【摘要】 目的:评价缩泉胶囊治疗小儿原发性单纯性遗尿症(肾气虚证)的有效性和安全性。方法:采用随机、双盲双模拟、阳性药平行对照、多中心临床试验设计。共纳入192例受试者,随机分为试验组(缩泉胶囊+遗尿停胶囊模拟剂)和对照组(遗尿停胶囊+缩泉胶囊模拟剂),疗程8周。结果:(1)遗尿次数改善疗效:试验组完全改善率为12.5%,部分改善率为78.5%;对照组完全改善率为10.6%,部分改善率为61.7%;两组比较,差异均有统计学意义(P<0.05)。(2)中医证候有效率:试验组临床痊愈率为32.0%,显效率为38.9%;对照组临床痊愈率为12.8%,显效率为38.3%,两组比较,差异均有统计学意义(P<0.05)。且试验过程中未见不良事件。结论:缩泉胶囊治疗小儿原发性单纯性遗尿症疗效确切,未发现毒副作用。更多还原

【Abstract】 Objective: To evaluate the efficacy and safety of Suoquan Capsule(SQC) on pediatric primary simple nocturia with kidney deficiency syndrome. Methods: A randomized, double-blind, double simulation, positive drug parallel controlled, multicenter clinical trial was designed. A total of 192 patients were randomized into treatment group [treated with SQC and Simulated agent of Yi’naioting Capsule( 遗尿停胶囊)] and control group(treaded with Yi’naioting Capsule and Simulated agent of SQC), treatment for 8 weeks. Results:(1)The frequency of enuresis improve curative effect: The fully improvement rate 12.5% and part of the improvement rate was 78.5% in treatment group; The fully improvement rate 10.6% and part of the improvement rate was61.7% in control group; the difference between the two groups was statistically significant(P<0.05).(2)TCM Syndromes of efficiency: The clinical cure rate was 32.0% and markedly effective rate was 38.9% in treatment group; The clinical cure rate was 12.8% and markedly effective rate was 38.3% in treatment group; the difference between the two groups was statistically significant(P<0.05). There were no adverse events occurred during the test. Conclusion: SQC showed curative effect on pediatric primary simple nocturia(kidney deficiency syndrome), without obvious side effects.更多还原