加味门冬清肺饮联合左甲状腺素钠片治疗桥本甲状腺炎气阴两虚证临床研究

Clinical Study on Modified Mendong Qingfei Decoction Combined with Levothyroxine Sodium Tablets in Treatment of Hashimoto’s Thyroiditis with Qi-yin Deficiency Syndrome

目的观察加味门冬清肺饮联合左甲状腺素钠片治疗桥本甲状腺炎气阴两虚证临床疗效。方法采用随机数字表法将70例患者分为治疗组和对照组各35例。对照组予左甲状腺素钠片,每次12.5μg,每日1次,口服;治疗组在对照组基础上予加味门冬清肺饮,每日1剂,每日2次,口服。2组均连续治疗3个月。评价2组临床疗效,观察2组治疗前后甲状腺体积、中医症状积分及血清游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)、甲状腺过氧化物酶抗体(TPOAb)、甲状腺球蛋白抗体(TGAb)、免疫球蛋白G4(IgG4)水平,监测2组不良反应。结果治疗组总有效率为91.4%(32/35),对照组为74.3%(26/35),2组比较差异有统计学意义(P<0.05)。与本组治疗前比较,2组治疗后甲状腺体积明显缩小(P<0.01);2组治疗后比较,治疗组甲状腺体积明显小于对照组(P<0.01)。与本组治疗前比较,2组治疗后FT3、FT4、TPOAb、TGAb、IgG4水平及中医症状积分明显下降,TSH水平明显上升(P<0.01);2组治疗后比较,治疗组上述指标均优于对照组(P<0.01)。2组均未见严重不良反应。结论加味门冬清肺饮联合左甲状腺素钠片治疗桥本甲状腺炎气阴两虚证临床疗效显著,安全性较高,其机制可能与下调患者自身抗体、IgG4水平,降低免疫反应,缩小甲状腺体积相关。

Objective To observe the clinical efficacy of modified Mendong Qingfei Decoction combined with levothyroxine sodium tablets for Hashimoto's thyroiditis with qi-yin deficiency syndrome.Methods Totally 70 patients were divided into treatment group and control group according to random number table method,with 35 cases in each group.The control group was given levothyroxine sodium tablets,12.5μg per time,once a day,orally,while the treatment group was given modified Mendong Qingfei Decoction on the basis of the control group,one dosage per day,twice a day,orally.The treatment for both groups lasted for three months.The clinical efficacy in the two groups was evaluated.Thyroid volume,TCM symptom scores,free triiodothyronine(FT3),free tetraiodothyroxine(FT4),thyroid stimulating hormone(TSH),thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TGAb)and serum immunoglobulin G4(IgG4)levels of both groups before and after treatment were observed.Adverse reactions of both groups were monitored.Results The total effective rate was 91.4%(32/35)in the treatment group and 74.3%(26/35)in the control group,with statistical significance(P<0.05).Compared with before treatment,the thyroid volume decreased after treatment in both groups;After treatment,the thyroid volume in the treatment group was significantly smaller than that in the control group(P<0.01).Compared with before treatment,the FT3,FT4,TPOAb,TGAb,IgG4 levels and TCM symptom scores were all reduced significant in the groups,while the TSH levels increased significantly(P<0.01);After treatment,the above indexes in the treatment group were significantly better than those in the control group(P<0.01).No serious adverse reactions occurred in both groups.Conclusion Modified Mendong Qingfei Decoction combined with levothyroxine sodium tablets have confirmed clinical efficacy for the treatment of Hashimoto's thyroiditis with qi-yin deficiency syndrome,with high safety.Its mechanism may be related to down-regulating patients'autoantibodies and IgG4 levels,reducing immune response,and reducing thyroid volume.