注射用鼠神经生长因子Ⅰ期临床耐受性试验研究

A phase Ⅰ tolerance study of mouse nerve growth factor for injection

目的:观察健康受试者单次使用注射用鼠神经生长因子的安全性及耐受性,特别注意注射局部的刺激反应。为临床推荐安全、合理的用药剂量。方法:根据GCP原则将74例健康志愿者,采用双盲、随机、安慰、阳性药平行对照设计。单次给药设3个剂量组,每个剂量组设试验药组、对照药组、赋形剂组和注射用生理盐水组4个组别。各组主要观察指标为自觉症状、体征、实验室检查、理化检查及注射局部反应。结果:使用注射用鼠神经生长因子的主要不良反应为注射部位局部胀痛、触压痛,偶有白细胞、中性粒细胞轻度下降,淋巴细胞升高。结论:注射用鼠神经生长因子会引起注射局部胀痛、触压痛,其发生率、疼痛程度及持续时间呈剂量相关性。在7500～20000AU剂量范围正常健康人可以耐受,建议后续临床试验不宜超出此范围的高限。

Objective ： To observe the tolerability of healthy subjects to injection of mouse nerve growth factor （mNGF） , especially for local reactions, and to recommend the safe and reasonable dosage for clinical use Methods ： A double blind, randomized, parallel controlled trial was adopted in 74 health volunteers. They received 3 doses of mNGF, control drug, excipient or saline. The major indexes were subjective symptoms, signs, laboratory tests, phy of mNGF sical and chemical examinations, and local reactions after injection. Results： The adverse drug reactions injection were swoller pain and touch tenderness at injection sites frequently; slight decline in leukocytes and neutrophils, and increase in lymphocytes occasionally. Conclusion： Mouse nerve growth factor for injection causes local swoller pain and touch tenderness; the occurrence, pain severity and lasting time are dose-related. The safe dose range is from 7 500 to 20 000 AU for health people, and the recommended doses should be within the up- per limit of this range in follow-up trials.