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负压伤口疗法在二期愈合伤口患者中的应用:一项随机对照试验的系统评价和荟萃分析。

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials.

机构信息

Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany.

Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

出版信息

Syst Rev. 2020 Oct 10;9(1):238. doi: 10.1186/s13643-020-01476-6.

Abstract

BACKGROUND

Negative pressure wound therapy (NPWT) is a widely used method of wound treatment. We performed a systematic review of randomised controlled trials (RCTs) comparing the patient-relevant benefits and harms of NPWT with standard wound therapy (SWT) in patients with wounds healing by secondary intention.

METHODS

We searched for RCTs in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and study registries (last search: July 2018) and screened reference lists of relevant systematic reviews and health technology assessments. Manufacturers and investigators were asked to provide unpublished data. Eligible studies investigated at least one patient-relevant outcome (e.g. wound closure). We assessed publication bias and, if feasible, performed meta-analyses, grading the results into different categories (hint, indication or proof of a greater benefit or harm).

RESULTS

We identified 48 eligible studies of generally low quality with evaluable data for 4315 patients and 30 eligible studies with missing data for at least 1386 patients. Due to potential publication bias (proportion of inaccessible data, 24%), we downgraded our conclusions. A meta-analysis of all wound healing data showed a significant effect in favour of NPWT (OR 1.56, 95% CI 1.15 to 2.13, p = 0.008). As further analyses of different definitions of wound closure did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. A meta-analysis of hospital stay (in days) showed a significant difference in favour of NPWT (MD - 4.78, 95% CI - 7.79 to - 1.76, p = 0.005). As further analyses of different definitions of hospital stay/readmission did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. There was neither proof (nor indication nor hint) of greater benefit or harm of NPWT for other patient-relevant outcomes such as mortality and adverse events.

CONCLUSIONS

In summary, low-quality data indicate a greater benefit of NPWT versus SWT for wound closure in patients with wounds healing by secondary intention. The length of hospital stay is also shortened. The data show no advantages or disadvantages of NPWT for other patient-relevant outcomes. Publication bias is an important problem in studies on NPWT, underlining that all clinical studies need to be fully reported.

摘要

背景

负压伤口治疗(NPWT)是一种广泛应用的伤口处理方法。我们对比较 NPWT 与标准伤口治疗(SWT)在二期愈合伤口患者中患者相关获益和危害的随机对照试验(RCT)进行了系统评价。

方法

我们在 MEDLINE、Embase、Cochrane 对照试验中心注册库和研究登记处(最后检索日期:2018 年 7 月)中检索 RCT,并筛选了相关系统评价和卫生技术评估的参考文献列表。制造商和研究者被要求提供未发表的数据。合格研究至少调查了一项患者相关结局(例如伤口闭合)。我们评估了发表偏倚,如果可行,我们进行了荟萃分析,将结果分为不同类别(提示、暗示或证明获益或危害更大)。

结果

我们确定了 48 项合格研究,这些研究质量普遍较低,有 4315 名患者可评估数据,30 项研究有至少 1386 名患者缺失数据。由于潜在的发表偏倚(无法获取数据的比例为 24%),我们降低了结论的可信度。所有伤口愈合数据的荟萃分析显示,NPWT 有显著的获益(OR 1.56,95%CI 1.15 至 2.13,p = 0.008)。由于对不同定义的伤口闭合的进一步分析并未反驳该分析,我们推断 NPWT 的获益更大。住院时间(天)的荟萃分析显示,NPWT 有显著的获益(MD -4.78,95%CI -7.79 至 -1.76,p = 0.005)。由于对不同定义的住院时间/再入院的进一步分析并未反驳该分析,我们推断 NPWT 的获益更大。对于其他患者相关结局(如死亡率和不良事件),NPWT 没有更大获益或危害的证据(也没有暗示或提示)。

结论

总之,低质量数据表明,在二期愈合伤口患者中,NPWT 相对于 SWT 在伤口闭合方面具有更大的获益。住院时间也缩短了。数据显示 NPWT 在其他患者相关结局方面没有优势。发表偏倚是 NPWT 研究中的一个重要问题,这突出表明所有临床研究都需要全面报告。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0fa/7548038/769858baa300/13643_2020_1476_Fig1_HTML.jpg

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