益肾通络法改善糖尿病肾脏疾病患者肾脏结局的临床疗效分析

Clinical efficacy analysis of Yishen Tongluo therapy in improving renal outcome in patients with diabetic kidney disease

目的:基于真实世界研究探讨益肾通络法改善糖尿病肾脏疾病(DKD)患者肾脏结局的临床疗效。方法:利用首都医科大学附属北京中医医院科研共享平台及肾病科临床数据库进行回顾性筛选,纳入符合本研究要求的DKD患者共130例,根据患者是否规律接受益肾通络法治疗分为益肾通络组(66例)和对照组(64例),收集其基线及随访诊疗信息,以进入终末期肾病为主要结局指标,比较两组患者终末期肾病发生率的差异,并分析益肾通络法干预是否为DKD患者肾功能进展的独立保护因素。结果:益肾通络组中位随访时间为25个月,终末期肾病累积发生率为20.6%;对照组中位随访时间为24个月,终末期肾病累积发生率为83.1%,Log-Rank检验显示益肾通络组终末期肾病发生率显著低于对照组(P<0.01)。COX比例风险回归分析显示,益肾通络法是DKD患者进展至终末期肾病的独立保护因素(P<0.01)。进一步分层分析结果显示,益肾通络法改善肾脏结局可能与患者性别及基础肾功能有关,在男性或eGFR<60mL·min^(-1)·1.73m^(-2)患者中,益肾通络组肾脏结局显著优于较对照组(P<0.01),而在女性或eGFR≥60mL·min^(-1)·^(-1).73m^(-2)患者中,两组肾脏结局差异无统计学意义。结论:基础治疗配合中医益肾通络法在一定程度上可有效延缓DKD肾功能进展,减少终末期肾病的发生率,显著改善肾脏结局。

Objective:To explore the efficacy of Yishen Tongluo therapy in delaying renal progression in patients with diabetic kidney disease(DKD)based on real word study.Methods:Diagnosis and treatment information were screened by applying the scientific research sharing platform of Beijing Hospital of Traditional Chinese Medicine,Capital Medical University and the clinical database of nephrology department of the hospital,and 130 patients were finally included.According to whether the patients were regularly treated with Yishen Tongluo therapy,the patients were divided into either the Yishen Tongluo group(66 cases)or the control group(64 cases),the baseline and follow-up diagnosis and treatment information were collected.Taking end-stage renal disease(ESRD)as the primary outcome,the incidence of ESRD between the two groups was compared,and whether Yishen Tongluo therapy was an independent protective factor for renal progression in DKD patients was analyzed.Results:The median follow-up time of Yishen Tongluo group was 25 months,and the cumulative incidence of ESRD was 20.6%;The median follow-up time of the control group was 24 months,and the cumulative incidence of ESRD was 83.1%.Log-Rank test showed that the incidence of ESRD in Yishen Tongluo group was significantly lower than that in the control group(P<0.01).COX proportional hazards regression analysis showed that Yishen Tongluo therapy was an independent protective factor for DKD patients to progress to ESRD(P<0.01).The stratified analysis further showed that the improvement of renal outcome by Yishen Tongluo therapy may be related to the gender and basic renal function.In men or patients with eGFR<60 mL·min^(-1).73 m^(-2),the renal outcome of patients in Yishen Tongluo group was significantly better than that of the control group(P<0.01),while in women or patients with eGFR≥60 mL·min^(-1).73 m^(-2),there was no significant difference between the two groups.Conclusion:On the basis of basic treatment,combined with Yishen Tongluo therapy can effectively delay the renal progression in DKD,reduce the incidence of ESRDand significantlyimprove renal outcome.