小儿遗尿颗粒与盐酸甲氯芬酯胶囊对照治疗肾气不足型小儿遗尿症Ⅲ期临床试验

目的 评价小儿遗尿颗粒治疗肾气不足型小儿遗尿症的有效性与安全性。方法 采用分层区组随机、双盲双模拟、平行对照、多中心试验的方法进行临床研究。结果 小儿遗尿颗粒对治疗肾气不足型小儿遗尿症的临床痊愈率26.33 %,显效率50.30 %, 总有效率为76.63 %;对照组的临床痊愈率为21.30 %, 显效率50.00 %, 总有效率为71.30 %。非劣效检验结果显示, 试验组疗效不劣于对照组。对中医证候的临床痊愈率20.71 %, 显效率41.42 %, 总有效率为62.13 %;对照组的临床痊愈率为16.67 %, 显效率37.04 %, 总有效率为53.71 %。两组比较, 差异无统计学意义。两组遗尿次数、睡眠深度等单项症状与异常舌脉的治疗前后组内比较, 差异均有统计学意义。本试验对照组发生ALT 疗后异转和异常加重各1 例, 占1.75 %。结论 小儿遗尿颗粒对肾气不足型小儿遗尿症的治疗效果不劣于对照药盐酸甲氯芬酯胶囊, 且临床应用未见不良反应发生。

Phase Ⅲ clinical trial of Xiaoeryiniao Granule on children with enuresis of kidney-qi deficiency in comparing with meclofenoxate hydrochlorid capsules

AIM: To evaluate the effect and safety of Xiaoeryiniao Granule in the treatment of children with enuresis of kidney-qi deficiency. METHODS: A stratified-block randomized, double-blind, doubledummy, parallel-controlled, multicenter trial was designed for clinical study. RESULTS: In treating the syndrome of kidney-qi deficiency of enuresis, the clinical cure rates, the markedly effective rates and the total effective rates in the two groups were 26.33 % vs 21.30 %, 50.30 % vs 50.00 % and 76.63 % vs 71.30 %, respectively. By non-inferior test, the results suggested that the treatment group was non-inferior to the control group in clinical curative effect. Improvements of Chinese mealicine symptoms of two groups were as follows: cure rates, the markedly effective rates and the total effective rates were 20.71 % vs 16.67 %, 41.42 % vs 37.04 % and 62.13 % vs 53.71 % respectively, there was no significant difference between the two groups (P >0.05). But there were significant differences between pretreatment and post-treatment in intra-group comparison on single symptoms, such as times of enuresis, depth of sleep and abnormal tongue and pulse display. And two patients in the control group shown abnormal alanine aminotransferase(ALT) levels (aggravation after treatment with an occurance rate of 1. 75 %). CONCLUSION: Xiaoeryiniao Granules on children enuresis of kidney-qi deficiency not only non-inferior to the control group in clinical curative effect, but also has better safety.