九味散结胶囊治疗桥本甲状腺炎临床研究

Clinical research of jiuwei sanjie capsules in the treatment of Hashimoto's thyroiditis

目的观察九味散结胶囊治疗桥本甲状腺炎(HT)的临床疗效。方法将120例符合HT痰气瘀结证患者随机分为治疗组和对照组,各60例。对照组口服甘露聚糖肽片,治疗组口服九味散结胶囊,疗程均为8周。观察两组患者中医证候积分,甲状腺相关抗体[包括甲状腺过氧化物酶抗体(TPOAb)、甲状腺球蛋白抗体(TGAb)],甲状腺功能[三碘甲状腺原氨酸(TT3)、游离三碘甲状腺原氨酸(FT3)、四碘甲状腺原氨酸(TT4)、游离四碘甲状腺原氨酸(FT4)、促甲状腺激素(TSH)],甲状腺B超(包括左、右叶及峡部厚度),T细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)及不良反应情况。结果两组患者治疗后治疗组总有效率为88.3%,对照组为61.6%,两组比较差异有统计学意义(P<0.05)。两组治疗后中医证候积分、甲状腺抗体均下降,且治疗组低于对照组(P<0.05);治疗后两组TT3、TT4、FT3、FT4水平升高,TSH水平降低,CD4^+、CD4^+/CD8^+细胞亚群数值增加,且治疗组优于对照组,差异具有统计学意义(P<0.05)。结论九味散结胶囊能有效调节甲状腺激素与抗体变化,改善免疫状态,缓解症状,提高患者生活质量。

Objective To observe the clinical therapeutic effects of jiuwei sanjie capsules on Hashimoto＇s thyroiditis(HT）. Methods A total of 120 patients of HT differentiated as stagnation of phlegm and qi were randomized into a treatment group and a control group,60 cases in each one. In the control group,mannatide tablets were prescribed for oral administration. In the treatment group,jiuwei sanjie capsules were prescribed for oral administration. The duration of treatment was 8 weeks. TCM symptoms,the related antibodies of thyroid gland(TPOAb,TGAb）,thyroid functions(TT3,FT3,TT4,FT4 and TSH）,the ultrasonic B test of thyroid gland(thickness of the left and right leaves as well as the isthmus）,T cell subsets(CD4＋,CD8＋,CD4＋/CD8＋） as well as adverse reactions were observed in the patients of the two groups. Results The total effective rate was 88. 3% in the treatment group and was 61. 6% in the control group after treatment,indicating the significant difference(P 〈 0. 05）. After treatment,TCM symptom score and thyroid antibodies were all reduced.The results in the treatment group were lower than the control group(P 〈 0. 05）. After treatment,the levels of TT3,FT3,TT4 and FT4 were increased,TSH decreased and CD4＋,CD8＋and CD4＋/CD8＋increased in the two groups. The results in the treatment group were better than the control group,indicating the significant differences(P 〈 0. 05）. Conclusion Jiuwei sanjie capsules effectively regulate thyroid hormone and antibodies,improve immunity and living quality and relieve the symptoms of the patients.