五灵颗粒治疗小儿多发性抽动症肝亢风动，痰火上扰证的临床研究

发布时间：2018-12-07 20:40

【摘要】：小儿多发性抽动症是儿科较常见神经精神系统疾病,现代医学对其发病原因不明确,西药治疗副作用大、易复发。中医临床上本病以肝亢风动,痰火上扰证为多见,中医药对于本病的治疗具有疗效稳定及副作用小等特点,有着广阔的前景。目的：对五灵颗粒治疗小儿多发性抽动症(肝亢风动,痰火上扰证)疗效和安全性作进一步评价,并初步探讨其作用机制。方法：临床研究收集江苏省中医院等6所医院门诊病例。600余例诊断为小儿多发性抽动症(肝亢风动,痰火上扰证),收集相关临床资料,根据随机、双盲等原则,对其分别予以口服五灵颗粒、泰比利及安慰剂治疗。以评价五灵颗粒对于小儿多发性抽动症的治疗效果及其安全性。结果：1.治疗后五灵颗粒在改善抽动症状方面疗效优于安慰剂组有效,总有效率80.20%,有显著差异。 2.治疗后五灵颗粒在改善抽动症状方面较泰比利未见明显差异。 3.治疗后五灵颗粒对改善中医症状较其它两组作用明显。 4.本次临床试验无不良事件报告,未观察到试验药物对心肝肾功能血液系统有异常影响报告。结论：五灵颗粒对于治疗小儿多发性抽动症在改善抽动症状方面较安慰剂有显著疗效,在改善抽动症状方面较泰比利未见明显差异,在改善相关中医症状方面较安慰剂和泰比利有明显优势,并且无明显不良反应。在治疗小儿多发性抽动症方面具有临床实用价值。
[Abstract]:Pediatric multiple tic syndrome is a common neuropsychiatric disease in pediatrics. The causes of the disease are not clear in modern medicine, and the side effects of western medicine are big and easy to recur. In clinic, this disease is characterized by hyperactivity of the liver and disturbance of phlegm and fire. Chinese medicine has the characteristics of stable curative effect and small side effects, and has a broad prospect. Objective: to evaluate the efficacy and safety of Wuling granule in the treatment of children with multiple tic syndrome (hyperactivity of the liver, phlegm and fire disturbance), and to explore its mechanism. Methods: clinical data were collected from 6 outpatients of 6 hospitals, including Jiangsu traditional Chinese Medicine Hospital. More than 600 cases were diagnosed with multiple tic syndrome (hyperactivity of the liver, phlegm and fire disturbance), and the related clinical data were collected according to the principles of randomness, double blindness and so on. They were treated with oral Wuling granule, tebureb and placebo, respectively. To evaluate the efficacy and safety of Wuling granule in the treatment of children with multiple tic syndrome. Results: 1. After treatment, Wuling granule was more effective than placebo group in improving tic symptoms, the total effective rate was 80.20 and there was significant difference. 2. After treatment, Wuling granule had no significant difference in improving tic symptoms as compared with that of terbureb. 3. The effect of Wuling granule on improving TCM symptoms was more obvious than that of the other two groups. 4. No adverse events were reported in the clinical trial, and no abnormal effects of the drugs on the heart, liver and kidney function and blood system were observed. Conclusion: Wuling granule is more effective than placebo in the treatment of children with multiple tic syndrome, but there is no significant difference in improving tic symptoms. There were significant advantages over placebo and terburide in improving the symptoms of traditional Chinese medicine, and there were no significant adverse reactions. In the treatment of children with multiple tic disorder has clinical practical value.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R272

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