参芪地黄汤合小承气汤灌肠联合血液透析治疗老年慢性肾脏病5期气阴两虚兼浊毒内蕴证的临床研究

Clinical study of Shenqi Dihuang Decoction and Xiaochengqi Decoction combined with hemodialysis in the treatment of the patients with CKD stage 5 and Qi and Yin deficiency and turbid poison inherent pattern

目的评价参芪地黄汤合小承气汤灌肠联合血液透析治疗老年慢性肾脏病(CKD)5期患者的临床疗效。方法随机对照试验研究。选择2020年5月-2022年1月北京市隆福医院肾内科102例老年CKD 5期气阴两虚兼浊毒内蕴证患者作为观察对象,采用随机数字表法分为2组,每组51例。对照组给予常规对症+血液透析治疗,观察组在对照组基础上应用参芪地黄汤合小承气汤保留灌肠。2组均治疗4周。分别于治疗前后进行中医证候评分,采用健康相关生命质量SF-12量表(SF-12)评估患者生活质量;采用全自动生化仪检测血清BUN、SCr、β2微球蛋白(β2-MG)水平及钾(K^(+))、钙(Ca^(2+))、磷(P^(3-))水平,全自动血细胞分析仪检测血红蛋白水平,乳胶增强免疫散射比浊法检测血清CRP、IL-6水平;观察记录治疗期间的不良反应,评价临床疗效。结果治疗期间,观察组2例患者因严重腹泻退出研究,其他患者均完成本研究并进入疗效统计。观察组总有效率为91.84%(45/49)、对照组为74.51%(38/51),2组比较差异有统计学意义(χ2=5.32,P=0.002)。观察组治疗后腰膝酸软、倦怠乏力、浮肿、头晕耳鸣、畏寒喜暖、面黄无华、大便干结积分及总分低于对照组(t值分别为8.38、13.44、15.14、13.09、7.12、7.73、11.16、11.45,P<0.01),SF-12量表中生理、心理评分高于对照组(t值分别为3.24、4.22,P<0.01)。治疗后,观察组血清BUN[(15.02±2.35)mmoL/L比(18.02±3.65)mmoL/L,t=4.87]、SCr[(155.26±23.65)μmol/L比(184.49±35.49)μmol/L,t=4.83]、β2-MG[(7.12±1.27)mg/L比(9.56±2.14)mg/L,t=6.90]水平及P^(3-)[(1.51±0.10)mmol/L比(2.02±0.19)mmol/L,t=16.70]、K^(+)[(3.65±0.54)mmol/L比(4.21±0.63)mmol/L,t=4.76]水平低于对照组(P<0.01),血清Ca^(2+)[(1.86±0.36)mmol/L比(2.35±0.42)mmol/L,t=6.25]水平高于对照组(P<0.01)。治疗期间2组均未发生严重不良反应(P>0.05)。结论参芪地黄汤合小承气汤灌肠联合血液透析更有助于改善老年CKD 5期患者肾功能及生活质量,纠正电解质紊乱、降低炎症因子水平,提高临床疗效。

Objective To investigate the clinical effect of Shenqi Dihuang Decoction and Xiaochengqi Decoction enema combined with hemodialysis in the treatment of qi deficiency,blood stasis and dampness and turbidity in chronic kidney disease(CKD)stage 5.Methods Randomized controlled trial.A total of 102 elderly CKD stage 5 patients with Qi and Yin deficiency and turbid poison inherent type were selected from May 2021 to January 2022 of the Beijing Longfu Hospital.The patients were divided into two groups by random number table method.Control group(51 cases)received hemodialysis treatment for 4 weeks,and the observation group(51 cases)received Shenqi Dihuang Decoction and Xiaochengqi Decoction enema combined with hemodialysis treatment for 4 weeks.The levels of BUN,SCr andβ2-microglobulin(β2-MG),and K^(+),Ca^(2+),P^(3-)content,hemoglobin were detected by automatic blood cell analyzer,and serum CRP and IL-6 levels were detected by latex enhanced immune scattering turbidimetry.The adverse reactions during the treatment and evaluate the clinical efficacy were observed and recorded.Results During the treatment,2 patients in the observation group withdrew from the study due to severe diarrhea,and other patients completed the study.There were significant differences in total response rate between observation group and control group[91.84%(45/49)vs.74.51%(38/51);χ2=5.32,P=0.002].After treatment,scores of lumbar and knee acerbity,tiredness and fatigue,edema,dizziness and tinnitus,fear of cold and warm,yellow face,dry stool and total score in observation group were significantly lower than those in the control group(t=8.38,13.44,15.14,13.09,7.12,7.73,11.16,11.45,P<0.01);the scores of SF-12-PCS and SF-12-MCS were significantly higher than those in the control group(t=3.24,4.22,P<0.01).After treatment,levels of serum BUN[(15.02±2.35)mmoL/L vs.(18.02±3.65)mmoL/L,t=4.87],SCr[(155.26±23.65)μmol/L vs.(184.49±35.49)μmol/L,t=4.83],β2-MG[(7.12±1.27)mg/L vs.(9.56±2.14)mg/L,t=6.90]and P^(3-)[(1.51±0.10)mmol/Lvs.(2.02±0.19)mmol/L,t=16.70],K^(+)[(3.65±0.54)mmol/L vs.(4.21±0.63)mmol/L,t=4.76]in observation group were significantly lower than those in the control group(P<0.01);Ca^(2+)[(1.86±0.36)mmol/L vs.(2.35±0.42)mmol/L,t=6.25]was significantly higher than that of the control group(P<0.01).No adverse reactions occurred during the treatment in the two groups(P>0.05).Conclusion Shenqi Dihuang Decoction and Xiaochengqi Decoction enema and hemodialysis can improve renal function,correct electrolyte disorder,reduce the level of inflammatory factors,improve the quality of life,and improve the therapeutic effect of the patients with CKD stage 5 and Qi and Yin deficiency and turbid poison inherent pattern.