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自身血小板凝胶和生长因子对锑治疗皮肤利什曼病创面的愈合作用:随机分组病变自身对照临床试验。

Healing effects of autologous platelet gel and growth factors on cutaneous leishmaniasis wounds in addition to antimony; a self-controlled clinical trial with randomized lesion assignment.

机构信息

Zoonoses Research Center, Jahrom University of Medical Sciences, Jahrom, Iran.

Department of Medical Parasitology and Mycology, School of Medicine, Jahrom University of Medical Sciences, Jahrom, Iran.

出版信息

BMC Res Notes. 2023 Sep 9;16(1):200. doi: 10.1186/s13104-023-06470-4.

Abstract

OBJECTIVE

Autologous platelet gel (APG) is used in most surgeries to treat a variety of tissue defects because of its healing factors composition. This randomized parallel clinical trial was conducted to investigate the healing effects of APG on cutaneous leishmaniasis (CL) wounds. Eighteen male patients with CL wounds were recruited and followed for two months. The patients had more than one cutaneous wound, one of which was examined as the control and the other one as the intervention wound. APG was applied to the intervention wounds once a week, up to eight times. The primary endpoint was wound healing which defined as complete epithelialization and tissue granulation. Other clinical evaluation criteria were assessment of the wound size, and histopathology analyses.

RESULTS

Of 18 patients, 15 patients completed the trial (83.3%, mean age 28 years). The use of APG on the wounds was associated with complete and faster healing in 66% of the wounds and partial healing in 34% of the wounds. During the study, none of the control wounds were completely healed. The wound area in the intervention cases showed a statistically significant decrease throughout the study (P < 0.01) compared with controls. Following treatment of CL lesions with APG, the inflammatory process in the epidermis and dermis were decreased significantly (P < 0.01) compared with controls.

CONCLUSION

Our preliminary results confirm the clinical healing improvement described in the literature for APG-GF treatment of chronic non-leishmania wounds via immunomodulation.

TRIAL REGISTRATION

IRCT, IRCT20190212042694N1. Registered 20 February 2019, https://en.irct.ir/trial/37522.

摘要

目的

自体血小板凝胶(APG)因其具有愈合因子组成而被用于大多数手术中,以治疗各种组织缺陷。本随机平行临床试验旨在研究 APG 对皮肤利什曼病(CL)创面的愈合效果。共招募了 18 名男性 CL 创面患者,并随访了两个月。这些患者有多个皮肤创面,其中一个作为对照,另一个作为干预创面。每周向干预创面施用一次 APG,最多 8 次。主要终点是定义为完全上皮化和组织肉芽形成的伤口愈合。其他临床评估标准包括评估伤口大小和组织病理学分析。

结果

在 18 名患者中,有 15 名患者完成了试验(83.3%,平均年龄 28 岁)。APG 对创面的使用与 66%的创面完全和更快愈合以及 34%的创面部分愈合相关。在研究过程中,对照组的创面均未完全愈合。与对照组相比,干预组的创面面积在整个研究过程中呈统计学显著下降(P<0.01)。与对照组相比,用 APG 治疗 CL 病变后,表皮和真皮中的炎症过程显著减少(P<0.01)。

结论

我们的初步结果证实了文献中描述的 APG-GF 通过免疫调节治疗慢性非利什曼创面的临床愈合改善。

试验注册

IRCT,IRCT20190212042694N1。于 2019 年 2 月 20 日注册,https://en.irct.ir/trial/37522.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce44/10493010/89066208d07a/13104_2023_6470_Fig1_HTML.jpg

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