【目的】 观察消瘿散结颗粒（由四逆散及半夏厚朴汤加味组方而成）治疗气郁痰阻型良性甲状腺结节患者的有效性及安 全性。【方法】 采用回顾性研究方法，根据治疗方法的不同，将 60例气郁痰阻型良性甲状腺结节患者分为观察组和对照组， 每组各30例。对照组仅给予健康知识宣教，观察组在对照组的基础上给予口服消瘿散结颗粒治疗，疗程为12周。观察2组 患者治疗前后中医证候积分、甲状腺结节横截面最大直径及甲状腺功能指标[促甲状腺激素（TSH）、游离三碘甲状腺原氨酸 （FT3）、游离甲状腺素（FT4）]的变化情况，比较 2组患者的临床疗效和不良反应的发生情况。【结果】（1）治疗 12周后，观察 组的总有效率为 73.33%（22/30），对照组为 10.00%（3/30），组间比较（χ2检验），观察组的疗效明显优于对照组（P＜0.01）。 （2）治疗后，观察组的中医证候积分较治疗前明显下降（P＜0.01），甲状腺结节横截面最大直径较治疗前明显缩小（P＜0.01）， 而对照组的中医证候积分及甲状腺结节横截面最大直径均无明显改善（P＞0.05），组间比较，观察组对中医证候积分的下降 程度及对甲状腺结节横截面最大直径的缩小程度均明显优于对照组（P＜0.01）。（3）治疗后，2组患者的血清TSH、FT3、FT4 水平较治疗前均无显著变化（P＞0.05），且组间比较，差异也均无统计学意义（P＞0.05）。（4）治疗过程中，2 组患者均未出 现明显不良反应，具有较高的安全性。【结论】 消瘿散结颗粒对气郁痰阻型良性甲状腺结节患者疗效确切，可明显缩小甲状 腺结节的横截面最大直径，改善患者临床症状，并且不良反应少，安全性高。

Objective To observe the efficacy and safety of Xiaoying Sanjie Granules（derived from the modified Sini San and Banxia Houpo Decoction）in the treatment of patients with benign thyroid nodules of qi stagnation and phlegm obstruction type. Methods A retrospective study was conducted. According to the treatment methods， 60 patients with benign thyroid nodules of qi stagnation and phlegm obstruction type were divided into observation group and control group， 30 cases in each group. The control group was given health training alone， and the observation group was given oral use of Xiaoying Sanjie Granules on the basis of treatment for the control group. The course of treatment covered 12 weeks. The changes of traditional Chinese medicine（TCM）syndrome scores， maximum cross-section diameter of the thyroid nodule and thyroid function indexes of thyroid stimulating hormone （TSH），free triiodothyronine（FT3）and free thyroxine（FT4）in the two groups before and after treatment were observed. After treatment， the clinical efficacy and adverse reactions were compared between the two groups. Results（1）After 12 weeks of treatment，the total effective rate of the observation group was 73.33%（22/30）， and that of the control group was 10.00%（3/30）. The intergroup comparison（tested by chi-square test）showed that the efficacy of the observation group was significantly superior to that of the control group（P＜0.01）.（2）After treatment，the TCM syndrome scores of the observation group were significantly lower than those before treatment （P＜0.01）， and the maximum cross-section diameter of the thyroid nodule was significantly smaller than that before treatment（P＜0.01）. However， no obvious improvement of TCM syndromes and the maximum crosssection diameter of the thyroid nodule was presented in the control group（P＞0.05）. The intergroup comparison showed that the decrease of TCM syndrome scores and the reduction of the maximum cross-section diameter of the thyroid nodule in the observation group were significantly superior to those in the control group（P＞0.05）.（4）During the treatment， no obvious adverse reactions occurred in the two groups， indicating high safety. Conclusion Xiaoying Sanjie Granules exerts certain effects on patients with benign thyroid nodules of qi stagnation and phlegm obstruction type. The granuels are effective on significantly reduce the maximum cross-section diameter of the thyroid nodule，improve the clinical symptoms of patients，and has fewer adverse reactions，with high safety.

R259.813

深圳市科技创新委员会资助项目（编号：JCYJ20190807110803624）；深圳市宝安区科技创新局资助项目（编号：2023JD128）； 深圳市宝安区中医药临床研究专项项目（编号：2023ZYYLCZX-18）