Endocrinology and Diabetology Unit, Medical Sciences Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
Ther Adv Endocrinol Metab. 2012 Jun;3(3):85-91. doi: 10.1177/2042018812444152.
To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope(®)) for the treatment of adult patients with growth hormone deficiency (GHD).
PATRO Adults is an observational, multicentre, open, longitudinal, noninterventional study being conducted in hospitals and specialized endocrinology clinics across several European countries. The primary objective is to assess the safety and efficacy of Omnitrope(®) in adults treated in routine clinical practice. Eligible patients are male or female adults who are receiving treatment with Omnitrope(®) and who have provided informed consent. Patients who have been treated with another human growth hormone (hGH) product before starting Omnitrope(®) therapy will also be eligible for inclusion. Efficacy assessments will be based on the analysis of the following: insulin-like growth factor-1 levels within age- and gender-adjusted normal ranges; anthropometric measures (weight, waist circumference, total fat mass, lean body mass, total body water); bone mineral density; lipids; effects on cardiovascular risk factors such as glucose metabolism, blood pressure and inflammatory markers (e.g. C-reactive protein); and quality of life. All adverse events will be monitored and recorded. Particular emphasis will be placed on long-term safety, the recording of malignancies, the occurrence and clinical impact of antirecombinant hGH antibodies, the incidence, severity and duration of hyperglycaemia, and the development of diabetes during treatment with Omnitrope(®).
PATRO Adults is a large, long-term, postmarketing surveillance study that will extend the safety database for Omnitrope(®), as well as contributing to the available data for all recombinant hGH products. Of particular interest, the study will provide important data on the impact of long-term GH replacement therapy on the development of diabetes mellitus, the recurrence/regrowth of hypothalamic-pituitary tumours, and de novo malignancy or recurrence of other (non-hypothalamic-pituitary) tumours.
描述 PATRO Adults 的原理和设计，这是一项关于生长激素缺乏症（GHD）成年患者使用生长激素（Omnitrope（®））治疗的长期疗效和安全性的上市后监测研究。
PATRO Adults 是一项在多个欧洲国家的医院和专门的内分泌科诊所进行的观察性、多中心、开放、纵向、非干预性研究。主要目的是评估 Omnitrope（®）在常规临床实践中治疗成人的安全性和疗效。符合条件的患者是正在接受 Omnitrope（®）治疗并已提供知情同意的男性或女性成年人。在开始 Omnitrope（®）治疗前曾接受过另一种人类生长激素（hGH）产品治疗的患者也有资格入选。疗效评估将基于以下方面的分析：在年龄和性别调整的正常范围内的胰岛素样生长因子-1 水平；人体测量学指标（体重、腰围、总脂肪量、瘦体重、总体水）；骨密度；血脂；对葡萄糖代谢、血压和炎症标志物（如 C 反应蛋白）等心血管危险因素的影响；以及生活质量。所有不良事件都将被监测和记录。特别关注长期安全性、恶性肿瘤的发生、抗重组 hGH 抗体的发生和临床影响、高血糖的发生率、严重程度和持续时间，以及在使用 Omnitrope（®）治疗期间糖尿病的发生。
PATRO Adults 是一项大型、长期的上市后监测研究，将扩展 Omnitrope（®）的安全性数据库，并为所有重组 hGH 产品提供可用数据。特别感兴趣的是，该研究将提供重要数据，说明长期 GH 替代治疗对糖尿病的发展、下丘脑-垂体肿瘤的复发/生长以及新发恶性肿瘤或其他（非下丘脑-垂体）肿瘤的复发的影响。
