Gender-, age- and time-dependent dosing of growth hormone in adults – real-world data from a decade of clinical practice in Germany

We evaluated treatment patterns and gender-dependent dosing of growth hormone (GH) substitution in adults with GH deficiency (AGHD). Data on GH dose were collected (2003–2013) from 509 GH-treated patients (mean age: 48.9 years; 47% female) enroled in the observational German NordiWin study (NCT01543880). The impact of gender, age, treatment duration and calendar year on GH treatment patterns was evaluated by multiple regression analysis. Mean (SD) baseline GH dose (mg/day) was similar between females (0.25 [0.19] and males (0.24 [0.15]), but increased with treatment duration (at year 10, 0.55 [0.48] and 0.31 [0.09] in females and males, respectively), reflecting patient dose titration. GH dose increased more in females than males during treatment; this was statistically significant in years 2–6 (<i>p </i>&lt;<i> </i>0.05). Over the 10-year study period, a time trend of an overall estimated GH dose increase by 0.06 mg/day (females) and decrease by 0.07 mg/day (males) was shown; this interaction of gender and calendar year was significant (<i>p </i>&lt;<i> </i>0.0001). In both genders, overall GH dose decreased with increasing age (<i>p </i>&lt;<i> </i>0.0001). Our study confirms that females and younger patients require higher GH doses compared with males and older patients.

本研究评估了成人生长激素缺乏症（adult GH deficiency, AGHD）患者的生长激素（growth hormone, GH）替代治疗模式与性别依赖性给药方案。研究于2003年至2013年间，从参与德国观察性NordiWin研究（临床试验编号：NCT01543880）的509名接受GH治疗的患者中收集了GH给药剂量数据，受试者平均年龄为48.9岁，女性占比47%。本研究采用多元回归分析（multiple regression analysis），评估了性别、年龄、治疗时长以及日历年份对GH治疗模式的影响。结果显示，女性受试者的平均（标准差，standard deviation, SD）基线GH给药剂量（单位：mg/天）为0.25（0.19），男性为0.24（0.15），二者无显著差异；但该剂量随治疗时长增加而升高：治疗至第10年时，女性与男性的给药剂量分别为0.55（0.48）与0.31（0.09），这一结果反映了受试者的剂量滴定过程。治疗期间，女性受试者的GH剂量增幅高于男性，且在治疗第2至6年时该差异具有统计学意义（p < 0.05）。在为期10年的研究周期内，整体呈现出时间趋势：女性受试者的预估GH总剂量每日增加0.06mg，而男性则每日减少0.07mg；性别与日历年份的交互作用具有显著统计学意义（p < 0.0001）。无论男女，GH总剂量均随年龄增长而降低（p < 0.0001）。本研究证实，与男性及老年患者相比，女性与年轻患者需要更高的GH给药剂量。