基于创新中医理论辨证施治慢性肾脏疾病的临床研究

Management of Chronic Kidney Disease Guided by the Theory of Traditional Chinese Medicine:an Experimental Study

目的探索在中医理论辩证原则下使用辨证施治对比中成药配合西药治疗慢性肾脏疾病的临床疗效。方法纳入同期门诊慢性肾脏疾病患者共225例,其中纳入接受了常规西药加中成药治疗患者170例作为对照组,纳入接受常规西药治疗配合中医理论"肾痿"治疗的患者55例作为治疗组。比较两组患者的治疗结局,并采用多元线性回归分析影响治疗结局的因素。结果治疗组和对照组的基线数据在年龄(P<0.01)、肾功能分期构成(P=0.007)和蛋白尿程度(P<0.01)上差异有统计学意义,但采用多元线性回归后,尚不认为性别、年龄、蛋白尿程度对治疗结局产生影响。治疗组对肌酐和尿素的降低优于对照组(P<0.001),两组对尿酸的影响差异无统计学意义(P=0.475)。治疗组和对照组对尿蛋白(P=0.058)和尿红细胞(P=0.577)的影响无差异,对尿白细胞的影响亦不明显(P=0.01)。治疗组相比对照组治疗后更多患者出现了估算肾小球滤过率上升(P<0.001)。采用多元线性回归确定对治疗结局有统计学意义的影响因素为治疗方法分组(P<0.001)和肾功能进展分期(P=0.008)。相比于肾功能分期(标准化回归系数0.165),分组(标准化回归系数0.395)对治疗结局的影响更大。结论常规西药治疗配合中医理论的"肾痿"辨证施治可以改善慢性肾脏疾病患者的肾小球滤过率,在肾功能分期严重的患者中更为明显,且疗效优于常规西药加中成药治疗。

Objective To determine the impact of Traditional Chinese Medicine on patients with chronic kidney disease （CKD）. Methods A total of 225 CKD patients in an outpatient department were recruited for this study, among whom 170 received regular Western and Chinese medicine treatments （control group） and 55 received treatments guided by the theory of Traditional Chinese Medicine （experimental group）. The effectiveness of the treatments was determined through a pre-post comparison. Results Significant pre-intervention differences in age （P〈0. 01） , stage of glomerular filtration rate （ GFR） （P= 0. 007 ） and urine protein （ P〈0. 01 ） were found between the two groups of patients. But age, gender and proteinuria were not significant predictors on clinical outcomes of the patient＇s in the multivariate regression models. The experimental group had a greater level of decrease in blood urea nitrogen （P〈0. 01） and serum creatine （P〈0. 01） than the control group. No significant differences between the groups were found in changes of uric acid （P = 0. 475）,urine protein （P =0. 058）,urine red cells （P = 0. 577）, and urine white cells （P =0.01）. A greater level of increase in estimated glomerular filtration rate was found in the experimental group compared with the control （P〈0. 001）, The multivariate linear regression analysis identified group （B=0.395,P〈0. 001）and stage of GFR （B=0. 165,P=0.008） as significant predictors on the outcomes of treatment. Conclusion The treatment of CKD patients guided by the theory of Traditional Chinese Medicine can improve renal function through influencing glomerular filtration rate. The effect is more prominent than the regular treatment regime.