Objective: To determine the efficacy and safety of early intervention with nimodipine treatment in diffuse axonal injury. Methods: Based on the characteristic radiological signs and criteria for diffuse axonal injury (DAI), 89patients with the diagnosis of DAI were enrolled in this randomized, double-blind, placebo-controlled trial. Results: Nimodipine proved to be safe and well tolerated. With TCD sonography we found that there was a higher incidence of cerebral vasospasm in this series (38.2%). Overall, Nimodipine produced a better clinical result than placebo, but there was no statistically significant difference in favorable outcome at 3 months after injury (P ＝ 0.11 ) between the two groups. A trend toward a favorable effect was suggested by the analyses in two small subgroups, either in the patients suffering from clinical Grade Ⅲ DAI (P ＝ 0.04), or in those with the TCDevidence of cerebral vasospasm during clinical observation (P ＝ 0.049). Conclusions: We postulate that a clinically valuable benefit is possible with nimodipine treatment in DAI patients. However, the effects on outcome should be verified by further controlled study.
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