| Objective: Through clinical randomized controlled trial,to study the clinical efficacy of TCM appropriate techniques(screw acupuncture and auricular point pressing)in preventing and controlling the progression of false myopia to true myopia in children,and to make a preliminary analysis of the mechanism of screw acupuncture and auricular point pressing,in order to provide treatment ideas for clinical reality.Methods: A total of 46 children(92 eyes)were selected from the Ophthalmology Clinic of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine.The time range was limited from March 2020 to June 2021.After examination of equivalent spherical lens ≥-0.50DS(i.e.[0DS,-0.5DS]),patients aged 6-10 years old were selected.Randomized controlled trial design was adopted,and the ratio of TCM appropriate technology group to health education group was 1:1.The grouping of the study was performed using the random number table method,and the samples divided into two groups were randomly assigned.In the experimental group,23 children(46 eyes in total)were treated with traditional Chinese medicine(TCM)technique of screw acupuncture + auricular point pressing pill + health education.In the control group,23 children(46 eyes in total)were treated with child health education only.Both the treatment cycle of TCM appropriate technology group and the publicity and education cycle of health education group regarded 6 weeks as a course of treatment,a total of 2 courses,a total of 12 weeks;The expected follow-up period was 24 weeks,and the total trial period was 36 weeks.The effectiveness evaluation indexes were best corrected visual acuity,diopter(equivalent spherical refraction),axial length,adjustment amplitude and effective rate.In this study,there were three time points in total for the patients in the TCM appropriate technology group and the health education group to observe and evaluate the changes of the above evaluation indicators: before intervention(0W),at the end of intervention(12W)and at the end of treatment(36W).At the same time,depending on the specific situation,6 weeks or 12 weeks as a limit,increase or decrease the observation time point,the comparison between the two groups,to compare the control rate of myopia progression after intervention and the end of follow-up.According to the "Chinese Expert Consensus on femtosecond laser Small Incision Corneal stromal Lens Removal Procedures in China" formulated by The Chinese Journal of Ophthalmology in 2018,the stability of myopia was determined by the annual increase of the spherical lens ≤0.5D,and the increase of the spherical lens ≤0.25 D before intervention and the comparison of the two groups with the 6-meter spherical lens was considered as stable.The two groups were considered stable if the increase of 6m before intervention and during followup was less than 0.25 D.Finally by observing the myopia progress control,namely,stable myopia cases or proportion of the total,as well as the best corrected visual acuity,diopter(equivalent ball for eyeglasses),axial length and amplitude adjustment index,comprehensive evaluation of TCM appropriate technologies(press the needle,ear pills)to control the clinical curative effect of children’s progress to the true sex myopia pseudomyopia.At the same time,this RCT study strictly follows the moral,ethical and scientific principles stipulated in the Declaration of Helsinki.Results: After data extraction and statistical analysis,in terms of the total effective rate,the total effective rate of the experimental group(namely the TCM appropriate technology group)was 97.83%,but the total effective rate of the health education group was 56.52%,which was considered statistically significant(P < 0.05).In terms of ocular axis growth rate(calculated by [(axis length after intervention-axis length before intervention)/axis length before intervention]),the average rate of ocular axis growth rate was 0.09% in 46 eyes of the experimental group(namely,the appropriate technique group of TCM)and 0.79% in 46 eyes of the control group(namely,the health education group).The final data analysis showed that the ocular axis growth rate of the TCM appropriate technology group was lower than that of the health education group,and we believed that the difference was statistically significant(P <0.05).Conclusion :(1)suitable techniques of TCM and health education can improve naked eye visual acuity,but health education alone can not increase or even decrease naked eye visual acuity.(2)Suitable technology of TCM + health education can not change the equivalent spherical lens degree,but can maintain a relatively stable state;However,health education alone could not reduce or even increase the equivalent spherical lens.(3)Suitable techniques of TCM+ health education could not change the ocular axis,but could maintain a relatively stable state of the ocular axis;However,health education alone could not alleviate the ocular axis changes,and even the ocular axis could be raised.(4)Neither suitable technical therapy nor health education can change the adjustment range.(5)Both methods have the effect of improving adolescent myopia,and both can prevent and control the transformation from pseudopyopia to true myopia in children to some extent,but the total effective rate of TCM appropriate technology group is miraculously higher than that of health education group.(6)Among the collected cases,there were no adverse reactions in the TCM appropriate technique group,and its safety was relatively good.However,as the skin needs to be pierced by the acupuncture,more attention should be paid to the acceptance degree and compliance of the children.(7)Conclusion: The suitable techniques of TRADITIONAL Chinese medicine(screw acupuncture and auricular point pressing pill)can obviously prevent and control the progression of pseudopyopia to true myopia in children,and its curative effect is obviously better than health education.There were no adverse events during the treatment,indicating that the suitable techniques of TRADITIONAL Chinese medicine(screw acupuncture and auricular point compression)are safe and worthy of clinical promotion. |
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