益气清解方联合免疫抑制剂治疗高危IgA肾病疗效倾向性评分匹配研究

Effect of Yiqi Qingjie Formula Combined with Immunosuppressive Therapies on IgA Nephropathy with High-risk Factor: A Propensity Score Matching Analysis

目的评价益气清解方(YQF)联合免疫抑制剂对高危IgA肾病患者的疗效。方法采用倾向性评分匹配法,选择广安门医院接受YQF联合糖皮质激素加环磷酰胺(CTX)治疗的高危IgA肾病患者作为治疗组,北京大学第一医院IgA肾病随访队列中接受同样免疫抑制剂治疗但未服中药的患者作为对照组,两组1:1匹配,形成治疗组和对照组各34例。比较两组患者启动治疗后6、12个月后的24h尿蛋白定量(24hUTP)、估算肾小球滤过率(eGFR)变化值,比较两组启动治疗方案后12个月内月平均eGFR变化速率(eGFR-Slope),观察随访至2016年12月31日进入终末期肾脏病(ESRD)的情况,记录与治疗相关的严重不良反应。结果与本组治疗前比较,治疗组6、12个月eGFR升高(P<0.01)。与对照组同期比较,治疗组6、12个月eGFR及△eGFR升高(P<0.01),eGFR-Slope升高(P<0.01)。随访中治疗组5例、对照组9例进入ESRD,2组累计肾脏存活率比较,差异无统计学意义(P=0.058)。对照组5例患者发生与治疗相关严重不良反应,治疗组无严重不良反应报告。结论免疫抑制剂治疗联合YQF治疗高危IgA肾病,对改善患者肾功能和降低免疫抑制治疗相关不良事件风险可能有益。

Objective To evaluate the efficacy of Yiqi Qingjie Formula ( YQF) combined with immunosuppressive agents for patients with high-risk IgA nephropathy ( IgAN). Methods Using propensity score matching, the patients with high-risk IgA nephropathy who received YQF combined with glucocorticoid and cyclophosphamide ( YQF Group) in Guang' anmen Hospital were selected as the treatment group,the patients in the follow-up cohort of IgA nephropathy in Peking University First Hospital who received the same immunosuppressive therapy but did not take Chinese medicine were recruited as the control group,and the two groups were matched in a ratio of 1∶ 1,forming 34 cases in the YQF group and 34 cases in the control group. The change of UTP / 24 h(△UTP / 24 h) and eGFR(△eGFR) at 6th and 12th months after initiation of treatment were compared between the two groups,and eGFR-slope per month during the first 12 month after initiation of treatment were measured and compared between the two groups. The incidence of endpoint-events[end stage renal disease ( ESRD) or CKD-related death]and serious adverse events associated with treatment in both groups were followed up until December 31 st,2016. Results Compared with before treatment,the eGFR was increased in the YQF group at 6th and 12th months (P < 0. 01). Compared with the control group,the eGFR and △eGFR were increased in the YQF group at 6th and 12th months (P <0. 01),and eGFR-Slope was increased (P <0. 01). During the follow-up,5 patients in the treatment group and 9 patients in the control group entered the ESRD. There was no significance of estimated kidney survival time between the two groups(P =0. 058). Five patients in the control group developed serious adverse reactions related to treatment,and there were no serious adverse reactions in YQF group. Conclusion In patients of IgA nephropathy with high-risk of progression, the combination of YQF and immunosuppressive agents may be beneficial to improve renal function and reduce the risk of severe adverse events.