中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2015, Vol. 10 ›› Issue (5): 819-828.doi: 10.4103/1673-5374.156989

• 原著:神经损伤修复保护与再生 • 上一篇    下一篇

神经生长因子治疗神经系统疾病安全有效：64项涉及6 297例患者随机对照实验的结局分析

  

  • 收稿日期:2014-12-13 出版日期:2015-05-15 发布日期:2015-05-15
  • 基金资助:

    国家重大专项“重大新药创制”课题（2012ZX09201-301-005）

Efficacy and safety of nerve growth factor for the treatment of neurological diseases: a meta-analysis of 64 randomized controlled trials involving 6,297 patients

Meng Zhao, Xiao-yan Li, Chun-ying Xu, Li-ping Zou   

  1. Department of Pediatrics, Chinese PLA General Hospital, Beijing, China
  • Received:2014-12-13 Online:2015-05-15 Published:2015-05-15
  • Contact: Li-ping Zou, M.D., zouliping21@sina.com
  • Supported by:

    This study was financially supported by the National Science and Technology Major Projects for “Major New Drugs Innovation and Development”, No. 2012ZX09201-301-005.

PDF

1173

摘要：

目的：中国是第一个应用神经生长因子进行临床治疗的国家。自从2003年国家批准注射用鼠神经生长因子作为药物已经过10年。这篇文章的目的就是评估神经生长因子在神经系统疾病的治疗效果和安全性。
数据来源：截至到2013年12月31日，检索Cochrane图书馆，PubMed，EMBASE，中国生物医学文献数据库（Sino Med）、中国医院知识仓库（CNKI）、维普中文生物医学期刊数据库（VIP）。检索词为“神经生长因子”或“NGF”；“随机对照临床试验”或“RCT”。
数据选择：有关神经生长因子的所有随机对照试验英文或中文研究；纳入的神经系统疾病包括周围神经损伤、中枢神经损伤、颅神经病变和神经系统感染；患者为7岁以上；类似的研究方法和一致的症状评估；神经传导速度测试结果。采用RevMan5.2.3软件进行Meta分析。
主要观察指标：总有效率，不良反应发生率和神经传导速度。
结果：纳入64项研究涉及6 297例神经系统疾病患者。与对照组相比，神经生长因子治疗组的治疗总有效率高（P＜0.0001，RR = 1.35，95% CI= 1.30-1.40），下肢的运动神经和感觉神经的平均神经传导速度明显高于对照组（MD= 4.59 m/s，95% CI=4.12-5.06，P＜0.000 01），注射部位疼痛或硬结的发生率明显升高（RR = 6.30，95% CI=3.53-11.27， P＜0.000 01），但不良反应较轻。
结论：神经生长因子能明显改善神经系统疾病患者的神经功能，安全有效。

关键词: 神经再生, 神经系统疾病, 神经生长因子, 随机对照试验, Meta分析, 不良反应, 神经传导速度

Abstract:

OBJECTIVE: China is the only country where nerve growth factor is approved for large-scale use as a clinical medicine. More than 10 years ago, in 2003, nerve growth factor injection was listed as a national drug. The goal of this article is to evaluate comprehensively the efficacy and safety of nerve growth factor for the treatment of neurological diseases.
DATA RETRIEVAL: A computer-based retrieval was performed from six databases, including the Cochrane Library, PubMed, EMBASE, Sino Med, CNKI, and the VIP database, searching from the clinical establishment of nerve growth factor for treatment until December 31, 2013. The key words for the searches were “nerve growth factor, randomized controlled trials” in Chinese and in English.
DATA SELECTION: Inclusion criteria: any study published in English or Chinese referring to randomized controlled trials of nerve growth factor; patients with neurological diseases such as peripheral nerve injury, central nerve injury, cranial neuropathy, and nervous system infections; patients older than 7 years; similar research methods and outcomes assessing symptoms; and measurement of nerve conduction velocities. The meta-analysis was conducted using Review Manager 5.2.3 software.
MAIN OUTCOME MEASURES: The total effective rate, the incidence of adverse effects, and the nerve conduction velocity were recorded for each study.
RESULTS: Sixty-four studies involving 6,297 patients with neurological diseases were included. The total effective rate in the group treated with nerve growth factor was significantly higher than that in the control group (P < 0.0001, RR: 1.35, 95%CI: 1.30–1.40). The average nerve conduction velocity in the nerve growth factor group was significantly higher than that in the control group (P < 0.00001, MD: 4.59 m/s, 95%CI: 4.12–5.06). The incidence of pain or scleroma at the injection site in the nerve growth factor group was also higher than that in the control group (P < 0.00001, RR: 6.30, 95%CI: 3.53–11.27), but such adverse effects were mild.
CONCLUSION: Nerve growth factor can significantly improve nerve function in patients with nervous system disease and is safe and effective.

Key words: nerve regeneration, neurological diseases, nerve growth factor, randomized controlled trials, meta-analysis, adverse effects, nerve conduction velocity, neural regeneration