| Objective:Wei’s macular edema decoction has been used for 20 years in our department to treat DME and the feedback from patients’ satisfaction is high.In order to further clarify the clinical efficacy of Wei’s macular edema decoction,this study was designed as a prospective randomised controlled trial to treat phlegm-blood stasis type CI-DME with macular edema decoction combined with intravitreal injection of Lucentis or intravitreal injection of Lucentis alone.The clinical efficacy of the macular edema decoction in the treatment of DME was analysed by observing and comparing the changes in visual function,macular-related thickness index,intraocular pressure and traditional Chinese medicine syndrome score before and after the intervention in the two groups,in the hope of providing objective clinical evidence for Wei’s macular edema decoction in the treatment of DME.Finally,it is expected to improve the visual quality of patients,reduce the times of injecting drugs into vitreous cavity,and reduce the economic and psychological burden for patients.The development of new ideas and methods for the treatment of this type of disease in TCM ophthalmology.Methods:From June 2022 to January 2023,42 patients with CI-DME who met the requirements of this study in the ophthalmology department of Dongfang Hospital of Beijing University of Chinese Medicine were randomly assigned to the test and control groups.In the experimental group,macular edema decoction combined with Lucentis was injected into vitreous cavity,in which Chinese medicine was used to promote blood circulation and removing blood stasis,diuresis and dispel dampness;The traditional Chinese medicine is composed of Shenqi Wuling decoction,Peel of Chen Pi,Radix Bupleurum and Panax notoginseng.Chinese medicine granules are taken orally once in the morning and once in the evening for a treatment period of 4 weeks,and the control group received only intravitreal injections of Lucentis.Best corrected visual acuity,central subfield thickness,cube volume and cube average thickness were recorded before treatment and at 2 weeks and 4 weeks after treatment for intra-group and inter-group comparisons between the two groups before treatment,at 2 weeks and at 4 weeks of treatment respectively.TCM syndrome scores and Intraocular pressure value were recorded before treatment and at 4 weeks of treatment for the two groups.The TCM syndrome scores and IOP values of the two groups were recorded before and after treatment for 4 weeks.The safety evaluation was whether the patient had a positive reaction in the anterior segment at any time during the trial period(the grade of anterior chamber cells was 0.5+～2+,and the grade of aqueous humor flashing was 1+～2+).Whether there is eye pain and vision loss,ciliary congestion and hyphema;Whether there is gastrointestinal discomfort;Whether there are abnormal changes in intraocular pressure,etc.Results:1.Baseline indicators:The differences between the two groups were not statistically significant in terms of gender composition,age distribution,eye selection and pretreatment observations(P>0.05),meaning both groups were comparable.2.Observable indicators:(1)TCM syndrome score of phlegm and blood stasis:The scores of the experimental group at each time point before treatment and at 4 weeks of treatment were 17±1.67 and 10±1.64 respectively,and the values were significantly lower after treatment compared to those before treatment,with statistically significant differences,(P<0.001);The scores in the control group were 17.38±1.99 and 16.9±1.87 at each time point before and after treatment respectively.No significant difference was found between the traditional Chinese medicine syndrome scores of the control group before and after 4 weeks of treatment(P=0.204).Significant differences were found between the test group and the control group when compared to the TCM evidence scores after 4 weeks of treatment(P<0.001).(2)Central subfield thickness:The values of the experimental group before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 400.95±120.90,322.05±94.52 and 267.81±61.75 respectively.Statistically significant change in central subzone thickness at 2 weeks of treatment in the test group compared to pre-treatment thickness(P<0.001)and the central subfield thickness after treatment for 4 weeks was strikingly higher than that after treatment.The values of the control group before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 379.24±138.65,347.57±122.51 and 326.43±98.58 respectively.In the control group,the change in central subfield thickness after two weeks of treatment was statistically significant compared with the pre-treatment value(P<0.001),while the change in central subfield thickness at four weeks of treatment was statistically significant compared with that before treatment(P<0.001).A statistically significant change in central subzone thickness at 4 weeks of treatment compared to thickness at 2 weeks of treatment(P=0.002)The comparison of values between the test and control groups was not statistically significant before treatment(P=0.406).The values were not statistically significant in the test group compared to the control group at 2 weeks of treatment(P=0.314)and statistically different in the test group compared to the control group at 4 weeks of treatment(P=0.01).(3)Cube average thickness:The values of the experimental group before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 348.57±62.98,309.67±51.46 and 279.91±53.55 respectively.The cube average thickness in the experimental group after treatment for 2 weeks was statistically different from that before treatment(P<0.001),and after treatment for 4 weeks,the cube average thickness was statistically significant.The values of the control group before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 343.48±73.84,331.91±68.36 and 317.91 ±49.59 respectively.The cube average thickness area at 2 weeks of therapy in the control group was statistically significant(P<0.001),and that at 4 weeks of treatment was statistically different from the change in thickness before treatment(P<0.001).The comparison of values between the test and control groups before treatment was not statistically significant(P=0.40).The comparison of values between the test and control groups at 2 weeks of treatment was not statistically meaning(P=0.247),and Values in the test group were statistically different from those in the control group at 4 weeks of treatment(P=0.004).(4)Cube volume:The values of the experimental group before treatment,2 weeks after treatment and 4 weeks after treatment were 12.55±2.26,11.96± 2.05 and 11.08±1.63 respectively.The cube volume change in the test group at 2 weeks of treatment was statistically significant compared to pre-treatment(P<0.001),and the change in cubic volume at 4 weeks of treatment compared to 2 weeks of treatment was statistically significant(P<0.001).The control group’s values before treatment,at 2 weeks of treatment and for 4 weeks were 12.50±2.70,12.00±2.27 and 11.66±2.15 respectively.The changes of cube at 2 weeks of treatment compared to pre-treatment was statistically significant in the control group(P<0.001).In addition the change in cubic volume at 4 weeks of treatment compared to pre-treatment was statistically different(P<0.001),the comparison of values between the test and control groups before treatment was not statistically significant(P=0.50).No statistically significant difference between the test and control groups at 2 weeks of treatment(P=0.90),and no statistically significant difference between the test and control groups at 4 weeks of treatmen(P=0.42)as well.(5)Best corrected vision:The values of the experimental group before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 0.24±0.29,0.2 6±0.30 and 0.28±0.32 respectively.The change of the best corrected vision in the experimental group after 2 weeks of treatment was statistically significant(P=0.007),and Statistically significant difference in change in best corrected visual acuity from pre-treatment at 4 weeks of treatment(P=0.002),Moreover the improvement in best corrected visual acuity over 4 weeks of treatment was statistically significant(P=0.042).Control group values before treatment,after treatment for 2 weeks and after treatment for 4 weeks were 0.20±0.14,0.25±0.14 and 0.24±0.18 respectively.Statistically significant change in best corrected visual acuity in the control group after 2 weeks of treatment(P=0.003),and was statistically different after 4 weeks of treatment.(P=0.004).Before the treatment,there was no statistical difference between the experimental group and the control group(P=0.38),but after 2 weeks of treatment(P=0.336)and after 4 weeks of treatment(P=0.502).(6)Intraocular pressure:The values of the experimental group before treatment and after treatment for 4 weeks were 16.00±2.87 and 15.44±2.51 respectively.For 4 weeks,there was no significant difference in IOP between the experimental group and the pre-treatment group.(P=0.421).The values of the control group before and after 4 weeks of treatment were 15.11±2.23 and 14.60±1.89 respectively,and after 4 weeks of treatment,there was no statistical difference in intraocular pressure(P=0.370).No statistical difference between experimental group and control group before treatment(P=0.217),and that was no statistical difference between the experimental group and the control group following treatment for 4 weeks(P=0.229).(7)Overall effective rate:The overall effectiveness of the experimental group was 95%and that of the control group was 76%.According to the Chi-square test for continuous correction,P=0.049(<0.05),the overall curative effect of the two groups was statistically different.Conclusion:It was found that whether Wei’s macular edema decoction combined with intravitreal injection of Lucentis or intravitreal injection of Lucentis alone can effectively improve the central subfield thickness,cube average thickness,cube volume and the best corrected vision.The experimental group has clear advantages over the control group in the improvement of TCM syndromes of phlegm and blood stasis,the central subfield thickness and the cube average thickness after 4 weeks of treatment.From the statistical point of view,the experimental group does not have a significant advantage compared to the with the control group in cube volume and best corrected vision.In summary,Wei’s macular edema decoction combined with intravitreal injection of Lucentis in the treatment of CI-DME with phlegm and blood stasis has obvious advantages in improving patients’ TCM syndromes and related indexes of macular thickness.And has therapeutic safety.In the further perspective,this is helpful to improve the visual quality of patients. |
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