小儿黄龙颗粒治疗注意缺陷多动障碍随机、双盲双模拟、多中心临床研究

A Randomized,Double Blind,Multicenter Clinical Research of Pediatric Huanglong Granule Treating Attention Deficit Hyperactivity Disorder

目的： 评价小儿黄龙颗粒治疗注意力缺陷多动障碍（ADHD）中医辨证属于阴虚阳亢证的有效性和安全性。 方法： 采用随机、双盲双模拟、阳性对照药静灵口服液平行对照、多中心临床试验设计，共计观察完全符合纳入标准的中医辨证属于阴虚阳亢证的ADHD小儿299例，其中试验组224例，对照组75例。试验组予小儿黄龙颗粒，6-9岁1次1袋，10-14岁1次2袋，1日2次，同时服用静灵口服液模拟剂；对照组予静灵口服液，6-9岁1次1支，10-14岁1次2支，1日2次，同时服用小儿黄龙颗粒模拟剂，疗程6周。入组前、服药后第3周，服药后第6周对SNAP-4量表评分，Conner氏量表多动指数、中医证候评分进行比较。 结果： 疾病疗效试验组控显率为52.68%，总有效率为83.48%；对照组控显率为37.34%，总有效率为66.67%；中医证候疗效试验组控显率为54.91%，总有效率为87.95%；对照组控显率为38.67%，总有效率为74.67%。两组疾病及中医证候疗效有效率差异均具显著性统计学意义（P 〈 0.01），试验组优于对照组；两组主要疗效指标SNAP-4量表评分、Conner氏量表多动指数治疗6周后经t检验表明两组差异有统计学意义（P 〈 0.05），中医证候积分治疗6周后经t检验表明两组差异有显著性统计学意义（P 〈 0.01），试验组优于对照组；两组依从性良好，差异无统计学意义。 结论： 小儿黄龙颗粒具有滋阴潜阳、安神定志的功效。用于注意缺陷多动障碍中医辨证属阴虚阳亢证者，能显著改善多动不宁，神思涣散，多言多语，性急易怒，盗汗，口干咽燥，手足心热，失眠多梦等中医症状，具有较好的临床效果和安全性，且临床疗效优于阳性对照药静灵口服液。

Objective： To evaluate the efficacy and safety of Pediatric Huanglong granule treating of attention deficit hyperactivity disorder （ADHD）,which belongs to hyperactivity of yang due to yin deficiency in traditional Chinese medicine（TCM）. Method： Adopt a randomized, double blind, double modeling, parallel controlled with Jing Ling oral liquid as positive control medicine, multicenter clinical trial design,for a total observation completely accords with the inclusion criteria of children with ADHD belongs to hyperactivity of yang due to yin deficiency in TCM syndrome differentiation 299 cases, including test group 224 cases, control group 75 cases.Test group take Pediatric Huanglong granule according to the method of children aged 6 to 9 years take a bag once, 10 to 14 years take two bags once, two times daily, while taking the simulation agent of Jingling oral liquid ; control group take Jingling oral liquid according to the method of children aged 6 to 9 years take one once, 10 to 14 years take two once, two times daily, while taking the simulation agent of pediatric Huanglong granule,for 6 weeks. Compare the SNAP - 4 rating scale, conner scale hyperactivity index and TCM syndrome scoring before into the groups and after taking the drug 3 weeks and 6 weeks. Result： Curative effect of the disease：the control effective rate of the test group was 52.68%, the total effective rate was 83.48%; the control effective rate of the control group was 37.34%, the total effective rate was 66.67%. Curative effect of TCM syndromes：the control effective rate of test group was 54.91%, the total effective rate was 87.95%; the control effective rate of control group was 38.67%, the total effective rate was 74.67%.The diseases and TCM syndromes curative effect difference of two groups has statistical significance （P〈0.01）, the test group were better than the control group.The primary therapeutic effect index of two groups：SNAP-4 rating scale, conner scale hyperactivity index were tested by t-test after 6 weeks of treatment. The result showed that the difference of two groups was statistical significance （P〈0.05）. The t-test result of TCM syndrome score after 6 weeks of treatment showed that there were statistical significance between the two groups （P〈0.01）, the test group were better than the control group. Patient compliance of two groups were both well,the difference was not statistically significant. Conclusion： Pediatric Huanglong granule has the efficacy of nourishing yin for suppressing hyperactive yang and calming the nerves. It uses for treating ADHD,which belongs to hyperactivity of yang due to yin deficiency in TCM, as it can significantly improve TCM syndrome such as hyperactivity restlessness, rhembasmus, loquacity, quick-tempered, night sweating, mouth and throat feeling dry, hand and foot and heart being prone to heat, insomnia and dreamful sleep,and so on. It has good clinical efficacy and safety, and its clinical curative effect is better than the positive control medicine Jingling oral liquid.