目的 :观察益气养阴化痰治则组方之消瘿合剂治疗风痰瘀滞、气阴两虚型甲状腺结节(瘿瘤)的疗效及安全性。方法 :共纳入120例患者,随机分为治疗组及对照组各60例,治疗组7例及对照组5例因各类原因脱落,对照组1例因口服优甲乐被剔除,最终纳入统计分析病例数为治疗组53例,对照组54例。治疗组予消瘿合剂治疗,对照组予内消瘰疬丸治疗。两组疗程均为16周,观察治疗后甲状腺结节体积大小改变、中医临床症状改善情况及安全性指标。结果:甲状腺结节缩小总有效率治疗组为69.81%,对照组为48.15%;中医临床症状改善总有效率治疗组为81.13%,对照组为57.40%,两组疗效比较治疗组均优于对照组(P<0.05)。结论 :益气养阴化痰治则组方的消瘿合剂治疗良性甲状腺结节临床疗效良好,安全性高。

Objective:To observe the efficacy and safety of Xiaoying mixture with the traditional Chinese medicine(TCM) therapeutic principle of supplementing qi,nourishing yin and resolving phlegm to treat thyroid nodule of stagnation of wind phlegm and deficiency of qi and yin. Methods:There were 120 patients enlisted,which were randomized into treatment group and control group,60 cases in each group. Seven cases were lost in the treatment group and 5 cases were lost in the control group for various reasons. Besides,1 case in the control group was eliminated for taking euthyrox. Finally,there were 53 cases in the treatment group,54 cases in the control group. The control group was treated with euthyrox while the treatment group was treated with Xiaoying mixture. Both groups were treated for 16 weeks. The change of thyroid nodule volume,improvement of the symptoms and safety index were observed. Results:The total effective rate of thyroid nodules reduction in the treatment group was 69.81%,while that in the control group was 48.15%. The total effective rate of TCM clinical symptom improvement in the treatment group and control group were 81.13%and 57.40%,respectively. The total effective rate in the treatment group was better than that in the control group(P<0.05). Conclusion:Xiaoying mixture with the principle of supplementing qi,nourishing yin,resolving phlegm treating benign thyroid nodules is of good effect and high safety.