基于真实世界的中医药对IgA肾病肾功能保护作用研究

Study on Protective Effect of TCM on Renal Function in IgA Nephropathy Based on Real World

目的评估中医药延缓IgA肾病肾功能减退的临床疗效。方法基于真实世界研究方法,选取2010年1月-2020年6月陈以平全国名老中医工作室门诊资料库及上海中医药大学附属龙华医院信息管理系统(HIS)数据库中连续服用中药≥6个月的IgA肾病患者175例,均处于慢性肾脏病(CKD)2~5期。按实际用药情况分为中医组(纯中药组+首诊前已停激素和免疫抑制剂)和中西结合组(携激素免疫抑制剂方案来诊+随访时增加)。定义终点事件(进入肾脏替代疗法或死亡),记录终点事件发生率。比较首诊前后患者每月估算肾小球滤过率(eGFR)减退速率、开始中医治疗后不同疗程临床疗效。分析CKD 4~5期患者肾病存活率,并通过Kaplan-Meier生存分析和多因素Cox回归分析影响其生存率的危险因素。结果①首诊前后eGFR减退速率比较:增加中药治疗后患者每月eGFR减退速率比较差异有统计学意义(P<0.01)。②短期疗效比较:与基线水平(0月)比较,CKD 2~3期患者在首诊后3、6、12个月血肌酐水平降低、eGFR升高、24 h尿蛋白定量降低、血清白蛋白升高(P<0.05,P<0.01),CKD 4期患者在首诊后3、6个月血肌酐水平降低、eGFR升高、24 h尿蛋白定量降低、血清白蛋白升高(P<0.05,P<0.01)。③长期预后分析:CKD 4期患者12例达到终点事件,CKD 5期患者4例达到终点事件。CKD 4~5期患者1、2、4年生存率分别为75.0%、53.4%、36.1%。中重度病理类型(RR=11.07)、治疗方式(RR=0.199)、血清肌酐水平(RR=1.011)是IgA肾病预后的危险因素(P<0.05)。结论单纯中药或中西药联用均可改善肾功能减退IgA肾病患者肾功能,扭转eGFR减退速率。对于中重度病理类型患者,中西药联用较单纯中药治疗更有优势。

Objective To explore the clinical efficacy of TCM in delaying renal dysfunction in IgA nephropathy.Methods Based on the“real world study”approach,175 patients with IgA nephropathy(continuously taking Chinese materia medica for≥6 months)were selected from the clinic database of Chen Yiping's national famous and senior TCM master studio and information management system(HIS)database of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2010 to June 2020,who were in CKD stage 2–5.According to the actual medication situation,they were divided into the TCM group(pure Chinese materia medica group+hormones and immunosuppressants stopped before the first visit)and the combined Chinese and Western medicine group(coming with hormone immunosuppressive agent plan+increasing during follow-up).The end point event(entry to renal replacement therapy or death)was defined,and the end point event rate was recorded.The patients before and after the first visit the rate of estimated glomerular filtration rate(eGFR)declined in patients every month,and the clinical efficacy of different courses of treatment after the beginning of TCM treatment were compared.The survival rate of patients with CKD stage 4 to 5 with nephropathy was analyzed,and the risk factors affecting their survival rate were also analyzed through Kaplan-Meier survival analysis and multivariate Cox regression analysis.Results 1)Comparison of eGFR decline rate before and after the first visit,there was a statistically difference(P<0.01)in the eGFR decline rate of the patients before and after the addition of TCM treatment.2)Comparison of short-term efficacy:compared with the baseline level(0 month),CKD stage 2 to 3 patients were followed up at 3,6,and 12 months after the first visit.The blood creatinine level was reduced,the eGFR increased,the 24-hour urine protein quantitative decreased and serum albumin increased(P<0.05,P<0.01).In patients with CKD stage 4,blood creatinine levels were reduced,eGFR increased,24-hour urine protein quantitatively decreased,and serum albumin increased at 3 and 6 months after the first visit(P<0.05,P<0.01).3)Long-term prognosis analysis:12 patients with CKD stage 4 reached the end event,and 4 patients with CKD stage 5 reached the end event.The 1-,2-,and 4-year survival rates of patients with CKD stages 4 to 5 were 75.0%,53.4%,and 36.1%,respectively.Moderate to severe pathological type(RR=11.07),treatment method(RR=0.199),and serum creatinine level(RR=1.011)were risk factors for the prognosis of IgA nephropathy(P<0.05).Conclusion TCM alone or in combination with Western medicine can improve the renal function of IgA nephropathy patients with renal dysfunction and can reverse the rate of eGFR decline in patients.For patients with moderate and severe pathological types,combined Chinese and Western therapy has more advantages than pure Chinese materia medica.