肾衰方治疗90例脾肾气虚湿浊内蕴证CKD4期患者的临床观察

Clinical observation of Shenshuai Formulation in treating 90 cases of CKD stage 4 patients with spleen and kidney qi deficiency wet turbidity inherent syndrome

[目的]观察肾衰方联合包醛氧淀粉胶囊及缬沙坦片对慢性肾脏病(CKD)4期患者残余肾功能及生活质量的干预作用。[方法]选择2020年10月—2021年9月天津中医药大学第一附属医院收治的90例CKD4期患者,根据随机数字表法随机分为对照组(45例)和中药组(45例)。对照组予包醛氧淀粉胶囊及缬沙坦片治疗,中药组予肾衰方联合包醛氧淀粉胶囊及缬沙坦片治疗,连续服用3个月。观测治疗前后2组临床疗效、血清肌酐(Scr)、尿素氮(BUN)、肾小球滤过率(GFR)、24 h尿蛋白定量、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)的变化、症状积分以及不良反应生率。[结果]治疗3个月后,中药组总有效率为82.2%,对照组总有效率为62.2%,中药组临床疗效优于对照组(P<0.05);症状积分、Scr、BUN、24 h尿蛋白定量水平均较治疗前降低,且中药组优于对照组(P<0.05);GFR较治疗前上升,且中药组优于对照组(P<0.05);治疗前后ALT、AST无明显变化(P>0.05),且均在正常范围之内;中药组及对照组治疗前后未见明显不良反应。[结论]肾衰方联合西药治疗能够更好地保护CKD4期患者残余肾功能,一定程度上提高患者生活质量,延缓进入终末期肾病的时间,提高临床疗效。

[Objective]To observe the intervention effect of Shenshuai Formulation combined with aldehyde oxygen starch capsules and valsartan tablets on residual renal function and quality of life in patients with CKD stage 4.[Methods]A total of 90 patients with CKD stage 4 admitted to our hospital from October 2020 to September 2021 were randomly divided into the control group(45 cases)and the traditional Chinese medicine group(45 cases)according to the random number table method.The control group was treated with Aldehyde Oxygen Starch Capsule and Valsartan Tablet,and the traditional Chinese medicine group was treated with Shenshuai Formulation combined with Aldehyde Oxygen Starch Capsule and Valsartan Tablet.The course of treatment in each group was 3 months.The clinical efficacy,Scr,BUN,GFR,24 h urine protein quantification,changes in ALT,AST,and adverse reactions were observed in the two groups before and after treatment.[Results]After 3 months treatment,the total effective rate of the traditional Chinese medicine group was 82.2%,while that of the control group was 62.2%.The clinical effect of the traditional Chinese medicine group was better than that of the control group(P<0.05).The symptom score,Scr,BUN and 24 h urine protein in the traditional Chinese medicine group were significantly lower than those before treatment,and the GFR in the traditional Chinese medicine group was better than that in the control group(P<0.05).The traditional Chinese medicine group was superior to the control group(P<0.05).ALT and AST were all within the normal range,they had no significant changes before and after treatment(P>0.05).There were no obvious adverse reactions in the traditional Chinese medicine group and the control group before and after treatment.[Conclusion]Shenshuai Formulation combined with western medicine can better protect residual renal function in patients with CKD stage 4,improve the quality of life,and improve clinical efficacy.