目的:比较常用的卸载装置治疗糖尿病患者神经性足溃疡的有效性。进行此荟萃分析(MA)是为了回答意大利糖尿病足综合征指南中有关此主题的临床问题。
方法:目前的MA包括随机对照研究(持续时间>12周),糖尿病和未感染的神经性足溃疡患者:任何卸载装置与无卸载装置或常规鞋类;可移动卸载装置与不可移动卸载装置;外科手术与其他卸载方法。主要终点是溃疡愈合。
结果:共确认184项研究,18人被认为符合分析条件.我们发现:任何足底卸载,与没有足底卸载装置相比,与更高的溃疡愈合相关(MH-OR:3.13[1.08,9.11],p=0.04,I2=0%);总接触铸造或不可拆卸膝高助行器,与其他卸载设备相比,溃疡愈合率较高(MH-OR:2.64[1.43,4.89],p=0.002,I2=51%);与单独卸载装置相比,活动性溃疡的手术卸载与手术后卸载相结合可实现更高的溃疡愈合率(MH-OR:6.77[1.64,27.93],p=0.008,I2=0%)。
结论:任何足底卸载,与没有足底卸载装置相比,与较高的溃疡愈合率有关。完全接触铸造或不可拆卸膝盖高助行器,与其他卸载设备相比,是可取的。活动性溃疡的手术卸载,结合手术后卸载装置,与其他单独卸载设备相比,溃疡愈合率更高。有必要对更多的糖尿病神经性足溃疡患者进行进一步研究,并延长随访期。
OBJECTIVE: To compare the effectiveness of commonly used offloading devices for the treatment of neuropathic foot ulcers in patients with diabetes mellitus. This meta-analysis (MA) has been performed for giving an answer to clinical questions on this topic of the Italian guideline on diabetic foot syndrome.
METHODS: The present MA includes randomized controlled studies (duration > 12 weeks) comparing, in patients with diabetes mellitus and non-infected neuropathic foot ulcer: any offloading device vs either no
offloading device or conventional footwear; removable versus non-removable
offloading devices; surgical procedure vs other
offloading approaches. The primary endpoint was ulcer healing.
RESULTS: A total of 184 studies were identified, and 18 were considered eligible for the analysis. We found that: any plantar off-loading, when compared to the absence of plantar offloading device, is associated with a higher ulcer healing (MH-OR: 3.13 [1.08, 9.11], p = 0.04, I2 = 0%); total contact cast or nonremovable knee-high walker, compared to other offloading devices, had a higher ulcer healing rate (MH-OR: 2.64 [1.43, 4.89], p = 0.002, I2 = 51%); surgical offloading for active ulcers in combination with post-surgery offloading achieves higher ulcer healing rate when compared to offloading devices alone (MH-OR: 6.77 [1.64, 27.93], p = 0.008, I2 = 0%).
CONCLUSIONS: Any plantar
offloading, compared to the absence of plantar
offloading device, is associated with a higher ulcer healing rate. Total contact cast or nonremovable knee-high walker, compared to other offloading devices, is preferable. Surgical
offloading for active ulcers, in combination with post-surgery
offloading devices, achieves a higher ulcer healing rate when compared to other
offloading devices alone. Further studies with a larger cohort of patients with diabetic neuropathic foot ulcers and extended follow-up periods are necessary.