METHODS: The aim of the current study was to evaluate the auxological and metabolic effects and the safety of long-term recombinant GH treatment in SGA children. The study included 15 SGA children (5 F, 10 M; mean age: 6.78 yrs) treated with GH for at least 48 months. Growth and metabolic parameters, including glycemic and lipid profile, transaminases, and urycemia, were collected every six months.
RESULTS: Compared to baseline, SGA children showed a significant improvement in height, weight, and growth rate after four yaers of treatment with GH (p ≤ 0.002), being already evident after six months of treatment (p < 0.001). Noteworthy, patients showed a constant, significant improvement in height throughout the treatment, as it was significantly higher at each follow-up compared to the previous one, until 42 months of treatment, except at 30 months of treatment (p < 0.001 T6VST12; p < 0.01 T12VST18, T18VST24; p < 0.05 T30VST36, T36VST42). Considering metabolic parameters, compared to baseline, a recurring increase in glycemia (p ≤ 0.028 vs T30, T36, and T48) and decrease in AST (p ≤ 0.035 vs T36, T42, and T48) and an occasional decrease in LDL cholesterol (p ≤ 0.04 vs T24 and T42) and triglycerides (p = 0.008 vs T18) and increase in urycemia (p = 0.034 vs T42). Considering safety profile, treatment was well tolerated, as the most frequently reported adverse event was poor compliance (20%); no hyperglycemia, hypercholesterolemia or hyperstransaminasemia occurred throughout the treatment, CONCLUSIONS: Long-term GH treatment showed to be effective in improving height and growth rate in SGA children, with a positive impact of metabolic profile and a safety profile, although glycemia should be carefully monitored over time.
方法:本研究的目的是评估长期重组GH治疗对SGA儿童的营养和代谢影响以及安全性。该研究包括15名SGA儿童(5F,10米;平均年龄:6.78岁)接受GH治疗至少48个月。生长和代谢参数,包括血糖和血脂,转氨酶,和尿酸血症,每六个月收集一次。
结果:与基线相比,SGA儿童的身高显着改善,体重,用GH治疗四次后的生长速率(p≤0.002),在治疗六个月后已经很明显(p<0.001)。值得注意的是,患者表现出恒定的,在整个治疗过程中高度显著改善,因为每次随访都明显高于上一次,直到42个月的治疗,治疗30个月时除外(p<0.001T6VST12;p<0.01T12VST18,T18VST24;p<0.05T30VST36,T36VST42)。考虑到代谢参数,与基线相比,血糖反复升高(p≤0.028vsT30,T36和T48),AST降低(p≤0.035vsT36,T42和T48),LDL胆固醇(p≤0.04vsT24和T42)和甘油三酯(p=0.008vsT18)偶尔降低,尿酸血症升高(p=0.034vsT42).考虑到安全性,治疗耐受性良好,因为最常报告的不良事件是依从性差(20%);没有高血糖,在整个治疗过程中都会出现高胆固醇血症或高血压。结论:长期GH治疗可有效改善SGA儿童的身高和生长速度,代谢概况和安全概况的积极影响,尽管血糖应该随着时间的推移而仔细监测。