中医辨证论治联合氯沙坦钾治疗肝肾阴虚型重症IgA肾病的多中心随机对照试验

TCM syndrome differentiation-based treatment combined with Losartan Potassium in treating severe IgA nephropathy with yin deficiency of liver and kidney syndrome:A multicenter randomized controlled trial

目的:观察中医辨证论治联合氯沙坦钾治疗肝肾阴虚型重症IgA肾病(IgAN)的临床疗效。方法:采用多中心、随机对照方法将4个中心122例IgAN患者纳入研究,随机分为治疗组(中药、西药)和对照组(中药模拟剂、西药),疗程6个月,观察两组患者治疗后24h尿蛋白定量(24hUpro)、尿微量白蛋白/肌酐(MA/Cr)、血肌酐(SCr)、血尿素氮(BUN)、血白蛋白(Alb)、肾小球滤过率(eGFR)、血红蛋白(Hb)、IgAN风险指数的变化。观察中医临床症状,治疗后评价中医证候疗效和临床疗效。结果:治疗组中医证候疗效及临床疗效总有效率分别为90.00%(54/60)、71.67%(43/60),显著高于对照组66.67%(40/60)、38.33%(23/60)(P<0.05,P<0.01)。治疗组目睛干涩、视物模糊、头晕、目眩、耳鸣、腰膝酸痛、五心烦热、潮热盗汗、咽燥、口干总有效率高于对照组(P<0.05)。与本组治疗前比较,治疗组治疗2、4、6个月24h UPro、MA/Cr、SCr、BUN、风险指数显著下降(P<0.01,P<0.05),eGFR显著升高(P<0.01);对照组治疗2、4、6个月BUN下降(P<0.05),治疗2、4个月风险指数显著下降(P<0.05,P<0.01),且治疗组治疗6个月24hUPro、MA/Cr、SCr、风险指数显著低于对照组(P<0.01,P<0.05),eGFR显著高于对照组(P<0.05)。结论:中医辨证论治联合西药能够减轻重症IgAN肝肾阴虚型患者24hUpro、MA/Cr、BUN、SCr水平,降低IgAN风险指数,提高患者eGFR,并能够改善中医症状,提高临床治疗效果。

Objective:To evaluate the clinical effect of TCM syndrome differentiation-based treatment combined with losartan potassium in treating severe IgA nephropathy with yin deficiency of liver and kidney syndrome.Methods:A multicenter,randomized controlled trial was conducted,with a total of 122 patients in 4 centers were randomly divided into the treatment group(traditional Chinese medicine and western medicine)and the control group(Chinese medicine analogue and western medicine).Apart from basic treatments,patients in each group were given traditional Chinese medicine and western medicine and Chinese medicine analogue and western medicine respectively during a course of 6 months.The changes in quantitative test of 24-hour urinary protein quantity(24 hUpro),urinary microalbumin/creatinine ration(MA/Cr)serum creatinine(SCr),blood urea nitrogen(BUN),serum albumin(Alb)and glomerular filtration rate(eGFR),hemoglobin(Hb),IgA nephropathy risk index were measured.Clinical symptoms of traditional Chinese medicine were observed to evaluate the symptoms of traditional Chinese medicine and clinical efficacy after treatment.Results:The TCM syndrome efficacy and total effective rate of the treatment group was 90.0%(54/60)and 71.67%(43/60),which was higher than 66.67%(40/60)and 38.33%(23/60)of the control group(P<0.05,P<0.01).In the treatment group,the total effective rate of dry eyes,blurred vision,dizziness,tinnitus,sour pain in waist and knee,dysphoria with feverish sensation in chest,tidal fever and night sweating,dry throat and dry mouth were higher than the control group(P<0.05).Compared with before treatment,24 hUPro,MA/Cr,SCr,BUN and IgA nephropathy risk index were significantly decreased in the treatment group at 2,4,6 months(P<0.05,P<0.01)and eGFR were significantly increased(P<0.01),which was statistically significant compared with the control group(P<0.05).The control group had a decrease in BUN at 2,4,6 months of treatment(P<0.05),and the IgA nephropathy risk index was decreased at 2,4 months of treatment(P<0.05,P<0.01).24 hUPro,MA/Cr,SCr,BUN and IgA nephropathy risk index in the treatment group were significantly lower than those of the control group at 6 months of treatment(P<0.05,P<0.01),and eGFR was significantly higher than that of he control group(P<0.05).Conclusion:TCM syndrome differentiation-based treatment combined with western medicine can contribute to clinical practice because of its action of decreasing the levels of the 24-hour urinary protein,MA/Cr,Scr,BUN and IgA nephropathy risk index levels and increasing eGFR of patients with yin deficiency of liver and kidney syndrome due to severe IgA nephropathy,and improving TCM symptoms as well as clinical efficacy.