芪明颗粒对气阴两虚型糖尿病视网膜病变患者早期肾损害指标的影响

Effect of Qiming Granule on Early Renal Damage Index in Diabetic Retinopathy Patients with Deficiency of Qi and Yin

目的基于中医"异病同治"理论,观察芪明颗粒对气阴两虚型糖尿病视网膜病变早期肾损害指标的影响,探讨其对糖尿病微血管病变眼、肾同治的有效性及安全性。方法拟选择符合标准的患者90例,随机分为3组,每组各30例。在糖尿病基础治疗之上,研究组1予芪明颗粒,研究组2予渴络欣胶囊,研究组3予芪明颗粒联合渴络欣胶囊。连续治疗3月后,观察3组治疗前后中医证候总积分、视力、眼底体征及早期肾损害指标[胱抑素C(Cys-C)、β2微球蛋白(β2-MG)、24 h尿蛋白定量(24 hUTP)]的变化,同期观察不良反应发生情况。结果共实际完成病例82例,芪明颗粒组27例,渴络欣组28组,联合组27例。3组患者治疗后Cys-C、β2-MG及24 hUTP水平较治疗前均有所降低(P<0.05),3组间治疗后上述指标改善情况相比无显著性差异(P>0.05)。3组间糖尿病肾病治疗有效率相比,差异无统计学意义(P>0.05)。3组间糖尿病视网膜病变治疗有效率相比,芪明颗粒组和联合组均明显优于渴络欣组(P<0.05)。3组患者治疗后中医证候积分较治疗前均明显降低(P<0.001);但3组间治疗后中医证候总有效率相比大致相当,差异无统计学意义(P>0.05)。结论芪明颗粒与渴络欣胶囊均可降低气阴两虚型糖尿病视网膜病变患者早期肾损害指标Cys-c、β2-MG、24 hUTP的表达,改善患者气阴两虚的症状。但相比渴络欣胶囊,芪明颗粒还能有效提高患者的视力,减轻眼底病变,可眼肾同调来防治糖尿病微血管病变,具有较好的疗效性及安全性。但确切结论有待更大样本的多中心的临床研究进行验证。

Objective Based on the theory of"different diseases with the same treatment"in traditional Chinese medicine,the efficacy and safety of Qiming Granules in the treatment of Qi and Yin deficiency type of microangiopathy of the eye and kidney were observed.Methods Ninety patients who met the criteria were selected and randomly divided into 3 groups,30 in each group.Besides the basic treatment of diabetes,the research group 1 was given Qiming Granules.The research group 2 was given Keluoxin Capsule,and the research group 3 was given Qiming Granule combined with Keluoxin Capsule.After 3 months of continuous treatment,the total score of TCM syndromes,visual acuity,fundus signs and early renal damage index Cystatin C(Cys-C),β-2-microglobulin(β-2-MG),24-hour urinary protein(24 hUTP)were observed before and after treatment in the three groups,and the occurrence of adverse reactions were observed at the same time.Results A total of 82 cases were completed,27 cases in research group 1,28 cases in research group 2 and 27 cases in research group 3.The levels of Cys-C,β2-MG and 24 hUTP in the three groups were lower than those before treatment(P<0.05).There was no significant difference between the three groups after treatment(P>0.05).There was no significant difference in the effective rate of treatment of diabetic nephropathy between the three groups(P>0.05).The TCM syndrome scores of the three groups were significantly lower than those before treatment(P<0.001).However,the total effective rate of TCM syndromes after treatment was similar,and the difference was not statistically significant(P>0.05).Conclusion Qiming Granule and Keluoxin Capsule can reduce the expressions of early renal damage indicators Cys-c,β2-MG and 24 hUTP in patients with diabetic nephropathy with Qi and Yin deficiency,and can improve the symptoms of Qi and Yin deficiency.However,compared with the Keluoxin Capsule,Qiming Granule can effectively improve the patient’s vision,reduce the fundus lesions,and can prevent and treat diabetic microangiopathy,which has good curative effect and safety.But the exact conclusion needs to be verified by a larger sample of multicenter clinical studies.