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首页> 外文期刊>BMC Pediatrics >Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial
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Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial

机译：低剂量可乐定对慢性疲劳青少年心血管和自主神经变量的影响：一项随机对照试验

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Chronic Fatigue Syndrome (CFS) is a common and disabling condition in adolescence with few treatment options. A central feature of CFS is orthostatic intolerance and abnormal autonomic cardiovascular control characterized by sympathetic predominance. We hypothesized that symptoms as well as the underlying pathophysiology might improve by treatment with the alpha2A–adrenoceptor agonist clonidine. A total of 176 adolescent CFS patients (12–18 years) were assessed for eligibility at a single referral center recruiting nation-wide. Patients were randomized 1:1 by a computer system and started treatment with clonidine capsules (25?μg or 50?μg twice daily, respectively, for body weight below/above 35?kg) or placebo capsules for 9?weeks. Double-blinding was provided. Data were collected from March 2010 until October 2012 as part of The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL). Effect of clonidine intervention was assessed by general linear models in intention-to-treat analyses, including baseline values as covariates in the model. A total of 120 patients (clonidine group n?=?60, placebo group n?=?60) were enrolled and started treatment. There were 14 drop-outs (5 in the clonidine group, 9 in the placebo group) during the intervention period. At 8?weeks, the clonidine group had lower plasma norepinephrine (difference?=?205 pmol/L, p?=?0.05) and urine norepinephrine/creatinine ratio (difference?=?3.9?nmol/mmol, p?=?0.002). During supine rest, the clonidine group had higher heart rate variability in the low-frequency range (LF-HRV, absolute units) (ratio?=?1.4, p?=?0.007) as well as higher standard deviation of all RR-intervals (SDNN) (difference?=?12.0?ms, p?=?0.05); during 20° head-up tilt there were no statistical differences in any cardiovascular variable. Symptoms of orthostatic intolerance did not change during the intervention period. Low-dose clonidine reduces catecholamine levels in adolescent CFS, but the effects on autonomic cardiovascular control are sparse. Clonidine does not improve symptoms of orthostatic intolerance. Clinical Trials ID: NCT01040429 , date of registration 12/28/2009.
机译：慢性疲劳综合症（CFS）是青春期常见的致残疾病，几乎没有治疗选择。 CFS的主要特征是体位性不耐受和以交感神经为主导的异常自主性心血管控制。我们假设通过使用α2A-肾上腺素受体激动剂可乐定治疗可能会改善症状以及潜在的病理生理。在全国范围内招募的单个转诊中心评估了总共176名CFS青少年（12至18岁）的资格。患者通过计算机系统按1：1的比例随机分组，并开始用可乐定胶囊（体重分别低于或超过35？kg每天两次，每次25？μg或50？μg）或安慰剂胶囊治疗9周。提供了双盲。数据收集自2010年3月至2012年10月，作为《挪威青少年慢性疲劳综合症研究：病理生理学和干预试验》（NorCAPITAL）的一部分。在意向性治疗分析中，一般线性模型评估了可乐定干预的效果，包括基线值作为模型中的协变量。共入组120例患者（可乐定组n≥60，安慰剂组n≥60）并开始治疗。在干预期间有14例辍学（可乐定组5例，安慰剂组9例）。在第8周时，可乐定组的血浆去甲肾上腺素较低（差异≥205pmol / L，p≥0.05），尿液去甲肾上腺素/肌酐比值较低（差异≥3.9nmol/ mmol，ρ≥0.002）。 ）。仰卧休息期间，可乐定组在低频范围内（LF-HRV，绝对单位）具有较高的心率变异性（比率？=？1.4，p？=？0.007），并且所有RR间隔的标准差均较高。 （SDNN）（差值＝12.0μms，p ＝ 0.05）。在20°抬头向上倾斜期间，任何心血管变量均无统计学差异。在干预期间，体位不耐受的症状没有改变。低剂量可乐定可降低青少年CFS中的儿茶酚胺水平，但对自主性心血管控制的影响却很少。可乐定不能改善体位不耐受的症状。临床试验ID：NCT01040429，注册日期：2009年12月28日。

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