我国输卵管介入再通研究文献的质量评价

Quality assessment of studies on interventional recanalization of fallopian tube in China

目的了解我国输卵管介入再通术治疗输卵管性不孕文献的一般状况。方法按照循证医学标准，分别按1997至2000年、2001至2004年、2005至2008年3个时间段对不同设计类型文献的一般情况进行分类。由2名评阅者对文献进行质量评价，对评阅者的评价结果进行Kappa检验，检验结果的一致性。参照Jadad评分量表，计算随机对照试验（RCT）和临床对照试验（CCT）文献的Jadad得分。对RCT和CCT中的内容进行描述性分析。结果纳入临床治疗性文献157篇，其中叙述性研究127篇，RCT和CCT文献30篇，其中RCT文献25篇、CCT文献5篇。2名评价者间Kappa值为0．85，P〈0．05，说明评价的一致性较好。RCT文献中，Jadad量表评分为0分者2篇，1分者15篇，2分者8篇。RCT和CCT纳入与排除标准明确者9篇（30．0％），疗效标准明确者12篇（40．0％），随机方法明确者4篇（13．3％），样本量≥60例者27篇（90．0％），有基线可比性者14篇（46．7％），仅1篇提到采用单盲法（3．3％），交代统计学方法的有17篇（56．7％），交代随访者13篇（43．3％），交代失访者4篇（13．3％），有14篇（46．7％）在推导方面同时考虑了统计学意义和临床意义。结论我国输卵管介入再通术临床治疗性文献总体研究的质量不高，证据的可信度级别较低，质量上与循证医学标准有一定的差距。

Objective To evaluate the current status of studies on interventional recanalization of fallopian tube. Methods According to the standard of evidence-based medicine, literatures were analyzed by two readers in three time periods ： 1997 to 2000,2001 to 2004 and 2005 to 2008. Two separate evaluation results were tested by the statistical method Kappa to test its consistency. Scores of clinical controlled trials （CCT） and randomized controlled trials （RCT） were calculated according to Jadad score scale. The accurate criteria of case selection, case exclusion, and effect determination; the method of randomization; the number of samples; the comparability of baseline; the blinded procedure; the therapeutic method; the method of statistical analysis; the follow-up cases ; the drop-out cases and the conclusions derivation of RCT and CCT into descriptive analysis were evaluated. Results One hundred and fifty seven therapeutic articles were searched and 30 RCT and CCT articles （25 RCT and 5 CCT） were analyzed. The Kappa value was 0. 85 and P 〈 0. 05 indicating that the evaluation was in good consistency. 2, 15 and 8 RCT received 0 point, 1 point and 2 points respectively in Jadad score scale. RCT and CCT contained 9 articles （ 30. 0% ） fulfilled the accurate criteria of case selection and exclusion; 12 articles （40. 0% ） met the accurate criteria of effect determination; 4 articles （ 13.3% ） utilized the definite method of randomization; 27 articles （90. 0% ） had the number of sample beyond 60; 14 articles （46. 7% ） met the baseline comparability; only 1 article （3.3%） used the single-blinded method, 17 articles （56.7%） utilized the method of statistical analysis; 13 （43.3%） mentioned follow-up in articles; 4 （13.3%） mentioned drop-out cases in the articles and 14 （46.7%） articles had the conclusions derived by considering the statistical significance and clinical significance. Conclusion The quality of studies on interventional recanalization of fallopian tube is poor and could not meet the standard of evidence-based medicine.