苗药刺梨对脾肾气虚型CKD3期患者FGF23-Klotho轴的干预

Intervention of Rosa Roxburghii Tratt on FGF23-Klotho Axis in Patients with Spleen and Kidney Deficiency Type CKD Stage 3

目的研究苗药刺梨对于脾肾气虚型CKD3期患者成纤维细胞生长因子23(FGF23)-Klotho轴的干预与安全性。方法将62例符合纳入标准的患者用随机数字表法分为治疗组和对照组。所有受试者在试验期间,均予西医基础治疗(控制高血压、纠正电解质代谢紊乱等)。治疗组:刺梨冻干粉,5 g/次,1次/d,餐后吞服。对照组:氯沙坦钾片,50 mg/次,1次/d。2组均观察24周,第0、24周行中医症状分级量化表评分,并采集外周静脉血检测血清中FGF23、Klotho蛋白水平,第0、2、8、16、24周观察血肌酐(CREA)、丙氨酰氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、血钾(K+)等安全性指标。结果治疗组总有效率为83.87%,对照组总有效率为38.7%,2组比较差异有统计学意义(P<0.05)。治疗后2组FGF23均较治疗前下降(P<0.05),且治疗组的下降幅度优于对照组(P<0.05);治疗后2组Klotho蛋白均较治疗前升高(P<0.05),且治疗组升高幅度优于对照组(P<0.05);治疗期间2组安全性指标均未见明显异常,未见不良反应。结论苗药刺梨对脾肾气虚型CKD3期患者具有较好的临床疗效与安全性,其机制可能为调控FGF23-Klotho轴的表达所致。

Objective:To study the intervention and safety of Rosa Roxburghii Tratt on fibroblast growth factor 23(FGF23)-Klotho axis in patients with spleen-kidney-deficiency CKD stage 3.Methods:62 patients who met the inclusion criteria were randomized into a treatment group and a control group.All subjects underwent basic medical treatment(control of hypertension,correction of electrolyte metabolic disorders,etc.)during the trial period.The treatment group was given lyophilized powder of Rosa Roxburghii Tratt,5g/time,once daily,swallowed after meal.The control group was given losartan potassium tablets,50 mg/time,once daily.The two groups were observed for 24 weeks.In the 0th and 24th week,the scores of TCM symptom classification were scored,and the serum levels of FGF23 and Klotho were detected in peripheral venous blood.In the 0th,2th,8th,16th,and 24th week,the serum creatinine(CREA),alanyl aminotransferase(ALT),aspartate aminotransferase(AST),serum potassium(K+)and other safety indicators were observed.Results:The total effective rate was 83.87%in the treatment group and 38.7%in the control group.The difference between the two groups was statistically significant(P<0.05).After treatment,the levels of FGF23 in the two groups were lower than those before treatment(P<0.05),and the decrease in the treatment group was better than that in the control group(P<0.05).The Klotho protein in the two groups was higher than that before treatment(P<0.05).The increase of the treatment group was better than that of the control group(P<0.05).There was significant difference between the two groups before and after treatment(P<0.05).The treatment group increased more than the control group.There were no obvious abnormalities in the safety indexes of the two groups during the treatment period,and no adverse reactions were observed.Conclusion:Rosa Roxburghii Tratt has good clinical effect and safety for patients with spleen-kidney qi deficiency type CKD stage 3,and its mechanism may be caused by regulation of FGF23-Klotho axis expression.