左甲状腺素钠片治疗妊娠期亚临床甲减的有效性、安全性分析

Effectiveness and safety analysis of levothyroxine sodium tablet for subclinical hypothyroidism in pregnancy

目的 探讨妊娠期亚临床甲状腺功能减退症(甲减)患者采用左甲状腺素钠片治疗的效果和用药安全性。方法 76例妊娠期亚临床甲减患者,采用随机数字表法分为对照组和观察组,每组38例。对照组患者给予常规治疗,观察组患者在对照组基础上加用左甲状腺素钠片进行治疗。对比两组甲状腺功能指标[促甲状腺激素(TSH)、游离甲状腺素(FT4)、甲状腺过氧化物酶抗体(TPOAb)]、妊娠期间并发症发生情况、妊娠结局、随访6个月存活胎儿发育状况[智力发育指数(MDI)以及运动发育指数(PDI)],统计观察组药物不良反应。结果 治疗前,两组TSH、FT4、TPOAb水平对比差异无统计学意义(P>0.05);治疗后,观察组的TSH(2.41±0.31)mIU/L、TPOAb(65.16±9.18)IU/ml均低于对照组的(3.40±0.69)mIU/L、(156.26±22.07)IU/ml, FT4(14.85±0.25)pmol/L高于对照组的(14.41±0.32)pmol/L,差异具有统计学意义(P<0.05)。观察组妊娠期间并发症发生率为2.63%,低于对照组的15.79%,差异具有统计学意义(P<0.05)。观察组剖宫产率10.53%、早产率2.63%、流产率0均低于对照组的28.95%、15.79%、10.53%,而胎儿存活率100.00%高于对照组的89.47%,差异具有统计学意义(P<0.05)。观察组随访6个月存活胎儿的MDI(121.65±11.18)分、PDI(118.63±7.89)分均高于对照组的(105.06±10.95)、(106.32±6.19)分,差异具有统计学意义(P<0.05)。观察组患者用药期间并未出现明显的药物不良反应。结论 妊娠期亚临床甲减患者采用左甲状腺素钠片治疗的效果满意,能够有效改善患者甲状腺功能,并维护母婴健康与安全,且该药物安全性良好。

Objective To discuss the effect and medication safet of levothyroxine sodium tablet for subclinical hypothyroidism in pregnancy.Methods A total of 76 patients with subclinical hypothyroidism in pregnancy were divided into control group and observation group by random numerical table,with 38 cases in each group.Patients in the control group were treated with conventional therapy,and patients in the observation group were additionally treated with levothyroxine sodium tablets on the basis of the control group.Both groups were compared in terms of thyroid function indexes[thyroid-stimulating hormone(TSH),free thyroxine(FT4),thyroid peroxidase antibody(TPOAb)],occurrence of complications during pregnancy,pregnancy outcomes,developmental status[mental development index(MDI)and psychomotor development index(PDI)]at 6-month follow-up.The adverse drug reactions in the observation group were counted.Results Before treatment,there was no statistically significant difference in the levels of TSH,FT4 and TPOAb between the two groups(P>0.05).After treatment,the TSH(2.41±0.31)mIU/L and TPOAb(65.16±9.18)IU/ml in the observation group were lower than(3.40±0.69)mIU/L and(156.26±22.07)IU/ml in the control group,and the FT4(14.85±0.25)pmol/L was higher than(14.41±0.32)pmol/L in the control group.All the differences were statistically significant(P<0.05).The incidence of complications during pregnancy in the observation group was 2.63%,which was lower than 15.79%in the control group,and the difference was statistically significant(P<0.05).The cesarean section rate of the observation group was 10.53%,the premature birth rate was 2.63%,and the miscarriage rate was 0,which were lower than 28.95%,15.79%,and 10.53%of the control group,while the fetal survival rate 100.00%was higher than 89.47%of the control group.All the differences were statistically significant(P<0.05).At 6-month follow-up,the MDI(121.65±11.18)and PDI(118.63±7.89)points of the survival fetuses in the observation group were higher than(105.06±10.95)and(106.32±6.19)points in the control group,and the differences were statistically significant(P<0.05).No significant adverse drug reactions occurred in the observation group.Conclusion The treatment effect of levothyroxine sodium tablets in patients with subclinical hypothyroidism during pregnancy is satisfactory,which can effectively improve the thyroid function of patients,and maintain the health and safety of mother and child,and the drug has good safety.