Hospital Ángeles Interlomas and Hospital Español, Mexico City, Mexico.
Hospital Español, Mexico City, Mexico.
J Endocrinol Invest. 2020 Oct;43(10):1447-1452. doi: 10.1007/s40618-020-01218-4. Epub 2020 Apr 1.
Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH: growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS).
ECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs.
This study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age: 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline: - 2.17 ± 0.97): 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027).
Adherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™-naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.
评估生长激素（GH）的依从性具有挑战性。Easypod™ connect 设备可提供预设定剂量的重组人生长激素（r-hGH），并存储可与医疗保健提供者共享的依从性数字记录。我们根据 r-hGH 的批准儿科适应证评估了使用 Easypod™ 给药的 r-hGH 的依从性：生长激素缺乏症（GHD）、出生时胎龄较小（SGA）但未能实现追赶生长以及特纳综合征（TS）。
ECOS（NCT01555528）是一项多中心（24 个国家）、5 年、纵向、观察性研究，旨在评估通过 Easypod™ 电子注射装置开具的 r-hGH 治疗的国家特定依从性。主要终点是每年的依从性。次要终点是身高速度、身高速度标准差评分（SDS）、身高、身高 SDS 和 IGF-1 浓度。临床和生长数据来自病历，依从性来自 Easypod™ 日志。
本研究纳入了 147 名来自墨西哥的 Easypod™ 初治儿童，在 3 年内进行评估（平均年龄：9.96±3.41 岁，56.8%为男孩，基线时身高 SDS 平均值：-2.17±0.97）：118 名 GHD、24 名 SGA 和 5 名 TS。共有 105 名（71.4%）患者为 GH 初治患者。治疗第一年总体中位数依从性>90%，第三年>80%。r-hGH 适应证或 GH 初治或经验丰富患者之间的依从性无差异。在 1 年随访时，身高 SDS 的平均变化为 0.57±0.34，而身高速度 SDS 的平均变化为 2.85±2.51。共有 84.7%的患者在 1 年随访时 IGF-1 浓度正常。依从性与身高 SDS 的变化相关（r=0.239，p=0.005）和身高速度 SDS（r=0.194，p=0.027）。
在 GHD、SGA 和 TS Easypod™ 初治墨西哥患者中，使用 Easypod™ 设备的依从率很高且随时间保持稳定。高依从性与更好的结果相关。Easypod™ 有助于医生监测 r-hGH 的依从性。
