1、-141-中国医学创新第 20 卷 第 5 期(总第 611 期)2023 年 2月经验交流 JingyanjiaoliuMedical Innovation of China Vol.20,No.5 February,2023*基金项目:抚州市指导性科技计划项目(抚科计字 20217号-63)江西省抚州市第二人民医院(江西省抚州市妇幼保健院)江西抚州344000通信作者:郑美云不同初始剂量左甲状腺素钠片治疗先天性甲状腺功能减退症患儿的效果、安全性及对垂体-甲状腺轴及IGF-1/IGFBP-3水平的影响*郑美云【摘要】目的:探讨不同初始剂量左甲状腺素钠片治疗先天性甲状腺功能减退症(CH)患儿的
2、效果、安全性及对垂体-甲状腺轴及胰岛素样生长因子-1(IGF-1)/胰岛素生长因子结合蛋白-3(IGFBP-3)水平的影响。方法:选取 2020 年 10 月-2021 年 10 月抚州市第二人民医院收治的 78 例 CH 患儿,采用随机数字表法分为观察组和对照组,各 39 例,两组均采用左甲状腺素钠片治疗,观察组初始剂量为8 g/(kgd),对照组初始剂量为 6 g/(kgd),治疗 1 年后,比较两组临床效果,治疗前后两组间垂体-甲状腺轴功能指标、IGF-1/IGFBP-3 水平变化,身高、体重、智力发育情况,以及治疗期间不良反应发生率。结果:治疗 1 年后,观察组和对照组总有效率分别为
3、94.87%和 84.62%,两组间差异无统计学意义(P0.05);两组患儿治疗后促甲状腺激素(TSH)均显著降低(P0.05),且观察组显著低于对照组(P0.05),血清游离甲状腺素(FT4)和四碘甲腺原氨酸(T4)均显著升高(P0.05),且观察组均显著高于对照组(P0.05);两组患儿治疗后 IGF-1、IGFBP-3、IGF-1/IGFBP-3 均显著升高(P0.05),且观察组均显著高于对照组(P0.05);两组患儿身高、体重、智力发育情况均显著升高(P0.05),且观察组身高、体重、智力发育情况均显著高于对照组(P0.05)。结论:相较于 6 g/(kgd)初始剂量,8 g/(kg
4、d)初始剂量左甲状腺素钠片治疗CH 效果确切,可明显改善甲状腺功能,促进身高、体重、智力发育,且安全性良好,值得推荐。【关键词】左甲状腺素钠片先天性甲状腺功能减退症安全性垂体-甲状腺轴Efficacy and Safety of Different Initial Doses of Levothyroxine Sodium Tablets in the Treatment of Children with Congenital Hypothyroidism and Its Influence on Pituitary-thyroid Axis and IGF-1/IGFBP-3/ZHENG M
5、eiyun./Medical Innovation of China,2023,20(05):141-145AbstractObjective:To investigate the efficacy and safety of Levothyroxine Sodium Tablets at different initial doses in treating congenital hypothyroidism(CH)in children,and its influence on the pituitary-thyroid axis and the levels of insulin-lik
6、e growth factor-1(IGF-1)/insulin growth factor-binding protein-3(IGFBP-3).Method:A total of 78 children with CH who were treated in the Second Peoples Hospital of Fuzhou from October 2020 to October 2021 were selected and classified into observation group(39 cases)and control group(39 cases)by means
7、 of the random number table method.Both groups were treated with Levothyroxine Sodium Tablets,with the initial dose of 8 g/(kgd)in observation group and 6 g/(kgd)in control group.After 1 year of treatment,the clinical effects after treatment,as well as pituitary-thyroid axis function indicators and
8、IGF-1/IGFBP-3,height,weight and intelligence development before and after treatment and incidence rates of adverse reactions during treatment were compared between the two groups.Result:After 1 year of treatment,the total effective rates of observation group and control group were 94.87%and 84.62%re
9、spectively,there was no significant difference between the two groups(P0.05).Thyroid-stimulating hormone(TSH)levels were significantly decreased in both groups after treatment-142-经验交流 Jingyanjiaoliu 中国医学创新第 20 卷 第 5 期(总第 611 期)2023 年 2月Medical Innovation of China Vol.20,No.5 February,2023 先 天 性 甲 状
10、 腺 功 能 减 退 症(congenital hypothyroidism,CH)多是由甲状腺功能减退、异位及甲状腺素合成中碘或酶缺乏导致甲状腺分泌功能下降,影响甲状腺激素正常分泌,当激素分泌不足时,将会导致患儿精神及生长发育迟缓、生理功能低下、代谢紊乱1。在临床上,早期 CH 缺乏特异性表现,不易确诊,只能通过实验室检查诊断,因此对于 CH 患儿需要尽早开始治疗,以免贻误治疗时机2。左甲状腺素钠片是 CH 治疗中首选药物,可快速补充血液甲状腺激素水平,进而有利于调节体内糖脂代谢等过程,加速细胞内物质的氧化,增强体内酶活性,促进机体内蛋白质合成,有利于生长发育,临床效果明显3。但有研究指出,
11、左甲状腺素钠片使用初始剂量对患儿预后具有重要影响,其剂量目前还没有统一的初始剂量标准,不同专家对于左甲状腺素钠片初始剂量使用推荐存在一定分歧4。本研究分析不同初始剂量左甲状腺素钠片治疗 CH 患儿,分析其临床疗效、安全性及对垂体-甲状腺轴及胰岛素样生长因子-1(IGF-1)/胰岛素生长因子结合蛋白-3(IGFBP-3)水平的影响,现报告如下。1资料与方法1.1一般资料选取 2020 年 10 月-2021 年 10 月抚州市第二人民医院收治的 78 例 CH 患儿为研究对象,纳入标准:符合文献 5儿科学中 CH 诊断标准。排除标准:(1)合并先天性心、脑、肾、肝等严重疾病;(2)合并先天畸形、
12、内分泌疾病、遗传代谢;(3)对药物治疗有禁忌。将所有患儿按随机数字表法分为观察组和对照组,各 39 例。本研究经医院医学伦理委员会批准。患儿家属签署知情同意书。1.2方法对两组患儿均给予左甲状腺素钠片(生产厂家:德国默克 Merck KGaA,批准文号:国药准字 J20160065,规格:50 g100 片)治疗,观察组初始剂量为 8 g/(kgd),对照组初始剂量为6 g/(kgd),1 次/d,早餐前 30 min 空腹服用,每隔 3 周增加 6.2512.5 g,服药期间,密切监测患儿的心理状态、血压、心率、体温等生命体征,如出现心率、心脏、体温上升,患儿烦躁不安等现象,治疗期间应立即降
13、低剂量,并保持原剂量的 1/3左右,维持剂量以临床上无甲状腺素过量的表现,且血清游离甲状腺素(free thyroxin T4,FT4)在正常范围之上限为剂量标准,每 23 个月来院复查。两组均治疗 1 年。1.3观察指标及评价标准(1)临床效果:治疗1 年后,观察两组患儿临床效果,其中有效为患儿临床症状消失,甲状腺功能恢复正常;显效为患儿症状无明显改善,甲状腺功能接近正常值;无效为患儿症状无明显改变,甲状腺功能无变化6。总有效率=(有效+显效)例数/总例数 100%。(2)垂体-甲状腺轴功能指标:于治疗前、治疗 1 年后,空腹采集静脉血 2 mL,采用化学免疫发光法测量患儿促甲状腺激素(TS
14、H,正常值范围:0.55.5 mU/L)、FT4(正常值范围:54174 pmol/L)、四碘甲腺原氨酸(T4,正常值范围:1031 nmol/L)。(3)胰岛素样生长因子-1(IGF-1)/胰岛素生长因子结合蛋白-3(IGFBP-3)测定:于治疗前、治疗 1 年后,采用酶联免疫吸附测试法分别测定 IGF-1 和 IGFBP-3(P0.05),and the observation group was significantly lower than that of the control group(P0.05).The levels of serum free thyroxine(FT4)
15、and tetraiodothyronine(T4)were increased significantly(P0.05),and the observation group were significantly higher than those of the control group(P0.05).After treatment,IGF-1,IGFBP-3 and IGF-1/IGFBP-3 of both groups were significantly enhanced(P0.05),and the observation group were significantly high
16、er than those of the control group(P0.05).The height,weight and mental development were obviously improved in both groups(P0.05),and the indicators were obviously higher in observation group than those of control group(P0.05).Conclusion:Compared with the initial dose of 6 g/(kgd),the initial dose of 8 g/(kgd)of Levothyroxine Sodium Tablets is more effective in the treatment of CH,and can better significantly improve the thyroid function,and promote the height,weight and intelligence development,