基于真实世界回顾性分析糖皮质激素干预IgA肾病的临床研究

Clinical Study of Glucocorticoid Intervention in IgA Nephropathy Based on Real-world Retrospective Analysis

目的:评估糖皮质激素对IgA肾病的疗效性与安全性。方法:基于真实世界研究方法,选取2009年05月—2015年05月于杭州市中医院经活检证实IgAN的患者,分为糖皮质激素联合RAS阻断剂治疗组和单用RAS阻断剂治疗组。比较两组患者的一般资料及两种治疗方案的疗效和副作用,分析影响IgAN疾病进展的因素;同时比较初始激素剂量大小对治疗疗效及副作用的发生率。结果:(1)共纳入符合标准IgAN患者共287例,除年龄和基线24 h蛋白尿外,两组间一般资料均无差异。激素组M1、S1、新月体比例高于RAS组;(2)激素组预后优于RAS组,预后与激素初始剂量无相关性。感染发生率激素组高于RAS组,常规剂量激素组高于小剂量激素组;(3)当基线24 h蛋白尿>0.75 g/d,或基线eGFR≤90 ml·min^(-1)·1.73 m^(-2),或肾脏病理提示球性硬化、M1、S1、C1时,激素组肾脏预后优于RAS组;(4)多因素COX比例风险模型提示糖皮质激素是影响IgAN疾病进展的独立因素。结论:在尿蛋白定量>0.75 g/d,或肾脏病理提示M1、S1、C1情况下,糖皮质激素干预有益于延缓肾功能进展,且小剂量的糖皮质激素可获得和常规激素同等的获益,而副作用更低。

Objective:To analyze the efficacy and safety of glucocorticoid in the treatment of IgAN.Methods:Based on real world research methods,patients with biopsy-proven IgAN in the Department of Nephrology of Hangzhou TCM Hospital from May 2009 to May 2015 are selected.Divided into glucocorticoid+RAS blocker treatment group and RAS blocker alone treatment group.The general data,efficacy and side effects between two groups are compared,and the factors that affecting the progress of IgAN disease are analyzed;We also compare the effects of initial glucocorticoid dose on therapeutic efficacy and the incidence of side effects.Results:(1)A total of 287 IgAN patients who met the criteria are included.There are no differences of two groups in general data except for age and the baseline 24 h proteinuria.There are significant differences between the two groups of M1,S1,and crescent ratio;(2)The overall therapeutic effect of the glucocorticoid group is better than that of the RAS group,and the initial glucocorticoid dose has no effect on the patient's prognosis.The incidence of infection in the glucocorticoid group is higher than that in the RAS group,and the conventional dose group of glucocorticoids is higher than that in the low dose group;(3)When the amount of 24 h proteinuria more than 0.75 g/d,or baseline eGFR less than 90 ml·min_(-1)·1.73 m^(-2),or renal pathology of glomerulosclerosis,M1,S1,or C1,the prognosis is better in the glucocorticoid group than the RAS group;(4)Multi-factor COX proportional hazard model suggests that the glucocorticoid therapy is an independent factor affecting the prognosis of IgAN.Conclusion:In the condition of urinary protein quantification>0.75 g/d,or renal pathology suggests M1,S1 and C1,Glucocorticoid therapy is beneficial to delay the progress of renal function;a small dose of glucocorticoid can obtain the same benefits as a large dose of glucocorticoid,with lower side effects.