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富血小板血浆治疗糖尿病溃疡患者的疗效与安全性:一项系统评价与荟萃分析。

Efficacy and Safety of Platelet-Rich Plasma for Patients with Diabetic Ulcers: A Systematic Review and Meta-analysis.

作者信息

Hu Zhicheng, Qu Shanqiang, Zhang Jian, Cao Xiaoling, Wang Peng, Huang Shaobin, Shi Fen, Dong Yunxian, Wu Jun, Tang Bing, Zhu Jiayuan

机构信息

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.

Department of Plastic Surgery, The Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.

出版信息

Adv Wound Care (New Rochelle). 2019 Jul 1;8(7):298-308. doi: 10.1089/wound.2018.0842. Epub 2019 Jul 2.

Abstract

Autologous platelet-rich plasma (PRP) has been suggested to be effective for wound healing. However, clinical evidence for its use in patients with diabetic ulcer remains inconsistent. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of PRP in patients with diabetic ulcer. Relevant randomized controlled trials (RCTs) were identified via systematic search of PubMed, MEDLINE, EMBASE, the Cochrane Library, and Web of Knowledge databases. Results were pooled using a random-effects model. The primary outcome of the study was the healing rate of ulcers in patients with PRP, when compared with controls. Secondary outcomes included the percentage of ulcer area reduction, recurrence rate, and amputation rate. Eight RCTs that involved 431 participants were included. Compared with controls, PRP was associated with a significantly increased ratio of complete ulcer healing (odds ratio [OR] = 3.77, 95% confidence interval [CI] = 1.91-7.45,  42.2%) and reduced areas of ulcers (standard mean difference = 0.86, 95% CI = 0.27-1.45,  0.0%). No differences were observed between patients allocated to PRP or controls, in terms of the outcomes of recurrence rate (OR = 3.32, 95% CI = 0.41-27.18,  66.3%) or amputation rate (OR = 0.15, 95% CI = 0.15-1.28). The results of the trial sequence analyses revealed that the cumulative Z-curve crossed both the traditional boundary ( = 0.05) and trial sequential monitoring boundary. Our findings suggest that PRP may improve ulcer healing without significant adverse effects for patients with diabetic ulcers.

摘要

自体富血小板血浆(PRP)已被认为对伤口愈合有效。然而,其用于糖尿病溃疡患者的临床证据仍不一致。本系统评价和荟萃分析的目的是评估PRP在糖尿病溃疡患者中的疗效和安全性。通过系统检索PubMed、MEDLINE、EMBASE、Cochrane图书馆和Web of Knowledge数据库,确定相关的随机对照试验(RCT)。使用随机效应模型汇总结果。该研究的主要结局是与对照组相比,PRP治疗患者溃疡的愈合率。次要结局包括溃疡面积缩小百分比、复发率和截肢率。纳入了八项涉及431名参与者的RCT。与对照组相比,PRP与溃疡完全愈合的比例显著增加相关(优势比[OR]=3.77,95%置信区间[CI]=1.91-7.45,P<0.001),且溃疡面积减小(标准化均数差=0.86,95%CI=0.27-1.45,P=0.004)。在复发率(OR=3.32,95%CI=0.41-27.18,P=0.25)或截肢率(OR=0.15,95%CI=0.01-1.28,P=0.08)方面,接受PRP治疗的患者与对照组之间未观察到差异。试验序贯分析结果显示,累积Z曲线越过了传统界值(α=0.05)和试验序贯监测界值。我们的研究结果表明,PRP可能改善糖尿病溃疡患者的溃疡愈合,且无明显不良反应。

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