评估替普利珠单抗治疗 1 型糖尿病的疗效和安全性:系统综述和荟萃分析

Xiao-Lan Ma, Dan Ge, Xue-Jian Hu
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摘要

背景:自身免疫性 1 型糖尿病(T1DM)患者的朗格汉斯胰岛β细胞会减少。Teplizumab是一种人源化的抗CD3单克隆抗体,可能对T1DM有帮助。但它对 T1DM 临床发展、安全性和有效性的长期影响尚不清楚。目的 评估替普利珠单抗作为 T1DM 患者治疗干预措施的有效性和安全性。方法 使用四个电子数据库(PubMed、Embase、Scopus 和 Cochrane Library)进行系统检索,选择在同行评审期刊上发表的英文出版物。我们计算了几率比(OR)和风险比(RR)及其 95%CI 。我们使用 Cochrane Q 和 I 2 统计量及相应的 P 值评估了异质性。结果 本次荟萃分析共有 8 项随机对照试验 (RCT),共涉及 1908 名不同年龄段的 T1DM 患者,其中 1361 名患者接受了替普利珠单抗治疗,547 名患者接受了安慰剂治疗。研究发现,替普利珠单抗与胰岛素消耗量的减少有很大关系,OR 值为 4.13(95%CI:1.72 至 9.90)。特普利珠单抗与 C 肽反应的改善(OR 2.49;95%CI:1.62 至 3.81)和 1 型糖尿病患者糖化血红蛋白 A1c(HbA1c)水平的显著变化有关[OR 1.75(95%CI:1.03 至 2.98)],其 RR 为 0.71(95%CI:0.53 至 0.95)。结论 在 1 型糖尿病患者中,替普利珠单抗可减少胰岛素消耗,改善 C 肽反应,并显著改变 HbA1c 水平,副作用几乎可以忽略不计。特普利珠单抗似乎能改善血糖控制和糖尿病管理,具有良好的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of teplizumab's efficacy and safety in treatment of type 1 diabetes mellitus: A systematic review and meta-analysis
BACKGROUND Islets of Langerhans beta cells diminish in autoimmune type 1 diabetes mellitus (T1DM). Teplizumab, a humanized anti-CD3 monoclonal antibody, may help T1DM. Its long-term implications on clinical T1DM development, safety, and efficacy are unknown. AIM To assess the effectiveness and safety of teplizumab as a therapeutic intervention for individuals with T1DM. METHODS A systematic search was conducted using four electronic databases (PubMed, Embase, Scopus, and Cochrane Library) to select publications published in peer-reviewed journals written in English. The odds ratio (OR) and risk ratio (RR) were calculated, along with their 95%CI. We assessed heterogeneity using Cochrane Q and I 2 statistics and the appropriate P value. RESULTS There were 8 randomized controlled trials (RCTs) in the current meta-analysis with a total of 1908 T1DM patients from diverse age cohorts, with 1361 patients receiving Teplizumab and 547 patients receiving a placebo. Teplizumab was found to have a substantial link with a decrease in insulin consumption, with an OR of 4.13 (95%CI: 1.72 to 9.90). Teplizumab is associated with an improved C-peptide response (OR 2.49; 95%CI: 1.62 to 3.81) and a significant change in Glycated haemoglobin A1c (HbA1c) levels in people with type 1 diabetes [OR 1.75 (95%CI: 1.03 to 2.98)], and it has a RR of 0.71 (95%CI: 0.53 to 0.95). CONCLUSION In type 1 diabetics, teplizumab decreased insulin consumption, improved C-peptide response, and significantly changed HbA1c levels with negligible side effects. Teplizumab appears to improve glycaemic control and diabetes management with good safety and efficacy.
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