Elliott J F, Marlin K L, Couch R M
Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Canada.
Diabetes Care. 1998 Oct;21(10):1691-3. doi: 10.2337/diacare.21.10.1691.
To determine whether administration of bacille Calmette-Guérin (BCG) vaccination to newly diagnosed IDDM patients can help preserve C-peptide secretion over the subsequent 18 months.
Twenty-six IDDM patients, all of whom had been diagnosed within the previous year, had basal C-peptide levels >0.06 nmol/l, and had negative reactions to Mantoux's test, were randomized pairwise as they presented and were given either 0.1 ml (100 microg) BCG vaccine or 0.1 ml saline intradermally Both the patients and the investigators were blinded to the treatment. Fasting and glucagon-induced C-peptide levels and HbA1c were measured in all patients at enrollment and at 1, 3, 6, 9, 12, and 18 months after vaccination, and insulin dose was recorded at each visit.
At enrollment, there was no significant difference in age, duration of diabetes, insulin dose, HbA1c, or fasting C-peptide levels between the BCG-vaccinated and control groups. The mean basal and stimulated C-peptide levels in the BCG-treated group did not differ significantly from those in the control group at any time during the 18 months of follow-up, and there was no difference in insulin dose or HbA1c at any time between the groups.
BCG vaccination in children who have been recently diagnosed with IDDM does not affect the progressive decline in C-peptide levels or alter the clinical course of the disease.
确定对新诊断的胰岛素依赖型糖尿病（IDDM）患者接种卡介苗（BCG）是否有助于在随后18个月内维持C肽分泌。
26例IDDM患者，均在过去一年内确诊，基础C肽水平>0.06 nmol/l，结核菌素试验阴性，就诊时按配对随机分组，分别皮内注射0.1 ml（100 μg）卡介苗疫苗或0.1 ml生理盐水。患者和研究人员均对治疗不知情。在入组时以及接种疫苗后1、3、6、9、12和18个月测量所有患者的空腹和胰高血糖素诱导的C肽水平及糖化血红蛋白（HbA1c），每次就诊时记录胰岛素剂量。
入组时，接种卡介苗组与对照组在年龄、糖尿病病程、胰岛素剂量、HbA1c或空腹C肽水平方面无显著差异。在18个月的随访期间，卡介苗治疗组的平均基础和刺激后C肽水平在任何时候与对照组相比均无显著差异，两组之间在任何时候的胰岛素剂量或HbA1c也无差异。
对近期诊断为IDDM的儿童接种卡介苗不会影响C肽水平的逐渐下降，也不会改变疾病的临床进程。
