| Thyroid associated ophthalmopathy(TAO)is an autoimmune orbital inflammatory disease.Although mild to moderate TAO affects the patient’s visual function,it can lead to orbital remodeling and destroy the adjacent tissue structure,affect the appearance and eye movement,cause diplopia,and seriously affect the patient’s quality of life.At present,the mainstream treatment is mainly oral hormone,local medication and risk factors.However,TAO patients are still facing problems such as recurrence and uncontrollable progress of disease.The disease is more common among the elderly,and may be accompanied by underlying diseases such as diabetes and hypertension.Multidisciplinary intervention has become a consensus in the treatment of the disease.Seeking safer and effective intervention measures is still a research hotspot.Acupuncture combined with pricking collaterals and bloodletting therapy has been used in the treatment of TAO for many years.It has the effect of dredging eyes and collaterals and regulating yin and Yang.Therefore,this study was conducted to evaluate the effect of this therapy on TAO and its possible therapeutic mechanism,in order to provide evidence-based basis for clinical application.PurposeA single blind,randomized controlled trial was conducted to compare the effects of acupuncture combined with collateral puncture and bloodletting therapy and triamcinolone acetonide retrobulbar injection on the clinical symptoms and quality of life of mild to moderate TAO.The possible therapeutic mechanism was further explored by measuring serum hyaluronic acid(HA).MethodFrom December 2020 to March 2022,43 patients with TAO were randomly divided into 22 cases in the experimental group and 21 cases in the control group.On the basis of local use of sodium hyaluronate and symptomatic treatment of endocrine diseases,the experimental group was treated with acupuncture combined with collateral puncture and bloodletting(acupuncture for 1 week/3 times and bloodletting for 1-2 weeks/time),and the control group was injected with triamcinolone acetonide for 1 month/time.Both groups were treated for 12 weeks.The primary efficacy index was exophthalmos,and the secondary efficacy indexes were upper corneal light spot distance,ocular muscle diameter,TAO activity scale(CAS Ⅱ),TAO quality of life questionnaire(GO-QOL)and serum HA.ResultFour patients were excluded for violating the study protocol,and the remaining 39 patients completed the study,including 20 patients in the experimental group and 19 patients in the control group.Intra-group comparison:1 Eye protrusion:After treatment,the eye protrusion in both groups was significantly reduced compared with before treatment,with statistical significance(t1=5.249,P 1=<0.001,t2=2.072,P2=0.048);2 The distance of upper corneal reflection point was significantly reduced in both groups after treatment compared with before treatment,with statistically significant differences(t1=2.193,P1=0.041,t2=2.136,P2=0.047).3 Eye muscle diameter:After treatment,the upper rectus muscle,lower rectus muscle and inner rectus muscle of experimental group were significantly decreased compared with before treatment(tup=-2.474,Pup=0.023,tdown=3.835,Pdown=0.001,tinside=3.493,Pinside=0.002),and the lower rectus muscle of control group was significantly decreased compared with before treatment(t=2.714,P=0.014).There was no significant difference in the diameter of external rectus muscle between the experimental group and the control group(P>0.05).4 TAO activity(CAS Ⅱ score):After treatment,the total CAS score of the experimental group was significantly lower than that before treatment,and the difference was statistically significant(t=4.524,P=0.002),while the total CAS score of the control group was not statistically significant(t=1.564,P=0.135).5 Quality of life of TAO patients(GO-QOL):After treatment,the total score of the scale,living ability and psychological evaluation scores of the 2 groups were significantly improved compared with before treatment(t1toal=-3.801,P1total=0.001,t1life=-4.045,P1life<0.001,t1psychological=-3.374,P1psychological=0.001,t2total=-4.040,P2total<0.001,t2life=-2.747,P2life=0.013,t2psychology=-2.854,P2psychology=0.011);6 HA:there was no statistically significant difference in peripheral HA content between the two groups before and after treatment(t1=0.900,P1=0380,t2=1.351,P2=0.193).Comparison between groups(non-inferiority test):1 The difference of eyeball protrusion before and after treatment:the experimental group was not inferior to the control group(95%CI-0.1351-0.65,CL-0.135>0.0.3,qualified in non-inferiority test);2 Distance difference of upper corneal reflection point before and after treatment:the experimental group was not inferior to the control group(95%CI-0.590～0.830,CL-0.590<-0.3,non-inferiority test failed);3 Eye musCLe diameter difference before and after treatment:Superior rectus musCLe:the experimental group was not inferior to the control group(95%CI-0.118-0.258,CL-0.118>-0.15,qualified in non-inferiority test);Lower rectus:the experimental group was not inferior to the control group(95%CI-0.030,0.570,CL-0.030<-0.15,non-inferiority test failed);Inner rectus musCLe:the experimental group was not inferior to the control group(95%CI-0.136-216,CL-0.136>-0.15,qualified in non-inferiority test);External rectus:the experimental group was not inferior to the control group(95%CI-0.185-0.185,CL-0.185<-0.15,non-inferiority test failed);4 Difference of CAS Ⅱ score before and after treatment:it is not considered that the experimental group is not inferior to the control group(95%CI-0.580-1.300,CL0.580<-0.15,non-inferiority test fails);5 GO-QOL score difference before and after treatment:the experimental group was not inferior to the control group(95%CI-0.118-0.258,CL-0.118>-0.15,qualified in non-inferiority test);6 Ha difference:it cannot be considered that the test group is not inferior to the control group(95%CI-16.735～16.244,CL-16.735<-3,non-inferiority test failed).Comparison between groups(superior effectiveness test):1.The difference of ocular protrusion before and after treatment was not statistically significant between the two groups(t=-1.425,P=0.163);2.The difference between the superior and internal rectus muscles before and after treatment:there was no statistical significance between the two groups(t=-1.320,P=0.195,t=-0.330,P=0.743);3.GO-QOL score difference before and after treatment:GO-QOL score of the experimental group after treatment was significantly better than that of the control group,with statistical significance(t=-7.474.P=0.001)Conclusion1 For patients with mild to moderate TAO,compared with periorbital triamcinolone acetonide injection,acupuncture combined with puncture and bleeding therapy can effectively relieve the symptoms of exophthalmos,hypertrophy of upper and inner rectus muscles,and the latter is not worse than the former,and avoids the risk of hormone,which can be used as an alternative therapy for mild to moderate TAO:2 Compared with triamcinolone acetonide periorbital injection,acupuncture combined with puncture and bloodletting therapy has more advantages in improving the overall quality of life of patients;3 No significant effect of acupuncture combined with puncture and bloodlet therapy and hormone periorbital injection on HA concentration in peripheral blood of mild to moderate TAO was observed. |
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