摘要目的 评价注射用鼠神经生长因子(mNGF)治疗正己烷中毒性周围神经病的疗效和安全性.方法 54例正己烷中毒患者用mNGF治疗,肌内注射,18μg/次,1次/d,56 d 1个疗程,其中15例重度患者治疗2个疗程,治疗前和治疗后每14天检查症状、体征、日常生活能力,根据症状体征及日常生活能力增分情况评价疗效;治疗前和治疗后每28天进行实验室检查,每天记录不良事件,进行安全性评价.结果 症状体征以及日常生活能力于治疗后14 d开始增分,至治疗后的28～56 d与疗前比较,增分明显,差异有统计学意义(P<0.01).54例患者均未发生严重不良事件,实验室指标未发现明显异常.注射部位疼痛是主要的不良反应,发生率为68.5%(37/54).结论 mNGF治疗正己烷中毒性周围神经病疗效确定,安全性较好.

abstractsObjective 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.