健脾化痰活血汤结合左甲状腺素钠片治疗亚临床甲状腺功能减退症临床研究

Clinical study of Jianpi-Huatan-Huoxue Decoction combine with levothyroxine sodium tablets in the treatment of subclinical hypothyroidism

目的评价健脾化痰活血汤结合左甲状腺素钠片治疗亚临床甲状腺功能减退症(subclinical hypothyroidism,SCH)的疗效。方法将符合入选标准的2017年1月-2018年12月广州中医药大学第一附属医院105例SCH患者,采用随机数字表法分为对照组52例和研究组53例。对照组口服左甲状腺素钠片治疗,研究组在对照组基础上加用健脾化痰活血汤。2组均连续治疗3个月。采用双抗夹心ELISA法检测血清促甲状腺激素(thyroid stimulating hormone,TSH)、游离三碘甲状腺原氨酸(free triiodothyronine,FT3)、游离甲状腺素(free thyroxine,FT4)、IL-10、IL-2、IL-2R水平,采用全自动生化分析仪检测血浆TC、TG、LDL-C及HDL-C水平,评价临床疗效。结果研究组总有效率为94.3%(50/53)、对照组为75.0%(39/52),2组比较差异有统计学意义(χ^2=7.601,P=0.006)。治疗后,研究组血清TSH[(4.39±1.05)mU/L比(8.20±2.11)mU/L,t=11.747]水平低于对照组(P<0.01),FT3[(5.53±1.33)μmol/L比(4.15±1.26)μmol/L,t=5.456]、FT4[(18.54±5.56)μmol/L比(16.18±5.12)μmol/L,t=2.261]水平高于对照组(P<0.05);血清IL-10水平高于对照组(t=3.218,P=0.002),IL-2、IL-2R水平低于对照组(t值分别为11.203、3.071,P值均<0.01);血浆TC、TG及LDL-C水平低于对照组(t值分别为2.764、9.473、9.628,P<0.05或P<0.01),HDL-C水平高于对照组(t=5.724,P<0.01)。结论健脾化痰活血汤可明显改善SCH患者的甲状腺功能和血脂水平,调节炎性细胞因子水平,提高疗效。

Objective To evaluate the clinical effect of Jianpi-Huatan-Huoxue Decoction combine with levothyroxine sodium tablets in the treatment of subclinical hypothyroidism(SCH).Methods According to the random digital table method,105 patients with SCH from January 2017 to December 2018 in the First Affiliated Hospital of Guangzhou University of Chinese Medicine were divided into control group(52 cases)and research group(53 cases).The control group was treated by takinglevothyroxine sodium tablets orally,while the research group was treated with Jianpi-Huatan-Huoxue Decoction based oncontrol group.The two groups both were treated for 3 months.The clinical efficacy of the two groups were evaluated and compared.The content of TSH,FT3,FT4,IL-10,IL-2 and IL-2R were detected by double antibody sandwich ELISA.The content of TC,TG,LDL-C and HDL-C were detected by automatic biochemical analyzer.Results The total effective rate was 94.3%(50/53)in the research group and 75.0%(39/52)in the control group,and the difference between the two groups was statistically significant(χ^2=7.601,P=0.006).After the treatment,the content of TSH(4.39±1.05 mU/L vs.8.20±2.11 mU/L,t=11.747)in the research group was significantly lower than the control group(P<0.05),the content of FT3(5.53±1.33μmol/L vs.4.15±1.26μmol/L,t=5.456)and FT4(18.54±5.56μmol/L vs.16.18±5.12μmol/L,t=2.261)were significantly higher than the control group(P<0.05),the serum level of IL-10 was significantly higher than the control group(t=3.218,P=0.002),and the levels of IL-2 and IL-2R were significantly lower than the control group(t=11.203,2.849,P<0.05),the levels of TC,TG and LDL-C were significantly lower than the control group(t=2.764,9.473,9.628,P<0.05),and the levels of HDL-C was significantly higher than the control group(t=4.506,P<0.05).Conclusions Jianpi-Huatan-Huoxue Decoction can improve the thyroid function and blood lipid level of patients with SCH,regulate the level of inflammatory factors,and improve the curative effect.