Acellular dermis

无细胞真皮
  • DOI:
    文章类型: Journal Article
    背景:下肢静脉溃疡(VLU)是下肢最常见的慢性伤口类型,通常与发红有关,肿胀,伤口部位疼痛。VLU治疗的主要重点是通过压缩疗法促进伤口愈合,伤口清创术,以及患肢的抬高。脱细胞基质已成为糖尿病足溃疡伤口愈合的潜在辅助手段。然而,无细胞产品在VLU设置中的临床效果尚未得到很好的报道。
    目的:回顾已发表的关于在VLU管理中使用无细胞产品的证据。
    方法:PubMed,Embase,科克伦,和GoogleScholar数据库最初于2023年3月2日搜索有关VLU和脱细胞真皮基质的文献。稍后,搜索范围扩大到包括任何和所有无细胞基质,2024年2月20日对相同数据库进行了二次搜索.还包括通过抵押品方法获得的物品。
    结果:共确定了27篇文章供审查。所有研究都是人体研究。四篇有一级证据,七篇有二级证据,而其余的文章有三级或四级证据。研究包括大小为0.5cm²至100cm2的大型和小型伤口。产品应用每周一次至两次,持续4周至36个月。总的来说,不管溃疡大小,大多数研究报告,使用多种脱细胞皮肤覆盖产品,伤口愈合效果良好,并发症少.一些研究还报道了在一小部分患者中使用无细胞皮肤替代品减轻疼痛。
    结论:脱细胞产物似乎具有支持VLU愈合的潜力。然而,需要更多提供I级证据的大规模随机对照试验.
    Venous leg ulcers (VLUs) are the most common type of chronic wound in the lower extremity and are often associated with redness, swelling, and pain at the site of the wound. The primary focus of VLU treatment is the promotion of wound healing through compression therapy, wound debridement, and elevation of the affected limb. Acellular matrices have gained traction as a potential adjunct to wound healing in diabetic foot ulcers. However, the clinical effect of acellular products in the setting of VLUs has not been well reported.
    To review the published evidence on the use of acellular products in the management of VLUs.
    PubMed, Embase, Cochrane, and Google Scholar databases were initially searched on March 2, 2023, for literature on VLU and acellular dermal matrix. Later, the search was broadened to include any and all acellular matrices, and a secondary search of the same databases was conducted on February 20, 2024. Articles obtained through collateral methods were also included.
    A total of 27 articles were identified for review. All studies were human studies. Four articles had level I evidence and 7 articles had level II evidence, while the remaining articles had level III or IV evidence. Studies included both large and small wound sizes ranging from 0.5 cm² to 100 cm2. Product application occurred once to twice weekly for 4 weeks to up to 36 months. Overall, regardless of ulcer size, the majority of studies reported favorable wound healing outcomes with the use of a variety of acellular skin coverage products with few complications. Some studies also reported pain reduction with the use of acellular skin substitutes in a small cohort of patients.
    Acellular products appear to have the potential to support healing in VLUs. However, more large-scale randomized controlled trials that provide level I evidence are needed.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    目的:我们的主要目的是综合现有数据,评估不同网状材料在预防性网状物放置中的有效性,并根据造口旁疝(PSH)和其他造口并发症的发生率对这些材料进行排序。
    方法:该网络荟萃分析根据系统评价和荟萃分析声明的首选报告项目进行了系统评价和荟萃分析。在四个数据库中搜索了预防性网状物放置的随机对照试验。汇总结果在贝叶斯分层随机效应模型的STATA例程中进行。
    结果:来自1203篇文章的13项随机对照试验,符合纳入标准,包括681个没有网格的案例,异种脱细胞真皮网状材料65例(猪/牛),27例聚丙烯/PG910,114例聚丙烯/聚glecaprone(Monocryl),117例聚丙烯/纤维素(ORC),233箱聚丙烯,和35例聚丙烯/PVDF。在网络A中,与没有网格相比,只有聚丙烯(RR0.24,95%CI0.04-0.80)与PSH发生率降低显著相关.在网络B中,网状物和无网状物之间在造口并发症方面未发现统计学差异。
    结论:基于网络荟萃分析和排名结果,聚丙烯网眼材料表现出最好的性能。然而,这一结论需要用更大的样本量和高质量的随机对照试验来证实.
    OBJECTIVE: We primary aimed to synthesise the available data, assess the effectiveness of different mesh materials in prophylactic mesh placement, and rank these materials according to the incidence of parastomal hernia (PSH) and other stoma complications.
    METHODS: This network meta-analysis performed a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Four databases were searched for randomised controlled trials of prophylactic mesh placement. The aggregated results were performed in the STATA routine for Bayesian hierarchical random effects models.
    RESULTS: Thirteen randomised controlled trials from 1203 articles, met the inclusion criteria, including 681 cases without meshes, 65 cases with mesh material of xenogeneic acellular dermis (porcine/bovine), 27 cases with polypropylene/PG910, 114 cases with polypropylene/polyglecaprone (Monocryl), 117 cases with polypropylene/cellulose (ORC), 233 cases with polypropylene, and 35 cases with polypropylene/PVDF. In network A, compared with no mesh, only polypropylene (RR 0.24, 95% CI 0.04-0.80) were significantly associated with a reduction in the incidence of PSH. In network B, no statistical difference regarding stoma complications was found between mesh and no mesh.
    CONCLUSIONS: Based on the network meta-analysis and ranking results, the polypropylene mesh material exhibited the best performance. However, this conclusion needs to be confirmed with larger sample sizes and high-quality randomised controlled trials.
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  • 文章类型: Journal Article
    背景:乳腺癌是英国女性中最常见的恶性肿瘤。乳房切除术后,重建现在是乳腺癌手术治疗不可或缺的一部分,其中基于植入物的重建(IBBR)是最常见的类型。由于并发症,IBBR最初从胸前发展到胸后,但是随着肿瘤发生技术和新植入技术的发展,对胸前IBBR的兴趣有所增加。许多外科医生使用无细胞真皮基质(ADM);然而,文献中很少有证据表明这是否能改善并发症方面的手术结果,失败和患者满意度。这篇综述旨在评估使用ADM和不使用ADM的乳房重建手术结果是否存在差异的现有证据。
    方法:将使用OvidMEDLINE进行数据库搜索,Embase,Cochrane中央控制试验登记册,Cochrane系统评价和临床试验数据库。org。搜索时间为10年。研究将使用纳入和排除标准进行筛选,并将数据提取到标准化电子表格中。将评估偏差的风险。筛选,提取和偏见风险评估将由两名审阅者独立进行,并讨论和纠正差异。数据分析和荟萃分析将使用MicrosoftExcel和R软件进行。森林地块将用于双臂研究,以计算总体效果的异质性和p值。
    结论:随着胸前IBBR的复兴,重要的是,外科医生有足够的证据来协助手术决策.评估文献中的证据对于帮助外科医生确定与不使用ADM相比,使用ADM进行IBBR是否有益非常重要。这对患者并发症有潜在影响,医疗信托的满意度和成本。
    背景:PROSPERO2023CRD42023389072。
    BACKGROUND: Breast cancer is the most common malignancy among women in the UK. Following mastectomy, reconstruction is now integral to the surgical management of breast cancer, of which implant-based reconstruction (IBBR) is the most common type. IBBR initially evolved from pre-pectoral to post-pectoral due to complications, but with developments in oncoplastic techniques and new implant technology, interest in pre-pectoral IBBR has increased. Many surgeons use acellular dermal matrices (ADM); however, there is little evidence in literature as to whether this improves surgical outcomes in terms of complications, failure and patient satisfaction. This review aims to assess the available evidence as to whether there is a difference in surgical outcomes for breast reconstructions using ADM versus non-use of ADM.
    METHODS: A database search will be performed using Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and Clinicaltrials.org. The search timeframe will be 10 years. Studies will be screened using inclusion and exclusion criteria and data extracted into a standardised spreadsheet. Risk of bias will be assessed. Screening, extraction and risk-of-bias assessments will be performed independently by two reviewers and discrepancies discussed and rectified. Data analysis and meta-analysis will be performed using Microsoft Excel and R software. Forest plots will be used for two-arm studies to calculate heterogeneity and p-value for overall effect.
    CONCLUSIONS: With the renaissance of pre-pectoral IBBR, it is important that surgeons have adequate evidence available to assist operative decision-making. Assessing evidence in literature is important to help surgeons determine whether using ADM for IBBR is beneficial compared to non-use of ADM. This has potential impacts for patient complications, satisfaction and cost to healthcare trusts.
    BACKGROUND: PROSPERO 2023 CRD42023389072.
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  • 文章类型: Journal Article
    完全可吸收网可以修复腹壁缺损,有效降低并发症的发生率。但不同类型的完全可吸收网有不同的重塑和再生效果。为了研究和比较不同完全可吸收网状物对动物重塑和再生的影响,降低临床转化的生物学风险,采用SYRCLE评估纳入研究的方法学质量,采用GRADE和ConQual对证据质量进行评价。根据纳入和排除标准,本系统综述共纳入了22项与完全可吸收网状物相关的研究.这些结果表明,纤维基合成材料和纤维基天然材料表现出更好的修复和再生效果,通过渗透和新生血管形成表明,与猪脱细胞真皮基质相比。此外,与猪脱细胞真皮基质相比,发现人脱细胞真皮基质对宿主细胞外基质和支架降解具有相似的再生作用,猪肠粘膜下层,和纤维基天然材料,但它提供了比其他三个更高的抗拉强度。该领域的证据质量较差。分析了降级的原因,对未来研究的建议包括更严格的研究设计,提高结果报告的透明度,更多的动物模型标准化和随访时间,以更好地评价腹壁疝修补术的重塑和再生性能,临床翻译中的生物学风险较小。
    Fully absorbable meshes can repair abdominal wall defects and effectively reduce the incidence of complications, but different types of fully absorbable meshes have different remodeling and regeneration effects. In order to investigate and compare the effects of different fully absorbable meshes on remodeling and regeneration in animals and reduce the biological risk of clinical translation, SYRCLE was adopted to evaluate the methodological quality of the included studies, and GRADE and ConQual were used to evaluate the quality of evidence. According to the inclusion and exclusion criteria, a total of 22 studies related to fully absorbable meshes were included in this systematic review. These results showed that fiber-based synthetic materials and fiber-based natural materials exhibited better restorative and regenerative effects indicated by infiltration and neovascularization, when compared with a porcine acellular dermal matrix. In addition, the human acellular dermal matrix was found to have a similar regenerative effect on the host extracellular matrix and scaffold degradation compared to the porcine acellular dermal matrix, porcine intestinal submucosa, and fiber-based natural materials, but it offered higher tensile strength than the other three. The quality of the evidence in this field was found to be poor. The reasons for downgrading were analyzed, and recommendations for future research included more rigor in study design, more transparency in result reporting, more standardization of animal models and follow-up time for better evaluation of the remodeling and regenerative performance of abdominal wall hernia repair meshes, and less biological risk in clinical translation.
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  • 文章类型: Systematic Review
    目的:本综述的主要目的是比较自体软组织移植物(结缔组织移植物-CTG和游离牙龈移植物-FGG)与不同类型的基质(无细胞真皮基质-ADM,异种移植胶原基质-XCM,体积稳定的胶原基质-VCMX)用于增加植入物周围的软组织。
    方法:对电子数据库进行搜索,以确定随机和非随机对照试验(RCT和CCT,分别)具有平行或分口设计,治疗≥10名患者。网络荟萃分析(NMA)用于比较不同的矩阵。软组织厚度尺寸变化和角化宽度(KMW)变化是主要结果指标。次要结果是评估:a)PROM;b)体积变化;c)外科手术时间;和d)不同的牙周测量。
    结果:共23项研究纳入定性分析,定量分析中的16项研究(11项RCT和5项CCT)。针对NMA评估了总共N=573个位点。CTG是增加种植体周围软组织厚度的最佳材料,在手术后180和360天。使用ADM显示出口腔厚度增加的良好结果,主要是在手术后的前三个月。前庭成形术+FGG导致最有效的植入物周围KMW增强技术,180天后。
    结论:虽然CTG在所有比较中显示出更好的性能,而FGG显示出最佳的移植物,以增加角化粘膜长达90天,ADM和VCMX可用于增加软组织水平厚度,降低患者发病率。
    结论:该NMA的限制如下:a)纳入研究的数量有限;b)它们之间的高度异质性(患者人数,治疗部位,外科技术,结果衡量标准,和后续行动)。
    结论:许多研究比较了自体和非自体移植在牙龈厚度方面的疗效,volume,角化宽度增加。然而,关于这个主题仍然没有明确的总体证据。这种NMA帮助临床医生在不同的种植体周围软组织手术中选择正确的材料。未来研究的建议是强制性的。
    OBJECTIVE: The primary objective of this review is to compare autogenous soft tissue grafts (connective tissue graft - CTG and free gingival graft-FGG) with different type of matrices (acellular dermal matrix-ADM, xenograft collagen matrix-XCM, volume-stable collagen matrix-VCMX) used to increase peri-implant soft tissues.
    METHODS: A search on electronic databases was performed to identify randomized and non-randomized controlled trials (RCTs and CCTs, respectively) with either parallel or split-mouth design, and treating ≥ 10 patients. A network meta-analysis (NMA) was used to compare different matrices. Soft tissue thickness dimensional changes and keratinized width (KMW) changes were the primary outcome measures. The secondary outcomes were to evaluate: a) PROMs; b) volumetric changes; c) surgical operating time; and d) different periodontal measurements.
    RESULTS: A total of 23 studies were included in the qualitative analysis, and 16 studies (11 RCTs and 5 CCTs) in the quantitative analysis. A total of N = 573 sites were evaluated for NMA. CTG resulted the best material for increasing peri-implant soft tissue thickness, at 180 and 360 days after surgery. The use of an ADM showed good results for buccal thickness increase, primarily in the first three months after surgery. Vestibuloplasty + FGG resulted in the most effective technique for peri-implant KMW augmentation, after 180 days.
    CONCLUSIONS: While CTG demonstrated better performance in all the comparison and FGG showed to be the best graft to increase keratinized mucosa up to 90 days, ADM and VCMX may be used to increase soft tissue horizontal thickness with lower patients\' morbidity.
    CONCLUSIONS: The limits of this NMA are the following: a) limited number of included studies; b) high heterogeneity among them (number of patients, treatment sites, surgical techniques, outcome measures, and follow-ups).
    CONCLUSIONS: Many studies compared the efficacy of autogenous and non-autogenous grafts in terms of gingival thickness, volume, and keratinized width increase. However, there is still not clear overall evidence on this topic. This NMA helps clinicians to choose the right material in different peri-implant soft tissue procedures. Recommendations for future studies are mandatory.
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  • 文章类型: Systematic Review
    背景:脱细胞真皮基质(ADM)通常用于整形和重建手术。随着大量随机对照试验(RCT)报告ADM结果的P值,这项研究使用了脆弱性指数(FI),反向脆弱性指数(rFI),和脆弱商(FQ)评估ADM随机对照试验结果的统计稳定性。
    方法:PubMed,Embase,Scopus,Medline,和Cochrane数据库对ADMRCTs(2003年至今)进行了审查,报告了二分法,明确的结果。计算FI和rFI(影响结果显著性的事件逆转)和FQ(标准化脆性)并报告为中位数。根据干预类型进行亚组分析。
    结果:在筛选的127项研究中,纳入56项RCTs,579项结果。中位数FI为4(3-5),FQ为0.04(0.03-0.07)。只有101个结果具有统计学意义,中位FI为3(1-6),FQ为0.04(0.02-0.08)。无显著性结局的中位FI为4(3-5),FQ为0.04(0.03-0.07)。值得注意的是,26%的结果有几名患者失去了等于或超过FI的随访。根据干预类型,中位数FIs表现出轻微波动,但仍然很低。
    结论:ADM相关随机对照试验的结果在统计学上是脆弱的。轻微的结果逆转或患者随访的维持可以改变结果的重要性。因此,建议未来的研究人员联合报告FI,FQ,和P值,以全面了解ADM文献中的稳健性。
    BACKGROUND: Acellular dermal matrix (ADM) is commonly used in plastic and reconstructive surgery. With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of the outcomes in ADM RCTs.
    METHODS: PubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median. Subgroup analysis was performed based on intervention types.
    RESULTS: Among the 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3-5) and FQ was 0.04 (0.03-0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1-6) and FQ of 0.04 (0.02-0.08). The nonsignificant outcomes had a median FI of 4 (3-5) and FQ of 0.04 (0.03-0.07). Notably, 26% of the outcomes had several patients lost to follow up equal to or surpassing the FI. Based on the intervention type, the median FIs showed minor fluctuations but remained low.
    CONCLUSIONS: Outcomes from ADM-related RCTs were statistically fragile. Slight outcome reversals or maintenance of patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.
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  • 文章类型: Review
    脱细胞真皮基质(ADMs)是生物工程组织,可以在乳房重建中提供免疫惰性支架。由于有关ADM成像特征的文献有限,放射科医生必须意识到ADM的常见成像外观,区分正常构象与残留或复发疾病。我们的目的是回顾ADM在基于植入物的乳房重建中的当前作用,描述超声的正常成像结果,乳房X线照相术,MRI也考虑了随时间的可能变化。在这篇图片文章中,我们回顾了文献中描述的ADM的影像学特征,并报道了我们在接受人或动物ADM重建手术治疗新诊断乳腺癌的患者中的经验.
    Acellular dermal matrices (ADMs) are biological engineered tissues, which may provide an immunologically inert scaffold in breast reconstruction. Since the literature on imaging features of ADMs is limited, radiologists must be aware of the common imaging appearances of ADM, to differentiate normal conformation from residual or recurrent disease. Our purpose is to review the current role of ADMs in implant-based breast reconstruction, describing the normal imaging findings at ultrasound, mammography, and MRI also considering the possible changes over time. In this pictorial essay, we reviewed imaging features of ADMs described in the literature and we reported our experience in patients who underwent reconstructive surgery with human or animal ADM for newly diagnosed breast cancer.
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  • 文章类型: Meta-Analysis
    目的:本研究旨在比较无细胞异种真皮基质移植物(AXDM)与结缔组织移植物(CTG)治疗多发性牙龈凹陷的疗效。
    方法:对电子数据库进行系统检索,以确定比较AXDM和CTG的随机临床试验(RCT)。选定的研究进行了偏倚风险评估,数据提取,和荟萃分析。参数,如牙龈后退高度,宽度,根覆盖率的平均百分比,并分析了完全的根系覆盖率。
    结果:共纳入了146例患者的7个随机对照试验。荟萃分析表明,在最终随访时,CTG在降低牙龈后退高度方面在统计学上优于AXDM(平均差异:-0.104mm,95%置信区间[CI]:-0.180-0.028,p=0.008)和最终随访时的宽度(平均差:-0.285mm,95%CI:-0.541-0.030,p=0.029)。在6个月的随访中,CTG还显示出明显更高的平均根覆盖率(平均值差异:-2.761mm,与AXDM相比,95%CI:-4.932-0.590,p=0.013)和6个月随访时完全根覆盖率更高(比值比[OR]:0.598,95%CI:0.4-0.892,p=0.012)。然而,CTG和AXDM之间完全牙根覆盖的牙齿数量(OR:1.610,95%CI:0.983-2.636,p=0.058)和美学结果(平均差:0.148,95%CI:-0.277-0.573,p=0.494)没有显着差异。
    结论:CTG比AXDM更有效地治疗多发性牙龈凹陷。牙龈凹陷高度和宽度的显著减少证明了这一点,根覆盖率的平均百分比更高,在6个月的随访中,完全根目录覆盖率更高。
    结论:在某些临床情况下,需要CTG的替代方法来治疗多发性牙龈凹陷。AXDM,尽管临床结果不如CTG令人满意,可以用于此目的。
    OBJECTIVE: This study aimed to compare the efficacy of acellular xenogeneic dermal matrix graft (AXDM) compared to connective tissue graft (CTG) in treating multiple gingival recessions.
    METHODS: A systematic search of electronic databases was conducted to identify randomized clinical trials (RCTs) that compared AXDM and CTG. The selected studies were subjected to bias risk assessment, data extraction, and meta-analyses. Parameters such as gingival recession height, width, mean percentage of root coverage, and complete root coverage were analyzed.
    RESULTS: Seven RCTs involving 146 patients were included. The meta-analyses indicated that CTG was statistically superior to AXDM in reducing gingival recession height at the final follow-up (mean difference: -0.104 mm, 95% confidence interval [CI]: -0.180-0.028, p = 0.008) and width at the final follow-up (mean difference: -0.285 mm, 95% CI: -0.541-0.030, p = 0.029). CTG also demonstrated a significantly higher mean percentage of root coverage at the 6-month follow-up (difference in means: -2.761 mm, 95% CI: -4.932-0.590, p = 0.013) and a higher percentage of complete root coverage at the 6-month follow-up (odds Ratio [OR]: 0.598, 95% CI: 0.4-0.892, p = 0.012) compared to AXDM. However, there was no significant difference in the number of teeth with complete root coverage between CTG and AXDM (OR: 1.610, 95% CI: 0.983-2.636, p = 0.058) and aesthetic outcomes (mean difference: 0.148, 95% CI: -0.277-0.573, p = 0.494).
    CONCLUSIONS: CTG is more effective than AXDM in treating multiple gingival recessions. This is evidenced by significant reductions in gingival recession height and width, a higher mean percentage of root coverage, and a greater percentage of complete root coverage at the 6-month follow-up.
    CONCLUSIONS: In some clinical situations an alternative to CTG is required for the treatment of multiple gingival recessions. AXDM, despite presenting clinical outcomes that are not as satisfactory as CTG, can be used for this purpose.
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  • 文章类型: Meta-Analysis
    背景:糖尿病足溃疡(DFU)已成为全球健康问题,这可能导致糖尿病足感染(DFI),小腿截肢,甚至死亡率。尽管护理标准(SOC)实践已被公认为DFU护理的“黄金标准”,仅SOC可能不足以治愈所有DFU并防止其复发。真皮基质的使用已成为增强DFU愈合的辅助治疗。本研究旨在评估真皮基质应用作为SOC辅助治疗的有效性和安全性。
    方法:PubMed的数据库,Embase和CENTRAL由两名作者独立搜索,具有以下关键术语:“糖尿病足溃疡”,“脱细胞真皮基质”,“伤口愈合”,等等。随机对照试验(RCT)评估了真皮基质在治疗DFU中的有效性和安全性。分析的主要结果包括最终随访时的完全愈合时间和完全愈合率,而次要结果包括伤口面积,溃疡复发率,截肢风险和并发症风险。使用随机效应或固定效应模型进行荟萃分析,基于异质性检验。
    结果:本研究共包括15个随机对照试验,共1524名受试者。其中,689例患者仅接受SOC治疗,835例患者接受SOC加真皮基质治疗。与SOC组相比,真皮基质组达到完全愈合所需的时间明显缩短(MD=2.84,95CI:1.37~4.32,p<0.001***)。与SOC组相比,真皮基质组的完全愈合率(OR=0.40,95CI:0.33〜0.49,p<0.001***)和总体(RR=1.83,95CI:1.15〜2.93,p=0.011*)和主要(RR=2.64,95CI:1.30〜5.36,p=0.007**)明显较低。伤口面积无明显差异,溃疡复发率,两组之间的并发症风险。
    结论:与单纯使用SOC相比,真皮基质作为辅助疗法与SOC联合应用可有效改善DFU的愈合过程并降低截肢风险。此外,受试者对真皮基质应用的耐受性良好,无增加的并发症风险.
    BACKGROUND: Diabetic foot ulcers (DFUs) have become a global health concern, which can lead to diabetic foot infection (DFI), lower leg amputation, and even mortality. Though the standard of care (SOC) practices have been recognized as the \"gold standard\" for DFU care, SOC alone may not be adequate to heal all DFUs and prevent their recurrence. The use of dermal matrix has emerged as an adjuvant treatment to enhance DFU healing. The current study aimed to evaluate the effectiveness and safety of dermal matrix application as an adjuvant treatment to the SOC.
    METHODS: The databases of PubMed, Embase and CENTRAL were independently searched by two authors, with the following key terms: \"diabetic foot ulcer\", \"acellular dermal matrix\", \"wound healing\", and so on. Randomized controlled trials (RCTs) evaluated the efficacy and safety of dermal matrix in the treatment of DFUs were eligible for inclusion. The primary outcomes analyzed included time to complete healing and complete healing rate at the final follow-up, while secondary outcomes included wound area, ulcer recurrence rate, amputation risk and complication risk. Meta-analyses were performed using random-effect or fixed-effect models, based on the heterogeneity test.
    RESULTS: This study included a total of 15 RCTs with a total of 1524 subjects. Of these, 689 patients were treated with SOC alone, while 835 patients received SOC plus dermal matrix. Compared to the SOC group, significantly shorter time (MD = 2.84, 95%CI: 1.37 ~ 4.32, p < 0.001***) was required to achieve complete healing in dermal matrix group. Significantly higher complete healing rate (OR = 0.40, 95%CI: 0.33 ~ 0.49, p < 0.001***) and lower overall (RR = 1.83, 95%CI: 1.15 ~ 2.93, p = 0.011*) and major (RR = 2.64, 95%CI: 1.30 ~ 5.36, p = 0.007**) amputation risks were achieved in dermal matrix group compared to SOC group. No significant difference was found in the wound area, ulcer recurrence rate, and complication risk between the two groups.
    CONCLUSIONS: The application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation risk when compared to SOC alone. Furthermore, dermal matrix application was well tolerated by the subjects with no added complication risk.
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