Laurent Irakoze, Astère Manirakiza, Wang Kan Ran, Cheng Qing-Feng, Li Qi Fu
Department of Endocrinology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Oncology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Diabetes Ther. 2017 Oct;8(5):967-979. doi: 10.1007/s13300-017-0298-8. Epub 2017 Sep 11.
Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. The objective of this study was to assess the efficacy and time sensitivity of human amnion/chorion membrane treatment in patients with chronic DFUs.
The Cochrane Library, PubMed, Embase and Web of Science databases were systematically searched to identify relevant articles up to 10 April 2017. All randomized controlled trials (RCTs) comparing human amnion/chorion membrane + standard therapy and standard therapy alone in patients with DFUs were included in the analysis. Eligible studies were reviewed and data extracted into standard form. The Cochrane Collaboration's tool for assessing the risk of bias was used. Review manager version 5.3 software was used for statistical analysis. Data were analyzed using a random effect model.
Overall, the initial search of the four databases identified 352 published studies; of these, seven RCTS were ultimately included in the meta-analysis. The overall test effect in the group assessed at 4 weeks was Z = 4.14 [P < 0.0001; odds ratio (OR) 0.05; 95% confidence interval (CI) 0.01-0.21]. The overall test effect in the group assessed at 6 weeks was Z = 4.28 (P < 0.0001; OR 0.07; 95% CI 0.02-0.23). The overall effect in the group assessed at 12 weeks was Z = 4.96 (P < 0.00001; OR 0.10; 95% CI 0.04-0.24. The results showed that patients receiving amniotic membrane + standard therapy had far fewer incomplete healing wounds than those receiving standard of care alone. Assessment of the wound healing state at 4 and 6 weeks revealed that the wound healing state was almost the same, but there was a net difference of wound healing state at 12 weeks.
Human amnion/chorion membrane + standard of care treatment heals DFUs significantly faster than standard of care alone. When using the amnion in patients with DFUs, the optimal times to assess progress in wound healing should be 4 and 12 weeks.
糖尿病足溃疡（DFUs）是复杂的慢性伤口，对患者的发病率、死亡率和生活质量有重大的长期影响。本研究的目的是评估人羊膜/绒毛膜治疗慢性糖尿病足溃疡患者的疗效和时间敏感性。
系统检索Cochrane图书馆、PubMed、Embase和Web of Science数据库，以识别截至2017年4月10日的相关文章。分析所有比较人羊膜/绒毛膜+标准治疗与单纯标准治疗的糖尿病足溃疡患者的随机对照试验（RCTs）。对符合条件的研究进行综述，并将数据提取为标准形式。使用Cochrane协作网的偏倚风险评估工具。使用Review Manager 5.3软件进行统计分析。采用随机效应模型分析数据。
总体而言，对四个数据库的初步检索共识别出352项已发表的研究；其中，七项随机对照试验最终纳入荟萃分析。在4周时评估的组中的总体检验效应为Z = 4.14 [P < 0.0001；比值比（OR）0.05；95%置信区间（CI）0.01 - 0.21]。在6周时评估的组中的总体检验效应为Z = 4.28（P < 0.0001；OR 0.07；95% CI 0.02 - 0.23）。在12周时评估的组中的总体效应为Z = 4.96（P < 0.00001；OR 0.10；95% CI 0.04 - 0.24）。结果表明，接受羊膜+标准治疗的患者未完全愈合的伤口比仅接受标准治疗的患者少得多。在4周和6周时对伤口愈合状态的评估显示，伤口愈合状态几乎相同，但在12周时伤口愈合状态存在净差异。
人羊膜/绒毛膜+标准治疗比单纯标准治疗能显著更快地治愈糖尿病足溃疡。在糖尿病足溃疡患者中使用羊膜时，评估伤口愈合进展的最佳时间应为4周和12周。
