痙性斜頸患者に対するB型ボツリヌス毒素製剤の安全性および有効性

Safety and Efficacy of Rimabotulinumtoxin B in Patients with Cervical Dystonia in Observational Study

B型ボツリヌス毒素製剤（ナーブロック^®筋注2500単位）の痙性斜頸患者に対する安全性および有効性について，国外も含めこれまでにない症例数での検討を行った。約80％でなんらかの改善が認められたことなど，本剤は臨床において有用な薬剤と考えられた。また，副作用は嚥下障害に次いで口内乾燥および口渇の発現割合が高く，本剤の自律神経への作用が示唆され，流涎など他疾患への応用の可能性が考えられた。

Abstract

This post-marketing observational study was conducted on botulinum toxin type B (NerBloc^® 2500 units) in 1537 patients with cervical dystonia, a sample size larger than the previous studies. The incidence of adverse drug reactions was 12.6% (188/1487 patients); the most common adverse drug reactions were dysphagia, thirst, injection site pain, and dry mouth, which were similar to those reported previously and no new problems were found. Dry mouth and thirst were considered characteristic to this product and thought to be reflective of the strong action on autonomic nerves, suggesting potential application in other disorders. The efficacy did not decrease substantially with an increased number of doses; the efficacy shown as the total of “significantly improved” and “improved” in clinical global impression up to 12 doses in at least 100 patients was around 45%, indicating an efficacy similar to type A. The efficacy at final observation shown as total of “significant improved” and “improved” was 38.5%, while the total of these and “moderately improved” was 76.9%. There was no significant difference in efficacy with different maximum doses of the product, with a dose as low as 5000 IU≤ thought to be effective in some patients.