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利妥昔单抗治疗成人频繁复发或依赖类固醇的微小病变病或局灶节段性肾小球硬化症的疗效和安全性:一项系统评价和荟萃分析。

Efficacy and safety of rituximab in adult frequent-relapsing or steroid-dependent minimal change disease or focal segmental glomerulosclerosis: a systematic review and meta-analysis.

作者信息

Xue Cheng, Yang Bo, Xu Jing, Zhou Chenchen, Zhang Liming, Gao Xiang, Dai Bing, Yu Shengqiang, Mao Zhiguo, Mei Changlin, Xu Chenggang

机构信息

Division of Nephrology, Kidney Institute of CPLA (Chinese People's Liberation Army), Changzheng Hospital, Second Military Medical University, Shanghai, China.

Department of Nephrology, the Third Affiliated Hospital of Second Military Medical University, Shanghai, China.

出版信息

Clin Kidney J. 2020 Nov 21;14(4):1042-1054. doi: 10.1093/ckj/sfaa191. eCollection 2021 Apr.

Abstract

BACKGROUND

The efficacy and safety of rituximab (RTX) in adult frequent-relapsing (FR) or steroid-dependent (SD) nephrotic syndrome (NS), including minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS), are still inconclusive.

METHODS

We performed a systematic review and meta-analysis registered in  PROSPERO (CRD42019148102) by pooling data of cohort studies or case series on adult patients with difficult-to-treat NS. Steroid-resistant NS was excluded. The primary outcomes were the complete remission (CR) rate and the relapse rate. Partial remission (PR) rate, no response (NR) rate and adverse events were the secondary outcomes. A random-effects model was performed for all the outcomes.

RESULTS

We included 21 studies involving 382 adult MCD/FSGS subjects with a median follow-up duration from 12 to 43 months. RTX treatment induced a pooled 84.2% CR rate [95% confidence interval (CI): 67.7-96.3%], while MCD patients had a high 91.6% CR rate and FSGS patients a moderate 43% CR rate. However, 27.4% (95% CI 20.7-34.5%) of the patients relapsed during the follow-up. The pooled PR and NR rates were 5.8% (95% CI 1.2-12.5%) and 5.2% (95% CI 0.0-15.0%), respectively. RTX was associated with trivial adverse events and good tolerance.

CONCLUSIONS

In summary, by pooling results of current pilot studies, RTX may be an effective and relatively safe alternative for most adult FR or SD MCD/FSGS to displace calcineurin inhibitors or prednisone in the hierarchy of treatment. More clinical trials comparing RTX with other immunosuppressants and concerning the long-term adverse events are needed.

摘要

背景

利妥昔单抗(RTX)在成人频繁复发(FR)或依赖类固醇(SD)的肾病综合征(NS)(包括微小病变病(MCD)或局灶节段性肾小球硬化(FSGS))中的疗效和安全性仍无定论。

方法

我们通过汇总关于成年难治性NS患者的队列研究或病例系列数据,进行了一项在PROSPERO(CRD42019148102)注册的系统评价和荟萃分析。排除了类固醇抵抗性NS。主要结局为完全缓解(CR)率和复发率。部分缓解(PR)率、无反应(NR)率和不良事件为次要结局。对所有结局采用随机效应模型。

结果

我们纳入了21项研究,涉及382例成年MCD/FSGS患者,中位随访时间为12至43个月。RTX治疗的汇总CR率为84.2%[95%置信区间(CI):67.7 - 96.3%],而MCD患者的CR率较高,为91.6%,FSGS患者的CR率为中等水平,为43%。然而,27.4%(95% CI 20.7 - 34.5%)的患者在随访期间复发。汇总的PR率和NR率分别为5.8%(95% CI 1.2 - 12.5%)和5.2%(95% CI 0.0 - 15.0%)。RTX与轻微不良事件相关且耐受性良好。

结论

总之,通过汇总当前初步研究的结果,对于大多数成年FR或SD MCD/FSGS患者,RTX可能是一种有效且相对安全的替代药物,可在治疗层级中取代钙调神经磷酸酶抑制剂或泼尼松。需要更多比较RTX与其他免疫抑制剂以及关注长期不良事件的临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1146/8173623/c68464198532/sfaa191f1.jpg

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