Macimorelin (aezs - 130)刺激生长激素(GH)测试:验证小说口腔刺激试验的诊断成人GH缺乏。

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加西亚JM, Swerdloff R,王C,凯尔M, Kipnes M,开帐单的BM,库克D,袁KC, Bonert V,强加于人,Molitch我,梅里厄姆GR

Macimorelin (aezs - 130)刺激生长激素(GH)测试:验证小说口腔刺激试验的诊断成人GH缺乏。

中国性金属底座。2013年6月,98 (6):2422 - 9。doi: 10.1210 / jc.2013 - 1157。Epub 2013年4月4。

PubMed ID

23559086 (在PubMed

]

文摘

背景:在缺乏panhypopituitarism和低血清IGF-I水平,成人GH缺乏的诊断(AGHD)需要与GH刺激测试确认。Macimorelin是一本小说,口服激素刺激GH分泌的模仿。目的:研究的目的是确定在AGHD macimorelin诊断疗效和安全性。设计:这是一个多中心开放研究比较口语的诊断准确性与精氨酸+ GHRH macimorelin AGHD病人和健康,匹配控制。43 AGHD患者和10控制进行测试后,GHRH模拟Geref诊断[GHRH(1至29)氨基]在美国成为不可用。这项研究是在测试完成10个额外AGHD患者和38控制macimorelin孤单。主要结果测量:GH峰值接受者操作特征曲线下面积macimorelin后测量。结果:50 AGHD主题和48控制进行评估。GH峰值水平AGHD macimorelin后病人和对照组2.36 + / - 5.69和17.71 + / - 19.11 ng / mL, (P分别<。)。macimorelin,接受者操作特征分析了最优GH削减2.7 ng / mL,敏感性为82%,特异性92%,13%的误分类率。 For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m(2)) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = -0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported. CONCLUSION: Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test.

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药物

Macimorelin