JCEM:儿童生长激素治疗的长期安全性

2021-02-13 MedSci原创 MedSci原创

生长激素(GH)治疗通常具有良好的安全性。近日,内分泌和代谢性疾病领域权威杂志Journal of Clinical Endocrinology & Metabolism上发表了一篇研究文章,

生长激素(GH)治疗通常具有良好的安全性。近日,内分泌和代谢性疾病领域权威杂志Journal of Clinical Endocrinology & Metabolism上发表了一篇研究文章,该研究旨在评估GH治疗在临床实践中的长期安全性。

研究人员从676家诊所收集了患者的数据,进行了两项多中心纵向观察性研究:NordiNet国际成果研究(2006-2016年,欧洲)和ANSWER计划(2002年-2016年,美国)。接受GH治疗的患儿根据诊断分为三个风险组。该研究的干预因素为每天GH治疗。该研究的主要结局指标为药物不良反应(ADR)、严重不良事件(SAE)和严重ADR的发生率(事件/1000名患者-年),及其与GH剂量之间的关系。

该研究共纳入了37702例患者(低危组别为68.4%,中危组别为27.5%,高危组别为4.1%)。低风险组包括小于胎龄儿(SGA; 20.7%)和非SGA儿童(例如GH缺乏症; 79.3%)。随着风险类别的增加,直至首次不良事件(AE)的平均GH剂量逐渐降低。在所有组别中,没有AE的患者接受的GH的平均剂量均高于AE>1的患者。在低风险组(分别为P=0.0029和P=0.0003)和非SGA亚组(分别为P=0.0022和P=0.0015)中,ADR和SAE发生率与GH剂量呈显著负相关。

由此可见,在任何风险组中,研究人员均未发现死亡风险或与GH剂量相关的AE发生率增加

原始出处:

Lars Sävendahl.et al.Long-term safety of growth hormone treatment in childhood: Two large observational studies NordiNet  IOS and ANSWER.JCEM.2021.https://doi.org/10.1210/clinem/dgab080

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    2021-06-01 achengzhao
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    2021-07-26 qinfeng

    生长激素

    0

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    2021-07-22 smallant2015
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    2021-02-15 6322400001

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