Abstract
OBJECTIVE To observe the clinical efficacy of Sanjie medicinal concoction in paste form(TCM)in treating thyroid eye disease(TED).METHODS A total of 77 patients(149 eyes)with TED of liver depression and blood stasis syndrome type who visited Nanjing Integrated Traditional Chinese and Western Medicine Hospital from March 2023 to March 2024 were enrolled.Participants were randomly divided into a treatment group(TG,39 cases,75 eyes)and a control group(CG,38 cases,74 eyes).The treatment group received oral Sanjie medicinal concoction in paste form(TCM),while the control group received oral Xiaoyao Pills,both for three months.Measurements included clinical activity score(CAS)for Graves'ophthalmopathy,proptosis,palpebral fissure height,upper eyelid retraction,lagophthalmos,blink frequency(complete and incomplete),ocular surface area,ocular surface area(OSA),conjunctival congestion score,corneal fluorescein staining(FL)score,tear film breakup time(BUT),Schirmer Ⅰ test(SⅠT),and ocular surface disease index(OSDI)score,recorded before and after treatment.RESULTS(1)Baseline thyroid parameters:No significant differences in free triiodothyronine,free thyroxine,thyroid-stimulating hormone,thyrotropin receptor antibody,thyroid peroxidase antibody,or thyroglobulin antibody were observed between groups before treatment(all P>0.05).(2)TED-related indicators:After treatment,the treatment group showed significant reductions in exophthalmos,palpebral fissure height,OSA,upper eyelid retraction,lagophthalmos,and CAS score compared to before treatment(all P<0.05).No statistically significant differences were found in the six TED-related indicators of the control group after treatment compared with those before treatment(P＞0.05).After treatment,all six TED-related indicators in the treatment group were lower than those in the control group,the differences were all statistically significant(all P<0.05).(3)Dry eye-related indicators:After treatment,the treatment group showed significant increases in BUT,SⅠT,blink frequency and complete blink count,and significant decreases in incomplete blink count,FL scores,OSDI scores,and conjunctival congestion scores compared to before treatment(all P<0.05).No statistically significant differences were observed in all eight dry eye-related indicators of the control group after treatment compared with those before treatment(P>0.05).After treatment,the treatment group had significantly higher BUT,SⅠT,blink frequency,and complete blink count,and significantly lower incomplete blink count,FL scores,OSDI scores,and conjunctival congestion scores than the control group,the differences were all statistically significant(all P<0.05).(4)TCM syndrome scores:Both groups showed significant reductions in TCM syndrome scores after treatment(P<0.05).After treatment,the TCM syndrome scores were significantly lower in the treatment group than in the control group(P<0.05).(5)Clinical efficacy rate:The total effective rate was higher in the treatment group(94.87%)than that in the control group(57.89%),with significant difference(P<0.05).(6)Safety evaluation:No significant difference in adverse reaction rates was observed between the treatment group and control group(P>0.05).CONCLUSIONS Sanjie medicinal concoction in paste form(TCM)can improve the ocular signs,ocular surface indexes and score scales in patients with TED.关键词
缓消癥结/甲状腺相关眼病/散结膏方/眼征/眼表指标Key words
gradually resolving masses/thyroid eye disease/Sanjie medicinal concoction in paste form(TCM)/ocular signs/ocular surface indices分类
医药卫生
