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中华肾病研究电子杂志

中华肾病研究电子杂志 ›› 2020, Vol. 09 ›› Issue (02) : 67 -73. doi: 10.3877/cma.j.issn.2095-3216.2020.02.004

所属专题： 文献；

论著

血浆置换联合激素或/和免疫抑制剂治疗ANCA相关性小血管炎严重肾损害临床疗效和预后的Meta分析
赵朵1, 刘赛磊2, 李静3,†()   
  1. 1. 030001　太原，山西医科大学第二医院肾内科
    2. 030001　太原，山西医科大学第二医院心内科
    3. 030001　太原，山西医科大学第二医院肾内科；030000　太原，山西省卫生计生委医疗质量控制管理中心血液净化质量控制中心
  • 收稿日期:2019-10-24 出版日期:2020-04-28
  • 通信作者: 李静

Meta-analysis of clinical efficacy and prognosis of plasma exchange combined with hormones and/or immunosuppressive agents in the treatment of severe renal impairment of ANCA-associated vasculitis

Duo Zhao1, Sailei Liu2, Jing Li3,†()   

  1. 1. Department of Nephrology, The Second Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China
    2. Department of Cardiology, The Second Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China
    3. Department of Nephrology, The Second Hospital of Shanxi Medical University, Taiyuan 030001; Quality Control Center for Blood Purification, Medical Quality Control Management Center, Shanxi Province Health Commission, Taiyuan 030000; Shanxi Province, China
  • Received:2019-10-24 Published:2020-04-28
  • Corresponding author: Jing Li
  • About author:
    Corresponding author: Li Jing, Email:
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赵朵, 刘赛磊, 李静. 血浆置换联合激素或/和免疫抑制剂治疗ANCA相关性小血管炎严重肾损害临床疗效和预后的Meta分析[J]. 中华肾病研究电子杂志, 2020, 09(02): 67-73.

Duo Zhao, Sailei Liu, Jing Li. Meta-analysis of clinical efficacy and prognosis of plasma exchange combined with hormones and/or immunosuppressive agents in the treatment of severe renal impairment of ANCA-associated vasculitis[J]. Chinese Journal of Kidney Disease Investigation(Electronic Edition), 2020, 09(02): 67-73.

目的

系统评价血浆置换联合激素或/和免疫抑制剂治疗对抗中性粒细胞胞浆抗体(ANCA)相关性血管炎性肾损害的临床疗效及预后。

方法

计算机检索MEDLINE via OvidSP、Embase、中国生物医学文献数据库、知网、万方及维普数据库，检索时限为建库至2019年4月，搜集血浆置换联合激素或/和免疫抑制剂治疗ANCA相关性血管炎肾损害的随机对照试验(RCT)及队列研究的相关文献。总共纳入939例患者，其中标准治疗组(单独的激素或/和免疫抑制剂治疗)共503例患者，联合治疗组(标准治疗联合血浆置换治疗)共436例患者，应用Review Manager 5.3软件行荟萃分析。

结果

(1)肾功能改善方面：联合治疗组血肌酐降低更明显，其差异有统计学意义(SMD＝－0.51，95% CI：－0.92～－0.09，P＝0.02)，亚组分析结果显示联合治疗组短期疗效及长期疗效和标准治疗组相比好转，且差异有统计学意义；联合治疗组血尿素氮降低不明显，其差异无统计学意义(SMD＝－0.25；95% CI：－0.37～ 0.87，P＝0.43)。(2)原发病控制方面：联合治疗组伯明翰血管炎活动性评分(BVAS)下降更明显，其差异有统计学意义(MD＝－1.51，95% CI：－2.38～ －0.64，P<0.05)；联合治疗组ANCA水平降低更明显，其差异有统计学意义(MD＝－27.68，95% CI：－42.17～－13.19，P<0.05)。(3)长期随访结局方面：联合治疗组发生死亡或终末期肾病的风险小于标准治疗组，其差异有统计学意义(RR＝0.67，95% CI：0.53～ 0.84，P＝0.0004)；联合治疗组脱离透析频率高于标准治疗组，其差异有统计学意义(RR＝1.32，95% CI：1.08～ 1.61，P＝0.007)。联合治疗组不良反应发生率和标准治疗组相当，不良反应主要包括肺部感染、肺结核、带状疱疹、胃肠道症状及肝损害，其差异无统计学意义(RR＝0.64，95%CI：0.39～ 1.05，P＝0.08)。

结论

血浆置换联合激素或/和免疫抑制剂治疗可有效降低血清肌酐值、血清ANCA水平、伯明翰血管炎活动评分；减少终末期肾病的复合终点和全因死亡，提高疾病控制率，但随访过程中两组不良反应发生率相似。

关键词: 血浆置换, ANCA相关性血管炎, Meta分析, 肾损害
Objective

To systematically evaluate the clinical efficacy and prognosis of plasma exchange combined with hormones and/or immunosuppressive agents in treating severe renal impairment of ANCA-associated vasculitis.

Methods

Computer search was made in MEDLINE via OvidSP, Embase, China Biomedical Literature Database, China National Knowledge Internet, Wanfang Data and CQVIP Database. The search period was from the establishment of the database to April 2019. Related literatures were collected from randomized controlled trials (RCT) and cohort studies on treatment of severe renal impairment in ANCA-associated vasculitis with plasma exchange combined with hormones and/or immunosuppressive agents. A total of 939 patients were included, including 503 patients in the standard treatment group (corticosteroids alone or combining immunosuppressive agents) and 436 patients in the combination treatment group (standard treatment combined with plasma exchange). Meta-analysis was performed with the software of Review Manager 5.3 version.

Results

Regarding the improvement of renal function: the blood creatinine decreased more in the combination treatment group (SMD=-0.51, 95%CI: -0.92 to -0.09, P=0.02). Subgroup analysis results showed that the short-term and long-term efficacy of the combination treatment group improved with statistically significant difference compared with the standard treatment group. There was no significant decrease in urea nitrogen in the combination treatment group (SMD=-0.25, 95%CI: -0.37 to 0.87, P=0.43). In terms of primary disease control: Birmingham vasculitis activity score (BVAS) of the combination treatment group decreased more significantly (MD=-1.51, 95%CI: -2.38 to -0.64, P<0.05); The decrease of ANCA level in combination treatment group was more obvious (MD=-27.68, 95%CI: -42.17 to -13.19, P<0.05). In terms of long-term follow-up outcomes: the risk of death or end-stage renal disease in the combination treatment group was less than that in the standard treatment group (RR= 0.67, 95%CI: 0.53-0.84, P<0.05); The frequency of freedom from dialysis in the combination treatment group was higher than that in the standard treatment group (RR=1.32, 95%CI: 1.08-1.61, P<0.05). The incidence of adverse reactions in the combination treatment group was similar to that in the standard treatment group, and the adverse reactions mainly included pulmonary infection, tuberculosis, herpes zoster, gastrointestinal symptoms, and liver damage (OR=0.64, 95%CI: 0.39-1.05, P=0.08).

Conclusion

Plasma exchange combined with hormones and/or immunosuppressive agents could effectively reduce serum creatinine level, serum ANCA level, BVAS, and the composite end point and all-cause mortality of end-stage renal disease, so as to improve disease control rate, while the incidence of adverse reactions was similar between the two groups during the follow-up.

Key words: Plasma exchange, ANCA-associated vasculitis, Meta-analysis, Renal damage
图1 文献筛选流程图
表1 纳入文献基本资料
纳入研究 联合治疗组 标准治疗组 随访时间 研究设计
例数 女性(%) 例数 女性(%)
周培一2016 32 12(37.5) 31 12(38.7) 6个月 RCT
陈洪2016 27 15(27.8) 27 15(27.8) / RCT
韩晓文2015 10 4(40) 25 10(40) 6个月 队列研究
欧阳楚君2016 21 9(42.8) 47 23(48.9) 1年 队列研究
张健2015 14 5(35.7) 17 6(35.3) 3个月 队列研究
白培进2015 22 10(45.5) 25 11(44) 6个月 队列研究
Walsh, M．2013 69 28(49) 68 24(35) 1年/5年 RCT
Gregersen，J.W.2012 25 19(76) 50 28(56) 1年 队列研究
Nishimura，K. 2019 12 5(41.7) 24 10(41.7) 2年 队列研究
Jayne, D. R．2007 70 29(41) 67 24(36) 3个月/1年 RCT
Solar－Cafaggi，D. 2016 24 12(50) 24 14(58) 1年 队列研究
Frasca, G. M. 2003 13 10(76.9) 13 4(30.7) 3年 队列研究
Szpirt, W. M. 2011 16 4(25) 16 3(18.8) 5年 RCT
Dhaun, N. 2015 58 31(53.4) 46 20(43.5) 1年 队列研究
图2 联合治疗组和标准治疗组疗效——肌酐的Meta分析
图4 联合治疗组和标准治疗组疗效——血清ANCA水平的Meta分析
图3 联合治疗组和标准治疗组疗效——BVAS的Meta分析
图5 联合治疗组和标准治疗组疗效——复合终点的Meta分析
图6 联合治疗组和标准治疗组疗效——脱离透析率的Meta分析
图7 联合治疗组和标准治疗组疗效——不良反应发生率的Meta分析
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