富含生长因子的血浆治疗慢性皮肤溃疡的疗效：系统评价和荟萃分析的随机对照试验。
Efficacy of plasma rich in growth factors for healing chronic skin ulcers: a systematic review of randomized controlled trials with meta-analysis.
机构信息
University Institute for Regenerative Medicine and Oral Implantology (UIRMI), Vitoria, Spain; BTI Biotechnology Institute, Vitoria, Spain.
出版信息
Wounds. 2024 Jun;36(6):189-200. doi: 10.25270/wnds/23122.
BACKGROUND
Chronic skin ulceration is a serious pathological condition for which the adjuvant use of platelet-rich plasma (PRP) has been indicated. However, evidence for the use of PRP in patients with chronic skin ulcers remains insufficient due to a large heterogeneity in experimental designs, PRP composition, and preparation protocols.
OBJECTIVE
To assess previously published reports of the clinical effect of plasma rich in growth factors (PRGF) on chronic skin wounds.
METHODS
A comprehensive search of the PubMed, Cochrane Library, and Scopus databases was performed to identify randomized controlled trials (RCTs) assessing the effect of PRGF on chronic ulcer healing, with no limitation regarding publication date (up to September 1, 2022). Percentage area reduction and probability of complete healing in chronic ulcers, pain reduction, infection risk, and cost savings were analyzed. A meta-analysis was performed, and the overall evidence was qualified using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.
RESULTS
A total of 113 studies were identified. After full-text screening, 5 RCTs met the inclusion criteria. The meta-analysis showed a significant effect of PRGF on both wound area reduction (mean difference, 56.90% [95% CI, 52.28-61.51], I² = 0%; P = .56) and on the probability of complete healing (RR, 7.07 [95% CI, 1.84-27.16], I² = 0%; P = .53) in chronic ulcers. The overall risk of bias rating was "some concerns," whereas the certainty of evidence was high for both outcomes. A qualitative analysis suggested that PRGF did not increase infection risk and was able to reduce wound pain.
CONCLUSION
The use of PRGF significantly enhances wound area reduction and also the probability of complete healing in chronic ulcers. More studies are needed to assess the effect of PRGF on pain and infection, as well as its cost-effectiveness.
背景
慢性皮肤溃疡是一种严重的病理状况，已表明可辅助使用富含血小板的血浆（PRP）。然而，由于实验设计、PRP 成分和制备方案存在很大的异质性，因此 PRP 在慢性皮肤溃疡患者中的应用证据仍然不足。
目的
评估先前发表的关于富含生长因子的血浆（PRGF）治疗慢性皮肤伤口的临床效果的报告。
方法
对 PubMed、Cochrane 图书馆和 Scopus 数据库进行全面检索，以确定评估 PRGF 对慢性溃疡愈合影响的随机对照试验（RCT），但不限制发表日期（截至 2022 年 9 月 1 日）。分析慢性溃疡的面积减少百分比和完全愈合的概率、疼痛减轻、感染风险和成本节约。进行了 meta 分析，并使用推荐评估、制定与评价（GRADE）方法对总体证据进行质量评定。
结果
共确定了 113 项研究。经过全文筛选，符合纳入标准的 RCT 有 5 项。meta 分析显示，PRGF 对伤口面积减少（平均差异，56.90%[95%CI，52.28-61.51]，I²=0%；P=.56）和慢性溃疡完全愈合的概率（RR，7.07[95%CI，1.84-27.16]，I²=0%；P=.53）均有显著影响。总体偏倚风险评分为“存在一些关注”，而这两个结局的证据确定性均较高。定性分析表明，PRGF 不会增加感染风险，且能够减轻伤口疼痛。
结论
使用 PRGF 可显著增加慢性溃疡的伤口面积减少和完全愈合的概率。需要更多研究来评估 PRGF 对疼痛和感染的影响，以及其成本效益。
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