苓芍枣仁配方颗粒治疗女性膀胱过度活动症临床研究

A clinical research of Lingshao-Zaoren granule for the female with overactive bladder symptom： a randomized, double-blind, placebo-controlled trial

目的 评价苓芍枣仁配方颗粒治疗女性膀胱过度活动症（overactive bladder,OAB）的疗效.方法 将符合入选标准的女性OAB患者60例,采用随机、对照、双盲的原则分为2组,每组30例.对照组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒安慰剂治疗,治疗组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒治疗,2组均治疗4周.采用膀胱过度活动症症状量表（Overactive Bladder Symptom Scale,OABSS）判定OAB严重程度.结果 治疗后14、28d,OABSS量表评分治疗组[（5.3±2.3）分、（1.4±1.2）分比（8.4±2.4）分,F=137.209]、对照组[（7.8±1.9）分、（6.8±1.4）分比（8.6±2.6）分,F=8.927]均低于同组治疗前（P〈0.01）,治疗组治疗后14、28d的OABSS量表评分低于对照组（t值分别为4.668、15.678,P值均＆lt;0.01）;治疗组疼痛症状评分[（5.9±1.9）分、（2.7±1.1）分比（9.5±2.3）分,F=108.819]低于同组治疗前（P〈0.01）,治疗组治疗后14、28d疼痛症状评分低于对照组（t值分别为6.342、14.812,P值均＆lt;0.01）;小腹不适评分治疗组[（1.9±1.4）分、（1.1±1.0）分比（3.3±1.1）分,F=28.762]、对照组[（2.7±1.0）、（2.4±0.8）分比（3.4±1.2）分,F=12.103]均低于同组治疗前（P〈0.01）,治疗组治疗后14、28d小腹不适评分低于对照组（t值分别为2.521、5.041,P〈0.05或P〈0.01）.结论 苓芍枣仁配方颗粒可明显降低女性OAB患者OABSS评分、疼痛症状评分、小腹不适症状评分,改善临床症状.

Objective To evaluate the effectiveness of Lingshao-Zaoren granule in the treatment of female overactive bladder. Methods A total of 60 female OAB patients who met the inclusion criteria were randomly divided into 2 groups, 30 cases in each group. The control group recieved the Tolterodine Tartrate Sustained Release Tablets and the Lingshao-Zaoren granule placebo, and the treatment group used the Tolterodine Tartrate Sustained Release Tablets and the true Lingshao-Zaoren granule treatment. Both groups were treated for 4 weeks. Overactive bladder symptom scale （OABSS） was used to determine the severity of OAB.Results After treatment 14,28 d,OABSS scores of the treatment group（5.3 ± 2.3,1.4 ± 1.2 vs.8.4 ± 2.4,F=137.209）,and control group（7.8 ± 1.9,6.8 ± 1.4 vs.8.6 ± 2.6,F=8.927）,were significantly lower than the baseline of each group respectively （P〈0.01）. Besides, OABSS scores of the treatment group after 14 and 28 d were significantly lower than the control group （t=4.668, 15.678, P〈0.01）. The pain scores （5.9 ± 1.9, 2.7 ± 1.1 vs.9.5 ±2.3,F=108.819）of treatment group at 14 and 28 d were significantly lower than the baseline（P〈0.01）;and the pain scores of treatment group at 14 and 28 d were significantly lower than the control group （t=6.342, 14.812,P〈0.01）.The lower abdomen discomfort scores at 14,28 d in treatment group（1.9 ± 1.4,1.1 ± 1.0 vs. 3.3 ±1.1,F=28.762）,and control group（2.7 ±1.0,2.4 ±0.8 vs.3.4 ±1.2,F=12.103）were significantly lower than the baseline of each group （P〈0.01）; and the abdominal discomfort scores of treatment group at 14, 28 d were significantly lower than the control group （t=2.521, 5.041, P〈0.05 or P〈0.01）. Conclusions The Lingshao-Zaoren granule could decrease OABSS score,pain score,abdominal discomfort symptoms,improve clinical symptoms of the female patients with OAB.