Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients.
Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients.
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生长激素缺乏症的成年人生长激素的长期安全性：159例GH治疗患者的概述。
DOI：
10.1210/clinem/dgac199
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发表时间：
2022-06-16
影响因子：
5.8
通讯作者：
Yuen, Kevin C. J.
中科院分区：
文献类型：
--
作者：
Johannsson, Gudmundur;Touraine, Philippe;Feldt-Rasmussen, Ulla;Pico, Antonio;Vila, Greisa;Mattsson, Anders F.;Carlsson, Martin;Korbonits, Marta;van Beek, Andre P.;Wajnrajch, Michael P.;Gomez, Roy;Yuen, Kevin C. J.
需要生长激素（GH）缺乏症（GHD）成人的生长激素（GH）替代的长期安全性数据。我们的目的是评估GH在整个KIMS（辉瑞国际代谢数据库）队列中的安全性。全球范围内的观察性KIMS研究包括确诊GHD的成人和青少年。患者接受GH（Genotropin [生长激素]; Pfizer，NY）治疗，并通过常规临床实践进行随访。收集不良事件（AE）和临床特征（如血脂、血糖）。分析了15809例GH治疗患者的队列（平均随访5.3年）。51.2%的患者报告了AE（18.8%与治疗相关）。年龄较大、患有垂体/下丘脑肿瘤所致GHD或成人发作GHD的患者的粗AE发生率较高。根据年龄、性别、病因和随访时间调整的AE发生率分析显示与GH剂量无关。共报告了606例死亡（3.8%）（146例死于肿瘤，71例死于心脏/血管疾病，48例死于脑血管疾病）。总体而言，新发癌症发生率与一般人群相当（标准发生率比0.92; 95% CI，0.83 - 1.01）。特发性/先天性GHD患者的新发癌症风险显著较低（0.64; 0.43 - 0.91），但与一般人群相比，垂体/下丘脑肿瘤或其他病因患者的新发癌症风险相似。无论是成人发病还是儿童发病GHD都与新发癌症风险增加无关。在血脂/空腹血糖水平中观察到中性效应。这些最终KIMS队列数据支持常规临床实践中规定的GHD成人长期GH替代治疗的安全性。
Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. The worldwide, observational KIMS study included adults and adolescents with confirmed GHD. Patients were treated with GH (Genotropin [somatropin]; Pfizer, NY) and followed through routine clinical practice. Adverse events (AEs) and clinical characteristics (eg, lipid profile, glucose) were collected. A cohort of 15 809 GH-treated patients were analyzed (mean follow-up of 5.3 years). AEs were reported in 51.2% of patients (treatment-related in 18.8%). Crude AE rate was higher in patients who were older, had GHD due to pituitary/hypothalamic tumors, or adult-onset GHD. AE rate analysis adjusted for age, gender, etiology, and follow-up time showed no correlation with GH dose. A total of 606 deaths (3.8%) were reported (146 by neoplasms, 71 by cardiac/vascular disorders, 48 by cerebrovascular disorders). Overall, de novo cancer incidence was comparable to that in the general population (standard incidence ratio 0.92; 95% CI, 0.83-1.01). De novo cancer risk was significantly lower in patients with idiopathic/congenital GHD (0.64; 0.43-0.91), but similar in those with pituitary/hypothalamic tumors or other etiologies versus the general population. Neither adult-onset nor childhood-onset GHD was associated with increased de novo cancer risks. Neutral effects were observed in lipids/fasting blood glucose levels. These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.
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DOI：
10.1210/jc.2012-2684
发表时间：
2013-03
期刊：
The Journal of clinical endocrinology and metabolism
影响因子：
--
作者：
Hartman ML;Xu R;Crowe BJ;Robison LL;Erfurth EM;Kleinberg DL;Zimmermann AG;Woodmansee WW;Cutler GB Jr;Chipman JJ;Melmed S;International HypoCCS Advisory Board
通讯作者：
International HypoCCS Advisory Board
影响因子：
5.8
作者：
Buchfelder, Michael;Kann, Peter Herbert;Nomikos, Panagiotis
通讯作者：
Nomikos, Panagiotis
影响因子：
5.8
作者：
Gotherstrom, G.;Bengtsson, B. -A.;Svensson, J.
通讯作者：
Svensson, J.
影响因子：
5.8
作者：
Child, Christopher J.;Zimmermann, Alan G.;Robison, Leslie L.
通讯作者：
Robison, Leslie L.
影响因子：
5.8
作者：
Hoybye, Charlotte;Ragnarsson, Oskar;Biller, Beverly M. K.
通讯作者：
Biller, Beverly M. K.