A comprehensive search of PubMed, Google Scholar, Scopus and Cochrane Central Register of Controlled Trials (CENTRAL) was conducted up to December 2022 to identify relevant randomized controlled trials. Meta-analysis was performed using a random-effects model, and odds ratios with 95% confidence intervals (CIs) were calculated to quantify the effects. The Cochrane risk of bias tool was employed for quality assessment.
In total, 11 randomized controlled trials involving 1397 participants (908 participants in the intervention arm, 489 participants in the control arm) were included in this review. The mean age of participants was 15 years, and the mean follow-up time was 2.04 years. Teplizumab was the most commonly studied intervention. Compared with placebo, anti-CD3 monoclonal antibody treatment significantly increased the C-peptide concentration in the area under the curve at shorter timeframes (mean difference = 0.114, 95% CI: 0.069 to 0.159, p = .000). Furthermore, anti-CD3 monoclonal antibodies significantly reduced the patients\' insulin intake across all timeframes (mean difference = -0.123, 95% CI: -0.151 to -0.094, p < .001). However, no significant effect on glycated haemoglobin concentration was observed.
The findings of this review suggest that anti-CD3 monoclonal antibody treatment increases endogenous insulin production and improves the lifestyle of patients by reducing insulin dosage. Future studies should consider the limitations, including sample size, heterogeneity and duration of follow-up, to validate the generalizability of these findings further.
方法:对PubMed的全面搜索,谷歌学者,Scopus和Cochrane中央对照试验注册中心(CENTRAL)于2022年12月进行,以确定相关的随机对照试验。使用随机效应模型进行荟萃分析,计算比值比和95%置信区间(CI)以量化效果。采用Cochrane偏倚风险工具进行质量评估。
结果:总计,11项随机对照试验,涉及1397名参与者(干预组908名参与者,控制臂中的489名参与者)被纳入本综述。参与者的平均年龄是15岁,平均随访时间为2.04年。Teplizumab是最常用的研究干预措施。与安慰剂相比,抗CD3单克隆抗体治疗在较短的时间范围内显着增加了曲线下面积中的C肽浓度(平均差=0.114,95%CI:0.069~0.159,p=.000).此外,抗CD3单克隆抗体在所有时间范围内显著降低了患者的胰岛素摄入量(平均差=-0.123,95%CI:-0.151至-0.094,p<.001).然而,未观察到对糖化血红蛋白浓度的显著影响.
结论:本综述的结果表明,抗CD3单克隆抗体治疗可通过减少胰岛素剂量增加内源性胰岛素产生并改善患者的生活方式。未来的研究应该考虑局限性,包括样本量,异质性和随访持续时间,进一步验证这些发现的普遍性。