升清降浊胶囊对慢性肾脏疾病3～5期非透析患者中医症状的改善作用及对患者肾功能的影响

Effects of Shengqing Jiangzhuo capsule on improvement of traditional Chinese medicine symptoms and renal function in stage 3 to 5 chronic kidney disease nondialysis patients

目的观察升清降浊胶囊治疗慢性肾脏疾病(CKD)3~5期非透析患者的中医症状疗效,以及对患者肾功能的影响。方法共纳入79例CKD 3~5期非透析患者,其中CKD 3期40例(CKD 3期组),CKD 4期19例(CKD 4期组),CKD 5期20例(CKD 5期组)。3组均在西医常规治疗基础上加用升清降浊胶囊治疗,共治疗12周。观察3组治疗后中医症状(包括疲倦乏力、腰膝痠软、肢体困重、食少纳呆、口干、口苦、口中黏腻、夜尿、面色晦黯及腰痛)改善情况并评价疗效,比较3组治疗前后肾功能[包括血肌酐(Cr)、尿素氮(BUN)、肾小球滤过率(GFR)]、钙磷代谢(包括钙、磷)、脂质代谢[包括总胆固醇(TC)、甘油三酯(TG)]及营养状态[包括血红蛋白(Hgb)、白蛋白(Alb)]水平变化情况,并以血清钾浓度作为安全性指标,比较3组治疗前后血清K的浓度变化情况。结果 3组均有较好的整体中医症状疗效,但组间比较差异无统计学意义(P>0.05);3组治疗后单个中医症状均有不同程度改善,但其中仅疲倦乏力组间比较差异有统计学意义(P<0.05),且CKD 3期组疲倦乏力症状改善最明显(P<0.05);3组治疗后与本组治疗前比较Cr水平均降低(P<0.05),GFR水平均升高(P<0.05),BUN水平与本组治疗前比较差异均无统计学意义(P>0.05);3组治疗后仅CKD 5期组Hgb水平与本组治疗前比较明显升高(P<0.05),其余各组各指标比较差异均无统计学意义(P>0.05);3组治疗前后血清钾水平均无明显变化(P>0.05)。结论升清降浊胶囊对CKD 3~5期非透析患者均有很好的治疗作用,可明显改善患者中医临床症状表现,改善肾功能,降低Cr水平,升高GFR水平,尤其对CKD 3期患者疲倦乏力症状改善最明显,提高患者生活质量,延缓CKD进展,安全可靠。

Objective To observe the effects of Shengqing Jiangzhuo capsule on improvement of traditional Chinese medicine（ TCM） symptoms and renal function in stage 3 to 5 chronic kidney disease（ CKD） nondialysis patients. Methods A total of 79 cases of CKD stage 3 to 5 nondialysis patients were included. Among them,there were 40 cases of CKD 3 stage,19 cases of CKD 4 stage,and 20 cases of CKD 5 stage. All three groups were treated by Shengqing Jiangzhuo capsule on the basis of western medicine treatment for a total of 12 weeks. After the treatment of the 3 groups,the symptoms of TCM were observed（ including fatigue,low back acid,heavy limbs,food less ano-rexia, dry mouth, bitter taste, sticky in the mouth,nocturnal,dark face and low back pain） and evaluated the curative effect. The renal function[including serum creatinine（ Cr）,urea nitrogen（ BUN）,glomerular filtration rate（ GFR） ],calcium and phosphorus metabolism [including calcium（ Ca）,phosphorus（ P） ],lipid metabolism [including total cholesterol（ TC）,triglyceride（ TG） ] and nutritional status [including hemoglobin（ Hgb）, albumin（ Alb） ]before and after treatment in the three groups were compared. The serum potassium（ K） concentration was usedas a safety index to compare the changes of serum K concentration between the three groups before and after treatment. Results All three groups had better overall TCM symptomatic efficacy,but there was no significant difference between the groups（ P〉0. 05）. After treatment,the symptoms of individual TCM patients in three groups improved to some extent,but only the fatigue had statistically significant differences between the groups（ P〈0. 05）,and the symptoms of fatigue and fatigue in CKD stage 3 group had the most obvious improvement（ P〈0. 05）. After treatment,Cr levels in three groups were lower than those in the group before treatment（ P〈0. 05）,GFR levels were increased（ P〈0. 05）,and there was no significant difference in BUN levels before and after treatment（ P〉0. 05）.After treatment,the Hgb levels in CKD stage 5 group were significantly higher than those before treatment in the three groups（ P〈0. 05）,and there was no significant difference in the other indexes between the other groups（ P〉0. 05）. There was no significant change in serum K levels before and after treatment in the three groups（ P〉0. 05）.Conclusion Shengqing Jiangzhuo capsule has a good therapeutic effect on CKD stage 3 to 5 nondialysis patients. It can obviously improve the clinical TCM symptoms,improve the renal function,reduce the level of Cr and increase the level of GFR,especially the improvement of fatigue symptoms in the CKD 3 group,improve the quality of life of patients,delay the progress of CKD,and be safe and reliable.