脐带血血小板凝胶治疗糖尿病足溃疡的疗效:一项双盲随机临床试验

Q1 Medicine Wound Medicine Pub Date : 2020-03-01 DOI:10.1016/j.wndm.2020.100178
Seyedeh Esmat Hosseini , Behnam Molavi , Alireza Goodarzi , Ahad Alizadeh , Alireza Yousefzadeh , Niloofar Sodeifi , Leila Arab , Nasser Aghdami
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引用次数: 2

摘要

2型糖尿病是世界上最普遍的疾病之一。足部溃疡是这种疾病的严重并发症。足部溃疡导致高发病率,影响生活质量,给卫生服务提供者带来极高的成本,并造成时间浪费。近年来,富血小板血浆(PRP)和血小板凝胶(PG)已被用于慢性伤口的治疗。在目前的随机、双盲、安慰剂对照研究中,来自脐带血的血小板凝胶(UCB)被用于治疗糖尿病足。方法将患者随机分为PG组、贫血小板血浆组(PPP)组和润滑凝胶组(安慰剂组)(比例为1:1:1)。每组受试者启动凝胶涂抹过程,每周2次,间隔3-4天。这种机制持续了8个星期。8周结束后,每2周随访一次,每隔1个月随访9个月。结果对30例患者进行统计分析。除舒张压组间差异有统计学意义外,患者基线人口统计学差异无统计学意义。创面基线组间差异无统计学意义(P = 0.09)。结果显示,在随访期间,三组之间没有统计学上显著的相互作用。结论本研究提供的证据表明,PG组、PPP组和安慰剂组在伤口大小上无显著差异。
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The efficacy of platelet gel derived from umbilical cord blood on diabetic foot ulcers: A double-blind randomized clinical trial

Introduction

Type 2 diabetes is one of the most prevalent diseases throughout the world. The foot ulcers are severe complications of this disease. Foot ulcers induce the high rate of morbidity, impair quality of life, bring about extreme costs to health service providers, and give rise to waste of time. Recently, platelet-rich plasma (PRP) and platelet gel (PG) have been used for the treatment of chronic wounds. In the present randomized, double-blind, placebo-controlled study, platelet gel derived from umbilical cord blood (UCB) was used to heal the diabetic foot.

Method

The patients were randomly divided into three groups, under the categories of PG, platelet-poor plasma (PPP) and lubricant gel (placebo) (ratio 1:1:1). The processes of gels application were launched for the subject of each group twice per week with 3–4 days’ interval. This mechanism protracted for eight weeks. After completion of 8 weeks, the patients were followed up after two weeks and then continued for nine months with one-month interval.

Result

30 patients underwent statistical analysis. Except for diastolic blood pressure which was significant between groups, there were no statistically significant differences in patients’ baseline demographics. No significant differences were detected between groups at baseline of wounds (P = 0.09). The results revealed that there is no statistically significant interaction among three groups during follow-up time.

Conclusion

The present study provides evidence that there are no significant differences in the size of wound among PG, PPP, and placebo groups.

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Wound Medicine
Wound Medicine Medicine-Surgery
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