苓芍枣仁配方颗粒联合酒石酸托特罗定治疗女性膀胱过度活动症随机、双盲对照研究

Efficacy of Combined Therapy with Lingshao Zaoren Formula Granule and Tolterodine Tartrate in Treating Female Overactive Bladder:A Randomized,Controlled and Double-blinded Trial

目的评价苓芍枣仁配方颗粒联合酒石酸托特罗定缓释片治疗女性膀胱过度活动症的临床疗效以及对酒石酸托特罗定缓释片不良反应的缓解作用。方法采用随机、双盲、平行对照研究方法,选择60例女性膀胱过度活动症门诊患者随机分为治疗组及对照组,每组30例。两组均口服酒石酸托特罗定缓释片4mg/d,治疗组口服苓芍枣仁配方颗粒4g,每天2次;对照组口服苓芍枣仁颗粒安慰剂4g,每天2次;连续治疗4周。比较两组治疗前后排尿症状评分、中医证候评分、不良反应评分。结果与本组治疗前比较,两组治疗14、28日排尿症状评分降低(P<0.05);治疗组治疗14、28日中医证候评分降低(P<0.05),治疗14日不良反应评分升高(P<0.05);对照组治疗14、28日不良反应评分明显升高(P<0.05)。与对照组同期比较,治疗组治疗28日排尿症状评分降低(P<0.05),治疗14、28日中医证候评分及不良反应评分降低(P<0.05)。结论苓芍枣仁配方颗粒可改善女性膀胱过度活动症患者排尿症状、中医证候,减轻酒石酸托特罗定不良反应。

Objective To evaluate the therapeutic efficacy of combined therapy with Lingshao Zaoren Formula Granule（LZFG） and Tolterodine Tartrate on female overactive bladder （OAB）. Methods Using randomized double-blinded controlled design, 60 female patients with OAB were randomly assigned to the treated group and the control group, 30 cases in each group. All patients were treated with Toltero- dine Tartrate sustained release Tablets（4 mg/d）, but to the treated group LZFG （4 g） was given addition- ally twice every day, while to the control group placebo capsule of equal dosage was given instead.The therapeutic course for all was 4 weeks.The urination symptom score, TCM syndrome score and adverse reaction score were measured before and after treatment. Results Compared with before treatment in the same group, the urination symptom score decreased in both groups after 14 and 28 days of treat-action score in the control group increased after 14 and 28 days of treatment（P 〈0.05）. Compared with the control group, the urination symptom score decreased in the treatment group after 28 days of treat- ment（P 〈0.05）, TCM syndrome score and adverse reaction score decreased after 14 and 28 days of treatment（P 〈0.05）. Conclusions LZFG could improve urination symptom and TCM Syndrome of female overactive bladder, and alleviate adverse reaction of Tolterodine Tartrate.