| ObjectiveProspective randomized parallel controlled clinical study method is used to observed the prevention and control effect of ShiNing oral liquid on mild and moderate myopia in children,using IOL-Master to study the refractive components of myopia children,to objectively evaluate the therapeutic effect of ShiNing oral liquid,and to explore its mechanism,to explore more effective interventions for children myopia prevention and control plan.MethodsCollect the myopic children who met the inclusion criteria were choiced between April 2019 to December 2019 in Guangdong Provincial Hospital.The myopic children in the treatment group were divided into the treatment group and the control group according to the random classification.After observation of 3 period of treatment,compared two groups of myopic children before and after treatment of vision,diopter,adjustment sensitivity,adjustment amplitude,axial length,keratometry,astigmatism,anterior chamber depth.Results:This study included 55 cases,105 eyes,including the treatment group of 28 cases,53 eyes,the control group of 27 cases,52 eyes,comparing the baseline comparison in myopic children of two groups such as gender,age,to be found it is no difference by statistical analysis.(P>0.05),there is the comparability between the two groups.1.Treatment efficacy:After 3 courses of treatment,2 eyes in the treatment group were cured,3 showed obvious effect,12 improved,and 36 had no effect.The total effective rate was 32.1%.In the control group,0 eyes were cured,0 showed obvious effect,2 improved,and 50 had no effect.The total effective rate was 3.8%.The curative effect of the treatment group was better than that of the control group(P<0.01).2.Vision:the vision of the treatment group before and after treatment were0.40(0.23,0.50)、0.45(0.28,0.50),the vision of the control group before and after treatment were 0.30(0.20,0.50)、0.30(0.20,0.48).Comparison between groups,the median visual acuity of the treatment group(M=0.50)after treatment was higher than that of the control group(M=0.30),and the difference was statistically significant(Z=-2.341,P=0.019<0.05).The visual acuity improvement of mild myopia and moderate myopia was different between the two groups.The visual acuity improvement of mild myopia was better than that of moderate myopia.Comparison in the group,there were statistically difference in visual acuity between the two groups before and after treatment(all P<0.05).The visual acuity after treatment was better than before treatment in both groups.3.Diopter(unit:D):the diopter of the treatment group before and after treatment were-1.75(-2.75,-1.25)、-2.00(-2.75,-1.25),the diopter of the control group before and after treatment were-1.63(-2.68,-1.06)、-1.75(-2.94,-1.25).Comparison between groups,the median diopter M=-2.00 in the treatment group was lower than that in the control group,but there was no statistical difference(Z=-0.351,P=0.754>0.05).There was no difference in diopter between the two groups.Comparison in the group,there was no statistical difference before and after treatment in the treatment group(Z=-0.914,P=0.441>0.05),but there was difference in the control group(Z=-4.347,P=<0.001).4.Adjustment sensitivity(unit:cpm):the adjustment sensitivity of the treatment group before and after treatment were 5.00(4.00,6.00)、9.00(8.00,10.00),the adjustment sensitivity of the control group before and after treatment were 5.00(3.00,6.00)、7.00(6.00,8.00).Comparison between groups,the median value of adjustment sensitivity in the treatment group was 9.00 higher than that in the control group(M=7.00),and the difference was statistically significant(Z=2.884,P=0.004<0.05).Comparison in the group,there were statistically difference in adjustment sensitivity between the two groups before and after treatment(all P<0.001).5.Adjustment amplitude(unit:D):The adjustment amplitude of the treatment group before and after treatment were 2.75(1.75,4.00)、5.25(3.88,7.25),the adjustment amplitude of the control group before and after treatment were 1.25(1.00,3.00)、2.25(1.56,4.25).Comparison between groups,the median adjustment amplitude in the treatment group was higher than that in the control group(M=5.25),with a statistical difference(Z=-5.595,P<0.001).Comparison in the group,there were statistically difference in adjustment sensitivity between the two groups before and after treatment(all P<0.001).6.Axial length(AL,unit:mm):The AL of the treatment group before and after treatment were 24.22(23.55,24.59)、24.25(23.64,24.69),the AL of the control group before and after treatment were 24.09(23.64,24.78)、24.20(23.74,24.92).Comparison between groups,there was no statistical difference in the AL between the two groups after treatment(P>0.05).Comparison in the group,there were statistically significant differences in AL between the two groups before and after treatment.The median improvement of the AL of the eye in the treatment group was M=0.08,while that in the control group was 0.14,showing a statistical difference(P<0.05).The AL growth rate of the eye in the treatment group was slower than that in the control group.7.Min keratometry(K1,unit:D):The K1 of the treatment group before and after treatment were 43.21(42.48,44.31)、43.16(42.14,44.30).,the K1 of the control group before and after treatment were 43.44(41.86,44.36)、43.50(41.85,44.29).Comparison between groups,there was no statistical difference between the two groups after treatment(Z=-0.392,P=0.696>0.05).Comparison in the group,there was no statistical difference in the comparison of K1 between the two groups before and after treatment(all P>0.05).8.Max keratometry(K2,unit:D):The K2 of the treatment group before and after treatment were 43.16(42.14,44.30)、44.35(42.92,45.30),the K2 of the control group before and after treatment were 43.50(41.85,44.29)、44.60(42.86,45.35).Comparison between groups,there was no statistical difference between the two groups after treatment(Z=-0.328,P=0.744>0.05).Comparison in the group,there was no statistical difference in the comparison of K2 between the two groups before and after treatment(all P>0.05).9.Astigmatism(unit:D):The astigmatism of the treatment group before and after treatment were 1.13(0.90,1.53)、1.08(0.77,1.40),the astigmatism of the control group before and after treatment were 1.12(0.81,1.54)、1.07(0.83,1.33).Comparison between groups,there was no statistical difference between the two groups after treatment(Z=274,P=0.787>0.05).Comparison in the group,the comparison of dispersion before and after treatment was statistically significant in the treatment group(Z=-3.729,P<0.05),while there was no statistically significant difference in the control group(Z=-0.275,P=0.799>0.05).10.Anterior chamber depth(ACD,unit:mm):The ACD of the treatment group before and after treatment were 3.58(3.48,3.74)、3.60(3.49,3.74),the ACD of the control group before and after treatment were 3.60(3.49,3.74)、3.65(3.50,3.79).Comparison between groups,there was no statistical difference between the two groups after treatment(Z=-1.608,P=0.108>0.05).Comparison in the group,there was no significant difference in anterior chamber depth before and after treatment in the treatment group(Z=-1.352,p=0.179>0.05),while there was a difference in the control group(Z=-2.360,P=0.017<0.05).11.Safety evaluation:During the treatment,allergic reactions,side effects and adverse reactions occurred in both groups were all zero.Conclusion:1.The treatment of ShiNing oral liquid combined with Wearing glasses significantly improved the myopic children’s vision more than wear glasses.However,there was no significant difference in improving diopter between the two groups.2.Both the treatment group and the control group could significantly improve the myopic children’adjustment ability.ShiNing oral liquid combined with wearing mirror treatment group was significantly better than the control group in adjustment sensitivity and adjustment amplitude,but there was no statistically significant difference in improving refractive components between the two groups.3.There were statistically significant differences between the intra-group comparison of the treatment group and the control group in improving visual acuity,diopter,adjustment sensitivity,adjustment amplitude and amplitude of axial length4.The mechanism of improving the visual acuity of children with mild and moderate myopia is to improve the ability of adjusting refraction and to control the rate of axial growth.5.NO adverse reactions occurred in the process of treatment either in the group of ShiNing oral liquid combined with Wearing glasses and the group of Wearing glasses,it shows both the treatments are safety. |
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