雷公藤多苷与硫唑嘌呤维持治疗狼疮性肾炎的长期疗效和安全性

发布时间：2017-12-27 10:11

本文关键词：雷公藤多苷与硫唑嘌呤维持治疗狼疮性肾炎的长期疗效和安全性　出处：《肾脏病与透析肾移植杂志》2015年05期 　论文类型：期刊论文

【摘要】：目的:前瞻性随机对照观察雷公藤多苷(TW)和硫唑嘌呤(AZA)维持治疗狼疮性肾炎(LN)的复发率及安全性。方法:2007年1月至2008年6月经诱导治疗获得临床完全缓解(CR)或部分缓解(PR)的增殖性LN患者,随机分配至TW组和AZA组,维持治疗24个月后,继续随访观察。主要观察指标为两组患者的复发率,次要观察指标包括复发时间、治疗期间新增CR例数、到达肾脏终点事件(包括终末期肾病、肌酐倍增、估算的肾小球滤过率下降≥30%)的例数、治疗中尿蛋白定量和血清肌酐的变化及不良事件等。结果:(1)截止至2014年4月,84例患者中位随访时间57.5月,TW组有10例(25.0%)患者复发,中位时间17.5月;AZA组9例(20.5%)患者复发,中位时间38个月。两组复发率及复发时间均无统计学差异;(2)TW组和AZA组到达肾脏终点事件的患者分别为14例(35.0%)和11例(25.0%),无统计学差异。治疗期间两组血清肌酐及尿蛋白无显著变化;(3)不良事件:TW组(75.0%)不良事件发生率与AZA组(59.1%)无统计学差异,其中月经紊乱的发生率明显高于AZA组,而白细胞减少显著降低,两组总的感染率无统计学差异,但是TW组阴道炎的发生率明显高于AZA组。结论:TW维持治疗LN的复发率与AZA维持治疗相当,虽然TW组月经紊乱的发生率高于AZA组,但两组总的不良事件无统计学差异。因此,TW是一种有效的维持期治疗药物。
[Abstract]:Objective: a prospective randomized controlled observation of tripterygium glycosides (TW) and azathioprine (AZA) treatment of lupus nephritis (LN) recurrence rate and safety. Methods: from January 2007 to 2008, 6 menstrual induction therapy was used to obtain LN patients with complete remission (CR) or partial remission (PR). They were randomly assigned to TW group and AZA group. After maintenance treatment for 24 months, follow-up observation was carried out. We observed for the two groups of patients with recurrence rate, secondary outcome measures included during the time of recurrence, the treatment of new CR cases, renal events (including the end point to end-stage renal disease, creatinine doubling, estimated glomerular filtration rate decreased more than 30%) changes in numbers of cases, in the treatment of urinary protein and serum creatinine and adverse events etc.. Results: (1) by the end of April 2014, 84 patients were followed up for 57.5 months. 10 patients (25%) had recurrence in group TW, and the median time was 17.5 months. In group AZA, 9 patients (20.5%) had relapse and the median time was 38 months. There was no statistically significant difference between the two groups in recurrence rate and recurrence time. (2) in group TW and group AZA, 14 cases (35%) and 11 cases (25%) reached the end point of kidney events, with no statistical difference. During the treatment, two groups of serum creatinine and urine protein had no significant change; (3) adverse events: TW group (75%) and the incidence of adverse events in AZA group (59.1%) there was no significant difference in the incidence of menstrual disorder, which was significantly higher than AZA group, but the decrease of white blood cells decreased significantly, the two groups of the total infection rate showed no significant the difference, but the incidence of vaginitis in TW group was significantly higher than AZA group. Conclusion: the recurrence rate of TW maintenance treatment for LN is similar to that of AZA maintenance treatment, although the incidence of menstrual disorder in TW group is higher than that in AZA group, but there is no significant difference in the total adverse events between the two groups. Therefore, TW is an effective maintenance medication.
【作者单位】：南京大学医学院附属金陵医院(南京军区南京总医院)肾脏科;南京大学医学院附属金陵医院(南京军区南京总医院)肾脏科国家肾脏疾病临床医学研究中心全军肾脏病研究所;
【基金】：国家科技支撑计划课题(2013BAI09B04,2015BAI12B05) 江苏省临床医学中心项目(BL2012007)
【分类号】：R593.242
【正文快照】： 狼疮性肾炎(LN)的治疗分为诱导期治疗和维持期治疗。LN患者经过诱导治疗缓解后,需要长期维持治疗以减少复发、提高人肾存活率。KDIGO指南推荐硫唑嘌呤(AZA)可作为LN的维持期治疗的方案之一[1]。AZA价格低廉,可抑制核糖核苷酸的代谢,但对T细胞的作用缺乏选择性,且部分患者存在

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