左甲状腺素钠联合归脾丸对甲状腺功能减退患者临床疗效及安全性研究

Efficacy and safety of levothyroxine sodium combined with guipi pills in the treatment of hypothyrosis

目的评价左甲状腺素钠联合归脾丸对甲状腺功能减退患者临床疗效及安全性。方法 114例甲状腺功能减退患者随机分为观察组57例与对照组57例,两组均给予常规治疗以及对症治疗,对照组给予左甲状腺素钠片25μg口服,每日一次,连续用药2周后根据患者病情增至50μg。观察组在对照组的基础上给予归脾丸72 g口服,每日三次。两组患者一个周期均为28 d,共治疗6个周期。比较两组临床疗效、治疗前后甲状腺激素、脂代谢指标水平以及不良反应发生情况。结果观察组治疗后的临床总有效率明显高于对照组,差异有统计学意义(χ2=5.02,P<0.05)。观察组患者治疗后血清促甲状腺激素(TSH)、总胆固醇(TC)、甘油三脂(TG)水平均明显低于对照组治疗后,差异均有统计学意义(t分别=4.30、3.18、2.78,P均<0.05)。观察组治疗后的游离三碘甲状腺原氨酸(FT3)、人游离甲状腺素(FT4)水平均明显高于对照组治疗后,差异均有统计学意义(t分别=2.57、2.45,P均<0.05)。两组患者的不良反应发生率比较,差异无统计学意义(χ2=2.71,P>0.05)。结论左甲状腺素钠联合归脾丸治疗甲状腺功能减退患者的临床疗效明显,安全性高。

Objective To evaluate the efficacy and safety of levothyroxine sodium combined with guipi pills in the treatment of hypothyrosis. Methods A total of 114 patients with hypothyrosis were randomly divided into the observation group and the control group with 57 patients in each,and both groups were given regular treatment.The control group was given levothyroxine sodium 25μg oral once a day and after 2 weeks according to the patient＇s condition to 50μg,the observation group was given guipi pills 72 g oral on the basis of the therapy of control group,3 times a day,28 days for a course and patients were treated for 6 courses. The clinical efficacy,thyroid hormone,lipid metabolic indexes and adverse drug reactions between the two groups were compared.Results The clinical efficacy of the observation group was significantly higher than the control group（χ2=5.02,P0.05）. After treatment,the serum level of thyroid-stimulating hormone（TSH）,total cholesterol（TC）,triglycerides（TG） of the observation group were significantly lower than the control group（t=4.30,3.18,2.78,P 0.05）,the serum three free triiodothyronine（FT3）,free thyroxine（FT4） of the observation group were significantly higher than the control group（t=2.57,2.45,P0.05）. The adverse drug reactions was not statistically different between the two groups（χ2=2.71,P0.05）.Conclusion The clinical effect of levothyroxine sodium combined with guipi pills in treatment of hypothyrosis is effective with high safety.