不同剂量重组人生长激素治疗小于胎龄儿的临床疗效研究
发布时间：2018-11-23 20:19
【摘要】：研究背景小于胎龄儿(small for gestational age,SGA)是指出生体重和(或)身高低于同性别、同胎龄儿正常参考值第10百分位数或两个标准差以上的新生儿[1,2]。SGA在早产儿、足月儿及过期产儿中均可发生,国内发生率约为6.61%,其中早产儿发生率约为13.1%,足月儿发生率约为6.05%[3,4]。SGA患儿常表现出生长发育滞后,约80%~90%患儿2岁内可实现追赶生长达到正常身高,约10%~20%患儿无法实现追赶生长[5,6],4岁之后,患儿很难通过自然生长实现追赶[7,8],其确切机制尚不明确。美国食品药品管理局(Food and Drug Administration,FDA)于2001年批准无追赶生长SGA可采用重组人生长激素(recombinant human growth hormone,rhGH)治疗[9]。然而,rhGH治疗SGA的剂量国内尚无统一标准。本研究旨在探讨不同剂量rhGH治疗对患儿身高标准差积分(height standard deviation score,HtSDS)、生长速率(grow velocity,GV)增长、体质指数(body mass index,BMI)等的影响及不良反应的发生情况,为临床个体化治疗提供依据。研究给予不同剂量重组人生长激素(rhGH)治疗无追赶生长小于胎龄儿的临床疗效,为临床个体化治疗提供依据。方法选取32例于2014年9月至2015年9月就诊于郑州大学第三附属医院儿童内分泌诊疗中心的SGA患儿,其中男孩13例,女孩19例,年龄4~8岁,平均年龄(6.11±1.74)岁。纳入标准[10]:(1)出生体重和(或)身高低于同性别、同胎龄正常平均值的第10百分位或2个标准差以上;(2)年龄≥4岁身高仍低于同性别、同年龄正常儿童平均身高参考值的2个标准差;(3)生长激素激发试验峰值≥10μg/L;(4)排除甲状腺功能减退症、先天性卵巢发育不全综合征、慢性器质性疾病、染色体异常等,且从未接受过rhGH治疗。依据给药剂量的不同分为小剂量组和大剂量组各16例,两组患儿的性别、年龄差异无统计学意义(P0.05)。结果给予rhGH治疗前,大剂量组与小剂量组患儿年龄、生长发育指标(BMI、GV、HtSDS)及实验室检查指标:胰岛素样生长因子-1(insulin-link growth factor,IGF-1)、胰岛素样生长因子结合蛋白-3(insulin link growth factor binding protein-3,IGFBP-3)、空腹血糖(glucose,GLU)、游离T4(free T4,FT4)、促甲状腺素(thyroid stimulating hormone,TSH)的比较,差异均无统计学意义(P0.05)。经rhGH治疗12个月后,大剂量组GV为(11.03±2.73)cm/y,小剂量组GV为(8.21±2.35)cm/y,大剂量组高于小剂量组,且差异有统计学意义(P0.05);大剂量组的HtSDS为(-1.42±0.19)cm/y,小剂量组HtSDS为(-1.95±0.37),差异有统计学意义(P0.05);两组间BMI的差异无统计学意义(P0.05);与治疗前相比,治疗后IGF-1及IGFBP-3均有升高,但两组间差异无统计学意义(P0.05);两组间GLU、FT4、TSH的比较,差异无统计学意义(P0.05)。结论(1)给予rhGH治疗,可有效促进无追赶生长小于胎龄儿的生长,治疗期间无明显不良反应;(2)使用不同剂量rhGH治疗的SGA患儿,大剂量组效果优于小目的剂量组,且大剂量组并不增加肥胖、空腹血糖异常、甲状腺功能异常的发生率。
[Abstract]:Background (small for gestational age,SGA is a newborn whose birth weight and / or height is lower than the same sex, and the normal reference value of the same gestational age is above 10th percentile or two standard deviations. The incidence of term infants and expired infants is about 6.61% in China. The incidence of preterm infants is about 13.1%. The incidence of full-term infants is about 6.05% [3 / 4]. The children with SGA often show delayed growth and development. About 80% of the children can catch up to normal height within 2 years of age, about 10% of the children can not achieve catch-up growth [5]. After 4 years old, it is very difficult for children to catch up through natural growth [78], and the exact mechanism is not clear. The Food and Drug Administration (Food and Drug Administration,FDA) approved the use of recombinant human growth hormone (recombinant human growth hormone,rhGH) for SGA without catch-up growth in 2001 [9]. However, there is no uniform standard for the dosage of rhGH in the treatment of SGA. The purpose of this study was to investigate the effects of different doses of rhGH on height standard deviation (height standard deviation score,HtSDS), growth rate (grow velocity,GV), body mass index (body mass index,BMI) and adverse reactions in children. To provide the basis for clinical individualized treatment. To study the clinical efficacy of different doses of recombinant human growth hormone (rhGH) in the treatment of infants without catch-up growth smaller than gestational age, and to provide evidence for individual clinical treatment. Methods from September 2014 to September 2015, 32 children with SGA were selected from the Children Endocrine diagnosis and treatment Center of the third affiliated Hospital of Zhengzhou University. There were 13 boys and 19 girls, aged 4 to 8 years, with an average age of (6.11 卤1.74) years. Inclusion criteria [10]: (1) birth weight and / or height were lower than the 10th percentile or more than 2 standard deviations of the normal average of the same sex and gestational age; (2) the height of age 鈮，
本文编号：2352585
[Abstract]:Background (small for gestational age,SGA is a newborn whose birth weight and / or height is lower than the same sex, and the normal reference value of the same gestational age is above 10th percentile or two standard deviations. The incidence of term infants and expired infants is about 6.61% in China. The incidence of preterm infants is about 13.1%. The incidence of full-term infants is about 6.05% [3 / 4]. The children with SGA often show delayed growth and development. About 80% of the children can catch up to normal height within 2 years of age, about 10% of the children can not achieve catch-up growth [5]. After 4 years old, it is very difficult for children to catch up through natural growth [78], and the exact mechanism is not clear. The Food and Drug Administration (Food and Drug Administration,FDA) approved the use of recombinant human growth hormone (recombinant human growth hormone,rhGH) for SGA without catch-up growth in 2001 [9]. However, there is no uniform standard for the dosage of rhGH in the treatment of SGA. The purpose of this study was to investigate the effects of different doses of rhGH on height standard deviation (height standard deviation score,HtSDS), growth rate (grow velocity,GV), body mass index (body mass index,BMI) and adverse reactions in children. To provide the basis for clinical individualized treatment. To study the clinical efficacy of different doses of recombinant human growth hormone (rhGH) in the treatment of infants without catch-up growth smaller than gestational age, and to provide evidence for individual clinical treatment. Methods from September 2014 to September 2015, 32 children with SGA were selected from the Children Endocrine diagnosis and treatment Center of the third affiliated Hospital of Zhengzhou University. There were 13 boys and 19 girls, aged 4 to 8 years, with an average age of (6.11 卤1.74) years. Inclusion criteria [10]: (1) birth weight and / or height were lower than the 10th percentile or more than 2 standard deviations of the normal average of the same sex and gestational age; (2) the height of age 鈮，
本文编号：2352585
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