Pescovitz O H, Tan E
Department of Pediatrics, University of Minnesota, Minneapolis.
Lancet. 1988 Oct 15;2(8616):874-7. doi: 10.1016/s0140-6736(88)92472-5.
Twelve short (more than two standard deviations below the mean height for age), prepubertal children (ten boys, two girls) who had a normal peak growth hormone (GH) response to provocative stimulation with clonidine (more than 10 ng/ml) were enrolled in a double-blind, placebo-controlled, crossover study of the effects of a single, nightly dose of clonidine (0.1 mg/m2 by mouth). The children's mean age was 7.2 years (range 3.6-10.5 years). The results of 6 months of clonidine therapy were compared with those of 6 months of placebo. Clonidine therapy resulted in no significant difference in height standard deviation score, growth velocity, bone age, 24 h integrated GH concentration, peak GH response to clonidine stimulation, levels of insulin-like growth factor 1, or predicted height by the RWT method. In contrast to other studies, this study shows no sustained increases in GH production or in improved growth velocity with long-term administration of a single daily dose of clonidine. Furthermore, this study demonstrates the need for well-designed, placebo-controlled trials in paediatrics.
12名身材矮小(身高低于年龄别平均身高两个标准差以上)的青春期前儿童(10名男孩,2名女孩),他们对可乐定激发刺激(剂量大于10 ng/ml)的生长激素(GH)峰值反应正常,被纳入一项双盲、安慰剂对照、交叉研究,以评估每晚单次口服可乐定(0.1 mg/m²)的效果。这些儿童的平均年龄为7.2岁(范围3.6 - 10.5岁)。将6个月的可乐定治疗结果与6个月的安慰剂治疗结果进行比较。可乐定治疗在身高标准差评分、生长速度、骨龄、24小时整合GH浓度、可乐定刺激后的GH峰值反应、胰岛素样生长因子1水平或RWT法预测身高方面均未产生显著差异。与其他研究不同,本研究表明长期每日单次服用可乐定不会使GH分泌持续增加或生长速度改善。此外,本研究证明了儿科需要设计良好的安慰剂对照试验。