中医药治疗慢性支气管炎随机对照试验文献的质量评价

目的:对中医药治疗慢性支气管炎的随机对照试验文献进行研究质量的评价和分析。方法:采用中医药治疗性文献质量评价及信息采集表、Jadad评分表对1979-2004年间发表的中医药治疗慢支随机对照试验文献进行研究质量评价。由两名评价员对纳入文献进行评价和数据采集。评价内容包括文献描述的疾病诊断标准、随机化方法、盲法、对照、结果报告和结论推导等。结果:共纳入文献150篇。其中有139篇(92.7%)报告了疾病诊断标准,有67篇(44.7%)叙述纳入或排除标准,仅有9篇文献(6.0%)对随机化方法进行了简单描述,仅有8篇(5.3%)文献采用盲法,137篇文献(91.3%)有疗效判定标准,有10.0%(15/150)研究报告了不良反应情况,仅有31篇(20.7%)文献中应用的统计学方法基本正确。进一步分析提示,文献报告的随机化方法信息很少,很少采用盲法且报告信息不详;Jadad评分为3分的仅有2篇(1.3%)、2分的仅有6篇(4.0%)。结论:中医药治疗慢性支气管炎随机对照试验报告的方法学质量多数较低,其低质量与杂志影响因子和研究基金资助无显著相关性。

Quality Evaluation on Literatures of Randomized Controlled Trial in Treating Chronic Bronchitis with Traditional Chinese Medicine

Objective: To carry out the research quality evaluation and analysis on literatures of randomized controlled trial in treating chronic bronchitis with traditional Chinese medicine(TCM).Methods: Adopting "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinic Research Literature" and "Jadad grading table",the literatures on randomized controlled trial of treating chronic bronchitis with traditional Chinese medicine,which published from the year 1994 to 2004,were carried out the research quality evaluation.There were two appraisers having evaluation on internalized literatures and data acquisition.The evaluation content were consisted of disease diagnostic criteria,randomization method,blind method,contrast control,result report and conclusion deduction etc that described in the literatures.Results: There were 150 literatures bringing into the evaluation.Among the total,139 literatures(92.7%) reported disease diagnostic criteria,67 literatures(44.7%) described the inclusion and exclusion standard,only 9 literatures(6.0%) had simply described the randomization method,and only 8 literatures adopted blind method.There were 137 literatures(91.3%) having curative effect determinant criterion;10.0%(15/150) researches had reported the adverse effect states;and only 31 literatures(20.7%) applied the basically correct statistics method.The further analysis presented that there was few information about randomization method in these literatures;they were seldom adopting blind method and the reported information were not in detail.Only 2 literatures(1.3%) gain 3 score of Jadad grading,and 6 literatures(4.0%) gain 2 score of it.Conclusion: Majority of the randomized controlled trial reports on treating chronic bronchitis with traditional Chinese medicine have low methodology quality,the low quality has no significant correlation with journal's influencing factor and research found assistance.