目的 评估翁沥通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 该研究针对156例OAB女性患者进行前瞻性、随机、多中心临床试验,最后123例患者(单用翁沥通组41例、单用托特罗定组39例、翁沥通联合托特罗定组43例)完成了为期8周的治疗.以膀胱过度活动症症状评分(OABSS),24 h排尿日记中每日平均排尿次数、平均排尿量和急迫性尿失禁症状作为主要疗效观察指标.结果 所有组的OABSS评分、24 h排尿日记中每日平均排尿次数、平均排尿量和急迫性尿失禁症状均有显著改善.相比于托特罗定,翁沥通对OABSS(P=0.012)、每日排尿次数(P=0.006)和平均排尿量(P=0.009)的改善较弱.而联合组在这三项中的改善则明显优于其他两组(P＜0.05).三组患者生活质量评分变化无显著性差异.安全性方面,只有托特罗定组出现了残余尿量的明显增加(P=0.004).相比于托特罗定组,翁沥通组口干(P=0.002)和尿液变细(P=0.002)的发生率更低,且残余尿更少(P＜0.001).结论 翁沥通联合托特罗定治疗女性OAB能发挥协同作用,临床疗效优于单用翁沥通或托特罗定,安全性更好,使OAB女性患者获益更多.%Objective To assess the efficacy and safety of a herbal medicine,Wenglitong(WLT),combined with tolterodine,in the treatment of female overactive bladder (OAB).Methods A prospective,randomized,multi-center trial with 156 OAB cases was conducted.Overactive bladder symptom score(OABSS) and micturition behaviors were measured.Totally 123 patients(combination ∶ WLT ∶ tolterodine =43 ∶ 41 ∶ 39) completed 8-weeks treatment.OABSS,voiding frequency,average voided volume and urgency incontinence were observed.Results All groups showed significant improvement in OABSS,voiding frequency,average voided volume and urgency incontinence.Compared to tolterodine,WLT had weaker effect in the improvement of OABSS(P =0.012),daily voiding frequency(P =0.006) and average voided volume(P =0.009).The combination group had better efficacy than the two other groups in the improvement of OABSS,voiding frequency and average voided volume.No significant difference in the change of quality of life scores was observed among the three groups.In terms of safety,residual urine increased significantly only in the tolterodine group(P=0.004) but not in the combination group.WLT had fewer adverse effects than tolterodine in dry mouth(P=0.002),weak stream(P=0.002) with much less residual urine(P＜0.001).Conclusion WLT combined with tolterodine shows synergic effect.It is safe and effective in the treatment of OAB.
展开▼
