脱细胞鱼皮移植治疗慢性溃疡的疗效：一项系统评价与荟萃分析。

Efficacy of acellular fish skin graft in the management of chronic ulcer: a systematic review and meta-analysis.

作者信息

Gao Jing, Ge Li-Xiu, Gao Qiao-Ying, Zhang Ai-Min, Hu Li-Juan

机构信息

Clinical Laboratory, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, Anshan West Road, Tianjin, 300193, China.

National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, No. 314, Anshan West Road, Tianjin, 300193, China.

出版信息

Langenbecks Arch Surg. 2024 Feb 16;409(1):64. doi: 10.1007/s00423-024-03230-1.

DOI:10.1007/s00423-024-03230-1

PMID:38363369

Abstract

BACKGROUND

The wounds failing to heal through a timely and orderly standard of care (SOC) treatment are considered as chronic wounds, which add significant burden to healthcare systems around the world. SOC treatment has been commonly applied for management of chronic wounds, but SOC alone may not be adequate to heal all ulcers effectively. Fish skin graft (FSG) is a xenogenic skin substitute which could be used for accelerating skin healing. The current study was performed with the view of evaluating the effectiveness of FSG as an adjuvant treatment of SOC for chronic ulcer treatment.

METHODS

Two authors independently searched the following electronic databases: PubMed, Embase, and CENTRAL, using keywords including "diabetic foot ulcer," "fish skin graft," and "wound healing." Clinical studies that evaluated the clinical outcomes of FSG in treatment of chronic ulcers were included in this meta-analysis. Random- or fixed-effect modeled meta-analyses were performed according to the heterogeneity test result (i.e., I), to analyze the clinical outcome of FSG.

RESULTS

A total of 8 studies were included in qualitative synthesis and meta-analysis, with 145 patients treated by SOC and 245 patients treated by SOC plus FSG. There was no significant difference between two groups for time to healing (MD = 1.99, 95% CI: -3.70~~7.67, p = 0.493). The complete healing rate was significantly higher in FSG group compared with SOC alone (OR = 3.44, 95% CI: 2.03~~5.82, p < 0.001***). Mean percentage area reduction (PAR) was reported in six studies, with a range of 71.6~~97.3%. However, many of these studies did not report the value of standard deviation (SD), so we could not pool the data. No significantly different ulcer recurrence rate (RR = 0.60, 95% CI: 0.07~~5.27, p = 0.645) and severe adverse events (SAEs) risk (RR = 1.67, 95% CI: 0.42~6.61, p = 0.467) were found between two groups.

CONCLUSIONS

The application of FSG treatment for patients with chronic ulcers that do not respond well to SOC management could significantly increase the complete healing rate compared with SOC alone, without increased recurrence rate and SAEs risk.

摘要

背景

未能通过及时且有序的标准护理（SOC）治疗愈合的伤口被视为慢性伤口，这给全球医疗系统带来了沉重负担。SOC治疗已普遍应用于慢性伤口的管理，但仅靠SOC可能不足以有效治愈所有溃疡。鱼皮移植（FSG）是一种可用于加速皮肤愈合的异种皮肤替代物。本研究旨在评估FSG作为SOC辅助治疗慢性溃疡的有效性。

方法

两位作者独立检索了以下电子数据库：PubMed、Embase和CENTRAL，使用的关键词包括“糖尿病足溃疡”“鱼皮移植”和“伤口愈合”。本荟萃分析纳入了评估FSG治疗慢性溃疡临床结局的临床研究。根据异质性检验结果（即I²）进行随机或固定效应模型的荟萃分析，以分析FSG的临床结局。

结果

定性合成和荟萃分析共纳入8项研究，其中145例患者接受SOC治疗，245例患者接受SOC加FSG治疗。两组之间的愈合时间无显著差异（MD = 1.99，95%CI：-3.70至7.67，p = 0.493）。与单独使用SOC相比，FSG组的完全愈合率显著更高（OR = 3.44，95%CI：2.03至5.82，p < 0.001***）。六项研究报告了平均面积缩小百分比（PAR），范围为71.6%至97.3%。然而，这些研究中的许多未报告标准差（SD）值，因此我们无法汇总数据。两组之间的溃疡复发率（RR = 0.60，95%CI：0.07至5.27，p = 0.645）和严重不良事件（SAEs）风险（RR = 1.67，95%CI：0.42至6.61，p = 0.467）无显著差异。