中医药对慢性肾脏病5期(非透析)患者治疗优势的临床研究

Clinical Study on Traditional Chinese Medicine in the Treatment of Patients with Chronic Kidney Disease in Phase 5 (Non-dialysis)

目的:通过观察健脾益肾法辨证治疗慢性肾脏病(CKD)5期(非透析)患者的临床疗效及安全性,初步探索中医药对终末期肾衰竭的治疗优势。方法:选取2015年11月至2016年6月金华市人民医院门诊或住院收治的符合纳入标准的CKD5期非透析患者50例,随机分为观察组和对照组,其中观察组30例,对照组20例。观察组予西医基础治疗联合中医健脾益肾法辨证治疗,对照组仅西医基础治疗,疗程为个24周。观察治疗前后2组患者中医主要症状及积分变化、中医证候疗效;肾功能、血红蛋白、血白蛋白、血钾、HCO_3^-等指标的改变;以及对不良事件和终点事件的分析,进行疗效评价和安全性观察。结果:观察组中医症状积分显著降低,组内或组间比较,差异有统计学意义(P<0.05),其中对畏寒肢冷、倦怠乏力、气短懒言、恶心呕吐等症状改善尤为明显;中医证候总有效率66.7%,对照组25%,差异有统计学意义(P<0.05)。与治疗前比较观察组血红蛋白、血白蛋白升高,营养不良-炎症评分(MIS)下降,差异有统计学意义(P<0.05),并明显优于对照组,差异有统计学意义(P<0.05);2组治疗后血肌酐均有升高、eGFR下降(P<0.05),但组间比较,差异有统计学意义(P>0.05)。2组在高钾血症、严重代谢性酸中毒等不良反应以及进入透析的终点事件发生率均无统计学差异。结论:中医药治疗CKD5期(非透析)患者可明显改善临床症状和营养状态,从而有助于延缓进入透析期。对该期患者在医生严密观察下应用中药治疗是相对安全的。

Objective： To preliminarily explore the advantages of traditional Chinese medicine treatment on end-stage renal failure（ ESRF） on non-dialysis CKD5 patients.Methods： The subjects were 50 non-dialysis inpatients and outpatients of CKD5 from Tongde Hospital of Zhejiang Province,and were divided into two groups including 30 cases of study group and 20 cases of control group.During the whole course of 24 weeks,the study group was treated with western medicine combined with traditional Chinese medicine,while the control group were only treated with western medicine.Main symptoms of traditional Chinese medicine and scores changes as well as TCM curative effects were observed before and after the treatment,and the change of renal function,hemoglobin,serum albumin,serum potassium,HCO_3^- and other indicators were observed as well as the adverse events and final events were analyzed.The efficacy and safety of those treatments were evaluated based on above.Results： TCM symptom scores of the study group were significantly lower than the control group（ P〈0.05）,among which the symptoms of chilliness and cold limbs,tiredness and fatigue,shortness of breath and less of words,nausea and vomiting were improved obviously,and the total improvement rate of Chinese medicine symptom of the study group was 66.7%,while the control group was 25%（ P〈0.05）.The hemoglobin and serum albumin of the patients in the study group were increased after the treatment,and the malnutrition inflammation score（ MIS） was decreased（ P〈0.05）,which were significantly better than the control group（ P〈0.05）.The serum creatinine level and eGFR in the two groups were both increased（ P〈0.05）,but the comparison between the two groups has no statistical significance（ P〈0.05）.And there was no significant difference between the two groups in the incidence of adverse events such as high potassium,severe metabolic acidosis,and the final event of dialysis.Conclusion： Traditional Chinese medicine in the treatment of CKD5 patients（ non-dialysis） could significantly improve the clinical symptoms and nutritional status,thereby help to slow down the steps of entering the dialysis stage.It is relatively safe to practice traditional Chinese medicine for the treatment of this period.