CAJ | 학술논문

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。
목적：중초약치료아이자해묵병적림상시험축점증다，본문취중초약치료해병적문헌발표질량진행계통평개。방법통과검색PubMed화CNKI수거고，선택수궤대조시험，의거CONSORT보고조목、초약제제질량보충조목급전업설계요구，대문헌발표질량진행평개。결과납입문헌29편，기중영문11편，중문18편。6편（20．7％）CONSORT조목보고수초과50％，중문평균10．94조（30％），영문평균20．27조（55％）。 Jadad평분3분혹이상문헌공9편（31％），중문1．67±0．77분，영문（3．18±1．66）분。초약제제질량보고조목평분2．5분급이상자공7편（24.1％），중문（1．58±0．39）분，영문（2.61±0．93）분。1편（3．4％）중문문헌대납입병예증후진행료평개，병대치료전후증후변화진행료비교。결론영문문헌발표질량상대교호，중문문헌주요불족표현위수궤화맹법설계세절흠상세、료정상대교단、대조약물급결국지표선택흠타。
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 in-tervention 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 indi-ces selected.