缩泉胶囊治疗小儿原发性单纯性遗尿症随机双盲多中心临床试验  

Randomized Double-Blind Multicenter Clinical Trial on Pediatric Primary Simple Nocturia by Suoquan Capsule (缩泉胶囊)

作　　者：程燕[1] 谭泽云 易小兰 张建伟 黄宇虹[1] 刘东文 张炜 杜永刚 刘德新[5] 洪丽军 冯自威 张广舫[8] 

机构地区：[1]天津中医药大学第二附属医院,天津300000 [2]湖南汉森医药研究有限公司,湖南长沙410000 [3]南阳市中医院,河南南阳473000 [4]长治市人民医院,山西长治046000 [5]柳州市中医院,广西柳州545000 [6]牡丹江市中医医院,黑龙江牡丹江157000 [7]漯河市中医院,河南漯河462000 [8]廊坊市中医医院,河北廊坊065000

出　　处：《中医药导报》2017年第5期57-60,共4页Guiding Journal of Traditional Chinese Medicine and Pharmacy

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。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 was 61.7% 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.

关 键 词：小儿原发性单纯性遗尿症 肾气虚 缩泉胶囊 遗尿停胶囊 随机对照试验 双盲法 

分 类 号：R272[医药卫生—中医儿科学]