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当前用于治疗生长激素缺乏症和未满足需求的成人的重组人生长激素治疗的安全性。

Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs.

机构信息

Department Molecular Medicine and Surgery, Karolinska institute and Department of Endocrinology, Karolinska University Hospital , Stockholm, Sweden.

Clinical Sciences and Community Health, Fondazione Istituto Di Ricovero E Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico , Milano, Italy.

出版信息

Expert Opin Drug Saf. 2020 Dec;19(12):1539-1548. doi: 10.1080/14740338.2020.1839410. Epub 2020 Oct 27.

Abstract

INTRODUCTION

Growth hormone (GH) deficiency (GHD) in adults is characterized by abnormal body composition, unfavorable cardiovascular risk factors, and poor quality of life. The diagnosis is made within appropriate clinical settings and according to established guidelines. Numerous studies have shown that GH treatment improves body composition, cardiovascular risk factors, physical capacity, and quality of life while issues on safety, in particular long-term safety, remain.

AREAS COVERED

Short- and long-term safety of GH replacement in adults with GHD.

EXPERT OPINION

Adults with GHD are an inhomogeneous group of patients and GH replacement requires individual considerations. Most adverse effects are mild and transient and related to fluid retention and GH dose. In patients without comorbidities long-term GH treatment is safe and development of diabetes, cardiovascular disease, or tumors are not increased. Furthermore, mortality is not increased. Patients with risk factors should be identified before GH treatment is initiated and an optimal balance between benefit and risk established. Studies with sufficient duration and power to identify the development of cardiovascular diseases and cancers are still awaited. Effective management of comorbidities can be expected to decrease morbidity and mortality and improve quality of life. Studies with long-acting GH formulations are ongoing and available data indicate similar effects and short-time safety.

摘要

简介

成年人生长激素缺乏症(GHD)的特征是身体成分异常、心血管危险因素不利和生活质量差。诊断是在适当的临床环境中根据既定的指南进行的。许多研究表明,GH 治疗可改善身体成分、心血管危险因素、身体能力和生活质量,但安全性问题,特别是长期安全性问题仍然存在。

涵盖领域

GHD 成年人中 GH 替代的短期和长期安全性。

专家意见

GHD 成年人是一组异质性患者,GH 替代需要个体化考虑。大多数不良反应轻微且短暂,与液体潴留和 GH 剂量有关。在没有合并症的患者中,长期 GH 治疗是安全的,不会增加糖尿病、心血管疾病或肿瘤的发生。此外,死亡率也没有增加。在开始 GH 治疗之前,应识别出有风险的患者,并在获益和风险之间建立最佳平衡。仍在等待具有足够持续时间和能力来确定心血管疾病和癌症发展的研究。有效管理合并症可降低发病率和死亡率并提高生活质量。长效 GH 制剂的研究正在进行中,现有数据表明其具有相似的效果和短期安全性。

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