文章摘要
李青,颜敏,吴晔,吴林彬,员亚明,严常开,施侣元,曾繁典.我国化学药品和治疗用生物制品再评价文献的系统性分析[J].中华流行病学杂志,2004,25(5):435-438
我国化学药品和治疗用生物制品再评价文献的系统性分析
Re-evaluation of marketed chemical drugs and biological products of therapeutic- a systematic review of literature
投稿时间:2003-07-17  
DOI:
中文关键词: 药品再评价;生物制品;化学药品
英文关键词: Drug re-evaluation;Biological products;Chemical drugs
基金项目:
作者单位
李青 华中科技大学同济医学院, 武汉 430030 
颜敏 国家药品监督管理局药品评价中心 
吴晔 国家药品监督管理局药品评价中心 
吴林彬 山西省药品不良反应监测中心 
员亚明 山西省药品不良反应监测中心 
严常开 华中科技大学同济医学院, 武汉 430030 
施侣元 华中科技大学同济医学院, 武汉 430030 
曾繁典 华中科技大学同济医学院, 武汉 430030 
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中文摘要:
      目的: 为药品上市后再评价相关立法提供参考, 回顾国内化学药品、治疗用生物制品上市后再评价公开发表的研究论文。方法: 以《中国药学文摘》、《中国生物医学文献数据库》为检索工具, 检索1985~2001年国内公开发表的有关化学药品、治疗用生物制品上市后再评价的文献, 将所得文献资料录入数据库进行统计分析。结果: 通过检索获得符合药品上市后再评价文献共4029篇, 分布于436种期刊, 涉及855种药品的临床再评价。再评价品种主要以抗感染类药物、心血管系统药物及消化系统药物为主, 分别占整个文献数量的27.1%、20.1%、11.1%。评价方法以临床试验方法为主, 占90%, 临床试验的样本量主要在200例以下, 占89.1%。50-100例之间的文献有41.4%, 5000例以上的大样本13篇, 占0.35%。符合Ⅰ级质量的论文有44篇(1.1%), Ⅱ级质量的论文有182篇(4.5%), Ⅲ、Ⅳ级质量分别为2466篇(61.2%)、1337篇(33.2%), 随年度增长, 论文质量有所提高。结论: 再评价论文主要集中于药物临床试验的有效性评价, 多数研究论文的试验设计和评价方面尚不规范, 评价例数不足, 总体质量较差,研究较为分散, 难以为临床用药提供可靠的再评价结论, 为上市药品监督管理提供的信息量较少。
英文摘要:
      Objective: To assess the current status on re-evaluation of marketed drug in China since the promulgation of drug law in 1985. Methods: Review of literature on Chinese pharmaceutical abstract and CBMdisc from 1985 to 2001 year was done. Results: 4029 papers and 855 marketed drugs from 1985 to 2001 were included. Drugs on anti-infection agent, cardiovascular system were the main drugs being re-evaluated drugs and literature were increasing year by year. The method used for revaluation were random and non-random clinical trial. 41.4% of all the samples had a sample size of 50-100 research subjects. There were 13 papers with more than 5000 samples. The level on evidence based literature was assed. 44 papers were graded as first class, and 182 papers the second, 2466 papers the third 1337 papers the fourth. The quality of literature was improved year by year. Conclusion: The amount, quality as well as te sample size of literature being re-evaluated on marketed drug were increased from 1985 to 2001. However, the design and evaluation those trials were not standardized.
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