Department of Family Medicine, MacKay Memorial Hospital, No. 92, Section 2, Zhongshan North Road, Taipei City 10449, Taiwan.
Department of Family Medicine, Hsinchu MacKay Memorial Hospital, No. 690, Section 2, Guangfu Road, East District, Hsinchu City 30071, Taiwan.
J Diabetes Res. 2020 Mar 26;2020:8954125. doi: 10.1155/2020/8954125. eCollection 2020.
Type 1 diabetes mellitus (T1DM) causes the irreversible destruction of pancreatic beta cells. The Bacillus Calmette-Guerin (BCG) vaccine can modulate the immune response and decelerate disease progression. The aim of this study is to investigate the efficacy of the BCG vaccine for the treatment of T1DM.
Six databases were systematically searched from inception to the end of August 2019. The randomized controlled trials (RCTs) that evaluated glycemic control in response to the BCG vaccine for T1DM were enrolled. The primary outcome was glycated hemoglobin (HbA1c) level, and secondary outcomes included fasting and stimulated C-peptide level, daily insulin dosage, and clinical remission. The revised Cochrane risk of bias tool was used for quality assessment, and meta-analyses were conducted to evaluate the efficacy of the BCG vaccine.
Four studies with a total of 198 subjects were included. The results of HbA1c and fasting C-peptide levels were extracted for further quantitative assessment. The pooled meta-analysis demonstrated no significant difference in HbA1c levels (mean difference [MD], -0.12; 95% confidence interval [CI], -0.53 to 0.30; = 56%) or fasting C-peptide levels (MD, -0.15; 95% CI, -0.35 to 0.06; = 0%) in the BCG intervention group as compared with that in the placebo group.
There is no robust evidence to support the use of the BCG vaccine for the treatment of T1DM although the HbA1c levels tended to improve. Additional RCTs to assess the long-term effects of the BCG vaccine on glycemic control are warranted.
1 型糖尿病（T1DM）可导致胰腺β细胞的不可逆转破坏。卡介苗（BCG）疫苗可调节免疫反应并减缓疾病进展。本研究旨在探讨 BCG 疫苗治疗 T1DM 的疗效。
系统检索从建库至 2019 年 8 月底的 6 个数据库，纳入评估 BCG 疫苗对 T1DM 血糖控制作用的随机对照试验（RCT）。主要结局指标为糖化血红蛋白（HbA1c）水平，次要结局指标包括空腹和刺激 C 肽水平、每日胰岛素剂量和临床缓解。采用 Cochrane 偏倚风险评价工具进行质量评价，并进行荟萃分析评估 BCG 疫苗的疗效。
纳入 4 项研究共 198 例受试者。提取 HbA1c 和空腹 C 肽水平的结果进行进一步定量评估。荟萃分析结果显示，BCG 干预组与安慰剂组相比，HbA1c 水平[MD，-0.12；95%置信区间（CI），-0.53 至 0.30； = 56%]或空腹 C 肽水平[MD，-0.15；95%CI，-0.35 至 0.06； = 0%]差异均无统计学意义。
虽然 HbA1c 水平有改善趋势，但尚无确凿证据支持使用 BCG 疫苗治疗 T1DM。需要更多 RCT 来评估 BCG 疫苗对血糖控制的长期影响。
