Blethen Sandra L, O'Brien Fanny, Reinhart Rosann
Medical Affairs, Serono Inc, Rockland, MA 02370, USA.
Pediatr Endocrinol Rev. 2005 Feb;2 Suppl 3:324-6.
The GHMonitor, introduced in 1998, monitors demographics and outcomes in children treated with Saizen (somatropin [recombinant hGH for injection]). Follow-up data are available on 697 patients. The proportion of male to female patients receiving growth hormone (GH) treatment was 67:33. Severity of the height deficit present at enrollment varied by diagnosis with patients with Turner syndrome being shortest [height standard deviation score (SDS)=-3.7+/-1.7] and those with organic GH deficiency the least severely stunted (height SDS=-1.9+/-1.5). Forty-eight patients (6.9%) discontinued participation in the registry. The most common reason for discontinuing GH was completion of growth; the second was family relocation. There were 53 adverse events reported in 33 patients in 1977 patient-years of followup. Most were self-limited but 13 were serious, and 5 resulted in discontinuation of treatment. Data from The GHMonitor provide a real world glimpse of current North American GH treatment practices.
1998年推出的生长激素监测项目(GHMonitor),对使用赛增(生长激素[注射用重组人生长激素])治疗的儿童的人口统计学数据和治疗结果进行监测。现有697例患者的随访数据。接受生长激素(GH)治疗的男性与女性患者比例为67:33。入组时身高不足的严重程度因诊断而异,特纳综合征患者最矮[身高标准差评分(SDS)=-3.7±1.7],器质性生长激素缺乏患者发育迟缓程度最轻(身高SDS=-1.9±1.5)。48例患者(6.9%)停止参与该登记项目。停止使用生长激素最常见的原因是生长完成;其次是家庭搬迁。在1977患者年的随访中,33例患者报告了53起不良事件。大多数不良事件为自限性,但有13起严重不良事件,5起导致治疗中断。生长激素监测项目的数据让我们得以一窥当前北美生长激素治疗的实际情况。