血必净注射液治疗重症肺炎系统评价的再评价

Xuebijing injection for treatment of severe pneumonia ： an overview of systematic reviews

目的根据已经发表的系统评价，评价血必净注射液治疗重症肺炎的临床研究水平和证据质量现状，为今后开展相关研究提供参考和启发。方法计算机检索中国知网CNKI、万方数据库、维普数据库、中国生物医学文献数据库（CBM）、Cochrane临床试验数据库、美国国立医学图书馆PubMed数据库和荷兰医学文摘EMBASE数据库建库至2014年12月发表的文献，获取血必净注射液治疗重症肺炎的系统评价，采用评价系统评价的测评工具（AMSTAR）和系统综述和Meta分析的优先报告条目（PRISMA）量表评价系统评价的方法学质量和报告质量，采用Cochrane随机对照试验（RCT）偏倚风险评估工具评价纳入系统评价中RCT的方法学质量，并用推荐等级的评估、制定与评价（GRADE）方法评估证据质量。结果纳入2篇相关系统评价，含有16个原始研究，系统评价的方法学质量和报告质量均存在缺陷，原始研究的方法学水平均不高。2篇系统评价共报告了18个结局指标，经证据强度评估，主要呈低级或极低级证据。结论血必净注射液治疗重症肺炎具有潜在疗效，但现有研究的方法学质量较差，证据质量低或者极低。临床医生在使用这些证据进行临床决策时尚需谨慎，未来还需要有大样本量和方法学质量高的临床研究加以验证。

Objective Based on having been published systematic reviews, to evaluate the present situation of clinical research level and quality of evidence of Xuebijing injection for treatment of severe pneumonia in order to provide reference and inspiration for carrying out related studies in the future. Methods Chinese Journal Full-text Database （CNKI）, Wanfang database, VIP database （VIP）, Chinese Biomedical Literature Database （CBM）, the Cochrane clinical trials, the PubMed database of the US National Library of Medicine and the Holland Medical Abstracts EMBASE database were used for computer retrieval of the published literatures concerning systematic reviews of Xuebijing injection for severe pneumonia from the establishment of the databases up to December 2014. The methodological and reporting qualities of included systemic reviews were assessed by using the clauses and sub-clauses of Assessing the Methodological Quality of Systematic Reviews tool （AMSTAR） and Preferred Reporting Items for Systematic Reviews and Meta-Analysis （PRISMA）, the Cochrane bias risk assessment tool of randomized controlled trial （RCT） was used to evaluate the methodological quality of RCT included in systematic reviews, and the evidence levels were evaluated by using the grading of recommendations assessment, development and evaluation （GRADE） method. Results Two related systematic reviews involving 16 original RCT were included, flaws existed in the methodological quality and the reporting quality of systematic reviews and the methodological levels of original studies were all poor. Two systematic reviews reported 18 outcome indexes, after the evidences were strongly evaluated, they mainly revealed as ＂low＂ or ＂very low＂ evidences. Conclusions Xuebijing injection in the treatment of severe pneumonia has potential efficacy, however, the methodological quality of present researches was relatively poor and the quality of evidence was low or very low. Clinicians should cautiously apply the evidence to make any decision in clinical practice. It is necessary to have a larger sample and higher methodological quality in clinical researches to validate the results in the future.