世界中医药

目的：探索小金胶囊联合左甲状腺素钠治疗结节性桥本氏甲状腺炎（HT）的疗效、安全性与作用机制。方法：选取2015年3月至2016年2月荆州市中心医院收治的中医辨证为气滞血瘀痰凝，且甲状腺功能正常或减低的结节性桥本氏甲状腺炎患者共240例，按随机数字表法，以1:1的比例随机分为观察组和对照组，每组120例。对照组给予左甲状腺素钠片治疗，起始剂量为25 μg/d，2周后调整为50 μg/d，之后每月复查1次甲状腺功能，并根据检测结果调整剂量。观察组在对照组基础上给予小金胶囊治疗，每日剂量9粒，即早餐后4粒，晚餐后5粒，每月连用21 d为1个疗程，停药7～10 d后继续下1个疗程，每月复查甲状腺功能与自身抗体，连续3个月甲状腺功能与抗体水平均恢复正常或治疗9个月抗体水平仍未下降，则减量至每日7粒，即早餐后3粒，晚餐后4粒，共治疗12个月。比较2组有效率，治疗前后甲状腺最大结节长径，中医症状评分，中医症状完全缓解率，甲状腺功能，甲状腺自身抗体、IL-8、IL-10水平，甲状腺癌的发生率和不良事件发生率。结果：共231例患者完成了研究，其中对照组完成研究115例。观察组临床治愈率显著高于对照组（P<0.05）；治疗后观察组最大结节长径明显缩小（P<0.05）；观察组甲状腺结节消失率（40.5%）高于对照组（P<0.05）；观察组中医临床症状评分减少值高于对照组（P<0.05）；2组甲状腺功能均改善（P<0.05），但组间比较差异无统计学意义（P>0.05）；治疗后观察组甲状腺自身抗体、IL-8、IL-10水平均下降（P<0.05），对照组均无改变（P>0.05），组间比较差异均有统计学意义（P<0.05）；治疗后观察组甲状腺癌发生率低于对照组（P<0.05）；观察组不良事件发生率低于对照组（P<0.05）。结论：小金胶囊具有调节Th1/Th2的平衡，减少甲状腺自身抗体的作用，与左甲状腺素钠联合，治疗甲状腺功能正常或减低的HT疗效确切，安全性良好。

English Summary:

To explore the efficacy，safety and mechanism of Xiaojin capsule in the treatment of nodular Hashimoto's thyroiditis.Methods:A total of 240 patients from Mar.2015 to Feb 2016 in Jinzhou Central Hospital with nodular Hashimoto's thyroiditis were included who were characterized by qi stagnation，blood stasis，phlegm coagulation，and thyroid function normal or reduce.They were randomly assigned to the observation group or the control group evenly according to the random number table.The control group was treated with Levothyroxine Sodium Tablets，and the initial dose was 25 μg/d，and then adjusted to 50 ug/d after 2 weeks.Then the thyroid function was rechecked once a month，and the dosage was adjusted according to the thyroid function.The observation group was treated with Xiaojin capsule on the basis of the control group，9 grains/d (0.35 g/ granules)，4 after breakfast，5 after dinner，21 days as a course of treatment，and continued for the next course after withdrawal for 7-10 days.The thyroid function and autoantibody were reexamined every month.When the thyroid function and antibody level were restored to normal for 3 months or the level of the 9 month antibody remained unchanged，it was reduced to 7 tablets daily，3 after breakfast and 4 after dinner.The total treatment time was 12 months.This efficiency，maximum thyroid nodule length，TCM symptom score，complete remission rate of TCM symptoms，thyroid function，thyroid autoantibody，IL-8，IL-10 levels，the incidence of thyroid cancer and the incidence of adverse events were observed.Results:A total of 231 patients completed the study，of which 115 cases were completed in the control group，2 cases were lost，3 cases were withdrawn.116 cases were completed in the observation group，3 cases were lost and 1 case was withdrawn from the study.The shedding rate and lost visit rate were comparable in the two group (P>0.05).There were no significant differences in sex，age，course of disease，TCM syndrome score，thyroid function，thyroid autoantibody level and color Doppler ultrasound before treatment in the two groups (P>0.05).The clinical cure rate of the observation group was significantly higher than that of the control group (P<0.05).After treatment，the length of the largest nodule in the observation group was narrowed more significantly (P<0.05).The disappearance rate of thyroid nodules in the observation group (40.5%) was significantly higher than that in the control group (P<0.05).The reduction of clinical symptom scores in the observation group was significantly higher than that in the control group (P<0.05).The thyroid function of the two groups was significantly improved (P<0.05)，and there was no significant difference between the two groups (P>0.05).The level of thyroid autoantibody in the observation group was significantly decreased (P<0.05)，but the control group did not significantly change (P>0.05)，and there was a significant difference between the groups (P<0.05).The level of IL-8 in the observation group decreased significantly (P<0.05)，while that in the control group did not change significantly (P>0.05)，and the difference between the two groups was statistically significant (P<0.05).The level of IL-10 in the observation group increased significantly (P<0.05)，while that in the control group did not change significantly (P>0.05)，and the difference between the two groups was statistically significant (P<0.05).After treatment，the incidence of thyroid cancer in the observation group was significantly lower than that in the control group (P<0.05).The incidence of adverse events in the observation group was significantly lower than that in the control group (P<0.05).Conclusion:Xiaojin capsule can regulate the balance of Th1/Th2 and reduce the level of thyroid autoantibody.It is effective and safe in treating nodular Hashimoto's thyroiditis with normal or reduced thyroid function，combined with levothyroxine sodium.It is worthy of promotion in clinical practice.

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