注射用鼠神经生长因子治疗正己烷中毒性周围神经病疗效与安全性评价

Objective To evaluate the efficacy and safety of mNGF to peripheral neuropathy induced by n-bexane. Methods 54 cases were treated with mNGF (18 μg i. m qd.) and the period of treatment is 56 days. 15 severe cases treated with two periods of treatment. Subjects received symptoms and signs of nerve system and activi-ties of daily living (ADL) scale were examined before and every 14 days after treated, The efficacy of mNGF was as-sessed by score increase of each index before and after treatment himself. To evaluate the safety, subjects received Is-boratory examinations before and every 28 days after treated, recorded adverse events everyday. Results During the trial, The indexes had improved remarkably in two weeks after the treatment , There were highly significant differ-ences in score increase after 4 ～ 8 weeks of treatment(P < 0. 01). It indicated that treatmented with mNGF was effec-tive. There were no severe adverse events (SAE) found among 54 trial subjects. There were no evident abnormalities in laboratory examinations before and after treatment. Pains of the injected sites are the main ADR, the incidence was 68.5% (37/54). Conclusion The results of the research indicated that mNGF clinical application could be consid-ered as safe and effective.

The safety and efficacy of mouse nerve growth factor for peripheral neuropathy associated With n-hexnae intoxication