Ishii Hitoshi, Shimatsu Akira, Nishinaga Hiromi, Murai Osamu, Chihara Kazuo
Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8521, Japan.
National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan.
Growth Horm IGF Res. 2017 Oct;36:36-43. doi: 10.1016/j.ghir.2017.08.005. Epub 2017 Sep 1.
Improvement of quality of life (QOL) by growth hormone (GH) therapy was not demonstrated in Japanese adult growth hormone deficiency (AGHD) patients by either the QOL Assessment of Growth Hormone Deficiency in Adults or the Questions on Life Satisfaction-Hypopituitarism, which are widely used to evaluate QOL in Western AGHD patients. We therefore evaluated QOL in Japanese AGHD patients receiving recombinant GH, Norditropin® (Novo Nordisk A/S, Denmark), using the newly developed Adult Hypopituitarism Questionnaire (AHQ).
This multicenter, non-interventional, observational study in Japanese patients with severe AGHD was conducted from 1 October 2009 to 30 September 2014. Patients with severe AGHD already receiving somatropin and somatropin-naïve patients were included. GH therapy (Norditropin®) was initiated as injections of 0.021mg/kg/week divided into 6-7 doses/week, and was adjusted according to clinical responses. Demographic/clinical data were obtained from medical records or by patient recall. QOL was assessed using the AHQ at baseline; 3, 6, and 12months; and annually up to 4years.
Of 387 registered patients, 161 were eligible for QOL analysis. AHQ scores significantly improved after 3months of treatment. Improvements in the psycho-social and physical domains were statistically significant throughout the 4-year study period. Although the GH dose was increased in females such that insulin-like growth factor-1 levels reached those of males, QOL improvements in females did not reach those of males. Despite the greater GH dose in child-onset patients, limited QOL improvements were observed in child-onset vs adult-onset cases.
Four-year GH treatment in Japanese AGHD patients elicits sustained improvement in QOL as assessed by AHQ scores.
对于日本成年生长激素缺乏症（AGHD）患者，成人生长激素缺乏症生活质量评估量表或生活满意度 - 垂体功能减退症问卷（这些问卷广泛用于评估西方AGHD患者的生活质量）均未证明生长激素（GH）治疗能改善生活质量（QOL）。因此，我们使用新开发的成人垂体功能减退症问卷（AHQ）评估了接受重组生长激素诺德人体生长激素（Norditropin®，丹麦诺和诺德公司）治疗的日本AGHD患者的生活质量。
这项针对日本严重AGHD患者的多中心、非干预性观察性研究于2009年10月1日至2014年9月30日进行。纳入了已接受生长激素治疗的严重AGHD患者和未接受过生长激素治疗的患者。生长激素治疗（诺德人体生长激素）开始时为每周注射0.021mg/kg，分为每周6 - 7次注射，并根据临床反应进行调整。人口统计学/临床数据通过病历记录或患者回忆获取。在基线、治疗3个月、6个月和12个月时，以及每年直至4年，使用AHQ评估生活质量。
在387名登记患者中，161名符合生活质量分析条件。治疗3个月后，AHQ评分显著改善。在整个4年研究期间，心理社会和身体领域的改善具有统计学意义。尽管女性的生长激素剂量增加，以使胰岛素样生长因子 - 1水平达到男性水平，但女性生活质量的改善未达到男性水平。尽管儿童期发病患者的生长激素剂量更大，但与成人期发病病例相比，儿童期发病患者的生活质量改善有限。
通过AHQ评分评估，日本AGHD患者接受4年生长激素治疗可使生活质量持续改善。
