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利妥昔单抗作为ABO血型相容且未致敏肾移植诱导治疗的有效性和安全性:一项随机对照试验的系统评价和荟萃分析

The effectiveness and safety of rituximab as induction therapy in ABO-compatible non-sensitized renal transplantation: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Cheungpasitporn Wisit, Thongprayoon Charat, Edmonds Peter J, Bruminhent Jackrapong, Tangdhanakanond Kawin

机构信息

a Division of Nephrology and Hypertension , Mayo Clinic , Rochester , MN , USA .

b SUNY Upstate Medical University , Syracuse , NY , USA .

出版信息

Ren Fail. 2015;37(9):1522-6. doi: 10.3109/0886022X.2015.1077310. Epub 2015 Sep 3.

DOI:10.3109/0886022X.2015.1077310
PMID:26337918
Abstract

BACKGROUND

The objective of this systematic review and meta-analysis was to evaluate the effectiveness and safety of rituximab as induction therapy in ABO-compatible, non-sensitized renal transplantation.

METHODS

A literature search for randomized controlled trials (RCTs) was performed from inception through February 2015. Studies that reported relative risks or hazard ratios comparing the risks of biopsy-proven acute rejection (BPAR), graft loss, leukopenia, infection or mortality in ABO-compatible, non-sensitized renal transplant recipients who received rituximab as induction therapy versus controls were included. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using a random-effect, generic inverse variance method.

RESULTS

Four RCTs with 480 patients were included in the meta-analysis. Pooled RR of BPAR in recipients with rituximab induction was 0.90 (95% CI 0.50-1.60). Compared to placebo, the risk of BPAR in rituximab group was 0.76 (95% CI 0.51-1.14, I(2) = 0). The risk of leukopenia was increased in rituximab group with the pooled RR of 8.22 (95% CI 2.08-32.47). There were no statistical differences in the risks of infection, graft loss and mortality at 3-6 months after transplantation with pool RRs of 1.02 (95% CI 0.85-1.21), 0.55 (95% CI 0.21-1.48) and 0.58 (95% CI 0.17-1.99), respectively.

CONCLUSION

This meta-analysis demonstrated insignificant reduced risks of BPAR, graft loss or mortality among in ABO-compatible, non-sensitized renal transplant recipients with rituximab induction. Although rituximab induction significantly increases risk of leukopenia, it appears to be safe with no significant risk of infection.

摘要

背景

本系统评价和荟萃分析的目的是评估利妥昔单抗作为诱导治疗在ABO血型相合、未致敏肾移植中的有效性和安全性。

方法

从数据库建立至2015年2月进行随机对照试验(RCT)的文献检索。纳入报告了比较接受利妥昔单抗作为诱导治疗的ABO血型相合、未致敏肾移植受者与对照组活检证实的急性排斥反应(BPAR)、移植肾丢失、白细胞减少、感染或死亡风险的相对风险或风险比的研究。采用随机效应、通用逆方差法计算合并风险比(RRs)和95%置信区间(CIs)。

结果

荟萃分析纳入了4项RCT,共480例患者。接受利妥昔单抗诱导的受者BPAR的合并RR为0.90(95%CI 0.50 - 1.60)。与安慰剂相比,利妥昔单抗组BPAR的风险为0.76(95%CI 0.51 - 1.14,I(2)=0)。利妥昔单抗组白细胞减少的风险增加,合并RR为8.22(95%CI 2.08 - 32.47)。移植后3 - 6个月,感染、移植肾丢失和死亡风险的合并RR分别为1.02(95%CI 0.85 - 1.21)、0.55(95%CI 0.21 - 1.48)和x0.58(95%CI 0.17 - 1.99),无统计学差异。

结论

本荟萃分析表明,在ABO血型相合、未致敏肾移植受者中,利妥昔单抗诱导治疗在降低BPAR、移植肾丢失或死亡风险方面无显著效果。虽然利妥昔单抗诱导显著增加白细胞减少的风险,但似乎是安全的,无显著感染风险。

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