Spielhagen Christin, Schwahn Christian, Möller Kristin, Friedrich Nele, Kohlmann Thomas, Moock Jörn, Kołtowska-Häggström Maria, Nauck Matthias, Buchfelder Michael, Wallaschofski Henri
Institute of Clinical Chemistry and Laboratory Medicine, University of Greifswald, Germany.
Growth Horm IGF Res. 2011 Feb;21(1):1-10. doi: 10.1016/j.ghir.2010.10.005. Epub 2010 Nov 19.
To evaluate the treatment effects of long-term growth hormone (GH) replacement therapy in adults with GH deficiency (GHD) who were followed in KIMS Germany (Pfizer International Metabolic Database), a national surveillance study.
The analysis was performed using baseline and long-term data (range: 4-10 years) of 440 consecutively documented patients (216 women and 224 men) with GHD, aged 20 to 49 years, enrolled in KIMS Germany. Serum insulin-like growth factor I (IGF-I), fasting blood glucose, fasting serum total cholesterol and low-density lipoprotein cholesterol (LDL-C) as well as body mass index (BMI), waist circumference (WC) and hip circumference (HC) at baseline and at last visit were studied. Furthermore, QoL-AGHDA score was determined to assess quality-of-life (QoL).
The mean dose of GH over all years was 0.41 mg per day in women and 0.37 mg per day in men. IGF-I and IGF-I SDS levels (standard deviation score) increased significantly (p<0.001) during GH treatment. The QoL-AGHDA score decreased significantly (p<0.001), indicating long-lasting improvement in QoL. In total cholesterol, LDL-C and fasting blood glucose, no significant changes were found. Only six patients developed type 2 diabetes during follow-up. Females and males similarly increased significantly in BMI, WC and HC. During GH treatment, recurrences of pituitary or central nervous system tumours or further de novo neoplasia were reported in 6 or 11 patients, respectively. The number of the most frequently reported GH treatment-associated adverse events was low.
These observational data show long-term beneficial effects of GH replacement therapy on QoL and show no significant effects on total cholesterol, LDL-C or BMI, WC and HC. Additionally, our data indicate that GH replacement therapy in adults is well tolerated.
在一项全国性监测研究——德国KIMS（辉瑞国际代谢数据库）中，评估长期生长激素（GH）替代疗法对成年生长激素缺乏症（GHD）患者的治疗效果。
分析采用了德国KIMS中440例连续记录的GHD患者（216名女性和224名男性）的基线和长期数据（范围：4 - 10年），这些患者年龄在20至49岁。研究了基线和末次访视时的血清胰岛素样生长因子I（IGF - I）、空腹血糖、空腹血清总胆固醇和低密度脂蛋白胆固醇（LDL - C）以及体重指数（BMI）、腰围（WC）和臀围（HC）。此外，测定了QoL - AGHDA评分以评估生活质量（QoL）。
多年来，女性GH的平均剂量为每天0.41毫克，男性为每天0.37毫克。在GH治疗期间，IGF - I和IGF - I SDS水平（标准差评分）显著升高（p<0.001）。QoL - AGHDA评分显著降低（p<0.001），表明QoL有持久改善。总胆固醇、LDL - C和空腹血糖未发现显著变化。随访期间仅有6例患者发生2型糖尿病。女性和男性的BMI、WC和HC均有显著增加。在GH治疗期间，分别有6例或11例患者报告垂体或中枢神经系统肿瘤复发或出现新的肿瘤。最常报告的与GH治疗相关的不良事件数量较少。
这些观察数据显示GH替代疗法对QoL有长期有益影响，对总胆固醇、LDL - C或BMI、WC和HC无显著影响。此外，我们的数据表明成人GH替代疗法耐受性良好。
