Meta-analysis on the effect of negative pressure therapy in body surface wound treatment

doi:10.3969/j.issn.2095-4344.2013.46.021

Abstract

Abstract:

BACKGROUND: Negative pressure wound therapy has been widely recognized, the currently published papers are limited in academic value and lack of scientific, objective, qualified index to confirm the therapy effectiveness.
OBJECTIVE: To systemically evaluate the clinical effect of negative pressure wound therapy, provide more evidence for its clinical application, and guide clinical research.
METHODS: Fifteen articles were screened out of peer-reviewed publications (Cochran library, Embase, PubMed-Medline and Chinese BioMedical Literature Database). Scientific data were collected and evaluated by two researchers. The data were statistically analyzed with RevMan software.
RESULTS AND CONCLUSION: Only 15 random-controlled trials were finally preserved, including 10 as B-grade moderate bias risk and focused on the effect of negative pressure wound therapy on chronic wounds, and 5 as C-grade high bias risk and focused on the effect of negative pressure wound therapy on acute wounds. There were significant differences in the main outcome measures between negative pressure wound therapy and conventional wound therapy. As for chronic wound patients, no significant difference was observed in the operation-preparing period, reducing wound area, promoting wound granulation, and amputation rate between two therapies. As for acute wound patients, the differences were significant in the operation-preparing period, promoting wound granulation, wound infection rate, and cost materials between two therapies. However, no difference was significant in the healing of wound and hospitalization time. Our findings indicate that, negative pressure wound therapy is an effective means for both acute and chronic wounds, it can shorten operation-preparing period, promote wound granulation, and reduce amputation rate and infection rate, thus providing evidence for clinical application. The well-designed study is needed to develop high-quality random controlled trails.

Key words: negative-pressure wound therapy, body surface area, ulcer, skin ulcer, wounds and injuries, diabetic foot

CLC Number:

R318

Bai Ming, Zhao Ru, Wang Zhi, Long Xiao, Zeng Ang, Zhang Hai-lin, Wang Xiao-jun. Meta-analysis on the effect of negative pressure therapy in body surface wound treatment[J]. Chinese Journal of Tissue Engineering Research, 2013, 17(46): 8108-8115.

Figures/Tables 6

2.3 纳入研究的一般情况统一设计临床资料提取表，填写15篇文献内容，见表1。 2.4 纳入研究的方法学质量评价按照Cochrane协作网提供的系统评价员手册要求(5.0.0 版)的7条标准进行偏倚风险评估。共有5篇文献为C级，具有高度偏倚风险；10篇文献为B级，具有中度偏倚风险，见表2。 2.5 对不同类型创面疗效的评价各个临床试验对所得出的结果不尽相同，可以分为：时间类指标(如达到某个效果的所用的时间)、数量类指标(如到达观察点后创面的各种变化)、事件类指标(截肢例数、愈合例数、疼痛强度等)。 2.6 创面负压治疗技术对慢性创面的疗效本组比较纳入10篇文献，各对照组采取的干预措施相同但结果判定指标不完全相同，按照不同的结果判定指标分类做以下分析。 2.6.1 创面完全愈合所用的时间 3个研究报告了该指标，在Braakenburg 等[7]的随机对照试验中，32例患者采用创面负压治疗技术治疗，对照组33例采用藻酸盐敷料、水胶体、水凝胶以及泡沫敷料，其报告到达创面愈合的时间治疗组为10.2 d(SD 47)，n=32；对照组为 16.8 d(SD 65.2)，n=33。 Mody等[12]的小样本随机对照试验中15例患者采用创面负压治疗技术治疗，对照组30例也采用的藻酸盐敷料、水胶体、水凝胶以及泡沫敷料，其报告的愈合时间治疗组为35.9 d(SD44.5)，n=15，对照组为42 d(SD 46.7)，n=30。 McCallon等[1]报告10例小样本的随机对照临床试验中，5例试验组患者接受创面负压治疗技术治疗，5 例对照组患者采用藻酸盐敷料治疗。创面负压治疗技术组平均愈合时间为22.8 d(SD 17.40)，对照组平均时间为42.8 d(SD 32.5)。合并效应量的检验Z值和P值为：Z=0.89，P=0.38，差异没有显著性意义，说明2种治疗方式下创面愈合所用的时间相同。见图2。 "

2.6.8 疼痛强度得分在Vuerstaek等[9]6的一项小样本随机对照临床试验中，30例试验组患者采用负压治疗，30例对照组患者采用藻酸盐及水凝胶换药治疗。负压治疗组患者疼痛平均得分0.2(SD=0.7)，对照组得分平均0.4(SD=0.6)，均数差MD=-0.20，95% CI为[-0.53，0.13]，P=0.23，差异无显著性意义，说明两种治疗方式在疼痛强度上没有区别。 2.6.9 并发症数量在Vuerstaek等[9]的一项小样本随机对照临床试验中，30例试验组患者采用负压治疗，30例对照组患者采用藻酸盐及水凝胶换药治疗。负压治疗组12例出现并发症，对照组出现7例，MD=2.19，95% CI为[0.72，6.70]，P=0.17，差异没有显著性意义。说明两种治疗方式在并发症数量上没有区别。 2.7 负压吸引对急性创面的疗效本组比较纳入5篇文献，由于每个试验所使用的干预措施不同，按照不同的结果指标分类做以下分析。 2.7.1 术前准备时间在Perez 2010的一项小样本随机对照临床试验中，20例试验组患者采用创面负压治疗技术，20例对照组患者采用传统纱布换药治疗。创面负压治疗技术组患者平均16.3 d(SD=9.7)可以满足进行手术干预，对照组为平均25 d(SD=15.5)，MD=-9.10，95% CI为[-17.11，-1.09]，P=0.03，差异有显著性意义。说明应用创面负压治疗技术在术前准备时间上明显短于传统纱布治疗。 2.7.2 肉芽组织覆盖创面75%所用的时间 2个研究报告了该指标，Armstrong等[6]的小样本随机对照试验中，77例患者采用创面负压治疗技术治疗，对照组85例采用藻酸盐敷料、水胶体、水凝胶以及泡沫敷料，其报告创面75%有肉芽组织生长的时间在治疗组为平均为 42 d(SD=37)，对照组平均为84 d(SD=69)。Sepulveda等[13]的小样本随机对照试验中12例患者采用创面负压治疗技术治疗，对照组12例采用藻酸盐敷料、水胶体、水凝胶等湿性敷料，其报告的创面75%有肉芽组织生长的时间在治疗组平均为18.8 d(SD=6)，对照组平均为32.3 d(SD=14)。合并效应量的检验Z值和P值为：Z=5.21，P < 0.001，差异有显著性意义。说明创面负压治疗技术组所用时间明显短于对照组。见图5。 2.7.3 创面完全愈合数量在Armstrong等[6]的一项小样本随机对照临床试验中，77例试验组患者采用创面负压治疗技术治疗，85例对照组患者采用藻酸盐敷料、水胶体、水凝胶以及泡沫敷料。治疗结束后，创面负压治疗技术组患者有43例创面完全愈合，对照组有33例患者创面完全愈合，OR=1.99，95% CI为[1.07，3.73]，P=0.03，差异有显著性意义。说明应用创面负压治疗技术组创面愈合的数量明显高于对照组。 2.7.4 发生感染病例数量两个研究报告了该指标，Armstrong等[6]的小样本随机对照试验中，77例患者采用创面负压治疗技术治疗，对照组85例采用藻酸盐敷料、水胶体、水凝胶以及泡沫敷料，其报告创面负压治疗技术组没有与治疗相关的感染发生，对照组感染发生2例。Stannard等[14]的小样本随机对照试验中35例患者采用创面负压治疗技术治疗，对照组23例采用湿性敷料治疗，其报告创面负压治疗技术有2例发生感染，对照组感染发生7例。合并效应量的检验Z值和P值为：Z=2.45，P=0.01，差异有显著性意义。说明负压治疗出现感染病例的数量明显少于对照组。见图6。 2.7.5 治疗期间的费用两个研究报告了该指标，Huang等[8]的小样本随机对照试验中，12例患者采用创面负压治疗技术治疗，对照组12例采用传统纱布换药，其报告治疗期间材料费用在创面负压治疗技术组为平均为100美元(SD=23.5)，对照组平均为15美元(SD=4.6)。Perez等[15]的小样本随机对照试验中20例患者采用创面负压治疗技术治疗，对照组20例采用盐水纱布换药治疗，其报告的材料费用在治疗组平均为360美元(SD=19.7)，对照组平均为271美元(SD=14.8)。合并效应量的检验Z值和P值为：Z=9.34，P < 0.001，差异有显著性意义。说明创面负压治疗技术在材料费用上明显高于传统纱布治疗。见图7。 2.7.6 住院时间在Huang等[8]的一项小样本随机对照临床试验中，12例试验组患者采用创面负压治疗技术治疗，12例对照组患者采用传统纱布换药治疗。创面负压治疗技术组患者平均住院32.1 d(SD =16.6)对照组为平均住院34.3 d(SD=24.7)，MD=-2.20，95%CI为[-19.04，14.64]，P=0.80，差异无显著性意义。说明两种治疗方式在住院时间上差异无显著性意义。 "

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