复方丹参滴丸治疗非增殖期糖尿病性视网膜病变（气滞血瘀证）的临床研究

发布时间：2019-02-24 08:49

【摘要】：目的:观察复方丹参滴丸治疗气滞血瘀型非增殖期糖尿病性视网膜病变(DR)的安全性、有效性。方法:本试验采用随机对照的实验设计,将符合纳入标准的48例本院眼科门诊及住院的气滞血瘀型非增殖期DR患者,按照随机化原则分为两组,实验组24人,对照组24人。治疗期间两组患者均根据情况接受降糖、降压、降脂等基础治疗,控制自身基础疾病。实验组患者24例24眼,服用复方丹参滴丸,对照组患者24例24眼服用羟苯磺酸钙分散片,疗程6个月。观察两组患者治疗前后视力、眼底、眼底荧光造影、中医症候等疗效指标的变化。血、尿、便常规、眼压、心电图等安全指标。采用spass19.0软件包对最终取得的数据,进行统计学分析。结果:治疗6个月后,治疗组患者视力明显提高,与对照组相比,差异有统计学意义。经治疗后,实验组患者视力改善率为91.67%,对照组视力改善率为62.5%,实验组明显优于对照组;治疗组患者中医症候缓解的有效率为87.5%,高于对照组的45.83%,两组有显著差异;两组眼底出血及微血管瘤的情况经治疗均有好转,治疗组眼底改善的有效率87.5%,对照组有效率58.33%,治疗组疗效优于对照组;治疗组视网膜循环时间改善的有效率79.16%,对照组有效率66.67%,治疗组视网膜循环时间改变明显,两组差异显著;两组患者总有效率分别是治疗组83.33%,对照组66.67%,两组组间比较,差异有统计学意义。治疗过程中,两组患者均未发生有临床意义的安全问题。结论:复方丹参滴丸能够提高气滞血瘀型非增殖期糖尿病性视网膜病变患者视力,改善眼底情况,有效率高于羟苯磺酸钙组。复方丹参滴丸能够改善非增殖期糖尿病性视网膜病变患者的视网膜循环时间,但与羟苯磺酸钙组相比较疗效无显著差异。复方丹参滴丸能缓解非增殖期糖尿病性视网膜病变气滞血瘀证患者的中医症候,且疗效明显高于羟苯磺酸钙组。复方丹参滴丸治疗非增殖期气滞血瘀非增殖性糖尿病性视网膜疗效确切,安全可靠,且疗效比羟苯磺酸钙更显著。
[Abstract]:Objective: to observe the safety and efficacy of compound Danshen dropping pills in the treatment of non proliferative diabetic retinopathy (DR) with qi stagnation and blood stasis. Methods: in this experiment, 48 DR patients with Qi stagnation and Blood stasis were randomly divided into two groups according to the principle of randomization: experimental group (n = 24) and control group (n = 24). During the treatment, the patients in both groups were treated with basic treatment such as hypoglycemia, hypotension and lipidemia according to the condition, so as to control their own underlying diseases. 24 eyes of 24 patients in the experimental group were treated with compound Danshen dropping pills, and 24 eyes of the control group were treated with calcium dobesilate dispersible tablets for 6 months. The changes of visual acuity, fundus fluorescein angiography and TCM symptoms were observed before and after treatment. Blood, urine, stool routine, intraocular pressure, electrocardiogram and other safety indicators. The final data was analyzed by spass19.0 software package. Results: after 6 months of treatment, the visual acuity of the patients in the treatment group was significantly improved compared with the control group. After treatment, the improvement rate of visual acuity in the experimental group was 91.67 and that in the control group was 62.5, which was obviously better than that in the control group. The effective rate of TCM symptom relief in the treatment group was 87.5, which was higher than that in the control group (45.83%), and there was a significant difference between the two groups. The condition of fundus hemorrhage and microhemangioma were improved in both groups. The effective rate of fundus improvement was 87.5% in the treatment group and 58.33% in the control group. The curative effect of the treatment group was better than that of the control group. The effective rate of improving retinal circulation time in the treatment group was 79.16 and that in the control group was 66.67. The retinal circulation time in the treatment group changed obviously, and the difference between the two groups was significant. The total effective rate was 83.33 in the treatment group and 66.67 in the control group. The difference between the two groups was statistically significant. In the course of treatment, no clinically significant safety problems occurred in both groups. Conclusion: compound Danshen dropping pills can improve the visual acuity and improve the fundus of patients with non-proliferative diabetic retinopathy of Qi stagnation and blood stasis type, and the effective rate is higher than that of calcium dobesilate group. Compound salvia miltiorrhiza drop pill could improve the retinal circulation time in patients with non-proliferative diabetic retinopathy, but there was no significant difference between the two groups in comparison with calcium dobesilate group. Compound Salvia miltiorrhiza drop pills can relieve the syndrome of qi stagnation and blood stasis in patients with non-proliferative diabetic retinopathy, and the curative effect is obviously higher than that of calcium dobesilate group. Compound Salvia miltiorrhiza drop pill is more effective than calcium dobesilate in the treatment of retina with non-proliferative qi stagnation and blood stasis and non-proliferative diabetes mellitus.
【学位授予单位】：长春中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259;R276.7

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