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巴利昔替尼治疗系统性红斑狼疮患者的疗效:一项随机对照试验的荟萃分析。

Efficacy of baricitinib for the treatment of systemic lupus erythematosus patients: A meta-analysis of randomized controlled trials.

机构信息

Department of Biotechnology, Berhampur University, Bhanja Bihar, Berhampur, Odisha, India.

Centre of Excellence on "Bioprospecting of Ethnopharmaceuticals of Southern Odisha" (CoE-BESO), Berhampur University, Bhanja Bihar, Berhampur, Odisha, India.

出版信息

Int J Rheum Dis. 2024 Jan;27(1):e14964. doi: 10.1111/1756-185X.14964. Epub 2023 Nov 10.

DOI:10.1111/1756-185X.14964
PMID:37950554
Abstract

BACKGROUND

Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by abnormal autoantibody production, inflammation, and organ damage. Most SLE treatment strategies aim to induce remission or reduce disease activity while avoiding flares. Baricitinib has been used effectively to manage various inflammatory diseases, and some randomized controlled trials (RCT) have shown that it is beneficial in treating SLE. The current study aims to assess the efficacy of baricitinib in treating SLE patients.

MATERIALS AND METHODS

Various databases such as PubMed, Scopus, and Science Direct were searched to obtain eligible studies for the present meta-analysis. Data such as baseline characteristics of patients, doses of the baricitinib, follow-up duration, and treatment outcome in the form of SLE responder index-4 (SRI-4) and lupus low disease activity state (LLDAS) were extracted. Combined odds ratio, 95% confidence interval, and probability values were calculated to study the efficacy of baricitinib in treating SLE patients. A p-value less than .05 was taken as significant. Comprehensive meta-analysis v3 was used for all analyses.

RESULTS

Three articles were found eligible for the present meta-analysis comprising 614 patients with placebo, 614 SLE patients receiving 4 mg, and 621 patients with 2 mg of baricitinib. Meta-analysis revealed a beneficial effect of 4 mg baricitinib in SLE patients compared to placebo, as measured by an increase in the SRI-4 (p = .006, OR = 1.370) and LLDAS (p = .083, OR = 1.252) rates. In contrast to the placebo group, however, patients receiving 2 mg of baricitinib exhibited no significant improvement. The trial sequential analysis revealed the need for additional RCTs to determine the role of baricitinib in treating SLE patients.

CONCLUSION

In treating SLE patients, administrating a higher dose of baricitinib (4 mg) may be effective. However, additional RCTs in different populations with larger sample sizes are required to validate our findings.

摘要

背景

系统性红斑狼疮(SLE)是一种自身免疫性疾病,其特征是异常的自身抗体产生、炎症和器官损伤。大多数 SLE 治疗策略旨在诱导缓解或降低疾病活动度,同时避免发作。巴利昔替尼已被有效地用于治疗各种炎症性疾病,一些随机对照试验(RCT)表明其在治疗 SLE 方面是有益的。本研究旨在评估巴利昔替尼治疗 SLE 患者的疗效。

材料和方法

通过检索 PubMed、Scopus 和 Science Direct 等各种数据库,获得本次荟萃分析的合格研究。提取患者基线特征、巴利昔替尼剂量、随访时间以及以 SLE 应答指数-4(SRI-4)和狼疮低疾病活动状态(LLDAS)形式的治疗结果等数据。计算合并比值比、95%置信区间和概率值,以研究巴利昔替尼治疗 SLE 患者的疗效。p 值小于.05 被认为具有统计学意义。所有分析均采用 Comprehensive Meta-Analysis v3 进行。

结果

发现 3 篇文章符合本荟萃分析的纳入标准,共纳入 614 例安慰剂组、614 例接受 4mg 巴利昔替尼组和 621 例接受 2mg 巴利昔替尼组的 SLE 患者。荟萃分析显示,与安慰剂相比,4mg 巴利昔替尼可使 SLE 患者的 SRI-4(p=.006,OR=1.370)和 LLDAS(p=.083,OR=1.252)率增加,从而产生有益的效果。然而,与安慰剂组相比,接受 2mg 巴利昔替尼的患者则没有显著改善。试验序贯分析表明,需要进行更多的 RCT 来确定巴利昔替尼在治疗 SLE 患者中的作用。

结论

在治疗 SLE 患者时,给予较高剂量的巴利昔替尼(4mg)可能是有效的。然而,需要在不同人群中进行更大规模的 RCT 来验证我们的发现。

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引用本文的文献

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