依那西普治疗强直性脊柱炎的疗效和安全性：系统评价和随机对照试验的荟萃分析。

Efficacy and safety of Iguratimod in the treatment of Ankylosing Spondylitis: A systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, Guangzhou, China.

People's Hospital of Ningxiang City, Ningxiang, China.

出版信息

Front Immunol. 2023 Mar 3;14:993860. doi: 10.3389/fimmu.2023.993860. eCollection 2023.

OBJECTIVE

To explore the efficacy and safety of Iguratimod (IGU) intervention in the treatment of Ankylosing Spondylitis (AS).

METHODS

We used computer to search literature databases, collected randomized controlled trials (RCTs) related to IGU treatment of AS, and searched the relevant literature in each database until Sep. 2022. Two researchers independently carried out literature screening, data extraction, and evaluation and analysis of the risk of bias in the included studies, and then used Rev Man5.3 software for meta-analysis. The protocol is CRD42020220798.

RESULTS

A total of 10 RCTs involves in 622 patients were collected. The statistical analysis showed that IGU can decrease the BASDAI score (SMD -1.62 [-2.20, -1.05], P<0.00001. Quality of evidence: low), the BASFI score (WMD -1.30 [-1.48, -1.12], P<0.00001. Quality of evidence: low) and the VAS (WMD -2.01 [-2.83, -1.19], P<0.00001. Quality of evidence: very low). Meanwhile, the addition of IGU into the conventional therapy would not increase the adverse events (RR 0.65 [0.43, 0.98], P=0.04. Quality of evidence: moderate).

CONCLUSION

IGU may be an effective and safe intervention for AS.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/display_record.php?, identifier CRD42020220798.

目的

探索来氟米特（IGU）干预治疗强直性脊柱炎（AS）的疗效和安全性。

方法

计算机检索文献数据库，收集有关 IGU 治疗 AS 的随机对照试验（RCT），并在各数据库中检索相关文献，检索时限均截至 2022 年 9 月。由 2 位研究者独立进行文献筛选、数据提取及纳入研究偏倚风险评价，并采用 Rev Man5.3 软件进行 meta 分析。方案注册：CRD42020220798。

结果

共纳入 10 项 RCT 涉及 622 例患者。统计分析结果显示，IGU 可降低 BASDAI 评分（SMD-1.62[-2.20，-1.05]，P<0.00001. 证据质量：低）、BASFI 评分（WMD-1.30[-1.48，-1.12]，P<0.00001. 证据质量：低）和 VAS（WMD-2.01[-2.83，-1.19]，P<0.00001. 证据质量：极低）。同时，加用 IGU 并不会增加不良反应发生率（RR 0.65[0.43，0.98]，P=0.04. 证据质量：中）。