主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

北京中医药大学学报 ›› 2015, Vol. 38 ›› Issue (9): 628-634.doi: 10.3969/j.issn.1006-2157.2015.09.011

• 临床研究 • 上一篇    下一篇

中草药治疗阿尔茨海默病的临床试验报告质量评价*

倪敬年 魏明清 时晶 张学凯 田金洲#   

  1. 北京中医药大学东直门医院 北京 100700
  • 收稿日期:2015-03-27 出版日期:2015-09-30 发布日期:2015-09-30
  • 通讯作者: 田金洲,男,教授,主任医师,研究方向:神经变性病的中医药防治研究,E-mail:jztian@hotmail.com
  • 作者简介:倪敬年, 男,博士,主治医师
  • 基金资助:
    *国家重大新药创制平台项目( No.2011ZX09302-006-01),教育部高等学校学科创新引智基地(No.B08006),北京市科委慢性病中医二级预防研究( No.Z111107056811043),北京中医药大学神经变性病创新团队(No. 2011-CXTD-21)

Quality assessment of reporting in randomized controlled trials of Chinese herbal medicines for the treatment of Alzheimers disease using CONSORT criteria *

NI Jingnian, WEI Mingqing, SHI Jing , ZHANG Xuekai, TIAN Jinzhou#   

  1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700
  • Received:2015-03-27 Online:2015-09-30 Published:2015-09-30

摘要: 目的 中草药治疗阿尔茨海默病的临床试验逐渐增多,本文就中草药治疗该病的文献发表质量进行系统评价。方法 通过检索PubMed和CNKI数据库,选择随机对照试验,依据CONSORT报告条目、草药制剂质量补充条目及专业设计要求,对文献发表质量进行评价。结果 纳入文献29篇,其中英文11篇,中文18篇。6篇(20.7%)CONSORT条目报告数超过50%,中文平均10.94条(30%),英文平均20.27条(55%)。Jadad评分3分或以上文献共9篇(31%),中文1.67±0.77分,英文(3.18±1.66)分。草药制剂质量报告条目评分2.5分及以上者共7篇(24.1%),中文(1.58±0.39)分,英文(2.61±0.93)分。1篇(3.4%)中文文献对纳入病例证候进行了评价,并对治疗前后证候变化进行了比较。结论 英文文献发表质量相对较好,中文文献主要不足表现为随机和盲法设计细节欠详细、疗程相对较短、对照药物及结局指标选择欠妥。

关键词: 阿尔茨海默病, 中草药, 随机对照试验报告, 质量评价

Abstract: Objective To assess the quality of reports and abstracts of randomized controlled trials (RCT) of treating Alzheimer’s disease (AD) with Chinese herbal medicines. Methods The RCT reports were included from online search of database of PubMed and CNKI. Based on the Consolidating Standards for Reporting Trials (CONSORT) checklists, supplementary checklists of herbal medicine intervention and requirements of medical design, the quality of studies were performed. Results Eleven reports in English and eighteen ones in Chinese published in general medical journals were included. The number of items in six reports (20.7%)was over 50%, while the mean items in Chinese was 10.94 (30%)and in English 20.27(55%). Altogether nine reports (31%)got the Jadad score of three or above, while the mean Jadad score of reports in Chinese was 1.67±0.77 and in English was 2.61±0.93. Seven reports(24.1%)got the score of 2.5 or above in checklists of herbal medicine intervention, in which in Chinese got the mean score of 1.58±0.39 and English got 2.61±0.93 . Zheng (TCM syndrome) was reported only in one paper(3.4%)in Chinese, and comparison of the types between and after treatment was conducted. Conclusion The quality of reports in English was better than that in Chinese. The main problems in Chinese study reports existed in lacking of details of random design and blind design, insufficient treatment duration, improper positive drugs controlled and poorly targeted indices selected.

Key words: Alzheimer's disease, Chinese herbal medicine, randomized controlled trial report, quality assessment

中图分类号: 

  • R256.2