接受生长激素替代疗法的女性在 NordiNet ® 国际结局研究（IOS）和美国 Norditropin ® 研究：网络辅助研究（ANSWER）计划中的妊娠结局。
Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program.
机构信息
Neuroendocrine Unit, Massachusetts General Hospital, Bulfinch 457B, Fruit St., Boston, MA, 02114, USA.
Department of Endocrinology, and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.
出版信息
Pituitary. 2021 Aug;24(4):611-621. doi: 10.1007/s11102-021-01138-3. Epub 2021 Mar 12.
PURPOSE
Data on the safety of growth hormone (GH) replacement therapy during pregnancy are limited. We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program.
METHODS
Pregnancy data were pooled from NordiNet® IOS and the ANSWER Program. Data were collected during routine clinic visits by participating physicians using a web-based system. Patients exposed to GH replacement therapy during pregnancy were included in the analysis.
RESULTS
The study population included 40 female patients with typical causes of adult GH deficiency (GHD). Overall, there were 54 pregnancies. Of these, 47 were exposed to GH between conception and delivery. In 48.9% of pregnancies exposed to GH, the dose was > 0.6 mg/day. GH was continued past conception and then stopped during the first, second, and third trimester, in 27.7%, 17.0%, and 2.1% of pregnancies, respectively. In 29.8%, GH was continued throughout pregnancy, with an unchanged dose in most cases. Of the 47 GH-exposed pregnancies, 37 (78.7%) progressed to normal delivery. There were three adverse events reported in two pregnancies.
CONCLUSION
These real-world data suggest that there were no new safety signals related to GH exposure in women with GHD during pregnancy. These results are consistent with findings from previous studies reporting data in pregnancies exposed to GH at conception or throughout pregnancy. This observational study in additional pregnancies provides further evidence that GH exposure does not adversely affect pregnancy outcome.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT00960128 (date of registration: August 13, 2009) and NCT01009905 (date of registration: November 5, 2009).
目的
关于妊娠期间生长激素（GH）替代治疗安全性的数据有限。我们报告了两项非干预性、多中心研究（NordiNet®国际结局研究（IOS）和美国 Norditropin®研究：网络启用研究（ANSWER）计划）中接受 GH 治疗的孕妇数据的联合分析。
方法
NordiNet®IOS 和 ANSWER 计划中的妊娠数据被汇总。参与医生使用基于网络的系统在常规临床就诊期间收集数据。纳入在妊娠期间接受 GH 替代治疗的患者进行分析。
结果
研究人群包括 40 名患有典型成人 GH 缺乏症（GHD）的女性患者。共有 54 例妊娠。其中，47 例在受孕至分娩期间接受 GH 治疗。在接受 GH 治疗的妊娠中，48.9%的剂量>0.6mg/天。在 27.7%、17.0%和 2.1%的妊娠中，分别在受孕后继续使用 GH 并在第一、二和三孕期停止使用。在 29.8%的妊娠中，GH 持续使用，大多数情况下剂量不变。在 47 例接受 GH 治疗的妊娠中，37 例（78.7%）进展为正常分娩。在两例妊娠中报告了 3 例不良事件。
结论
这些真实世界的数据表明，在妊娠期间患有 GHD 的女性中，GH 暴露没有新的安全性信号。这些结果与之前报告在受孕或整个妊娠期间暴露于 GH 的妊娠数据的研究结果一致。在额外妊娠中的这项观察性研究提供了进一步的证据，表明 GH 暴露不会对妊娠结局产生不利影响。
临床试验注册
ClinicalTrials.gov NCT00960128（注册日期：2009 年 8 月 13 日）和 NCT01009905（注册日期：2009 年 11 月 5 日）。
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