Neurology Department, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, 100191, China.
Beijing Municipal Key Laboratory of Biomarker and Translational Research in Neurodegenerative Disease, Beijing, China.
Sci Rep. 2021 Jul 19;11(1):14697. doi: 10.1038/s41598-021-94284-4.
This randomized controlled study used corneal confocal microscopy (CCM) to compare the efficacy of Mecobalamin intramuscular injections vs oral tablets in treating mild to moderate diabetic peripheral neuropathy (DPN) by detecting early nerve fiber repair. Enrolled patients were randomized approximately 1:1 to receive Mecobalamin intramuscular injections (0.5 mg/day, 3 times/week) or Mecobalamin oral tablets (1.5 mg/day) for 8 weeks. Primary outcome was change of inferior whorl length (IWL) from baseline. Secondary outcomes included changes of corneal nerve fibre length (CNFL), corneal nerve fibre density (CNFD), corneal nerve branch density (CNBD) and the Survey of Autonomic Symptoms (SAS). 15 (93.75%) patients in the injection group and 17 (89.47%) patients in the tablet group completed the study. The injection treatment significantly improved patients' IWL from baseline (21.64 ± 3.00 mm/mm vs 17.64 ± 4.83 mm/mm, P < 0.01) while the tablet treatment didn't. Additionally, the injection treatment led to significantly improved CNFL, CNBD and SAS from baseline (all P < 0.05) while the tablet treatment did not. No patient experienced any adverse events. In conclusion, CCM is sensitive enough to detect the superior efficacy of 8-week Mecobalamin intramuscular injection treatment for DPN compared to the oral tablet treatment.ClinicalTrials.gov registration number: NCT04372316 (30/04/2020).
这项随机对照研究使用角膜共焦显微镜（CCM）比较甲钴胺肌内注射与口服片剂治疗轻中度糖尿病周围神经病变（DPN）的疗效，通过检测早期神经纤维修复。纳入的患者按 1:1 比例随机接受甲钴胺肌内注射（0.5mg/天，每周 3 次）或甲钴胺口服片剂（1.5mg/天）治疗 8 周。主要结局是从基线开始下旋长度（IWL）的变化。次要结局包括角膜神经纤维长度（CNFL）、角膜神经纤维密度（CNFD）、角膜神经分支密度（CNBD）和自主症状调查（SAS）的变化。注射组 15 例（93.75%）和片剂组 17 例（89.47%）患者完成了研究。注射治疗可显著改善患者的 IWL （21.64±3.00mm/mm vs 17.64±4.83mm/mm，P<0.01），而片剂治疗则没有。此外，注射治疗还可显著改善 CNFL、CNBD 和 SAS （均 P<0.05），而片剂治疗则没有。无患者出现任何不良反应。结论：CCM 足够敏感，可检测到 8 周甲钴胺肌内注射治疗 DPN 的疗效优于口服片剂治疗。临床试验注册号：NCT04372316（30/04/2020）。
