Abstract：
OBJECTIVE: This study aimed to assess the effectiveness of ozone therapy in treating Diabetes-related Foot Ulcer (DFU) and its outcomes.
METHODS: A systematic search was conducted in PubMed/MEDLINE, Scopus, Web of Science, and ProQuest databases for published studies evaluating the use of ozone as an adjunct treatment for DFU, from inception to December 21, 2022. The primary outcome measure was the change in wound size after the intervention compared to pretreatment. Secondary outcomes included time to complete ulcer healing, number of healed patients, adverse events, amputation rates, and hospital length of stay. Quantitative data synthesis for the meta-analysis was performed using a random-effects model and generic inverse variance method, while overall heterogeneity analysis was conducted using a fixed-effects model. Interstudy heterogeneity was assessed using the I2 index (<50%) and the Cochrane Q statistic test. Sensitivity analysis was performed using the leave-one-out method.
RESULTS: The meta-analysis included 11 studies comprising 960 patients with DFU. The results demonstrated a significant positive effect of ozone therapy on reducing foot ulcer size (Standardized Mean Difference (SMD): -25.84, 95% CI: -51.65 to -0.04, p = 0.05), shortening mean healing time (SMD: -38.59, 95% CI: -51.81 to -25.37, p < 0.001), decreasing hospital length of stay (SMD: -8.75, 95% CI: -14.81 to -2.69, p < 0.001), and reducing amputation rates (Relative Risk (RR): 0.46, 95% CI: 0.30-0.71, p < 0.001), compared to standard treatment.
CONCLUSIONS: This meta-analysis indicates that ozone therapy has additional benefits in expediting complete DFU healing, reducing the amputation rates, and decreasing hospital length of stay, though its effects do not differ from standard treatments for complete ulcer resolution. Further research is needed to address the heterogeneity among studies and to better understand the potential beneficial effects of ozone therapy.
METHODS: A systematic search was conducted in PubMed/MEDLINE, Scopus, Web of Science, and ProQuest databases for published studies evaluating the use of ozone as an adjunct treatment for DFU, from inception to December 21, 2022. The primary outcome measure was the change in wound size after the intervention compared to pretreatment. Secondary outcomes included time to complete ulcer healing, number of healed patients, adverse events, amputation rates, and hospital length of stay. Quantitative data synthesis for the meta-analysis was performed using a random-effects model and generic inverse variance method, while overall heterogeneity analysis was conducted using a fixed-effects model. Interstudy heterogeneity was assessed using the I2 index (<50%) and the Cochrane Q statistic test. Sensitivity analysis was performed using the leave-one-out method.
RESULTS: The meta-analysis included 11 studies comprising 960 patients with DFU. The results demonstrated a significant positive effect of ozone therapy on reducing foot ulcer size (Standardized Mean Difference (SMD): -25.84, 95% CI: -51.65 to -0.04, p = 0.05), shortening mean healing time (SMD: -38.59, 95% CI: -51.81 to -25.37, p < 0.001), decreasing hospital length of stay (SMD: -8.75, 95% CI: -14.81 to -2.69, p < 0.001), and reducing amputation rates (Relative Risk (RR): 0.46, 95% CI: 0.30-0.71, p < 0.001), compared to standard treatment.
CONCLUSIONS: This meta-analysis indicates that ozone therapy has additional benefits in expediting complete DFU healing, reducing the amputation rates, and decreasing hospital length of stay, though its effects do not differ from standard treatments for complete ulcer resolution. Further research is needed to address the heterogeneity among studies and to better understand the potential beneficial effects of ozone therapy.
摘要：
目的：本研究旨在评估臭氧疗法治疗糖尿病相关足部溃疡（DFU）的有效性及其结果。
方法：在PubMed/MEDLINE中进行了系统搜索，Scopus,WebofScience,和ProQuest数据库，用于评估将臭氧用作DFU的辅助治疗的已发表研究，从成立到2022年12月21日。主要结果指标是与预处理相比，干预后伤口大小的变化。次要结果包括溃疡完全愈合的时间，治愈的患者数量，不良事件,截肢率,和住院时间。使用随机效应模型和通用逆方差方法进行荟萃分析的定量数据合成，而总体异质性分析是使用固定效应模型进行的。使用I2指数（<50％）和CochraneQ统计检验评估研究间异质性。使用留一法进行敏感性分析。
结果：荟萃分析包括11项研究，包括960名DFU患者。结果表明，臭氧治疗对减少足部溃疡大小具有显著的积极作用（标准化平均差（SMD）：-25.84，95％CI：-51.65至-0.04，p=0.05），缩短平均愈合时间（SMD：-38.59，95％CI：-51.81至-25.37，p<0.001），住院时间缩短（SMD：-8.75，95%CI：-14.81至-2.69，p<0.001），并降低截肢率（相对风险（RR）：0.46，95％CI：0.30-0.71，p<0.001），与标准治疗相比。
结论：这项荟萃分析表明，臭氧疗法在加速DFU完全愈合方面具有额外的益处，降低截肢率，减少住院时间，尽管其效果与完全溃疡消退的标准治疗方法没有区别。需要进一步的研究来解决研究之间的异质性，并更好地了解臭氧治疗的潜在有益影响。
方法：在PubMed/MEDLINE中进行了系统搜索，Scopus,WebofScience,和ProQuest数据库，用于评估将臭氧用作DFU的辅助治疗的已发表研究，从成立到2022年12月21日。主要结果指标是与预处理相比，干预后伤口大小的变化。次要结果包括溃疡完全愈合的时间，治愈的患者数量，不良事件,截肢率,和住院时间。使用随机效应模型和通用逆方差方法进行荟萃分析的定量数据合成，而总体异质性分析是使用固定效应模型进行的。使用I2指数（<50％）和CochraneQ统计检验评估研究间异质性。使用留一法进行敏感性分析。
结果：荟萃分析包括11项研究，包括960名DFU患者。结果表明，臭氧治疗对减少足部溃疡大小具有显著的积极作用（标准化平均差（SMD）：-25.84，95％CI：-51.65至-0.04，p=0.05），缩短平均愈合时间（SMD：-38.59，95％CI：-51.81至-25.37，p<0.001），住院时间缩短（SMD：-8.75，95%CI：-14.81至-2.69，p<0.001），并降低截肢率（相对风险（RR）：0.46，95％CI：0.30-0.71，p<0.001），与标准治疗相比。
结论：这项荟萃分析表明，臭氧疗法在加速DFU完全愈合方面具有额外的益处，降低截肢率，减少住院时间，尽管其效果与完全溃疡消退的标准治疗方法没有区别。需要进一步的研究来解决研究之间的异质性，并更好地了解臭氧治疗的潜在有益影响。
