摘要
分析近30年来中国临床研究文献中有关安慰剂的信息,包括安慰剂的剂型、成分、制备工艺、质量监控等方面内容。检索中国知网(CNKI)全文数据库,初步得到安慰剂临床研究相关文献700篇,再通过手工筛选得符合纳入标准的文献共301篇,后通过逐一阅览文献提取研究中安慰剂的相关信息,并做出统计及分析讨论。结果表明,中国随机安慰剂对照临床研究中安慰剂剂型种类呈现出多样化的特点,组成成分的报道极度欠缺,301篇文献中明确描述了安慰剂制备工艺或具体配比情况的仅有17篇。安慰剂对照的临床试验所研究疾病的疾病谱较广,但从系统分类来看疾病具有一定的的趋向性。安慰剂在盲法临床研究中作用关键,但临床研究中研究者对安慰剂的叙述普遍不够,可能是由于临床研究者对安慰剂关注程度不够,或因其更关注研究过程,或其他客观条件限制所致;且安慰剂的生产、质量监控、质量评价也亟待标准化。
To analyze and discuss placebo-related information in clinical research literatures in the past 30 years, including placebo＇s dosage form, ingredients, preparation process and quality control. Effort were made to research the CNKI full-text database to preliminary find 700 placebo-related clinical research literature, screen out 301 eligible articles by hand, read the literatures to extract placebo-related information and make statistics and discussions. According to the results, Chinese randomized placebo-controlled clinical studies were characterized by diverse dosage forms of placebo with lack of reports for components, as evidenced by the only 17 literatures describing placebo＇s preparation or specific composition among the 301 literatures. Placebo-controlled clinical trials covered a wide range of disease spectra, but with a specific tropism of diseases in terms of system classification. Although placebo plays a key role in blinded clinical studies, researchers made less records of placebo, perhaps because they paid less attention to placebo or more attention to the research process or restricted by other objective conditions. Moreover, placebo production, quality control and quality evaluation also need to be further standardized.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2015年第7期1410-1414,共5页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2013ZX09303301)
关键词
安慰剂
临床研究
随机对照
placebo
clinical study
randomized controlled
