抗 CD3 单克隆抗体治疗 1 型糖尿病：系统评价和荟萃分析。
Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis.
机构信息
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine/the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China.
出版信息
Endocrine. 2024 Feb;83(2):322-329. doi: 10.1007/s12020-023-03499-0. Epub 2023 Sep 1.
PURPOSE
This meta-analysis aimed to assess the efficacy and safety of anti-CD3 monoclonal antibodies (mAbs) for type 1 diabetes.
METHODS
We searched PubMed, Embase and Cochrane until 23 February 2023 for randomized controlled trials that compared anti-CD3 mAbs with placebo in type 1 diabetes. The primary outcome was the area under the curve (AUC) of C-peptide, daily insulin dose or HbA.
RESULTS
Totally 12 trials that included 1870 participants were eligible for inclusion in the review. Compared with the control group, anti-CD3 mAbs increased AUC of C-peptide at 1 year (P = 0.0005, MD 0.14, 95% CI [0.06, 0.22], I = 94%), and 2 years (P = 0.0003, MD 0.20, 95% CI [0.09, 0.30], I = 88%). The use of anti-CD3 mAbs decreased insulin use at 1 year (P = 0.001, MD -0.09, 95% CI [-0.15, -0.04], I = 90%), and 2 years (P < 0.00001, MD -0.18, 95% CI [-0.25, -0.12], I = 86%). But there was no statistically significant effect on HbA levels. Vomiting, nausea, rash, pyrexia and headache were reported more frequently with anti-CD3 mAbs than with placebo. However, incidence of total adverse events and serious adverse events was similar when comparing anti-CD3 mAbs with placebo.
CONCLUSIONS
Our results suggest that anti-CD3 mAbs were a potential therapy for improving AUC of C-peptide and insulin use in type 1 diabetes.
目的
本荟萃分析旨在评估抗 CD3 单克隆抗体（mAb）治疗 1 型糖尿病的疗效和安全性。
方法
我们检索了 PubMed、Embase 和 Cochrane 数据库，截至 2023 年 2 月 23 日，以寻找比较抗 CD3 mAb 与安慰剂治疗 1 型糖尿病的随机对照试验。主要结局指标为 C 肽、每日胰岛素剂量或糖化血红蛋白（HbA）的曲线下面积（AUC）。
结果
共有 12 项试验，纳入了 1870 名参与者，符合本综述的纳入标准。与对照组相比，抗 CD3 mAb 治疗组在 1 年（P=0.0005，MD 0.14，95%CI [0.06，0.22]，I²=94%）和 2 年（P=0.0003，MD 0.20，95%CI [0.09，0.30]，I²=88%）时 C 肽 AUC 增加。抗 CD3 mAb 治疗组在 1 年（P=0.001，MD -0.09，95%CI [-0.15，-0.04]，I²=90%）和 2 年（P<0.00001，MD -0.18，95%CI [-0.25，-0.12]，I²=86%）时胰岛素使用减少。但对 HbA 水平无统计学显著影响。与安慰剂相比，抗 CD3 mAb 治疗组更常出现呕吐、恶心、皮疹、发热和头痛。然而，与安慰剂相比，抗 CD3 mAb 组总不良事件和严重不良事件的发生率相似。
结论
我们的研究结果表明，抗 CD3 mAb 可能是改善 1 型糖尿病患者 C 肽 AUC 和胰岛素使用的潜在治疗方法。
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