Safety and Efficacy of Intravenous Ultra-high Dose Methylcobalamin Treatment for Peripheral Neuropathy: A Phase I/II Open Label Clinical Trial
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- Shibuya Kazumoto
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Misawa Sonoko
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Nasu Saiko
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Sekiguchi Yukari
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Beppu Minako
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Iwai Yuta
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Mitsuma Satsuki
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Isose Sagiri
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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- Arimura Kimiyoshi
- Okatsu Neurology and Rehabilitation Hospital, Japan
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- Kaji Ryuji
- Department of Clinical Neuroscience, Institute of Health Biosciences, The University of Tokushima Graduate School, Japan
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- Kuwabara Satoshi
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan
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抄録
Objective No clinically effective treatment for promoting peripheral axonal regeneration has yet been established. Several experimental studies in vitro and in vivo have shown that a high dose of methylcobalamin (MeCbl), an analogue of vitamin B12, promotes axonal growth in peripheral nerve injury. We herein assessed the safety and efficacy of an ultra-high dose MeCbl treatment for patients with peripheral neuropathy and chronic axonal degeneration.<br> Methods Fourteen patients with immune-mediated or hereditary neuropathy in the chronic progressive or stable phase were enrolled. MeCbl, 25 mg/day for 10 days followed by monthly 25 mg for 5 months, was intravenously administered. The patients were evaluated before and 1 year following treatment. The primary endpoints were safety and improvement in the Medical Research Council (MRC) sum score in at least two muscles of the 20 muscles. This trial is registered with the University Hospital Medical Information Network (UMIN) Center in Japan under the ID: UMIN000009359.<br> Results There were no adverse effects in twelve of the patients, whereas treatment was discontinued in two patients who had seborrheic dermatitis at 3 months and respiratory tract infection at 2 months, respectively. Therefore, twelve patients were evaluated for the primary outcomes; the MRC sum score was improved in seven of the patients and unchanged or worsened in the remaining five patients.<br> Conclusion Intravenous ultra-high dose MeCbl treatment is a safe and potentially efficacious therapy for patients with peripheral neuropathy and chronic axonal degeneration.<br>
収録刊行物
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- Internal Medicine
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Internal Medicine 53 (17), 1927-1931, 2014
一般社団法人 日本内科学会