中药汤剂口服治疗对慢性肾脏病3-5期非透析患者终点事件的影响——一项回顾性队列研究

Effect of Oral Chinese Medicine Decoction on Endpoint Events in Non-dialysis Patients with Stage 3-5 Chronic Kidney Disease:A Retrospective Cohort Study

目的探讨中药汤剂治疗对慢性肾脏病(CKD)3-5期非透析患者终点事件的影响。方法回顾性收集2010年3月1日至2019年5月20日在广东省中医院肾病科慢病管理门诊首诊的CKD 3-5期患者的临床资料,根据既往服用中药情况,将患者分为中药汤剂组和非中药汤剂组。收集患者基本信息、实验室指标及发生终点事件(透析或移植,死亡)情况,以2020年12月30日前所能查到的最后一个时点的终点状态为准,若发生终点事件则记录为到达终点。采用倾向性评分匹配的方法平衡基线差异,对匹配前后的队列采用Kaplan-Meier曲线分析比较两组患者累积终点事件发生率,再用单因素和多因素COX回归分析匹配前后患者口服中药汤剂及其他因素对发生终点事件风险的影响。结果匹配前中药汤剂组患者728例中185例发生了终点事件,非中药汤剂组患者57例中21例发生了终点事件。匹配后中药汤剂组患者111例中26例发生了终点事件,非中药汤剂组患者56例中21例发生了终点事件。Kaplan-Meier曲线分析结果显示,匹配前后中药汤剂组患者累积终点事件发生率均显著低于非中药汤剂组(P_(匹配前)=0.029,P_(匹配后)=0.040)。多因素COX回归分析结果显示,匹配前后与非中药汤剂组比较,中药汤剂组患者发生终点事件的风险均显著降低[HR:0.45,95%CI(0.28,0.72),P_(匹配前)=0.001;HR:0.35,95%CI(0.16,0.76),P_(匹配后)=0.008]。血红蛋白(Hb)、CKD分期、尿蛋白(PRO)亦是发生终点事件风险影响因素(P<0.05)。结论中药汤剂治疗可能有效降低CKD 3-5期患者终点事件发生风险,延缓疾病进展。

Objective To evaluate the effect of Chinese medicine decoction(CMD)on endpoint events in nondialysis patients with stage 3-5 chronic kidney disease(CKD).Methods Data of patients who had a first visit to the Chronic Disease Management Clinic at the Nephrology Department of the Guangdong Provincial Hospital of Chinese Medicine between March 1 st,2010 and May 20 th,2019 were retrospectively collected,and patients were divided to the CMD group and the non-CMD group according to previous CMD history.The basic information,laboratory indicators and endpoint events(dialysis or transplantation,death)were collected.The endpoint status at the last time point before December 30 th,2020 was recorded,and if an endpoint event occurs,it will be recorded as reaching the endpoint.Propensity score matching(PSM)was used to balance the baseline differences,and Kaplan-Meier curve analysis was used to compare the cumulative endpoint event rates of the two groups before and after matching.Univariate and multivariate COX regression analysis was performed to analyze the influence of oral administration of CMD and other factors on the occurrence of endpoint events before and after PSM.Results Before matching,185 out of 728 cases in the CMD group,and 21 out of 57 cases in the non-CMD group had endpoint events.The proportions changed into 26/111 and 21/56 after matching.Kaplan-Meier curve analysis showed that the incidence rate of cumulative endpoint events in the CMD group was significantly lower than that of non-CMD group either before or after matching(before matching:P=0.029;after matching:P=0.040).Multivariate Cox regression showed that patients in the CMD group had a significantly lower risk of endpoint events compared to those in the non-CMD group either before(HR=0.45;95%CI:0.28,0.72;P=0.001)or after PSM(HR=0.35;95%CI:0.16,0.76;P=0.008).Hemoglobin,CKD stage,and urine protein were also risk factors for the occurrence of endpoint events(P<0.05).Conclusion Oral administration of CMD might effectively reduce the incidence of endpoint events and delay the disease progression in patients with stages 3-5 CKD.