【目的】评价清肝消瘿明目膏治疗肝火旺盛型活动期甲状腺相关眼病（TAO）的临床疗效及安全性。【方法】采用回顾性 队列设计，纳入2023 年1 月至2025 年6 月期间在深圳市宝安区中医院内分泌科就诊的108 例肝火旺盛型活动期TAO 患者，根 据治疗方案的不同将患者分为观察组与对照组，每组各54 例。所有患者均给予基础治疗，在此基础上，对照组给予激素（甲 泼尼龙）冲击疗法治疗，观察组给予甲泼尼龙冲击疗法联合清肝消瘿明目膏治疗。2 组均以4 周为1 个周期，共治疗3 个周期 （合计12 周）。观察2 组患者治疗前后眼球突出度、临床活动性评分（CAS）、甲状腺相关眼病生活质量量表（TAO-QOL）评分、 欧洲Graves 眼病专家组（EUGOGO）疾病严重程度分级、甲状腺功能[游离三碘甲状腺原氨酸（FT3）、游离甲状腺素（FT4）、促 甲状腺激素（TSH）]、血清促甲状腺素受体抗体（TRAb）水平及中医证候积分的变化情况，并评价2 组患者的中医证候疗效、 西医临床疗效与用药安全性。【结果】（1）中医证候疗效方面，治疗12 周后，观察组的总有效率为72.22%（39/54），对照组为 42.59%（23/54）；组间比较（χ2 检验），观察组的中医证候疗效明显优于对照组（P＜0.05）。（2）西医临床疗效方面，治疗12 周 后，观察组的总有效率为68.52%（37/54），对照组为38.89%（21/54）；组间比较（χ2 检验），观察组的西医临床疗效明显优于对 照组（P＜0.05）。（3）眼球突出度方面，治疗后，2 组患者的左右两侧眼球突出度均较治疗前有所改善（P＜0.05），且观察组的 改善幅度均明显优于对照组（P＜0.05）。（4）CAS 评分、TAO-QOL 评分与疾病严重程度分级方面，治疗后，2 组患者的CAS 评 分均较治疗前降低（P＜0.05），TAO-QOL 评分均较治疗前升高（P＜0.05），疾病严重程度分级（包括轻度、中重度）均较治疗 前改善（P＜0.05），且观察组对CAS 评分的降低幅度和TAO-QOL 评分的升高程度以及疾病严重程度分级的改善幅度均明显 优于对照组（P＜0.05）。（5）甲状腺功能及TRAb 水平方面，治疗后，2 组患者的FT3、FT4 水平及观察组的TRAb 水平均较治疗 前降低（P＜0.05），而2 组患者的TSH 水平及对照组的TRAb 水平均未见明显改善（P＞0.05）；组间比较，2 组患者治疗后的 FT3、FT4、TSH 均无显著性差异（P＞0.05），但观察组对TRAb 的降低幅度明显优于对照组（P＜0.05）。（6）中医证候积分方 面，治疗后，观察组的中医证候积分较治疗前明显降低（P＜0.05），而对照组较治疗前有降低趋势，但差异无统计学意义 （P＞0.05）；组间比较，观察组对中医证候积分的降低幅度明显优于对照组（P＜0.05）。（7）安全性方面，研究过程中，2 组患 者均未发生严重不良反应，具有较高的安全性。【结论】清肝消瘿明目膏联合激素冲击疗法可有效改善肝火旺盛型活动期 TAO 患者的突眼度，减轻患者的临床症状，提升患者的生活质量及临床有效率，且安全性良好。

Objective To evaluate the clinical efficacy and safety of Qinggan Xiaoying Mingmu（liver-clearing， goiter-dissipating and vision-improving）Soft Extract in the treatment of active thyroid-associated ophthalmopathy （TAO）with liver fire hyperactivity syndrome. Methods A retrospective cohort design was adopted，enrolling 108 patients with active TAO of liver fire hyperactivity syndrome who attended the Department of Endocrinology， Shenzhen Bao’an Traditional Chinese Medicine Hospital Group from January 2023 to June 2025. According to the treatment protocol，the patients were divided into an observation group and a control group，with 54 cases in each group. All patients received basic treatment. On this basis， the control group received hormone （methylprednisolone）pulse therapy，while the observation group received methylprednisolone pulse therapy combined with Qinggan Xiaoying Mingmu Soft Extract. Both groups were treated for 3 cycles（12 weeks），with 4 weeks as one cycle. The changes in proptosis，clinical activity score（CAS），thyroid-associated ophthalmopathy quality of life scale（TAO-QOL）score，European Group on Graves’Orbitopathy（EUGOGO）disease severity classification，levels of thyroid function indicators [free triiodothyronine（FT3），free thyroxine（FT4），thyroid stimulating hormone（TSH）]，serum thyrotropin receptor antibody（TRAb），and traditional Chinese medicine （TCM）syndrome scores were observed before and after treatment in both groups. The TCM syndrome efficacy， western medicine efficacy，and medication safety were evaluated in both groups. Results（1）Regarding TCM syndrome efficacy，after 12 weeks of treatment，the total effective rate was 72.22%（39/54）in the observation group and 42.59%（23/54）in the control group；intergroup comparison（by chi-square test）showed that the TCM syndrome efficacy in the observation group was significantly superior to that in the control group（P＜0.05）. （2）Regarding western medicine efficacy，after 12 weeks of treatment，the total effective rate was 68.52%（37/54） in the observation group and 38.89%（21/54）in the control group；intergroup comparison（by chi-square test） showed that the western medicine efficacy in the observation group was significantly superior to that in the control group（P＜0.05）.（3）Regarding proptosis，after treatment，the proptosis of both eyes of the two groups were improved compared with that before treatment（P＜0.05），and the improvement in the observation group was significantly greater than that in the control group（P＜0.05）.（4）Regarding CAS score，TAO-QOL score，and disease severity classification，after treatment，the CAS scores in both groups decreased compared with those before treatment（P＜0.05），the TAO-QOL scores increased compared with those before treatment（P＜0.05）， and the disease severity classification（including the mild and moderate-to-severe）were improved compared with that before treatment（P＜0.05）. The observation group showed significantly greater reductions in CAS score， increases in TAO-QOL score，and improvements in disease severity classification than the control group（P＜ 0.05）.（5）Regarding thyroid function and TRAb levels，after treatment，the levels of FT3 and FT4 in both groups and the TRAb level in the observation group decreased compared with those before treatment（P＜0.05），while no significant improvements were observed in TSH levels in either group or TRAb level in the control group（P＞ 0.05）. Intergroup comparison showed no significant differences in FT 3，FT4，or TSH levels between the two groups after treatment（P＞0.05），but the reduction in TRAb level in the observation group was significantly greater than that in the control group（P＜0.05）.（6）Regarding TCM syndrome scores，after treatment，the TCM syndrome score in the observation group significantly decreased compared with that before treatment（P＜0.05）， while the control group showed a decreasing trend without statistical significance（P＞0.05）. Intergroup comparison showed that the reduction in TCM syndrome score in the observation group was significantly greater than that in the control group（P＜0.05）.（7）Regarding safety，no serious adverse reactions occurred in either group during the study，indicating a favorable safety profile. Conclusion Qinggan Xiaoying Mingmu Soft Extract combined with hormone pulse therapy can effectively improve proptosis，alleviate clinical symptoms，enhance quality of life，and increase clinical efficacy in patients with active TAO with liver fire hyperactivity syndrome，showing good safety.

R276.7

广东省中医药局科研项目（编号：20241272）；深圳市宝安区科技创新局科研项目（编号：2023JD128，2024JD112）；深圳市宝安 区中医药协会资助项目（编号：2023ZYYLCZX-18）；深圳市宝安区医学会医疗卫生科研项目（编号：BAYXH2024021）