Prospective safety surveillance of GH-deficient adults: comparison of GH-treated vs untreated patients.
Prospective safety surveillance of GH-deficient adults: comparison of GH-treated vs untreated patients.
复制标题
DOI：
10.1210/jc.2012-2684
复制
发表时间：
2013-03
期刊：
影响因子：
--
通讯作者：
International HypoCCS Advisory Board
中科院分区：
文献类型：
--
作者：
Hartman ML;Xu R;Crowe BJ;Robison LL;Erfurth EM;Kleinberg DL;Zimmermann AG;Woodmansee WW;Cutler GB Jr;Chipman JJ;Melmed S;International HypoCCS Advisory Board
在临床实践中，生长激素替代疗法与非替代疗法相比，对生长激素缺乏的成年人的安全性尚不清楚。这项研究的目的是比较接受生长激素治疗的生长激素缺陷型成人和未接受生长激素替代治疗的生长激素缺陷型成人的不良事件。这是一项以美国临床实践为背景的前瞻性观察性研究。在调整基线组差异和控制假发现率后，比较了GH治疗组(n=1988)和未治疗组(n=442)GH缺陷成人的AES。标准化死亡率是使用美国死亡率计算的。经过平均2.3年的随访，接受生长激素治疗的患者与未接受治疗的患者相比，死亡率、癌症、颅内肿瘤生长或复发、糖尿病或心血管事件的发生率没有显著差异。标化死亡率在两组中均未见增加。意想不到的不良反应(GH治疗和未治疗，P≤.05)包括失眠(6.4%比2.7%)、呼吸困难(4.2%比2.0%)、焦虑(3.4%比0.9%)、睡眠呼吸暂停(3.3%比0.9%)和性欲下降(2.1%比0.2%)。其中一些不良反应与基线危险因素(包括肥胖和心肺疾病)、较高的生长激素剂量或伴随的生长激素副作用有关。在生长激素缺乏的成年人中，没有证据表明生长激素治疗对死亡、癌症、颅内肿瘤复发、糖尿病或心血管事件有效果，尽管对这些长期事件的随访期不够长，不能得出结论。意外的生长激素相关不良反应的发现进一步证实了患者选择和生长激素剂量滴定对于确保成人生长激素替代手术的安全性是重要的。
In clinical practice, the safety profile of GH replacement therapy for GH-deficient adults compared with no replacement therapy is unknown. The objective of this study was to compare adverse events (AEs) in GH-deficient adults who were GH-treated with those in GH-deficient adults who did not receive GH replacement. This was a prospective observational study in the setting of US clinical practices. AEs were compared between GH-treated (n = 1988) and untreated (n = 442) GH-deficient adults after adjusting for baseline group differences and controlling the false discovery rate. The standardized mortality ratio was calculated using US mortality rates. After a mean follow-up of 2.3 years, there was no significant difference in rates of death, cancer, intracranial tumor growth or recurrence, diabetes, or cardiovascular events in GH-treated compared with untreated patients. The standardized mortality ratio was not increased in either group. Unexpected AEs (GH-treated vs untreated, P ≤ .05) included insomnia (6.4% vs 2.7%), dyspnea (4.2% vs 2.0%), anxiety (3.4% vs 0.9%), sleep apnea (3.3% vs 0.9%), and decreased libido (2.1% vs 0.2%). Some of these AEs were related to baseline risk factors (including obesity and cardiopulmonary disease), higher GH dose, or concomitant GH side effects. In GH-deficient adults, there was no evidence for a GH treatment effect on death, cancer, intracranial tumor recurrence, diabetes, or cardiovascular events, although the follow-up period was of insufficient duration to be conclusive for these long-term events. The identification of unexpected GH-related AEs reinforces the fact that patient selection and GH dose titration are important to ensure safety of adult GH replacement.
登录
查看更多内容
影响因子：
5.8
作者：
Frajese, G;Drake, WM;Monson, JP
通讯作者：
Monson, JP
影响因子：
3.2
作者：
Jostel, A;Mukherjee, A;Shalet, SM
通讯作者：
Shalet, SM
影响因子：
5.8
作者：
Miller, J;Silverstein, J;Wagner, M
通讯作者：
Wagner, M
影响因子：
3.2
作者：
Nolte, W;Rädisch, C;Hüfner, M
通讯作者：
Hüfner, M
影响因子：
5.8
作者：
Savendahl, Lars;Maes, Marc;Hokken-Koelega, Anita
通讯作者：
Hokken-Koelega, Anita