| Objective:To evaluate the efficacy and safety of the stasis-dissipating and phlegm-removing method (No.l decoction for Retinal Vein Obstruction) for the treatment of RVO of phlegm-stasis Syndrome.Methods:The trial is designed abide by the principle of random and control. Patients diagnosed with retinal vein occlusion (RVO) who meet our inclusion and exclusion criteria were randomly divided into trial group and control group according to the simple randomization method. Control group were treated with conventional western medicine treatment only while the experimental group were treated with the combination therapy of Chinese traditional medicine No.l decoction for RVO(the Stasis-dissipating and Phlegm-removing Method) and conventional western medicine. The period of observation is 12 weeks. The observation target are the vision, fundus, syndrome of traditional Chinese medicine(TCM), fundus fluorescence angiography (FFA), optical coherence tomography(OCT) of the two groups of patients before and after treatment and then evaluate the clinical efficacy. We detect safety indexes including vital signs, blood routine, urine routine, stool routine, hepatic and renal function, electrocardiogram (ECG) for drug safety evaluation at the same time.Results:Except 10 lost cases because of fail to fellow-up,67 patients of RVO who meet our inclusion and exclusion criteria were included.32 cases were in trial group and 35 in control group. There was no significant difference on baseline data such as gender, age, type of RVO between trail group and control group after statistics analysis(P> 0.05). Baseline data are comparable.1.Vision comparison:The cure rate, marked effective rate and effective rate in treatment group are 21.88%(7/32),31.25%(10/32),25.00%(8/32), while in control group are 11.43%(4/35),8.57%(3/35),14.29%(5/35). The difference of comparison between groups was statistically significant with P= 0.001. Total vision effective rate after treatment:the treatment group is 78.12%(25/32), the control group is 34.29%(12/35). Vision has improved at 4th week,8th week,12th week:treatment group was 59.38% (19/32),87.50%(28/32),81.25%(26/32); the control group was 31.43%(11/35),48.57% (17/35),57.14%(20/35). In each period, vision improvement between groups was statistically significant, treatment group is better than control group (P< 0.05).2.Area of fundus bleeding comparison:All of the two groups of patients were fundus bleeding before treatment. Patients of the fundus bleeding area≤10PD,10-20PD,> 20PD in treatment group were 31.25%(10/32),37.50%(12/32),31.25% (10/32) respectively, while in the control group were 51.43%(18/35),34.29%(12/35), 14.29%(5/35). There was no statistically significant difference between groups before treatment with P= 0.054. Treatment group and control group each have 1 case of retinal hemorrhage with full absorption after treatment of 12 weeks. Patients of the fundus bleeding area≤10PD,10-20PD,>20PD after treatment in experimental group were 75.00%(24/32),18.75%(6/32),3.13%(1/32) respectively, while in the control group were 71.43%(25/35),8.57%(3/35),17.14%(6/35). Fundus bleeding area at the 12th week were significantly reduced than before treatment both in the treatment group and in control group. Difference are statistically significant within groups (the experimental group P< 0.001. the control group P= 0.033). There is no statistical difference between groups with P= 0.535.3. Retinal circulation time comparison:The retinal circulation time of experimental group and control group before treatment were 15.5 (7) s,17 (10) s respectively, after treatment were 14 (7) s,13 (5) s respectively. There is no significant statistical difference between groups before and after treatment(before treatment P= 0.338, after treatment P= 0.431). There is significant statistical difference within groups before and after treatment with P=0.025 in treatment group and P<0.001 in control group.4. Macular edema comparison:There were 14 cases of no macular edema in two groups both before and after treatment.9 cases were in treatment group and 5 cases in control group. There were 2 cases in treatment group 7 cases in control group occurred macular edema after treatment while there was no macular edema before treatment. Compared with before treatment,5 cases in experimental group and 11 cases in control group with macular edema were cured after treatment. Statistical analysis of patients with macular edema before treatment(44cases) shows that the central macular retinal thickness (CRT) in treatment group and control group before treatment were 449.43±132.83 um and 481.52±133.12 um, after the were 341 (232) um and 302 (175) um respectively. There is significant statistical difference in control group before and after treatment(P<0.05) while there is no statistical difference in treatment group(P= 0.322). CRT between the two groups of patients before and after the treatment is no significant statistical difference (P> 0.05).5.Evaluation of new blood vessels:One case with BRVO in control group occurred new blood vessels in the treatment process among all of the 67 cases. Laser photocoagulation treatment was carried out in the follow-up after treatment. There were no new blood vessels happening during the rest of the patients.6. Syndrome of TCM comparison:The total effective rate of TCM syndrome at 4th week, 8th week,12th week treatment group was 21.88%(7/32),68.75%(22/32),93.75% (30/32); the control group was 5.71%(2/35),22.86%(8/35),28.57%(10/35). Contrast difference of the total effective rate of TCM syndrome in the treatment of 8th week,12th week between groups is statistically significant (8th week P< 0.001,12th week P< 0.0001).7. No adverse reactions occurred in the process of treatment either in trail group or in contrast group and there were no obvious abnormal security laboratory indexes before and after treatment.Conclusion:1. No.l decoction as an adjuvant treatment for RVO (the stasis-dissipating and phlegm-removing method) can improve the RVO patients’vision, promote the absorption of retinal hemorrhage effectively, and the longer the treatment time the more obvious the improvement.2. No.l decoction as an adjuvant treatment for RVO (the stasis-dissipating and phlegm-removing method) can improve retinal circulation time of RVO, while the treatment effect is no better than pure western medicine treatment.3. No.1 decoction for RVO (the stasis-dissipating and phlegm-removing method) can definitely improve the syndromes of patients of RVO defined as phlegm and blood stasis.4. There were no adverse reactions or adverse events in the process of taking No.1 decoction for RVO. It’s safe and reliable. |
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