Banerjee Jaideep, Lasiter Andrew, Nherera Leo
Smith & Nephew, Fort Worth, Texas, USA.
Adv Wound Care (New Rochelle). 2024 Dec;13(12):639-651. doi: 10.1089/wound.2023.0075. Epub 2024 Jul 10.
This Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant review focuses on the efficacy of cellular, acellular, and matrix-like products (CAMPs) in the management of diabetic foot ulcers (DFUs) based on published randomized controlled trials (RCTs). Although CAMPs have been incorporated into the clinical algorithm for chronic wounds, evidence is lacking to comparatively evaluate the efficacy of these products. Level 1 RCT studies are the gold standard to evaluate the efficacy of different treatment approaches; however, due to differences in surgical techniques, patient demographics, and compliance, standard-of-care (SOC) outcomes in the wound care space can vary significantly between different RCTs, making it difficult to compare them against each other. To mitigate variability between different RCTs, wound closure outcomes can be reported as risk ratios (RRs). This review of all the currently published RCTs (with a similar trial design) in patients with DFU and RRs confirms that CAMPs adjunct to SOC result in statistically superior wound closure outcomes in DFUs, when compared with SOC alone, with a RR of 1.72 [1.56, 1.90], < 0.00001. Enough evidence is still lacking to determine a statistical difference between broad categories of cellular/acellular and amniotic/nonamniotic CAMPs, and hence, decision makers should consider published head-to-head comparative studies, real-world evidence, and cost-effectiveness evidence between individual CAMPs to decide on which to use in practice.
本系统评价和Meta分析采用首选报告项目(PRISMA)规范,基于已发表的随机对照试验(RCT),聚焦于细胞、无细胞和类基质产品(CAMPs)在糖尿病足溃疡(DFUs)治疗中的疗效。尽管CAMPs已被纳入慢性伤口的临床治疗方案,但缺乏对这些产品疗效进行比较评估的证据。一级RCT研究是评估不同治疗方法疗效的金标准;然而,由于手术技术、患者人口统计学特征和依从性的差异,不同RCT之间伤口护理领域的标准治疗(SOC)结果可能存在显著差异,难以相互比较。为减少不同RCT之间的变异性,伤口愈合结果可报告为风险比(RRs)。本对所有目前已发表的DFU患者RCT(具有相似试验设计)及RRs的综述证实,与单纯SOC相比,CAMPs辅助SOC在DFUs中能产生统计学上更优的伤口愈合结果,RR为1.72[1.56, 1.90],P<0.00001。仍缺乏足够证据来确定细胞/无细胞和羊膜/非羊膜CAMPs大类之间的统计学差异,因此,决策者应考虑已发表的各CAMPs之间的直接比较研究、真实世界证据和成本效益证据,以决定在实践中使用哪种产品。