1.Background:Refractive amblyopia is a common type of amblyopia,which includes ametropic amblyopia and anisometropic amblyopia.The incidence rate of amblyopia in children aged 3~10 years in China is 4%~6%,of which refractive amblyopia accounts for about 32.5%.Modern western medicine therapy mainly includes optical correction,covering,drug-induced depression,optical depression,visual therapy,surgical treatment,drug treatment,etc.However,these methods have limitations such as long treatment cycle,poor compliance,adverse drug reactions and controversial efficacy.Traditional Chinese medicine therapy includes traditional Chinese medicine therapy,acupuncture and moxibustion therapy and traditional Chinese medicine combined with acupuncture and moxibustion therapy.However,all types of amblyopia were mainly included in the study,and there were few literatures on the treatment of refractive amblyopia with acupuncture and moxibustion alone.Professor Tian Cong-huo’s experience in the treatment of eye diseases,especially refractive amblyopia,is worthy of further promotion.Therefore,this study is carried out.2.Objective:To evaluate the efficacy and safety of Professor Tian Cong-huo’s "combination of form and spirit" acupuncture in the treatment of mild to moderate refractive amblyopia.3.Method:This study is a non randomized controlled study.According to the patients’conditions and wishes,40 patients with refractive amblyopia were divided into experimental group and control group,with 20 cases in each group.The experimental group was treated with acupuncture combined with fine eyesight training,and the control group was treated with fine eyesight training.Acupoint selection:TE23,B2,ST2,DU20,DU14,GB20,SJ3,ST36.The patients were treated for 8 weeks and followed up for 4 weeks.The main outcome measure of this study was the effective rate after 8 weeks of treatment.At the same time,the uncorrected visual acuity,corrected visual acuity and PedsQL scale at other time points were observed.At the same time,the safety and compliance of patients were evaluated.Spss25.0 statistical software was used to analyze the data.Two sided test was used for statistical test,a=0.05,P<0.05,and the difference was considered to be statistically significant.Measurement data of normal distribution,with mean ± standard deviation(x±s)form,paired sample t-test is used for intra group comparison,and independent sample t-test is used for inter group comparison;The data that do not conform to the normal distribution are expressed in the form of median(P25,P75).The paired rank sum test is used for intra group comparison,and the rank sum test is used for inter group comparison;Counting data are expressed in the form of frequency and frequency(%),and χ2 test is selected.4.Results:4.1 Main outcome indicators:effective rateAfter 8 weeks of treatment,the effective rate of the experimental group was 89.7%and that of the control group was 62.5%.The curative effect of the experimental group was better than that of the control group(P<0.05).4.2 Secondary outcome indicators(1)Naked eye visual acuity:intra group comparison:the naked eye visual acuity of the test group and the control group can be improved after 4 weeks,8 weeks of treatment and 12 weeks of follow-up(P<0.001,P<0.001).Comparison between groups:the experimental group was higher than the control group at 4,8 weeks of treatment and 12 weeks of follow-up(P<0.001).(2)Corrected visual acuity:intra group comparison:the corrected visual acuity of the test group and the control group could be improved after 8 weeks of treatment(P<0.001,P<0.001).Comparison between groups:the experimental group was higher than the control group(P<0.05).(3)PedsQL scale:intra group comparison:the quality of daily life of the patients in the test group and the control group could be improved after 4 weeks,8 weeks of treatment and 12 weeks of follow-up(P<0.001,P<0.001).Comparison between the two groups:there was no significant difference between the two groups at 4,8 weeks of treatment and 12 weeks of follow-up(P>0.05).4.3 Safety evaluationDuring the 8-week treatment period,3 cases of small subcutaneous hematoma occurred in the test group,which were relieved by local cold compress for 20 minutes,12 cases of pinhole hemorrhage,and hemostasis after cotton ball pressing,which did not affect the next treatment.5.Conclusion:(1)Tian Cong-huo’s acupuncture with " the method of form and spirit adjustment"can improve the corrected visual acuity of patients with mild to moderate refractive amblyopia and may improve naked eye vision.(2)Tian Cong-huo’s acupuncture with "the method of form and spirit adjustment"has a certain effect on improving the quality of daily life of patients.(3)Tian Cong-huo’s acupuncture with "the method of form and spirit adjustment"is safe for patients with mild to moderate refractive amblyopia. |