中国药物警戒 ›› 2010, Vol. 7 ›› Issue (7): 397-399.

• 临床研究 • 上一篇    下一篇

鼠神经生长因子随机双盲安慰剂对照ⅠⅡⅢ期临床试验中注射部位疼痛的综合分析

胡海棠, 林英勇*, 扈会平   

  1. 丽珠医药集团医学临床研究中心，广东 珠海 519020
  • 收稿日期:2016-02-22 修回日期:2016-02-22 出版日期:2010-07-08 发布日期:2016-02-22
  • 通讯作者: 林英勇,男,硕士,临床药理。E-mail:linyingyong@livzon.com.cn
  • 作者简介:胡海棠,男,高级工程师（教授级）,临床药理。

Injection Site Pain of Mouse Nervous Growth Factor：A Review of Randomized，Double-Blinded，Parallel Placebo Controlled Phase to Ⅲ Clinical Trials

HU Hai-tang, LIN Ying-yong*, HU Hui-ping   

  1. Clinical trial center Livzon pharmaceutical group Inc., Guangdong Zhuhai China, 519020
  • Received:2016-02-22 Revised:2016-02-22 Online:2010-07-08 Published:2016-02-22

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摘要： 目的 分析注射用鼠神经生长因子致局部疼痛的原因和影响因素。方法 采用随机、双盲、安慰剂平行对照设计进行Ⅰ、Ⅱ、Ⅲ期临床试验。结果 肌注鼠神经生长因子，常见不良反应为注射部位肌肉疼痛，临床推荐剂量15 000AU，健康受试者8例中4例出现疼痛，Ⅱ期临床试验视神经挫伤患者注射局部疼痛发生率32.56%（14/43），Ⅲ期临床为12.83%（39/304），无严重不良事件。结论 注射部位疼痛是很常见的不良反应，由鼠神经生长因子引起，呈剂量依赖性，与赋型剂及溶媒无关，强的松或可减缓疼痛，视神经挫伤患者对临床推荐剂量一般可以耐受。

关键词: 鼠神经生长因子, 疼痛, 临床试验

Abstract: Objective To investigate the agent and influencing factors of injection site pain following intramuscular injection of mouse nervous growth factor. Methods Randomized, double-blinded, parallel placebo controlled Phase to clinical trials. Results 4 of 8 health volunteers developed injection site pain in the phase 1, 32.56%(14/43) optic nerve contused wound subjects in the phase 2 clinical trial and 12.83%(39/304) in the phase 3 at the dose 30 g(15 000AU), which was recommended as clinical therapeutic dose. The duration and severity of the local pain varied in a dose-dependent manner. No life-threatening adverse events was seen at any dose. Conclusion s Injection site pain was the most frequent adverse event, but well tolerated at recommended dose. The pain was induced by mouse nerve growth factor and probably attenuated by prednisone.

Key words: mouse never growth factor, pain, clinical trial

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