Mancini Antonio, Vergani Edoardo, Bruno Carmine, Palladino Andrea, Brunetti Alessandro
Operative Unit of Endocrinology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
Front Endocrinol (Lausanne). 2019 Jun 28;10:416. doi: 10.3389/fendo.2019.00416. eCollection 2019.
Non-compliance to recombinant human growth hormone (r-hGH) therapy in adult growth hormone deficiency (aGHD) is a major concern for endocrinologist, as it affects significantly efficacy outcomes. This 12-month observational study was aimed to assess adherence in GHD patients treated with r-hGH administered via Easypod, an electronic, fully automated injection device designed to track the time, date and dose administered. 65 patients receiving r-hGH therapy were included in the study and 32 completed the study. The primary endpoint, adherence to treatment, was calculated as the proportion of injections correctly administered during the observational period out of the expected total number of injections. Adherence, tracked by the Easypod, was evaluated at months 6 (V1) and 12 (V2) after baseline (V0). As secondary end-point, serum IGF-1 levels were also determined. The Easypod data showed a median adherence of 80% throughout the period V0-V2. Females are more compliant than males. Adherence levels are correlated to IGF-1 ones. Adherence is connected with therapy efficacy in aGHD. The injection-recording system and other characteristics of Easypod could enhance the ability of physicians to monitor adherence to r-hGH treatment, identifying non-compliant patients, thus enabling physicians to modify their management to maximize the benefits of the treatment.
成年人生长激素缺乏症(aGHD)患者对重组人生长激素(r-hGH)治疗的不依从性是内分泌科医生主要关注的问题,因为这会显著影响疗效。这项为期12个月的观察性研究旨在评估使用Easypod(一种旨在追踪给药时间、日期和剂量的电子全自动注射装置)给予r-hGH治疗的生长激素缺乏症患者的依从性。65例接受r-hGH治疗的患者纳入研究,32例完成研究。主要终点即治疗依从性,计算方法为观察期内正确给药的注射次数占预期总注射次数的比例。通过Easypod追踪的依从性在基线(V0)后第6个月(V1)和第12个月(V2)进行评估。作为次要终点,还测定了血清胰岛素样生长因子-1(IGF-1)水平。Easypod数据显示,在V0-V2期间,依从性中位数为80%。女性比男性更依从。依从性水平与IGF-1水平相关。在aGHD中,依从性与治疗疗效相关。Easypod的注射记录系统及其他特性可增强医生监测r-hGH治疗依从性的能力,识别不依从患者,从而使医生能够调整管理方式以最大化治疗益处。