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
Guiding Journal of Traditional Chinese Medicine and Pharmacology(2017)
Abstract
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.
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Key words
pediatric primary simple nocturia,kidney deficiency,suoquan capsule,yi'naioting capsule,randomized controlled trial,double blind method
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