Department of Endocrinology and Metabolism, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shantou 515041, China.
Shantou University Medical College, 22 Xinling Road, Shantou 515041, China.
J Diabetes Res. 2020 Feb 1;2020:6245758. doi: 10.1155/2020/6245758. eCollection 2020.
Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies. The clinical effects of AM therapy were not well established. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to examine the efficacy and safety of AM therapy for patients with DFUs.
A literature search of 5 databases was performed to identify RCTs comparing AM therapy to standard therapy (ST) in patients with DFUs. The primary outcome was the complete healing rate and the secondary outcomes mainly included time to complete healing and adverse events.
Nine RCTs involving 897 patients were included. Compared with ST group, patients allocated to AM group had a higher complete healing rate both at 12 weeks (risk ratio (RR) = 1.73, 95% confidence interval (CI): 1.31 to 2.30) and 16 weeks (RR = 1.56, 95% CI: 1.28 to 1.91), a shorter time to complete healing (mean difference (MD) = -2.41; 95% CI: -3.49 to -1.32), and fewer adverse events (RR = 0.64, 95% CI: 0.44 to 0.93).
The present study suggests that AM therapy as an adjuvant treatment could further promote the healing of full-thickness, noninfected, and nonischemia DFUs. AM therapy also has a safety profile. More large well-designed randomized clinical trials with long follow-up duration are needed to further explore the efficacy and safety of AM therapy for DFUs.
脱细胞基质 (AM) 疗法在多项研究中已显示出治疗糖尿病足溃疡 (DFUs) 的潜力。然而，AM 疗法的临床疗效尚未得到充分证实。因此，我们进行了一项荟萃分析，旨在评估 AM 疗法治疗 DFUs 患者的疗效和安全性。
我们对 5 个数据库进行了文献检索，以确定比较 AM 疗法与标准疗法 (ST) 治疗 DFUs 患者的随机对照试验 (RCT)。主要结局为完全愈合率，次要结局主要包括愈合时间和不良事件。
纳入了 9 项 RCT，共 897 例患者。与 ST 组相比，AM 组在 12 周（风险比 (RR) = 1.73，95%置信区间 (CI)：1.31 至 2.30）和 16 周（RR = 1.56，95% CI：1.28 至 1.91）时的完全愈合率更高，愈合时间更短（均数差 (MD) = -2.41；95% CI：-3.49 至 -1.32），不良事件更少（RR = 0.64，95% CI：0.44 至 0.93）。
本研究表明，AM 疗法作为辅助治疗可进一步促进全层、非感染、非缺血性 DFUs 的愈合。AM 疗法具有良好的安全性。需要更多设计良好、随访时间长的大型随机对照临床试验来进一步探讨 AM 疗法治疗 DFUs 的疗效和安全性。
