补肾通淋汤治疗女性特发性膀胱过度活动症(肾气亏虚型)的临床研究

Clinical Research of Female Idiopathic Overactive Bladder(Kidney Qi Deficiency)Treated with Bushen Tonglin Decoction

目的评价补肾通淋汤治疗女性特发性膀胱过度活动症的有效性、安全性。方法临床选择符合纳入标准的女性患者96例,随机分为治疗组和对照组,每组48例。治疗组给予补肾通淋汤水煎剂,100mL/次,日2次口服;对照组给予舍尼亭(酒石酸托特罗定片),2mg/次,日2次口服。观察两组的临床疗效。结果治疗4周后,治疗组总有效率为87.50%,对照组总有效率70.83%,治疗组总有效率明显优于对照组(P<0.05);试验组患者不良事件的总发生率为0,而对照组不良事件总发生率为36.5%,口干发生率为23.3%;治疗组尿急、尿痛、尿道灼热症状改善较对照组明显,尿频症状改善与对照组相当。结论补肾通淋汤治疗女性特发性膀胱过度活动症安全、有效。

Objective：To evaluate the efficacy and safety of bushen tonglin decoction in the treatment of female idiopathic overactive bladder（IOAB）.Methods：96 female cases that met the inclusive criteria were optioned clinically and randomized into treatment group and control group,48 cases in each one.In treatment group,bushen tonglin decoction was administered orally,100 mL/time,twice per day.In control group,tolterodine tartrate tablet was prescribed for oral administration,2 mg/time,twice per day.The clinical efficacy was observed in two groups.Results：In treatment of 4 weeks,the total effective rate was 87.50% in treatment group and was 70.83% in control group.The total effective in treatment group was superior to that in control group（P0.05）.The overall incidence of adverse event was 0 in treatment group and was 36.5% in control group,of which,the incidence of dry mouth was 23.3%.In treatment group,the improvements in urgent and painful urine with burning sensation were obvious as compared with control group,but the improvement in frequent urine was same as that in control group.Conclusion：Bushen tonglin decoction is safe and effective in treatment of female IOAB.