负压封闭引流对开放性骨折创面影响的Meta分析及试验序贯分析

Meta⁃analysis and Trial Sequential Analysis of the Effect of Negative Pressure Wound Therapy on Open Fracture Wounds

目的系统分析负压封闭引流对开放性骨折创面的治疗效果。方法计算机检索中国期刊全文数据库(中国知网)、中国生物医学文献数据库(CBM)、中文科技期刊数据库(维普)、中国学术期刊数据库(万方)、The Cochrane Library、PubMed、OVID、Web of Science、CINAHL等数据库建库至2018年8月公开发表的负压封闭引流治疗开放性骨折创面的相关文献,根据纳入与排除标准筛选符合标准的文献,采用Cochrane 5.1.0手册中的偏倚风险评估标准对纳入文献进行质量评价,采用Rev Man 5.3软件对纳入文献进行Meta分析、TSA 0.9软件对纳入文献进行试验序贯分析。结果共纳入符合标准的文献10篇,包含开放性骨折患者1097例。Meta分析结果显示,创面行负压封闭引流治疗的开放性骨折患者创面感染率明显低于常规治疗[RR=0.43,95%CI(0.31,0.60),P<0.001],治疗有效率明显高于常规治疗[RR=1.33,95%CI(1.19,1.50),P<0.001],创面愈合时间明显短于常规治疗[SMD=-4.87,95%CI(-7.21,-2.52),P<0.001];试验序贯分析结果显示,各结局指标在样本量达到期望信息量之前已获得肯定结果。结论与常规治疗方法相比,负压封闭引流能更有效降低开放性骨折创面感染率,提高治疗有效率,缩短创面愈合时间。

Objective To systematically analyze the effect of negative pressure wound therapy(NPWT)on open fracture wounds.Methods Computer⁃based literature search was conducted to retrieve studies on NPWT in treating open fracture wounds published by August 2018 from the establishment of the following databases as China National Knowledge Infrastructure(CNKI),Chinese Biomedical Literature Database(CBM),China Science and Technology Journal Database(VIP),China Science Periodical Database(Wanfang),the Cochrane Library,PubMed,OVID,Web of Science and CINAHL.Based on the inclusion and exclusion criteria,the qualified study documents were screened out from the retrieved literature.The bias risk assessment criteria in Cochrane 5.1.0 manual were used to evaluate the quality of the included study documents,Rev Man 5.3 software and TSA 0.9 software were applied respectively for Meta⁃analysis and trial sequen⁃tial analysis of these documents.Results A total of 10 papers screened out from the retrieved literature were included into the study,with 1097 patients of open fracture wounds involved.Meta⁃analysis showed that,compared with the conventional therapy,the wound infection rate of open fracture patients treated with NPWT was significantly lower[RR=0.43,95%CI(0.31,0.60),P<0.001],the effective rate of treatment was significantly higher[RR=1.33,95%CI(1.19,1.50),P<0.001]and the wound healing time was obviously shorter[SMD=-4.87,95%CI(-7.21,-2.52),P<0.001].The results of trial sequential analysis found that all outcome indicators have already been positive before the sample size reached the required information size.Conclusion Compared with the conventional therapy,negative pressure wound therapy can more effectively decrease the wound infection rate of open fracture,improve the clinical efficacy and shorten the wound healing time.