国内期刊偏头痛中医药治疗性文章的文献学质量分析

Quality analysis on articles in domestic journals about medical treatment of bilious headache

[目的]对国内偏头痛的中医药临床治疗性文献进行科研设计质量的评价。[方法]按照临床流行病学原则,用《中医临床类文献质量评价表》,对1979—2006年间的偏头痛中医药临床治疗性文献进行评价。[结果]32.8%的文献采用了随机对照方法,但随机的质量和可信度较差;盲法很少被采用;无一篇文章提及样本含量估计及患者种族;有50.2%的文献没有明确的诊断标准;有86.7%的文献提及疗效标准,但是其中有795篇(64.6%)是自拟的疗效标准;18.9%的文献(233篇)提出明确的统计方法,但是其中有些方法的应用欠准确。其他需要注意的问题还有组间基线均衡性的比较、结局指标的选择等方面。[结论]偏头痛中医治疗性文献的质量普遍不高,试验设计和统计学方法的运用均有待提高。

[Objective] To carry out a qualitative analysis on research design about the clinical treatment of bilious headache in domestic journals. [Methods] In accordance with the principle of clinical epidemiology, the scale in the literatures from 1979 to 2006 about the clinical evaluation on the treatment of bilious headache in the domestic journals was evaluated. [Results] The 32.8% of the literature used a randomized controlled trial, but the quality and reliability of random design were poor; the blind method was rarely used; no any article mentioned the quantity of samples and the race of the patients; haft of the literatures （50.2%） had no clear diagnostic criteria; 86.7% of the literatures mentioned the therapeutic standard, but in 795 of them （64.6%） the standard was the self-worked out; 18.9% of the literatures （233） used a clear statistical methods, but some of them method were less accurate. Other problems, requiring attention were the comparison of baseline between groups and the choice of indicators of the outcome, and so on. [Conclusions] Generally speaking, the quality in the TCM literatures about migraine treatment was not so high, and the experimental design and the statistical methods should to be enhanced.