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Ningdong granule: a complementary and alternative therapy in the treatment of attention deficit/hyperactivity disorder.

机译:宁东冲剂:一种补充和替代疗法,用于治疗注意力不足/多动障碍。

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BACKGROUND: Attention deficit/hyperactivity disorder (ADHD) is a common neurobehavioral and neuropsychiatric disorder in school-age children, and recent studies provide evidence implicating the metabolic abnormalities of dopamine (DA) for its pathophysiology. Methylphenidate, a kind of psychostimulant, is widely used in the treatment of ADHD, but some patients do not respond to it or cannot bear its side effects. As a traditional Chinese medicine preparation, Ningdong granule (NDG) has been used in the treatment of ADHD for several years in China. However, a systematical pharmacological study on its safety and mechanism still remains obscure. OBJECTIVE: This paper aims to evaluate the efficiency, safety, and possible mechanism of NDG on ADHD children compared to methylphenidate. METHODS: Seventy-two ADHD children were recruited to perform an 8-week, randomized, methylphenidate-controlled, doubled-blinded trial. The subjects were equally assigned to two groups receiving either NDG 5 mg/kg/day or methylphenidate 1 mg/kg/day for 8 weeks. The efficiency was assessed by the Teacher and Parent ADHD Rating Scales every 2 weeks for a total of 8 weeks. The side effects were recorded during the study. Blood, urine, and stool routine samples, liver and renal function test, and DA and homovanillic acid (HVA) concentration in sera were tested at the beginning and end of the trial. RESULTS: NDG ameliorated ADHD symptoms after an 8-week medication with fewer side effects compared to methylphenidate (P < 0.05). The result also showed NDG to be safe and tolerable for ADHD children as monitored by the blood, urine, and stool analysis and liver and renal function for 8 weeks (P < 0.05). Moreover, the level of HVA in sera increased in NDG-treated group (P < 0.05), while the content of DA had no significant change during the study. An analysis of Pearson correlation coefficients also showed that the increased content of HVA in sera was associated with the improved scores of Teacher and Parent ADHD Rating Scales. CONCLUSIONS: Compared to methylphenidate, NDG is effective and safe for ADHD children in the short term, increases the HVA concentration in sera to regulate DA metabolism, and promises to be an alternative medication, safely and effectively.
机译:背景:注意缺陷/多动障碍(ADHD)是学龄儿童中常见的神经行为和神经精神病性疾病,最近的研究提供了证据证明多巴胺(DA)的代谢异常与其病理生理有关。哌醋甲酯是一种精神刺激药,被广泛用于治疗多动症,但有些患者对此无反应或无法承受其副作用。作为一种中药制剂,宁东颗粒(NDG)在中国已被用于治疗多动症。然而,对其安全性和机理的系统的药理研究仍然不清楚。目的:本研究旨在评估与哌醋甲酯相比,ADG儿童NDG的有效性,安全性和可能的​​机制。方法:招募了72名ADHD儿童进行为期8周的随机,哌醋甲酯对照,双盲试验。将受试者平均分为两组,分别接受NDG 5 mg / kg /天或哌醋甲酯1 mg / kg /天,共8周。每2周通过教师和家长ADHD评分量表评估效率,共8周。在研究期间记录了副作用。在试验开始和结束时,对血液,尿液和粪便的常规样本,肝和肾功能测试以及血清中的DA和高香草酸(HVA)浓度进行了测试。结果:与哌醋甲酯相比,NGD减轻了8周用药后的ADHD症状,副作用更少(P <0.05)。结果还显示,通过血液,尿液和粪便分析以及肝和肾功能监测8周,NDG对于ADHD儿童是安全且可耐受的(P <0.05)。此外,NDG治疗组血清HVA水平升高(P <0.05),而DA含量在研究期间无明显变化。对皮尔森相关系数的分析还显示,血清中HVA含量的增加与教师和父母ADHD评分量表的得分提高有关。结论:与哌醋甲酯相比,NDG在短期内对多动症儿童有效且安全,可增加血清中HVA浓度以调节DA代谢,并有望成为安全有效的替代药物。

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