患者在用药前1周及用药后1周自行记录排尿日记,通过排尿日记比较2组患者服药前后1周平均24h内排尿次数和尿急次数的改善情况,同时结合患者治疗前后最大尿流率、初始尿意容量、最大膀胱压容量的变化对琥珀酸索利那新的疗效进行评价;通过用药不良反应发生率的对比分析,对其安全性进行评估。结果实验组患者的24h尿急次数和排尿次数以及初始尿意容量、最大膀胱压容量、最大尿流率较对照组有明显改善(P<0.05);实验组患者口干、视野模糊、便秘等不良反应发生率均较对照组低(P均<0.05)。结论琥珀酸索利那新治疗OAB较托特罗定有更好的效果和更高的安全性,琥珀酸索利那新将可能成为治疗OAB的首选药物。

Objective To evaluate the efficacy and safety of solifenacin vesicare therapy in patients with overactive bladder（OAB）. Methods A double-blind randomized controlled clinical trial was conducted.A total of 76 patients with OAB were enrolled in the trial and assigned to treatment group and control group （n=38 each）. Solifenacin vesicare was taken （5 mg qd after breakfast for 8 weeks） in treatment group,and tolterodine was taken （2 mg bid for 8 weeks） in control group.The courses of treatment were all eight weeks in two groups.The urination diary was recorded by oneself in all patients 1 week before and after treatment.The efficacy of solifenacin vesicare was assessed by comparing the improvement of mean frequency of urination and frequency of urgency episodes in 24 h in 1 week before and after medication according to urination diary and the changes of maximum flow rate（Qmax）,volume of first desire to void（FDV）and maximum cystometric bladder capacity （MCBC） in two groups.The safety of solifenacin vesicare was appraised by comparing the incidence of drug adverse reactions in two groups. Results Compared with control group,the frequency of urination in 24 h,the frequency of urgency episodes in 24 h,FDV,MCBC and Qmax were all significantly improved in treatment group（all P〈0.05）. Adverse reactions of drug in treatment group including xerostoma,visual field obscure and constipation were all lower than those in control group （all P〈0〈05）. Conclusions Solifenacin vesicare is a safer and more effective drug over tolterodine for the treatment of patients with OAB,and it could be served as a drug of first choice for treating OAB