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用于治疗慢性伤口的自体富血小板血浆。

Autologous platelet-rich plasma for treating chronic wounds.

作者信息

Martinez-Zapata Maria José, Martí-Carvajal Arturo J, Solà Ivan, Expósito José Angel, Bolíbar Ignasi, Rodríguez Luciano, Garcia Joan

机构信息

Iberoamerican Cochrane Centre. Universitat Autònoma de Barcelona. Institute of Biomedical Research Sant Pau (IIB Sant Pau),Barcelona, CIBER Epidemiología y Salud Pública (CIBERESP), Spain, Barcelona, Spain.

出版信息

Cochrane Database Syst Rev. 2012 Oct 17;10:CD006899. doi: 10.1002/14651858.CD006899.pub2.

Abstract

BACKGROUND

Autologous platelet-rich plasma (PRP) is a treatment that contains fibrin and high concentrations of growth factors and has the potential to aid wound healing.

OBJECTIVES

To determine whether autologous PRP promotes the healing of chronic wounds.

SEARCH METHODS

We searched the Cochrane Wounds Group Specialised Register (searched 15 August 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 8); Ovid MEDLINE (1950 to August Week 1 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, August 14, 2012); Ovid EMBASE (1980 to 2012 Week 32); EBSCO CINAHL (1982 to 10 August 2012) and International Clinical Trials Registry Platform (ICTRP)(accessed 22 August 2012). No date or language restrictions were applied.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) that compared autologous PRP with placebo or alternative treatments for any type of chronic wound in adults.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed each study against the inclusion criteria, extracted data and assessed risk of bias for all included trials. We calculated the risk ratio (RR) or the mean difference (MD) and time to wound healing was analysed as survival data using the hazard ratio (HR). We considered heterogeneity as significant when I(2) was >75%.

MAIN RESULTS

Nine eligible RCTs were included, with a total of 325 participants of whom 44% were women. The median number of participants per RCT was 26 (range 10 to 86). Four RCTs recruited people with mixed chronic wounds (there were participants with wounds caused by more than one aetiology and participants who had wounds of several aetiologies in the same trial), three RCTs recruited people with venous leg ulcers and two RCTs considered foot ulcers in people with diabetes. The median length of treatment was 12 weeks (range eight to 40 weeks).One study was at low risk of bias, three studies were at high risk of bias with the remainder being at overall unclear risk of bias. The proportion of completely healed chronic wounds was reported in seven RCTs that compared PRP with standard treatment or placebo, with no statistically significant difference between the groups, in diabetic foot ulcers (RR 1.16; 95% CI 0.57 to 2.35), in venous leg ulcers (pooled RR 1.02; 95% CI 0.81 to 1.27; I(2)=0% ) and in mixed chronic wounds (pooled RR 1.85; 95% CI 0.76 to 4.51; I(2)=42%). The total area epithelialised at the end of the intervention was reported in three RCTs of mixed chronic wounds, there was no statistically significant difference between the groups (pooled MD -1.94 cm(2); 95% CI -4.74 to 0.86; I(2)=47%). The percentage of wound area healed was reported in two RCTs of mixed chronic wounds, and results were statistically significant in favour of the PRP group (RR 51.78%; 95% CI 32.70 to 70.86; I(2)= 0%). Wound complications like infection or necrosis were reported by three RCTs, and there was no statistically significant difference between groups (RR 1.08; 95% CI 0.31 to 3.73). Adverse effects were reported by three studies and there was no statistically significant difference between people treated with PRP and those not given PRP (pooled RR 1.07; 95% CI 0.32 to 3.58; I(2)=0%).

AUTHORS' CONCLUSIONS: There is currently no evidence to suggest that autologous PRP is of value for treating chronic wounds. However, current evidence is based on a small number of RCTs, most of which are either at high or unclear risk of bias. Well-designed and adequately powered clinical trials are needed.

摘要

背景

自体富血小板血浆(PRP)是一种含有纤维蛋白和高浓度生长因子的治疗方法,具有促进伤口愈合的潜力。

目的

确定自体PRP是否能促进慢性伤口的愈合。

检索方法

我们检索了Cochrane伤口小组专业注册库(检索时间为2012年8月15日);Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2012年第8期);Ovid MEDLINE(1950年至2012年8月第1周);Ovid MEDLINE(在研及其他未索引引文,2012年8月14日);Ovid EMBASE(1980年至2012年第32周);EBSCO CINAHL(1982年至2012年8月10日)以及国际临床试验注册平台(ICTRP)(访问时间为2012年8月22日)。未设置日期或语言限制。

入选标准

我们纳入了将自体PRP与安慰剂或其他治疗方法进行比较的随机对照试验(RCT),这些试验针对的是成人的任何类型慢性伤口。

数据收集与分析

两位综述作者独立根据纳入标准评估每项研究,提取数据并评估所有纳入试验的偏倚风险。我们计算风险比(RR)或均值差(MD),并将伤口愈合时间作为生存数据使用风险比(HR)进行分析。当I²>75%时,我们认为异质性显著。

主要结果

纳入了9项符合条件的RCT,共有325名参与者,其中44%为女性。每项RCT的参与者中位数为26名(范围为10至86名)。4项RCT招募了患有混合性慢性伤口的人群(同一试验中有因多种病因导致伤口的参与者以及患有多种病因伤口的参与者),3项RCT招募了下肢静脉溃疡患者,2项RCT研究了糖尿病患者的足部溃疡。治疗的中位数时长为12周(范围为8至40周)。1项研究偏倚风险较低,3项研究偏倚风险较高,其余研究总体偏倚风险不明确。7项RCT报告了慢性伤口完全愈合的比例,这些试验将PRP与标准治疗或安慰剂进行了比较,在糖尿病足溃疡(RR 1.16;95%CI 0.57至2.35)、下肢静脉溃疡(合并RR 1.02;95%CI 0.81至1.27;I² = 0%)和混合性慢性伤口(合并RR 1.85;95%CI 0.76至4.51;I² = 42%)中,各组之间无统计学显著差异。3项关于混合性慢性伤口的RCT报告了干预结束时上皮化的总面积,各组之间无统计学显著差异(合并MD -1.94 cm²;95%CI -4.74至0.86;I² = 47%)。2项关于混合性慢性伤口的RCT报告了伤口愈合面积的百分比,结果在统计学上显著有利于PRP组(RR 51.78%;95%CI 32.70至70.86;I² = 0%)。3项RCT报告了伤口并发症如感染或坏死情况,各组之间无统计学显著差异(RR 1.08;95%CI 0.31至3.73)。3项研究报告了不良反应,接受PRP治疗的人与未接受PRP治疗的人之间无统计学显著差异(合并RR 1.07;95%CI 0.32至3.58;I² = 0%)。

作者结论

目前没有证据表明自体PRP对治疗慢性伤口有价值。然而,当前证据基于少数RCT,其中大多数偏倚风险较高或不明确。需要设计良好且样本量充足的临床试验。

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