柴胡旋覆花汤干预桥本甲状腺炎的随机对照盲法研究

A randomized controlled blind study of Chaihu Xuanfuhua Decoction for intervention of Hashimoto's thyroiditis

目的对中药柴胡旋覆花汤干预桥本甲状腺炎(HT)免疫损伤的临床疗效进行客观评价。方法筛选30例HT合并亚临床/临床甲状腺功能减退患者,采用随机信封法按1∶1分为中药组与对照组。2组均采用替代治疗,对照组加用安慰剂,中药组予柴胡旋覆花汤颗粒治疗,均以8周为1个疗程。分别在治疗前后及24周、2年随访,比较2组甲状腺功能及相关抗体的变化,并统计替代治疗剂量。结果治疗后及随访24周、2年,柴胡旋覆花汤中药组患者血清促甲状腺素(TSH)、甲状腺过氧化物酶抗体(TPOAb)、甲状腺球蛋白抗体(TGAb)水平较治疗前显著下降(P<0.05);治疗8周,2组间TSH差异无统计学意义(P>0.05),TPOAb、TGAb差异有统计学意义(P<0.05);随访24周,2组间TSH、TPOAb、TGAb差异均有统计学意义(P<0.05);随访2年,2组间TSH、TGAb差异无统计学意义(P>0.05),TPOAb差异有统计学意义(P<0.05)。中药组治疗8周、随访24周、2年服用优甲乐剂量均较治疗前下降(P<0.05)。结论柴胡旋覆花汤可干预桥本甲状腺炎患者的免疫损伤。

Objective To objectively evaluate the clinical efficacy of Chaihu Xuanfuhua Decoction in intervention of Hashimoto's thyroiditis(HT)immune injury.Methods 30 patients with HT combined with subclinical/clinical hypothyroidism were selected and divided into traditional Chinese medicine group and control group with 1:1 by random envelope method.Both two groups were treated on the basis of replacement therapy.The control group was given a placebo,and the Chinese medicine group was treated with Chaihu Xuanfuhua Decoction.Participants will be treated for 8 weeks,and followed up for 24 weeks and 2 years.The changes o£thyroid function and related antibodies before and after treatment were compared between the two groups,and the replacement therapy doses of the two groups were counted.Results Compared with pre-treatment,the serum thyroid stimulating hormone(TSH),thyroid peroxidase antibody(TPOAb)and thyroglobulin antibody(TGAb)of patients in the Chaihu Xuanfuhua Decoction group after the treatment for 8 weeks and follow-up for 24 weeks and 2 years were significantly decreased(P<0.05);after 8 weeks of treatment,there was no statistically significant difference in TSH between the two groups(P>0.05),and the difference in TPOAb and TGAb was statistically significant(P<0.05);for follow-up for 24 weeks,the difference in TSH,TPOAb and TGAb between the two groups was statistically significant(P<0.05).After 2 years of follow-up,there was no statistically significant difference in TSH and TGAb between the two groups(P>0.05).The difference in TPOAb was statistically significant(P<0.05).In the traditional Chinese medicine group treated for 8 weeks,followed up for 24 weeks,and 2 years,the dose of Youjiale was lower than that before treatment(P<0.05).Conclusion Chaihu Xuanfuhua Decoction can intervene the immune damage of patients with Hashimoto's thyroiditis.