【摘要】：目的:觀察復(fù)方丹參滴丸治療氣滯血瘀型非增殖期糖尿病性視網(wǎng)膜病變(DR)的安全性、有效性。方法:本試驗采用隨機對照的實驗設(shè)計,將符合納入標(biāo)準(zhǔn)的48例本院眼科門診及住院的氣滯血瘀型非增殖期DR患者,按照隨機化原則分為兩組,實驗組24人,對照組24人。治療期間兩組患者均根據(jù)情況接受降糖、降壓、降脂等基礎(chǔ)治療,控制自身基礎(chǔ)疾病。實驗組患者24例24眼,服用復(fù)方丹參滴丸,對照組患者24例24眼服用羥苯磺酸鈣分散片,療程6個月。觀察兩組患者治療前后視力、眼底、眼底熒光造影、中醫(yī)癥候等療效指標(biāo)的變化。血、尿、便常規(guī)、眼壓、心電圖等安全指標(biāo)。采用spass19.0軟件包對最終取得的數(shù)據(jù),進行統(tǒng)計學(xué)分析。結(jié)果:治療6個月后,治療組患者視力明顯提高,與對照組相比,差異有統(tǒng)計學(xué)意義。經(jīng)治療后,實驗組患者視力改善率為91.67%,對照組視力改善率為62.5%,實驗組明顯優(yōu)于對照組;治療組患者中醫(yī)癥候緩解的有效率為87.5%,高于對照組的45.83%,兩組有顯著差異;兩組眼底出血及微血管瘤的情況經(jīng)治療均有好轉(zhuǎn),治療組眼底改善的有效率87.5%,對照組有效率58.33%,治療組療效優(yōu)于對照組;治療組視網(wǎng)膜循環(huán)時間改善的有效率79.16%,對照組有效率66.67%,治療組視網(wǎng)膜循環(huán)時間改變明顯,兩組差異顯著;兩組患者總有效率分別是治療組83.33%,對照組66.67%,兩組組間比較,差異有統(tǒng)計學(xué)意義。治療過程中,兩組患者均未發(fā)生有臨床意義的安全問題。結(jié)論:復(fù)方丹參滴丸能夠提高氣滯血瘀型非增殖期糖尿病性視網(wǎng)膜病變患者視力,改善眼底情況,有效率高于羥苯磺酸鈣組。復(fù)方丹參滴丸能夠改善非增殖期糖尿病性視網(wǎng)膜病變患者的視網(wǎng)膜循環(huán)時間,但與羥苯磺酸鈣組相比較療效無顯著差異。復(fù)方丹參滴丸能緩解非增殖期糖尿病性視網(wǎng)膜病變氣滯血瘀證患者的中醫(yī)癥候,且療效明顯高于羥苯磺酸鈣組。復(fù)方丹參滴丸治療非增殖期氣滯血瘀非增殖性糖尿病性視網(wǎng)膜療效確切,安全可靠,且療效比羥苯磺酸鈣更顯著。
[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.
【學(xué)位授予單位】：長春中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R259;R276.7

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