递法明片联合复方樟柳碱治疗糖尿病视网膜病变的临床研究

Clinical study on Difaming Tablets combined with anisodine in treatment of diabetic retinopathy

目的探讨递法明片联合复方樟柳碱治疗糖尿病视网膜病变的有效性与安全性。方法选取2017年1月—2018年1月遂宁市中心医院接诊的130例(171眼)糖尿病视网膜病变患者作为研究对象,两组患者根据随机数字化原则分成对照组和治疗组,每组各65例。对照组患者给予复方樟柳碱注射液,每次取2 m L于患侧颞浅动脉旁皮下注射,1次/d。治疗组患者在对照组治疗基础上口服递法明片,3片/次,2次/d。两组患者均连续治疗1个月。观察两组的临床疗效,比较两组治疗前后视力水平、视野平均缺损程度、血清脂联素、超敏C反应蛋白(hs-CRP)及血管内皮生长因子(VEGF)的变化情况。结果治疗后,对照组和治疗组的总有效率分别是84.71%、95.35%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者视力水平显著提高,视野平均缺损程度、脂联素、hs-CRP及VEGF水平显著降低,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组视力水平显著高于对照组,视野平均缺损程度、血清脂联素、hs-CRP及VEGF水平显著低于对照组,两组比较差异具有统计学意义(P<0.05)。对照组和治疗组的不良反应发生率分别为13.85%、3.08%,两组比较差异具有统计学意义(P<0.05)。结论递法明片联合复方樟柳碱治疗糖尿病视网膜病变具有较好的临床疗效,可显著改善患者眼底病变程度,抑制患者体内炎症反应水平,具有一定的临床推广应用价值。

Objective To explore the efficacy and safety of Difaming Tablets combined with anisodine in treatment of diabetic retinopathy. Methods Patients（76 cases, 171 eyes） with diabetic retinopathy in Suining Central Hospital from January 2017 to January 2018 were randomly divided into control（65 cases） and treatment（65 cases） groups according to the difference of treatment. Patients in the control group were sc administered with Compound Anisodine Hydrobromide Injection on ill lateral superficial temporal artery, 2 m L/time, once daily. Patients in the treatment group were po administered with Difaming Tablets on the basis of the control group, 3 tablets/time, twice daily. Patients in two groups were treated for 1 month. After treatment, the clinical efficacy was evaluated, and the changes of visual acuity, mean visual field defect, serum adiponectin, hs-CRP and VEGF in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment group were 84.71% and 95.35%, and there were differences between two groups（P 〈 0.05）. After treatment, visual acuity was significantly increased in two groups, but mean visual field defect, serum adiponectin, hs-CRP and VEGF were significantly decreased in two groups, and there were differences in the same group（P 〈 0.05）. After treatment, visual acuity in the treatment group was higher than that in the control group, but mean visual field defect, serum adiponectin, hs-CRP and VEGF in the treatment group were lower than those in the control group, and there were differences between two groups（P 〈 0.05）. After treatment, the adverse reaction rate in the control and treatment groups was 13.85% and 3.08%, and there were differences between two groups（P 〈 0.05）. Conclusion Difaming Tablets combined with anisodine has significant clinical effect in treatment of diabetic retinopathy, and can significantly improve the fundus lesions degree and inhibit the level of inflammatory response, which has a certain clinical application value.