国内口服水化治疗预防冠脉介入术后急性肾损伤随机对照试验文献质量评析

Quality evaluation of literature of randomized controlled trials on oral hydration for prevention of acute kidney injury after percutaneous coronary intervention in China

目的：了解国内期刊发表的口服水化治疗预防冠脉介入术后急性肾损伤的随机对照试验（ RCT）的文献质量。方法应用中国生物医学文献数据库（ CBM）、中国知网（ CNKI）、万方医学期刊数据库、维普中文科技期刊数据库，对国内期刊发表的口服水化治疗预防冠脉介入术后急性肾损伤的RCT文献进行检索，对检索到的文献按照纳入、排除标准进行筛选。采用 Cochrane 偏倚风险评估工具和Jadad评价表对文献质量进行评价。结果共纳入10篇文献。 Cochrane偏倚风险评估工具显示，无文献描述对未完成试验的研究对象是否进行意向性分析且无文献对随机分配方案的隐藏、对研究对象及结果测评者采取盲法等信息进行描述。 Jadad评分均低于2分，文献均只提及“随机”字样，但对具体的随机方法未见描述，只有1篇文献说明盲法，无一篇文献对退出与失访的病例进行报道。结论国内期刊发表的口服水化治疗预防冠脉介入术后急性肾损伤的RCT文献质量总体不高，今后应进行高质量的研究，以更好地指导临床实践。

Objective To understand the quality of literature of randomized controlled trials（ RCTs） on oral hydration for prevention of acute kidney injury after percutaneous coronary intervention published（ PCI） in journals in China.Methods Literature of RCTs on oral hydration for prevention of acute kidney injury after PCI published in journals in China was searched in CBM, CNKI, Wan Fang data, and VIP database. And then, they were screened according to the inclusion and exclusion criteria. Besides, the quality of literature was evaluated based on the Cochrane collaboration′s tool for assessing risk of bias and the Jadad scale. Results A total of 10 RCTs were included. The results of the Cochrane collaboration′s tool for assessing risk of bias showed that there was no document to describe whether the data of subjects without completing the trail were analyzed with intentional analysis, random allocation concealment, blinding of participants and outcome assessment and so on. Moreover, the score of Jadad was less than two. There was only one document which mentioned the word‘random’ without involving specific randomized methods, one document which explained the blind method, no document which reported the case that withdrew from the trail and was lost.Conclusions The quality of literature of RCTs on oral hydration for prevention of acute kidney injury after PCI published in journals in China is low. Because of this, high quality researches should be conducted so as to provide good guidance for clinical practice.