【摘要】：研究背景小于胎齡兒(small for gestational age,SGA)是指出生體重和(或)身高低于同性別、同胎齡兒正常參考值第10百分位數(shù)或兩個標(biāo)準(zhǔn)差以上的新生兒[1,2]。SGA在早產(chǎn)兒、足月兒及過期產(chǎn)兒中均可發(fā)生,國內(nèi)發(fā)生率約為6.61%,其中早產(chǎn)兒發(fā)生率約為13.1%,足月兒發(fā)生率約為6.05%[3,4]。SGA患兒常表現(xiàn)出生長發(fā)育滯后,約80%~90%患兒2歲內(nèi)可實現(xiàn)追趕生長達到正常身高,約10%~20%患兒無法實現(xiàn)追趕生長[5,6],4歲之后,患兒很難通過自然生長實現(xiàn)追趕[7,8],其確切機制尚不明確。美國食品藥品管理局(Food and Drug Administration,FDA)于2001年批準(zhǔn)無追趕生長SGA可采用重組人生長激素(recombinant human growth hormone,rhGH)治療[9]。然而,rhGH治療SGA的劑量國內(nèi)尚無統(tǒng)一標(biāo)準(zhǔn)。本研究旨在探討不同劑量rhGH治療對患兒身高標(biāo)準(zhǔn)差積分(height standard deviation score,HtSDS)、生長速率(grow velocity,GV)增長、體質(zhì)指數(shù)(body mass index,BMI)等的影響及不良反應(yīng)的發(fā)生情況,為臨床個體化治療提供依據(jù)。研究給予不同劑量重組人生長激素(rhGH)治療無追趕生長小于胎齡兒的臨床療效,為臨床個體化治療提供依據(jù)。方法選取32例于2014年9月至2015年9月就診于鄭州大學(xué)第三附屬醫(yī)院兒童內(nèi)分泌診療中心的SGA患兒,其中男孩13例,女孩19例,年齡4~8歲,平均年齡(6.11±1.74)歲。納入標(biāo)準(zhǔn)[10]:(1)出生體重和(或)身高低于同性別、同胎齡正常平均值的第10百分位或2個標(biāo)準(zhǔn)差以上;(2)年齡≥4歲身高仍低于同性別、同年齡正常兒童平均身高參考值的2個標(biāo)準(zhǔn)差;(3)生長激素激發(fā)試驗峰值≥10μg/L;(4)排除甲狀腺功能減退癥、先天性卵巢發(fā)育不全綜合征、慢性器質(zhì)性疾病、染色體異常等,且從未接受過rhGH治療。依據(jù)給藥劑量的不同分為小劑量組和大劑量組各16例,兩組患兒的性別、年齡差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)果給予rhGH治療前,大劑量組與小劑量組患兒年齡、生長發(fā)育指標(biāo)(BMI、GV、HtSDS)及實驗室檢查指標(biāo):胰島素樣生長因子-1(insulin-link growth factor,IGF-1)、胰島素樣生長因子結(jié)合蛋白-3(insulin link growth factor binding protein-3,IGFBP-3)、空腹血糖(glucose,GLU)、游離T4(free T4,FT4)、促甲狀腺素(thyroid stimulating hormone,TSH)的比較,差異均無統(tǒng)計學(xué)意義(P0.05)。經(jīng)rhGH治療12個月后,大劑量組GV為(11.03±2.73)cm/y,小劑量組GV為(8.21±2.35)cm/y,大劑量組高于小劑量組,且差異有統(tǒng)計學(xué)意義(P0.05);大劑量組的HtSDS為(-1.42±0.19)cm/y,小劑量組HtSDS為(-1.95±0.37),差異有統(tǒng)計學(xué)意義(P0.05);兩組間BMI的差異無統(tǒng)計學(xué)意義(P0.05);與治療前相比,治療后IGF-1及IGFBP-3均有升高,但兩組間差異無統(tǒng)計學(xué)意義(P0.05);兩組間GLU、FT4、TSH的比較,差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)論(1)給予rhGH治療,可有效促進無追趕生長小于胎齡兒的生長,治療期間無明顯不良反應(yīng);(2)使用不同劑量rhGH治療的SGA患兒,大劑量組效果優(yōu)于小目的劑量組,且大劑量組并不增加肥胖、空腹血糖異常、甲狀腺功能異常的發(fā)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 鹵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，

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