摘要
目的 研究不同剂量左甲状腺素钠(L-T4)治疗妊娠期甲状腺功能减退症(HDP)及对孕妇凝血功能、甲状腺激素、母婴结局的影响.方法 前瞻性选择2020年1月至2023年10月于阜阳市人民医院接受治疗的HDP患者96例为研究对象.按照随机数字表法将其分为试验组和对照组,每组各48例.对照组给予小剂量L-T4治疗,25 μg/次,口服,1次/d,2周后按照促甲状腺激素(TSH)水平将L-T4片剂量增加至最大剂量,50 µg/次,口服,1次/d,再行2周治疗;试验组给予大剂量L-T4治疗,50 µg/次,口服,1次/d,2周后按照TSH水平将L-T4片剂量增加至最大剂量,100 µg/次,口服,1次/d,再行2周治疗.两组均治疗4周.比较两组的临床疗效,观察两组治疗前及治疗4周后凝血功能指标[活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、凝血酶原时间(PT)、纤维蛋白原(FiB)]及血清甲状腺激素[TSH、游离甲状腺素(FT4)、游离三碘甲状腺原氨酸(FT3)]水平,并比较两组的不良母婴结局及不良反应发生情况.结果 试验组总有效率为95.83％,高于对照组(79.17％),差异有统计学意义(P＜0.05).治疗4周后,试验组APTT、TT、PT 及 FiB 水平分别为(30.65±3.29)s、(12.89±1.48)s、(11.26±1.35)s、(2.66±0.29)g/L,均低于对照组[(32.44±3.55)s、(13.65±1.60)s、(12.05±1.40)s、(2.82±0.31)g/L],差异均有统计学意义(P＜0.05).治疗 4周后,试验组血清TSH水平为(2.44±0.26)mIU/L,低于对照组[(2.58±0.28)mIU/L],血清FT4、FT3水平分别为(12.74±1.49)、(4.63±0.49)pmol/L,均高于对照组[(11.95±1.44)、(4.39±0.44)pmol/L],差异均有统计学意义(P＜0.05).观察组总不良母婴结局发生率为4.17％,低于对照组(18.75％),差异有统计学意义(P＜0.05).试验组总不良反应发生率与对照组比较(12.50％vs.6.25％),差异无统计学意义(P＞0.05).结论 大剂量L-T4治疗HDP疗效显著,可有效改善孕妇凝血功能,纠正异常甲状腺激素水平,减少不良母婴结局,且具有较高的安全性.
Abstract
Objective To study the effects of different doses of levothyroxine sodium(L-T4)on the treatment of hypothyroidism during pregnancy(HDP)and on coagulation function,thyroid hormone,maternal and infant outcomes.Methods A total of 96 patients with HDP treated in Fuyang People's Hospital from January 2020 to October 2023 were prospectively selected as the study subjects.According to the random number table method,they were divided into the experimental group and the control group,with 48 cases in each group.The control group was treated with low-dose L-T4,25 µg/time,orally,once a day.After 2 weeks,the dose of L-T4 tablets was increased to the maximum dose of 50 µg/time according to the thyroid stimulating hormone(TSH)level,orally,once a day,and then treated for 2 weeks.The experimental group was given high-dose L-T4 treatment,50 µg/time,orally,once a day.After 2 weeks,the dose of L-T4 tablets was increased to the maximum dose of 100 µg/time according to the TSH level,orally,once a day,and then treated for2 weeks.Both groups were treated for4 weeks.The clinical effi-cacy of the two groups was compared.The levels of coagulation function indexes[activated partial thromboplastin time(APTT),thrombin time(TT),prothrombin time(PT),fibrinogen(FiB)]and serum thyroid hormones[TSH,free thyroxine(FT4),free triiodothyronine(FT3)]were observed before and 4 weeks after treatment.The adverse maternal and infant outcomes and adverse reactions were compared between the two groups.Results The total effective rate of the experimental group was 95.83％,which was higher than that of the control group(79.17％),and the difference was statistically significant(P＜0.05).After 4 weeks of treatment,the levels of APTT,TT,PT and FiB in the experimental group were(30.65±3.29)s,(12.89±1.48)s,(11.26±1.35)s,(2.66±0.29)g/L,respectively,which were lower than those in the control group[(32.44±3.55)s,(13.65±1.60)s,(12.05±1.40)s,(2.82±0.31)g/L],the differences were statistically significant(P＜0.05).After 4 weeks of treatment,the serum TSH level in the experimental group was(2.44±0.26)mIU/L,which was lower than that in the control group[(2.58±0.28)mIU/L],the serum FT4 and FT3 levels in the experimental group were(12.74±1.49)and(4.63±0.49)pmol/L,respectively,which were higher than those in the control group[(11.95±1.44)and(4.39±0.44)pmol/L],the differences were statistically significant(P＜0.05).The incidence of total adverse maternal and infant outcomes in the observation group was 4.17％,which was lower than that in the control group(18.75％),and the difference was statistically significant(P＜0.05).The incidence of adverse maternal and infant outcomes in the observation group was 4.17％,which was lower than that in the control group(18.75％)(P＜0.05).There was no statistically significant difference in the incidence of total adverse reactions between the experimental group and the control group(12.50％vs.6.25％)(P＞0.05).Conclusion High dose of L-T4 is effective in the treatment of hypothyroidism during pregnancy,which can effectively improve the coagulation function of pregnant women,correct abnormal thyroid hormone levels,reduce adverse maternal and infant outcomes,and has a high safety.
基金项目
安徽省卫生健康委科研项目资助(AHWJ2021b119)
NETL
NSTL
万方数据