利妥昔单抗治疗系统性红斑狼疮的疗效与安全性：一项荟萃分析。

Efficacy and safety of rituximab for systemic lupus erythematosus treatment: a meta-analysis.

作者信息

Wu Shanshan, Wang Yanhai, Zhang Jiaojiao, Han Bo, Wang Baishan, Gao Wanli, Zhang Ning, Zhang Cheng, Yan Feng, Li Zhijing

机构信息

Clinical Laboratory Department, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, Huanggu District, Shenyang, 110032, Liaoning, China.

Clinical Laboratory Department, Dong Sheng People's Hospital of Ordos, Ordos, 017000, The Inner Mongolia Autonomous Region, China.

出版信息

Afr Health Sci. 2020 Jun;20(2):871-884. doi: 10.4314/ahs.v20i2.41.

DOI:10.4314/ahs.v20i2.41

PMID:33163054

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7609121/

Abstract

BACKGROUND

Given the inconsistency of previous studies and the newly emerging evidence, we decided to conduct a meta-analysis.

METHODS

The meta-analysis included 2 randomized controlled trials and 13 observational studies 742 patients in total. Qualified studies were properly searched from databases . Data were analyzed by the RevMan 5.3 software. Results were demonstrated as WMD , SMD and RR with 95% CIs, I and P value.

RESULTS

we observed that a remarkable increase of complement C3 in the rituximab group than placebo group (WMDfixed= 7.67mg/dL, 95%CIs=-0.16~~15.50, I=0%, P=0.05). A significant increase of complement C4 was observed in the rituximab group than placebo group (WMDfixed=3.14mg/dL, 95%CIs=1.06~~5.22, I=0%, P=0.003). Notably decreased peripheral CD19+B cells in rituximab group than placebo group (WMDfixed=-117.93n/µl, 95%CIs=-172.94~-62.91, I=0%, P<0.0001) in RCTs. Patients with severe or refractory SLE got more satisfactory efficacy results after receiving rituximab in observational studies, such as British Isles Lupus Assessment Group index score, SLE Disease Activity Index score, complement C3/C4, anti-dsDNA antibodies, peripheral CD19B cells and so on. Safety profiles were no difference between rituximab and placebo groups.

CONCLUSION

although the efficacy of rituximab is highly controversial for SLE, our study shows that rituximab presents a satisfying efficacy and safety for SLE.

摘要

背景

鉴于既往研究结果不一致以及新出现的证据，我们决定进行一项荟萃分析。

方法

该荟萃分析纳入了2项随机对照试验和13项观察性研究，共742例患者。通过数据库对合格研究进行了适当检索。使用RevMan 5.3软件进行数据分析。结果以加权均数差（WMD）、标准化均数差（SMD）和风险比（RR）及95%置信区间（CIs）、I²和P值表示。

结果

我们观察到，与安慰剂组相比，利妥昔单抗组的补体C3显著升高（固定效应模型WMD = 7.67mg/dL，95%CI = -0.16~~15.50，I² = 0%，P = 0.05）。与安慰剂组相比，利妥昔单抗组的补体C4显著升高（固定效应模型WMD = 3.14mg/dL，95%CI = 1.06~~5.22，I² = 0%，P = 0.003）。在随机对照试验中，与安慰剂组相比，利妥昔单抗组外周血CD19⁺B细胞显著减少（固定效应模型WMD = -117.93n/µl，95%CI = -172.94~-62.91，I² = 0%，P < 0.0001）。在观察性研究中，重度或难治性系统性红斑狼疮（SLE）患者接受利妥昔单抗治疗后，在诸如不列颠群岛狼疮评估组指数评分、SLE疾病活动指数评分、补体C3/C4、抗双链DNA抗体、外周血CD19B细胞等方面获得了更满意的疗效结果。利妥昔单抗组和安慰剂组的安全性概况无差异。