| Objective:To preliminarily evaluate the effectiveness and safety of the Compound Danshen Dripping Pills in treating non proliferative diabetic retinopathy (syndrome of qi stagnation and blood stasis), as well as to explore the appropriate dose and course.Method:Withing stratified blocked randomization method, layered according to the centers,240 subjects (test drug and the control drug) were arranged at random (i.e. random code table).There were four groups:High dose group:1 bottle (30 pills of Compound Danshen dripping pills) po tid;Middle dose group:1 bottle (20 pills of Compound Danshen dripping pills+10 simulated pills day) po tid;Low dose group:1 bottle (10 pills of Compound Danshen dripping pills+20 simulated pills) po tid;The placebo group:1 bottle (30 simulation pills) po tid. The observer distribute drugs to patients according to the patients’ order and number of drugs. All the patients should obey the comprehensive therapy for diabetes mellitus which was formulated by doctors in Endocrine Department, including diet, exercise, medication and self monitoring of blood glucose. During the test all the traditional Chinese and Western medicines having the same efficacy with Compound Danshen Dripping Pills were forbided (Note:including antiplatelet, anticoagulant and fibrinolytic drugs, and the drugs used to treat diabetic retinopathy etc.)Visit the patients every 4 weeks and take fundus photograph and FFA examination before the test, at the 12th week and the 24th week. To make out the difference in the fundus change, FFA examination, The corrected visual acuity and TCM syndrome integral.Results:1 General situationIn total 223 cases (223 eyes), except 30 cases fall off and 11 cases were excluded, and ultimately included 223 cases (223 eyes) in FAS,182 cases(182 eyes) in PPS. The high dose group included 55 cases-23 males and 32 females-and the average age was 61.97 years old; middle dose treatment group of 56 cases-25 males and 31 females-and the average age was 61 years old; the low dose treatment group of 56 cases- 18 males and 38 females-and the average age was 61.33 years old. The control group of 56 cases-27 males and 29 female-and the average age was 57.41 years old. Baseline data for groups by statistical analysis, there were no significant difference (P>0.05). All the data was comparable.2 FFA effectiveness evaluation:the efficiency and the effective rate of the treatment group was higher than that of the placebo group, and the efficiency and the effective rate was declined along with dose reduction, and the deterioration rate of the placebo group was higher than the treatment groups(P<0.05). Compared the FFA effectiveness evaluation among the groups, thete was no significant difference between the high dose group and middle dose group, nor the low dose group and the control group (P>0.05), however, significant difference was shown in high dose group and middle dose group compared to the control group (P<0.05), as well as high dose group and middle dose group compared to the low dose group (P<0.05).3 The effectiveness evaluation of fundus changes:the efficiency and the effective rate of the treatment group was higher than that of the low dose group and placebo group, and the deterioration rate of the placebo group was higher than the treatment groups(P<0.05).4 The visual acuity improvement:according to visual acuity declined more than 2 lines, the control group was more than the treatment group, while according to the visual acuity improved more than two lines, the treatment groups were more than the control group, however, there was no significant difference(P>0.05).5 Comparison of TCM syndrome curative effect:the total scores were decreased significantly compared the treaments to the control group(P<0.01). There was no significant difference between high dose group and middle does group, not low does group to control group(P>0.05), however, there was significant difference compared high does group and middle does group to the control group, as well as high does group and middle does group to the low group (P<0.05).6 No adverse reaction was found during the test, also did not appear adverse events.Conclusion:1 Compound Danshen dripping pill is effective for the treatment of qi stagnation and blood stasis type NPDR, it can delay the disease development(1) Compound Danshen dripping pill can significantly improve the total retinal circulation time(2) Compound Danshen Dripping Pills have a positive effect on the fundus changes (microvascular disease, macular edema etc.)(3) Compound Danshen dripping pill have a significant curative effect on the TCM syndrome in patients with NPDR2 Taking high doses of Compound Danshen Dripping Pills on the curative effect of qi stagnation and blood stasis type NPDR is better than the low dose group3 Compound Danshen Dripping Pills on qi stagnation and blood stasis type NPDR treatment is safe and reliable... |
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