Holmes S J, Shalet S M
Department of Endocrinology, Christie Hospital NHS Trust, Manchester, UK.
Clin Endocrinol (Oxf). 1995 Aug;43(2):151-7. doi: 10.1111/j.1365-2265.1995.tb01909.x.
Growth hormone replacement in adults may be considered beneficial by clinicians, but patients may not perceive any benefits. The purpose of this study was to determine whether there were any factors which influenced whether an adult wished to continue on long-term GH replacement after taking part in a study of GH replacement.
A 12-month study (double-blind placebo controlled for the first 6 months and open for the second 6 months) of GH replacement (0.125 IU/kg/week for the first month and 0.25 IU/kg/week thereafter) in adults.
Sixty-three adults (27 men, 36 women, aged 34.9 +/- 1.4 (mean +/- SE, range 20.1-59.5) years) with GH deficiency (peak serum GH response to provocative testing less than 10 mU/l) who entered a 12-month study of GH replacement. Thirty patients (48%) wished to continue on GH replacement and 33 patients (52%) did not wish to continue on GH replacement after the study.
Biochemical, anthropometric and demographic characteristics, and well-being, were compared in those patients who wished to continue on long-term GH replacement and in those who did not. In the two groups of patients the age, height, weight, body mass index, serum insulin-like growth factor (IGF)-I, IGF binding protein (IGFBP)-3 and IGF-I age matched standard deviation score (SDS) were compared at entry into the study, and changes in IGF-I, IGFBP-3 and IGF-I SDS were compared after 6 months of GH replacement. The patients were compared according to pretreatment peak serum GH response to provocative testing, sex, estimated duration of GH deficiency, whether GH deficiency was of childhood or adult onset, presence or absence of additional pituitary hormone deficiencies, underlying pathological disorder, previous therapeutic interventions, employment status, marital status and living arrangement, and according to development of side-effects of GH replacement and the requirement for reduction in dose of GH because of side-effects during the study. Scores on two questionnaire measures of well-being or distress, the Nottingham Health Profile (NHP) and the Psychological General Well-Being Schedule (PGWBS), were compared at entry into the study in the two groups, as were change in scores on these questionnaires after 6 months of GH replacement.
Those who continued on GH replacement tended to have a greater severity of GH deficiency (median peak serum GH concentration 0.7 vs 2.3 mU/l, P = 0.06), tended to have greater distress in terms of energy (NHP, P = 0.06) and vitality (PGWBS, P = 0.06) at entry into the study and showed an improvement in energy during the study compared with no change in those who did not wish to continue on GH replacement (NHP, P = 0.06).
Those adults who wished to continue on GH replacement tended to have a greater severity of GH deficiency, to experience more distress in terms of energy and vitality at entry into the study and to experience an improvement in energy after 6 months treatment with GH.
临床医生可能认为成人使用生长激素替代疗法有益,但患者可能并未察觉到任何益处。本研究的目的是确定在参与生长激素替代疗法研究后,是否存在影响成人是否希望继续长期使用生长激素替代疗法的因素。
一项为期12个月的成人生长激素替代疗法研究(前6个月为双盲安慰剂对照,后6个月为开放试验),剂量为第一个月0.125IU/kg/周,此后为0.25IU/kg/周。
63名成人(27名男性,36名女性,年龄34.9±1.4(平均±标准误,范围20.1 - 59.5)岁),患有生长激素缺乏症(激发试验后血清生长激素峰值反应低于10mU/l),参与为期12个月的生长激素替代疗法研究。30名患者(48%)希望继续使用生长激素替代疗法,33名患者(52%)在研究结束后不希望继续使用。
比较希望继续长期使用生长激素替代疗法的患者和不希望继续使用的患者的生化、人体测量和人口统计学特征以及幸福感。在两组患者中,比较研究开始时的年龄、身高、体重、体重指数、血清胰岛素样生长因子(IGF)-I、IGF结合蛋白(IGFBP)-3和IGF-I年龄匹配标准差评分(SDS),以及生长激素替代疗法6个月后的IGF-I、IGFBP-3和IGF-I SDS变化。根据激发试验前血清生长激素峰值反应、性别、估计的生长激素缺乏持续时间、生长激素缺乏是儿童期还是成人期发病、是否存在其他垂体激素缺乏、潜在病理疾病、既往治疗干预、就业状况、婚姻状况和生活安排,以及根据生长激素替代疗法的副作用发生情况和研究期间因副作用而需要减少生长激素剂量的情况对患者进行比较。比较两组患者在研究开始时两份幸福感或痛苦程度问卷测量的得分,即诺丁汉健康量表(NHP)和心理总体幸福感量表(PGWBS),以及生长激素替代疗法6个月后这些问卷得分的变化。
继续使用生长激素替代疗法的患者往往生长激素缺乏程度更严重(血清生长激素峰值浓度中位数0.7对2.3mU/l,P = 0.06),在研究开始时在精力(NHP,P = 0.06)和活力(PGWBS,P = 0.06)方面往往有更大的痛苦,并且与不希望继续使用生长激素替代疗法的患者无变化相比(NHP,P = 0.06),在研究期间精力有所改善。
希望继续使用生长激素替代疗法的成人往往生长激素缺乏程度更严重,在研究开始时在精力和活力方面经历更多痛苦,并且在接受生长激素治疗6个月后精力有所改善。