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北京大学学报（医学版） ›› 2022, Vol. 54 ›› Issue (5): 1038-1046. doi: 10.19723/j.issn.1671-167X.2022.05.034

• 论著 • 上一篇    下一篇

血浆置换治疗新月体型IgA肾病的有效性分析: 多中心队列研究

王梓1,张军军2,左力3,王悦4,李文歌5,程虹6,蔡广研7,裴华颖8,王利华9,周绪杰1,师素芳1,刘立军1,吕继成1,*(),张宏1   

  1. 1. 北京大学第一医院肾内科，北京大学肾脏疾病研究所，卫生部肾脏疾病重点实验室，慢性肾脏病防治教育部重点实验室(北京大学)，中国医学科学院免疫介导肾病诊治创新单元，北京 100034
    2. 郑州大学附属第一医院肾内科，郑州 450052
    3. 北京大学人民医院肾内科，北京 100044
    4. 北京大学第三医院肾内科，北京 100191
    5. 中日友好医院肾内科，北京 100029
    6. 首都医科大学附属北京安贞医院肾内科，北京 10029
    7. 中国人民解放军总医院肾内科，北京 100853
    8. 河北医科大学第二医院肾内科，石家庄 050000
    9. 山西医科大学第二医院肾内科，太原 030001
  • 收稿日期:2022-06-07 出版日期:2022-10-18 发布日期:2022-10-14
  • 通讯作者: 吕继成 E-mail:chenglv@263.com
  • 作者简介:吕继成, 北京大学第一医院主任医师, 教授, 博士生导师。现任国际IgA肾病联盟研究科学委员会委员, 中国研究型医院学会肾脏病专委会委员, 中华医学会北京肾脏病分会青年委员。国家杰出青年基金、科技部中青年科技创新领军人才以及教育部新世纪优秀人才获得者, 并被评选为首届(2021年)北京大学杰出青年医师。
    主要从事IgA肾病发病机制及治疗研究, 以及慢性肾脏病循证医学研究, 在一系列IgA肾病及慢性肾脏病治疗(包括糖皮质激素、强化降压、RAAS阻断剂应用)的循证医学研究做出了重要贡献, 推动了相关领域指南(包括KDIGO肾小球肾炎指南、KDIGO慢性肾脏病高血压指南及美国高血压指南)的修订。在Lancet、JAMA、JASN、KI、AJKD等期刊发表SCI论文超过100篇, 入选了2021年爱思唯尔中国被高引学者榜单; 同时积极探索肾炎领域新药研发及转化, 包括开发IgA肾病原研一类新药(first in class)、IgA肾病无创诊断分子探针、居家简易肾功能检测仪, 实现转化合同超过2亿元人民币
  • 基金资助:
    国家自然科学基金(81322009);国家自然科学基金(81270795);首都临床特色应用研究(Z161100000516005)

Efficacy of plasma exchange in severe crescentic IgA nephropathy: A multicentered, cohort study

Zi WANG1,Jun-jun ZHANG2,Li ZUO3,Yue WANG4,Wen-ge LI5,Hong CHENG6,Guang-yan CAI7,Hua-ying PEI8,Li-hua WANG9,Xu-jie ZHOU1,Su-fang SHI1,Li-jun LIU1,Ji-cheng LV1,*(),Hong ZHANG1   

  1. 1. Renal Division, Peking University First Hospital; Institute of Nephrology, Peking University; Key Laboratory of Renal Disease, Ministry of Health of China; Key Laboratory of CKD Prevention and Treatment, Ministry of Education of China, Research Units of Diagnosis and Treatment of lmmune-Mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing 100191, China
    2. Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China
    3. Department of Nephrology, Peking University People's Hospital, Beijing 100044, China
    4. Department of Nephrology, Peking University Third Hospital, Beijing 100191, China
    5. Department of Nephrology, China-Japan Friendship Hospital, Beijing 100029, China
    6. Division of Nephrology, Beijing Anzhen Hospital, Capital Medical University, Beijing 10029, China
    7. Department of Nephrology, Chinese PLA General Hospital, Beijing 100853, China
    8. Renal Division, Department of Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
    9. Renal Division, Shanxi Medical University Second Affiliated Hospital, Taiyuan 030001, China
  • Received:2022-06-07 Online:2022-10-18 Published:2022-10-14
  • Contact: Ji-cheng LV E-mail:chenglv@263.com
  • Supported by:
    the National Natural Science Foundation of China(81322009);the National Natural Science Foundation of China(81270795);the Clinical Characteristic Applied Research Fund of Capital(Z161100000516005)

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摘要：

目的: 探究血浆置换治疗新月体型IgA肾病(IgA nephropathy, IgAN)的有效性。方法: 选择2012年1月—2020年9月在北京大学第一医院肾内科等国内9家医院经肾活检确诊为原发性新月体型IgAN的患者病例资料进行回顾性分析，收集患者基线的临床、病理资料及治疗方案信息。为了尽可能减少基线特征中潜在混杂因素的影响，研究采用倾向性评分最近邻匹配法1 ∶1匹配血浆置换组和常规强化免疫抑制治疗组患者临床及病理信息。研究以终末期肾病(end-stage kidney disease, ESKD)为主要结局，采用Kaplan-Meier方法比较两组患者肾生存差异。结果: 共纳入95例新月体型IgA肾病伴急性肾病(acute kidney disease, AKD)患者，其中37例患者接受了血浆置换治疗，58例患者接受常规强化免疫抑制治疗。整体人群肾活检时估算肾小球滤过率(estimated glomerular filtration rate, eGFR)[M(P25, P75)]12.77 (7.28, 21.29) mL/(min·1.73 m2)，24-h尿蛋白定量5.9 (4.0, 8.9) g，新月体百分比为64.71%(54.55%, 73.68%)。倾向性评分匹配共23对患者，中位随访时间7 (1, 26) 个月，共29例(63.0%)患者进入终末期肾病, 其中血浆置换治疗组16例(69.6%)，常规强化免疫抑制治疗组13例(56.5%)。两组患者基线eGFR[14.30(9.31~17.58) mL/(min·1.73 m2) vs. 11.45(5.59~20.79) mL/(min·1.73 m2)]、24-h尿蛋白定量[(7.4±3.4) g vs. (6.6±3.8) g]、新月体百分比(64.49%±13.23% vs. 66.41%±12.65%)、肾活检后应用激素治疗比例[23(100.0%) vs. 21(91.3%)] 比较，差异均无统计学意义(P均>0.05)。Kaplan-Meier生存分析结果示生存率组间比较，差异无统计学意义(Log-rank检验，P=0.933)。结论: 在常规强化免疫抑制治疗的基础上加用血浆置换治疗未能进一步改善新月体型IgA肾病预后。

关键词: 肾小球肾炎, IgA肾病, 新月体肾小球肾炎, 血浆置换

Abstract:

Objective: To evaluate the efficacy of plasma exchange therapy on crescentic IgA nephropathy (IgAN). Methods: A retrospective analysis was performed in a cohort of patients with crescentic IgAN from January 2012 to September 2020 at 9 sites across China. Clinical and pathological data, as well as therapeutic regimens, were collected. In order to minimize the effect of potential confounders in baseline characteristics, propensity score matching using a 1 ∶1 ratio nearest neighbor algorithm was performed between the adjunctive plasma exchange therapy group and the intensive immunosuppressive therapy group. The primary outcome was end-stage of kidney disease (ESKD). Kaplan-Meier method was used to compare the difference in renal survival between the two groups. Results: A total of 95 crescentic IgAN patients with acute kidney disease were included in this study, including 37 (38.9%) patients receiving adjunctive plasma exchange therapy, and 58 (61.1%) patients receiving intensive immunosuppressive therapy. In the whole cohort, the baseline eGFR was 12.77 (7.28, 21.29) mL/(min·1.73 m2), 24-hour urinary protein quantification was 5.9 (4.0, 8.9) g, and crescent percentage was 64.71% (54.55%, 73.68%). In the study, 23 patients in each group were matched after propensity score matching The median follow-up time was 7 (1, 26) months. As a whole, 29 patients (63.0%) reached ESKD, including 16 patients (69.6%) in the adjunctive plasma exchange therapy group and 13 (56.5%) patients in the intensive immunosuppressive therapy group.. There were no stastical difference between the two groups in terms of baseline eGFR [14.30 (9.31, 17.58) mL/(min·1.73 m2) vs. 11.45 (5.59, 20.79) mL/(min·1.73 m2)], 24-hour urinary protein (7.4±3.4) g vs. (6.6±3.8) g, crescent percentage 64.49%±13.23% vs. 66.41%±12.65% and the proportion of patients received steroid therapy[23 (100.0%) vs. 21 (91.3%)] (All P>0.05). Kaplan-Meier survival analysis demonstrated that there was no significant difference in renal survival rate between the two groups (Log-rank test, P=0.933). Conclusion: The adjunctive plasma exchange therapy in addition to conventional intense immunosuppressive therapy did not additionally improve the prognosis of crescentic IgA nephropathy.

Key words: Glomerulonephritis, IgA nephropathy, Crescentic glomerulonephritis, Plasma exchange therapy

中图分类号: 

  • R692

表1

新月体型IgA肾病多中心队列患者基线信息"

Items Total population
(n=95)		 PLEX+IS group
(n=37)		 IS group
(n=58)		 P
Age/years, M(P25, P75) 32 (23, 55) 40 (23, 59) 31 (22, 46) 0.262
Male, n(%) 58 (61.1) 22 (59.5) 36 (62.1) 0.799
Time of follow-up/months, M(P25, P75) 10 (1, 27) 6 (0, 24) 15 (2, 33) 0.087
Course of disease/months, M(P25, P75) 3.0 (1.0, 8.0) 3.0 (1.0, 12.0) 2.8 (1.0, 7.3) 0.652
Prodromic infection, n(%) 35 (36.84) 17 (45.95) 18 (31.03) 0.072
Auria or oligouria, n(%) 14 (14.74) 8 (21.62) 6 (10.34) 0.131
Gross hematuria, n(%) 20 (21.05) 5 (13.51) 15 (25.86) 0.150
Hypertension history, n(%) 73 (76.84) 32 (86.49) 41 (70.69) 0.075
Dialysis prior to RB, n(%) 30 (31.58) 19 (51.35) 11 (18.97) 0.001
ACEi/ARB use prior to RB, n(%) 19 (20.00) 7 (18.92) 12 (20.69) 0.833
Steroids use prior to RB, n(%) 31 (32.63) 16 (43.24) 15 (25.86) 0.099
IS use prior to RB, n(%) 14 (14.74) 7 (18.92) 7 (12.07) 0.397
MAP/mmHg, ˉx±s 107.3±11.5 109.3±12.3 105.9±10.9 0.172
Hb/(g/L), ˉx±s 103.2±23.2 99.2±17.9 105.7±25.8 0.152
ESR/(mm/h), M(P25, P75) 34.0 (23.0，61.5) 41.0 (25.8，57.8) 31.5 (19.0，67.8) 0.706
Urine RBC/(/μL), M(P25, P75) 395. 3 (117.1，1 483.0) 670.1 (142.7，1 932.6) 354.7 (105.9，801.9) 0.055
24-hour proteinuria/g, M(P25, P75) 5.9 (4.0，8.9) 5.7 (4.0，7.8) 6.3 (3.8，9.1) 0.556
Scr/(μmol/L), M(P25, P75) 380.8 (254.0, 616.6) 472.2 (340.7，641.1) 309.8 (184.4，556.7) 0.026
eGFR/[mL/(min·1.73m2)], M(P25, P75) 12.77 (7.28，21.29) 9.38 (6.81，14.94) 16.06 (7.54，32.35) 0.035
Alb/(g/L), M(P25, P75) 29.9 (25.2，33.5) 28.7 (25.3，32.9) 30.4 (24.9，34.6) 0.514
IgG/(g/L), M(P25, P75) 7.20 (5.43，10.95) 7.20 (5.44，10.80) 7.25 (5.25，11.05) 0.751
IgA/(g/L), M(P25, P75) 2.86 (2.01，3.82) 2.87 (1.71，3.91) 2.85 (2.08，3.69) 0.774
IgM/(g/L), M(P25, P75) 0.72 (0.57，1.11) 0.72 (0.59，0.91) 0.81 (0.55，1.48) 0.234
C3/(g/L), M(P25, P75) 0.82 (0.65，1.05) 0.74 (0.61，0.87) 0.86 (0.69，1.18) 0.008
C4/(g/L), M(P25, P75) 0.27 (0.20，0.33) 0.24 (0.19，0.32) 0.28 (0.21，0.35) 0.250
CRP/(g/L), M(P25, P75) 3.28 (1.07，9.21) 4.29 (1.39，9.69) 1.58 (0.65，7.28) 0.116
Global sclerosis/%, M(P25, P75) 0 (0，9.10) 0 (0，9.11) 0 (0，9.10) 0.526
Ischemic sclerosis/%, M(P25, P75) 1.79 (0，11.76) 6.25 (0，11.81) 0 (0，11.82) 0.563
Crescents/%, M(P25, P75) 64.71 (54.55，73.68) 65.00 (54.42，76.08) 63.87 (55.30，73.81) 0.878
Total crescents/%, M(P25, P75) 68.75 (60.00，81.82) 69.23 (61.11，84.92) 67.91 (59.84，80.88) 0.410
ACEi/ARB use post to RB, n(%) 28 (29.47) 13 (35.14) 15 (25.86) 0.334
Steroids use post to RB, n(%) 86 (90.53) 34 (91.89) 52 (89.66) 0.717
Steroid impulse post to RB, n(%) 67 (70.53) 24 (64.86) 43 (74.14) 0.268
IS use post to RB, n(%) 49 (51.58) 19 (51.35) 30 (51.72) 0.989

图1

新月体型IgA肾病队列筛选流程图"

表2

新月体型IgA肾病队列倾向性评分匹配后患者信息"

Items Total population
(n=46)		 PLEX+IS group
(n=23)		 IS group
(n=23)		 P
Age/years, ˉx±s 38±18 37±18 39±19 0.769
Male/% 31 (67.4) 16 (69.6) 15 (65.2) 0.753
Time of follow-up/months, M(P25, P75) 7 (1，26) 9 (3，27) 2 (0，22) 0.212
Course of disease/months, M(P25, P75) 2.0 (1.0，6.3) 4.0 (1.0，12.0) 2.0 (1.0，5.0) 0.073
Prodromic infection/% 17 (37.0) 9 (39.1) 8 (34.8) 0.760
Auria or oligouria/% 5 (10.9) 3 (13.0) 2 (8.7) 0.639
Gross hematuria/% 12 (26.1) 4 (17.4) 8 (34.8) 0.184
Hypertension history/% 34 (73.9) 19 (82.6) 15 (65.2) 0.184
Dialysis prior to RB/% 13 (28.3) 6 (26.1) 7 (30.4) 0.743
ACEi/ARB use prior to RB/% 9 (19.6) 6 (26.1) 3 (13.0) 0.270
Steroids use prior to RB/% 16 (34.8) 12 (52.2) 4 (17.4) 0.014
IS use prior to RB/% 7 (15.2) 6 (26.1) 1 (4.3) 0.042
MAP/mmHg, ˉx±s 110.3±11.7 109.9±12.2 110.7±11.4 0.813
Hb/(g/L), ˉx±s 103.8±21.6 107.2±16.7 100.5±25.6 0.296
ESR/(mm/h), M(P25, P75) 45.4±22.2 45.7±21.9 44.4±24.8 0.901
Urine RBC/(/μL), M(P25, P75) 466.4 (141.8，1 390.5) 554.4 (140.1，1 728.9) 457.0 (134.0，1 000.0) 0.733
24-hour proteinuria/g, M(P25, P75) 7.0±3.6 7.4±3.4 6.6±3.8 0.502
Scr/(μmol/L), M(P25, P75) 377.6 (283.3，633.7) 352.8 (309.0，522.3) 451.0 (258.7，775.0) 0.374
eGFR/[mL/(min·1.73m2)], M(P25, P75) 12.74 (7.27，18.85) 14.30 (9.31，17.58) 11.45 (5.59，20.79) 0.318
Alb/(g/L), M(P25, P75) 28.3±5.6 27.8±5.5 28.7±5.8 0.627
IgG/(g/L), M(P25, P75) 7.12(5.74，10.30) 7.13(5.71，10.42) 6.41(5.00，10.01) 0.849
IgA/(g/L), M(P25, P75) 2.86(2.04，3.54) 2.79(1.70，3.69) 3.00(2.13，3.45) 0.107
IgM/(g/L), M(P25, P75) 0.75±0.32 0.76±0.34 0.74±0.31 0.864
C3/(g/L), M(P25, P75) 0.83±0.26 0.78±0.26 0.89±0.24 0.165
C4/(g/L), M(P25, P75) 0.26±0.09 0.25±0.08 0.27±0.11 0.525
CRP/(g/L), M(P25, P75) 6.68±7.15 6.89±6.50 6.28±8.58 0.823
Global sclerosis/%, M(P25, P75) 0(0，8.33) 0(0，10.00) 0(0，7.69) 0.694
Ischemic sclerosis/%, M(P25, P75) 8.82±9.97 8.11±10.03 9.54±10.07 0.484
Crescents/%, M(P25, P75) 65.45±12.83 64.49±13.23 66.41±12.65 0.617
Total crescents/%, M(P25, P75) 71.08±13.00 71.03±14.04 71.12±12.20 0.981
ACEi/ARB use post to RB, n(%) 9 (19.6) 6 (26.1) 3 (13.0) 0.270
Steroids use post to RB, n(%) 44 (95.7) 23 (100.0) 21 (91.3) 0.153
Steroid impulse post to RB, n(%) 34 (73.9) 17 (73.9) 17 (73.9) 1.000
IS use post to RB, n(%) 23 (51.1) 13 (59.1) 10 (43.5) 0.295

图2

血浆置换联合治疗新月体型IgA肾病患者肾生存差异"

表3

血浆置换联合疗法治疗新月体型IgA肾病患者有效性分析"

Outcomes PLEX+IS group, n(%) IS group, n(%) HR (95%CI) P
Primary outcomes
  ESKD 16 (69.6) 13 (56.5) 0.959 (0.458－2.010) 0.912*
Second outcomes
  All cause of death 2 (8.7) 1 (4.3) 1.048 (0.899－1.221) 0.555
  ESKD at 6 months 8 (34.8) 10 (43.5) 0.867 (0.544－1.382) 0.546
  ESKD at 12 months 10 (43.5) 10 (43.5) 1.000 (0.602－1.660) 1.000
  Dialysis-free at 3 months 3 (50.0) 2 (28.6) 1.429 (0.565－3.611) 0.447
  Dialysis-free at 12 months 1 (16.7) 1 (14.3) 1.029 (0.644－1.643) 0.909

图3

血浆置换联合疗法治疗新月体型IgA肾病患者肾生存差异landmark分析"

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