3D打印左甲状腺素钠片治疗先天性甲状腺功能减退症的临床效果  

Clinical effects of 3D printed levothyroxine sodium tablets in the treatment of congenital hypothyroidism

作　　者：刘妙雯 林素芬 杨帆[2] 张金凤 莫明明 文芳 郑燕彩 曾卫强 LIU Miaowen;LIN Sufen;YANG Fan;ZHANG Jinfeng;MO Mingming;WEN Fang;ZHENG Yancai;ZENG Weiqiang(Department of Pharmacy,Shunde Women and Children's Hospital of Guangdong Medical University,Foshan 528300,China;Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems and Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System/The Center for Drug Research and Development,Guangdong Pharmaceutical University,Guangzhou 510006,China;Newborn Screening Center,Shunde Women and Children’s Hospital of Guangdong Medical University,Foshan 528300,China;Department of Child Health Care,Shunde Women and Children's Hospital of Guangdong Medical University,Foshan 528300,China)

机构地区：[1]广东医科大学顺德妇女儿童医院药学部,广东佛山528300 [2]广东药科大学新药研发中心/广东省药物新剂型重点实验室/广东省局部精准药物递药制剂工程技术研究中心,广东广州510006 [3]广东医科大学顺德妇女儿童医院新生儿筛查中心,广东佛山528300 [4]广东医科大学顺德妇女儿童医院儿童保健科,广东佛山528300

出　　处：《广东药科大学学报》2024年第6期111-115,共5页Journal of Guangdong Pharmaceutical University

基　　金：广东省佛山市医学类科技攻关项目(2220001005135);广东医科大学顺德妇女儿童医院青年人才项目(2022QNRC009);中国药学会科技开发中心科普项目[CMEI2021KPYJ(ZAMM)00211]。

摘　　要：目的探讨3D打印的个体化精准剂量左甲状腺素钠片(L-T4)治疗先天性甲状腺功能减退症(congenital hypothyroidism,CH)的应用效果。方法选取2023年1月至2024年1月在我院新生儿筛查中心确诊的60例CH患儿为研究对象,采用随机数字表法将其分为常规分剂量组和3D打印组,每组30例。常规分剂量组予以市售片剂L-T4,3D打印组予以3D打印的个体化精准L-T4,对比两组疗效、不良反应发生率和依从性。结果服药2周后,3D打印组的TSH和FT4水平的改善程度优于常规分剂量组(P<0.05)。服药3个月后,3D打印组血清促甲状腺激素(TSH)的改善程度优于常规分剂量组(P<0.05),服药6个月后,两组的TSH、三碘甲腺原氨酸(FT3)和游离甲状腺素(FT4)水平差异无统计学意义(P>0.05)。服药6个月期间,3D打印组的身高增长速率优于常规分剂量组(P<0.05),体重增长速率差异无统计学意义(P>0.05)。3D打印组的服药依从性明显优于常规分剂量组(P<0.05)。两组不良反应发生率差异无统计学意义(P>0.05)。结论利用3D打印技术进行L-T4个体化分剂量对先天性CH患儿的疗效显著,不仅能促进患儿身体发育,而且安全性高,甲状腺功能的改善程度和服药依从性均优于普通市售L-T4,值得临床推广。Objective To investigate the effect of 3D printed personalized precise dose of levothyroxine sodium tablets(L-T4)in the treatment of congenital hypothyroidism(CH).Methods A total of 60 children with CH diagnosed in the neonatal screening Center of our hospital from January 2023 to January 2024 were selected as the study objects and were divided into a routine dose group and 3D printing group by random number table method,with 30 cases in each group.The conventional group was fed with the commercially available L-T4 tablets,and the 3D printing group was fed with the individualized 3D printed L-T4.The efficacy,incidence of adverse reactions and compliance of the two groups were compared.Results After 2 weeks of medication,the improvement degree of TSH and FT4 levels in the 3D printing group was better than that in the conventional group(P<0.05).After 3 months of medication,the improvement of TSH in the 3D printing group was better than that in the conventional group(P<0.05).After 6 months of medication,there was no significant difference in TSH,FT3 and FT4 levels between the two groups(P>0.05).During the period of 6 months,the height growth rate of the 3D printing group was better than that of the conventional group(P<0.05),and the weight growth rate was not significantly different(P>0.05).The medication compliance of the 3D printing group was significantly better than that of the conventional group(P<0.05).There was no statistical significance in the incidence of adverse reactions between the two groups.Conclusion The individualization and dosing of L-T4 using 3D printing technology has significant effect on children with congenital CH,which can improve thyroid function and promote physical development of children with CH,with high safety and better medication compliance than ordinary L-T4.

关 键 词：3D打印 左甲状腺素钠片 先天性甲状腺功能减退症 分剂量 个体化治疗 

分 类 号：R977.14[医药卫生—药品]