| Objective:Accurately evaluate the safety and effectiveness of treatment of retinal vein occlusion "fundus bleeding"(the obstruction of collaterals by blood stasis and the internal heat due to Yin deficiency)with Zhixuequyumingmu Tablet.Methods:The subject adopted the trial design of randomized,double-blind and double-dummy,multi-center.The patients diagnosed with retinal vein occlusion "fundus hemorrhage"(obstruction of collaterals by blood stasis,Internal Heat Due to Yin Deficiency)who meet our inclusion and exclusion criteria were divided into trial group and control group according to Stratified blocked randomization method.The trial group were treated with Zhixuequyumingmu Tablet and stimulant ofCompound Xueshuantong Capsule,the control group were treated with Compound Xueshuantong Capsule and stimulant of Zhixuequyumingmu Tablet.The period of treatment was 12 weeks,and the period of follow-up was 12 weeks.The observation target were the changes of the area of fundus bleeding,vision,retinal circulation time,syndrome of traditional Chinese medicine(TCM),the thickness of macular central concave of the two groups of patients before and after treatment.at the same time,we also detected vital signs,blood routine,urinalysis,stool routine,liver and kidney function and electrocardiogram for drug safety evaluation.Results:The subject contained 9 centers and planned adopting 336 patients.In the end,there were 292 patients meet our standard.This paper only analyze the data of 3 centers which planned adopting 88 patients,and in the end there were 87 patients meet our standard.82 patients of RVO who meet our exhaust standard were randomly divided into trial group(60)and control group(22)by ratio(3:1),except 5 lost cases due to fail to fellow-up.The baseline data both gender and age of RVO between trail group and control group are comparable after statistics analysis(P>0.05).1.Area of fundus bleeding comparison:there was no statistically difference of comparison between the two groups at every period(P>0.05),while the difference of comparison within treatment and control group was statistically significant(P<0.05).There was no obvious statistically difference of comparison between the two groups for CRVO patients before and after treatment(P>0.05).Area of fundus bleeding of BRVO patients were significantly reduced than before treatment both in the treantment group and in the control group.Difference are ststistically significant between the two groups(P<0.05).There were obvious statistically difference of comparison within group for the two groups for CRVO and BRVO before and after groups(P<0.05).2.Vision comparison:the marked effective rate and effective rate in treatment group were 28.33%(17/60),33.33%(20/60),while in control group were 27.27%(6/22),40.91%(9/22).The difference of comparison between groups was not statistically significant with P=0.797.Total vision effective rate after treatment:the treatment group(marked effective +effective)was61.66%(37/60),control group was68.18%(15/22).Vision had improved at 4th week,8th week,12th week:treatment group was 21.67%(13/60),56.67%(34/60),85.00%(51/60);the control group was 18.18%(4/22),59.09%(13/22),81.82%(18/22).At 12th week,the difference of comparison between the two groups was statistically significant(P=0.031).At each observation point,the difference of comparison within treatment group and control group before and after treatment were statistically significant(P<0.05).3.Retinal circulation time comparison:the retinal circulation time of treatment group and control group before treatment were 25.50±12.67s,25.31±10.63s,after treatment were 20.66±11.39s,21.45± 10.09s.There was no statistically significant of comparison between groups before and after treatment(before treatment P=0.951,after treatment P=0.774).There were no statistically significant of comparison between groups for CRVO and BRVO(P>0.05).The difference of comparison within treatment group before and after treatment was statistically significant for two types of RVO(P<0.01),the difference of comparison within control group before and after treatment was not statistically significant for CRVO and BRVO(P>0.05).4.The changes of the syndrome in TCM of the two groups of patients before and aftertreatment:the total effective rate of TCM syndrome of the treatment group at the 4th week,8th week,12th weekwere23.33%(14/60),43.33%(26/60),68.33%(41/60);the control group were 13.64%(3/22),40.91%(9/22),59.09%(13/22).The difference of comparison between the two groups was not statistically significant(P>0.05).5.The changes of the thickness of macular central concave of the two groups of patients before and after treatment:the CRT of treatment group and control group before treatment were330.68±1 56.61(?m)and 348.27±171.00(?m).the CRT of treatment group and control group after treatment were328.00±137.98(?m)and 326.14±163.12(?m).The comparison between groupsand within the groups before and after treatmenthad no statistical difference(P>0.05).6.Safety evaluation:the treatment group and control group patients in the process of drug use and observation did not appear any adverse reactions and adverse events.Liver and kidney function,blood routine,urinalysis,stool routine and electrocardiogram all did not appear abnormal before and after treatment.Conclusion:1.Zhixuequyumingmu Tablet and Compound Xueshuantong Capsule can effectively improve patients' absorption of fundus hemorrhage,improve vision and general symptoms of RVO"fundus bleeding" defined asthe obstruction of collaterals by blood stasis and the internal heat due to Yin deficiency,and the longer the treatment time the more obvious the improvement.2.Zhixuequyumingmu Tablet can effectively improve the retinal circulation time of RVO patients.3.Zhixuequyumingmu Tablet was better than Compound Xueshuantong Capsule in improving BRVO patients' absorption of fundus hemorrhage.4.There were no adverse reactions or adverse events in the process of taking Zhixuequyumingmu Tablet. |
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