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使用二甲双胍实现狼疮患者的治疗目标:一项汇总分析。

Attaining treat-to-target endpoints with metformin in lupus patients: a pooled analysis.

机构信息

Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.

出版信息

Clin Exp Rheumatol. 2022 Sep;40(9):1733-1737. doi: 10.55563/clinexprheumatol/7y5ku8. Epub 2021 Dec 7.

Abstract

OBJECTIVES

Low disease activity status and remission are crucial treat-to-target (T2T) endpoints in systemic lupus erythematosus (SLE). To evaluate the efficacy of metformin add-on in attaining T2T among Chinese patients with mild-to-moderate lupus, a post-hoc analysis combining our previous two randomised trials was carried out.

METHODS

Data from the open-labeled proof-of-concept trial (ChiCTR-TRC-12002419) and placebo-controlled trial (NCT02741960) were integrated together. Disease flares were compared between patients attaining T2T or not at baseline. The efficacy of metformin versus placebo/nil add-on to standard therapy in SLE patients who did not meet the T2T criteria at baseline was evaluated in terms of attaining T2T at 12-month follow-up.

RESULTS

Of 253 SLE patients, 43.8% (n=89) attained T2T at baseline. During the 12 months, 15 patients flared in the T2T group, which was significantly lower than that in the non-T2T group (16.9% vs. 36.0%, p=0.001). For 164 patients who did not meet the T2T criteria at entry, 59.0% and 43.6% of the 78 patients taking metformin in this population attained the lupus low disease activity status (LLDAS) and remission endpoints at last visit, respectively, as compared to 37.2% and 24.4% of the 86 patients in the placebo/nil group (LLDAS p=0.008; remission p=0.013). Over time, metformin helped patients achieving T2T earlier and maintain longer T2T duration over placebo/nil (LLDAS duration: 44.9% vs. 26.4%, p=0.002; remission duration:19.1% vs. 10.7%, p=0.014).

CONCLUSIONS

This post-hoc analysis suggested that metformin might be an adjuvant therapy in achieving treat-to-target in SLE patients.

摘要

目的

低疾病活动状态和缓解是系统性红斑狼疮(SLE)治疗目标(T2T)的关键终点。为了评估二甲双胍在实现中国轻中度狼疮患者 T2T 中的疗效,我们对之前的两项随机试验进行了事后分析。

方法

将开放标签概念验证试验(ChiCTR-TRC-12002419)和安慰剂对照试验(NCT02741960)的数据整合在一起。比较基线时达到 T2T 与未达到 T2T 的患者之间的疾病发作情况。在基线时未达到 T2T 标准的 SLE 患者中,评估二甲双胍与安慰剂/无添加标准治疗相比在 12 个月随访时达到 T2T 的疗效。

结果

在 253 例 SLE 患者中,43.8%(n=89)基线时达到 T2T。在 12 个月期间,T2T 组中有 15 例患者发作,明显低于非 T2T 组(16.9%比 36.0%,p=0.001)。对于 164 例入组时未达到 T2T 标准的患者,在该人群中服用二甲双胍的 78 例患者中,分别有 59.0%和 43.6%的患者在最后一次就诊时达到狼疮低疾病活动状态(LLDAS)和缓解终点,而安慰剂/无添加组的 86 例患者中分别为 37.2%和 24.4%(LLDAS p=0.008;缓解 p=0.013)。随着时间的推移,二甲双胍帮助患者更早地达到 T2T,并比安慰剂/无添加维持更长的 T2T 持续时间(LLDAS 持续时间:44.9%比 26.4%,p=0.002;缓解持续时间:19.1%比 10.7%,p=0.014)。

结论

这项事后分析表明,二甲双胍可能是 SLE 患者实现 T2T 的辅助治疗。

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