Martinez-Zapata Maria José, Martí-Carvajal Arturo J, Solà Ivan, Expósito José Angel, Bolíbar Ignasi, Rodríguez Luciano, Garcia Joan, Zaror Carlos
Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), CIBER Epidemiología y Salud Pública (CIBERESP), Sant Antoni Maria Claret 167, Pavilion 18, Barcelona, Catalunya, Spain, 08025.
Cochrane Database Syst Rev. 2016 May 25;2016(5):CD006899. doi: 10.1002/14651858.CD006899.pub3.
Autologous platelet-rich plasma (PRP) is a treatment that contains fibrin and high concentrations of growth factors with the potential to improve the healing of chronic wounds. This is the first update of a review first published in 2012.
To determine whether autologous PRP promotes the healing of chronic wounds.
In June 2015, for this first update, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library): Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also searched for ongoing and unpublished clinical trials in the WHO International Clinical Trials Registry Platform (ICTRP) (searched January 2015). We did not impose any restrictions with respect to language, date of publication, or study setting.
We included randomised controlled trials (RCTs) that compared autologous PRP with placebo or alternative treatments for any type of chronic wound in adults. We did not apply any date or language restrictions.
We used standard Cochrane methodology, including two reviewers independently selecting studies for inclusion, extracting data, and assessing risk of bias.
The search identified one new RCT, making a total of 10 included RCTs (442 participants, 42% women). The median number of participants per RCT was 29 (range 10 to 117). Four RCTs recruited people with a range of chronic wounds; three RCTs recruited people with venous leg ulcers, and three RCTs considered foot ulcers in people with diabetes. The median length of treatment was 12 weeks (range 8 to 40 weeks).It is unclear whether autologous PRP improves the healing of chronic wounds generally compared with standard treatment (with or without placebo) (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.95 to 1.50; I(2) = 27%, low quality evidence, 8 RCTs, 391 participants). Autologous PRP may increase the healing of foot ulcers in people with diabetes compared with standard care (with or without placebo) (RR 1.22, 95% CI 1.01 to 1.49; I(2) = 0%, low quality evidence, 2 RCTs, 189 participants). It is unclear if autologous PRP affects the healing of venous leg ulcers (RR 1.02, 95% CI 0.81 to 1.27; I(2) = 0% ). It is unclear if there is a difference in the risk of adverse events in people treated with PRP or standard care (RR 1.05, 95% CI 0.29 to 3.88; I(2) = 0%, low quality evidence from 3 trials, 102 participants).
AUTHORS' CONCLUSIONS: PRP may improve the healing of foot ulcers associated with diabetes, but this conclusion is based on low quality evidence from two small RCTs. It is unclear whether PRP influences the healing of other chronic wounds. The overall quality of evidence of autologous PRP for treating chronic wounds is low. There are very few RCTs evaluating PRP, they are underpowered to detect treatment effects, if they exist, and are generally at high or unclear risk of bias. Well designed and adequately powered clinical trials are needed.
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，有可能促进慢性伤口的愈合。这是对2012年首次发表的一篇综述的首次更新。
确定自体PRP是否能促进慢性伤口的愈合。
2015年6月，为进行此次首次更新，我们检索了Cochrane伤口专业注册库；Cochrane对照试验中央注册库（CENTRAL）（Cochrane图书馆）；Ovid MEDLINE；Ovid MEDLINE（在研及其他未索引引文）；Ovid EMBASE；以及EBSCO CINAHL。我们还在世卫组织国际临床试验注册平台（ICTRP）中检索了正在进行和未发表的临床试验（2015年1月检索）。我们没有对语言、出版日期或研究背景施加任何限制。
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。我们没有应用任何日期或语言限制。
我们采用标准的Cochrane方法，包括两名综述作者独立选择纳入研究、提取数据并评估偏倚风险。
检索到一项新的RCT，总共纳入了10项RCT（442名参与者，42%为女性）。每项RCT的参与者中位数为29名（范围为10至117名）。四项RCT招募了患有多种慢性伤口的人群；三项RCT招募了患有下肢静脉溃疡的人群，三项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）。与标准治疗（有或无安慰剂）相比，尚不清楚自体PRP总体上是否能改善慢性伤口的愈合（风险比（RR）1.19，95%置信区间（CI）0.95至1.50；I² = 27%，低质量证据，8项RCT，391名参与者）。与标准护理（有或无安慰剂）相比，自体PRP可能会增加糖尿病患者足部溃疡的愈合（RR 1.22，95%CI 1.01至1.49；I² = 0%，低质量证据，2项RCT，189名参与者）。尚不清楚自体PRP是否会影响下肢静脉溃疡的愈合（RR 1.02，95%CI 0.81至1.27；I² = 0%）。尚不清楚接受PRP治疗或标准护理的人群在不良事件风险方面是否存在差异（RR 1.05，95%CI 0.29至3.88；I² = 0%，来自3项试验的低质量证据，102名参与者）。
PRP可能会改善与糖尿病相关的足部溃疡的愈合，但这一结论基于两项小型RCT的低质量证据。尚不清楚PRP是否会影响其他慢性伤口的愈合。自体PRP治疗慢性伤口的总体证据质量较低。评估PRP的RCT非常少，它们检测治疗效果（如果存在的话）的能力不足，而且总体上处于高偏倚风险或偏倚风险不明确的状态。需要设计良好且有足够效力的临床试验。
