Department of Endocrinology, Sahlgrenska University Hospital & Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, SE-413 45, Gothenburg, Sweden.
Department of Endocrinology and Reproductive Medicine, Center for Rare Endocrine and Gynecological Disorders, Sorbonne Université, Assistance Publique Hopitaux de Paris, Paris, France.
J Clin Endocrinol Metab. 2022 Jun 16;107(7):1906-1919. doi: 10.1210/clinem/dgac199.
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.
需要了解生长激素（GH）替代治疗在成人生长激素缺乏症（GHD）患者中的长期安全性数据。
我们旨在评估 KIMS（辉瑞国际代谢数据库）全队列中 GH 的安全性。
这项全球性、观察性 KIMS 研究纳入了确诊为 GHD 的成人和青少年患者。患者接受 GH（健豪宁[生长激素]；辉瑞公司，纽约）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（如血脂谱、血糖）数据。
分析了 15809 例接受 GH 治疗的患者队列（平均随访 5.3 年）。51.2%的患者报告了 AE（18.8%为与治疗相关的 AE）。年龄较大、因垂体/下丘脑肿瘤或成人起病的 GHD 导致 GHD 的患者中，AE 发生率较高。经年龄、性别、病因和随访时间校正的 AE 发生率分析显示，AE 发生率与 GH 剂量无相关性。共报告了 606 例死亡（3.8%）（146 例由肿瘤引起，71 例由心脏/血管疾病引起，48 例由脑血管疾病引起）。总体而言，新发癌症发病率与普通人群相当（标准化发病比 0.92；95%CI，0.83-1.01）。特发性/先天性 GHD 患者新发癌症风险显著降低（0.64；0.43-0.91），而垂体/下丘脑肿瘤或其他病因患者与普通人群相似。成人起病或儿童起病的 GHD 均与新发癌症风险增加无关。血脂/空腹血糖水平观察到中性效应。
这些最终的 KIMS 队列数据支持在常规临床实践中，根据处方使用 GH 替代治疗成人 GHD 的安全性。
