逐瘀固本方治疗肾虚血瘀型糖尿病黄斑水肿的随机对照临床研究

Zhuyu Guben Decoction in treating diabetic macula edema of type of kidney deficiency and blood stasis:A randomized controlled clinical study

目的评价逐瘀固本方治疗肾虚血瘀型糖尿病黄斑水肿的临床疗效。方法选择2019年6月—2020年4月在石家庄市中医院治疗的肾虚血瘀型糖尿病黄斑水肿患者60例(120眼),采用随机数字表法将患者分为观察组30例(60眼)和对照组30例(60眼),2组均依照中国糖尿病防治指南原则进行基础治疗。在此基础上,观察组给予逐瘀固本方口服,对照组给予安慰剂口服,2组均连续治疗3个月。观察2组治疗前后中医症状积分、黄斑中心厚度(CMT)、最佳矫正视力(BCVA)、玻璃体液中血管内皮生长因子(VEGF)水平、血糖指标[空腹血糖(FPG)、糖化血红蛋白(HbA1c)]以及肝肾功能指标(谷草转氨酶、谷丙转氨酶、尿素氮、肌酐)变化。结果与治疗前比较,治疗后观察组中医症状积分、CMT及玻璃体液中VEGF、FPG、HbA1c水平均显著降低(P均<0.05),BCVA显著增高(P<0.05),对照组上述指标均无明显变化(P均>0.05);2组治疗后比较,观察组中医症状积分、CMT及玻璃体液中VEGF、FPG、HbA1c水平均显著低于对照组(P均<0.05),BCVA显著高于对照组(P<0.05)。2组治疗后肝肾功能指标均无明显变化(P均>0.05)。结论逐瘀固本方治疗肾虚血瘀型糖尿病黄斑水肿可以明显改善患者的中医症状,提高患眼视力,降低黄斑中心厚度及血糖,降低眼内VEGF可能是其作用机制。

Objective It is to evaluate the clinical efficacy of Zhuyu Guben Decoction in the treatment of diabetic macular edema of type of kidney deficiency and blood stasis.Methods Sixty patients(120 eyes)with diabetic macular edema of type of kidney deficiency and blood stasis treated in Shijiazhuang Hospital of Traditional Chinese Medicine from June 2019 to April 2020 were selected and divided into observation group including 30 patients(60 eyes)and control group including 30 cases(60 eyes)by random number table method.Both groups received basic treatment in accordance with the principles of Chinese diabetes prevention and treatment guidelines.Additionally,the observation group was given Zhuyu Guben Decoction orally,and the control group was given a placebo orally.Both groups were treated for 3 consecutive months.The changes in scores of TCM symptoms,central macular thickness(CMT),best corrected visual acuity(BCVA),the levels of vascular endothelial growth factor(VEGF)in vitreous humor,blood glucose indicators[fasting blood glucose(FPG),glycosylated hemoglobin(HbA1c)]and liver and kidney function indicators(aspartate aminotransferase,alanine aminotransferase,urea nitrogen,creatinine)were observed before and after treatment in the two groups.Results Compared with before treatment,the TCM symptom scores,CMT and the levels of VEGF,FPG,and HbA1c in vitreous humor in the observation group after treatment were significantly reduced(P<0.05),and BCVA was significantly increased(P<0.05),no significant changes in the above indicators were found in the control group(all P>0.05);the scores of TCM symptoms,CMT and vitreous VEGF,FPG,and HbA1c levels in the observation group were significantly lower than those in the control group after treatment(all P<0.05),and the BCVA was significantly higher than that in the control group(P<0.05).There were no significant changes in liver and kidney function indexes in the two groups after treatment(all P>0.05).Conclusion Zhuyu Guben Decoction can significantly improve the symptoms of TCM,improve the visual acuity of the affected eye,reduce CMT and blood sugar in the treatment of diabetic macular edema of type of kidney deficiency and blood stasis,and reduce intraocular VEGF may be its mechanism of action.