背景:卸载治疗对于治愈糖尿病相关的足部溃疡(DFU)至关重要。本系统评价旨在评估DFU患者卸载干预措施的有效性。
方法:我们搜索了PubMed,EMBASE,Cochrane数据库,和所有与DFU患者卸载干预相关的研究的试验注册,以解决14个临床问题比较。结果包括溃疡愈合,足底压力,负重活动,坚持,新的病变,falls,感染,截肢,生活质量,成本,成本效益,balance,持续的愈合。纳入的对照研究独立评估偏倚风险,并提取关键数据。当可以汇集来自研究的结果数据时,进行荟萃分析。当结果数据存在时,使用GRADE方法制定了证据陈述。
结果:从19,923项筛选的研究中,确定了194项符合条件的研究(47项对照,147非控制),进行了35次荟萃分析,和128证据陈述。我们发现,与可移动卸载设备相比,不可移动卸载设备可能会增加溃疡愈合(风险比[RR]1.24,95%CI1.09-1.41;N=14,n=1083),并可能增加依从性,成本效益和减少感染,但可能会增加新的病变。与可移动踝关节高卸载装置相比,可移动膝高卸载装置对溃疡愈合影响不大(RR1.00,0.86-1.16;N=6,n=439),但可能会降低足底压力和依从性。与治疗鞋相比,任何卸载装置都可能增加溃疡愈合(RR1.39,0.89-2.18;N=5,n=235)和成本效益,并可能降低足底压力和感染。与单用器械相比,带卸载器械的数字屈肌肌腱切开术可能增加溃疡愈合(RR2.43,1.05-5.59;N=1,n=16)和持续愈合。可以降低足底压力和感染,但可能会增加新的转移病变。与单独使用卸载装置相比,跟腱延长可能会增加溃疡愈合(RR1.10,0.97-1.27;N=1,n=64)和持续愈合。但可能会增加新的足跟溃疡。
结论:非可拆卸卸载装置可能优于所有其他卸载干预措施,以治愈大多数足底DFU。对于某些特定的足底DFU位置,数字屈肌肌腱切开术和跟腱加长结合卸载装置可能更优越。否则,任何卸载装置都可能优于治疗性鞋类和其他非手术卸载干预措施,以治愈大多数足底DFU。然而,所有这些干预措施都有支持其结局的低至中等确定性证据,需要更多高质量的试验来提高我们对大多数卸载干预措施有效性的确定性.
BACKGROUND: Offloading treatment is crucial to heal diabetes-related foot ulcers (DFU). This systematic
review aimed to assess the effectiveness of
offloading interventions for people with DFU.
METHODS: We searched PubMed, EMBASE, Cochrane databases, and trials registries for all studies relating to offloading interventions in people with DFU to address 14 clinical question comparisons. Outcomes included ulcers healed, plantar pressure, weight-bearing activity, adherence, new lesions, falls, infections, amputations, quality of life, costs, cost-effectiveness, balance, and sustained healing. Included controlled studies were independently assessed for risk of bias and had key data extracted. Meta-analyses were performed when outcome data from studies could be pooled. Evidence statements were developed using the GRADE approach when outcome data existed.
RESULTS: From 19,923 studies screened, 194 eligible studies were identified (47 controlled, 147 non-controlled), 35 meta-analyses performed, and 128 evidence statements developed. We found non-removable
offloading devices likely increase ulcers healed compared to removable
offloading devices (risk ratio [RR] 1.24, 95% CI 1.09-1.41; N = 14, n = 1083), and may increase adherence, cost-effectiveness and decrease infections, but may increase new lesions. Removable knee-high offloading devices may make little difference to ulcers healed compared to removable ankle-high offloading devices (RR 1.00, 0.86-1.16; N = 6, n = 439), but may decrease plantar pressure and adherence. Any offloading device may increase ulcers healed (RR 1.39, 0.89-2.18; N = 5, n = 235) and cost-effectiveness compared to therapeutic footwear and may decrease plantar pressure and infections. Digital flexor tenotomies with offloading devices likely increase ulcers healed (RR 2.43, 1.05-5.59; N = 1, n = 16) and sustained healing compared to devices alone, and may decrease plantar pressure and infections, but may increase new transfer lesions. Achilles tendon lengthening with offloading devices likely increase ulcers healed (RR 1.10, 0.97-1.27; N = 1, n = 64) and sustained healing compared to devices alone, but likely increase new heel ulcers.
CONCLUSIONS: Non-removable
offloading devices are likely superior to all other
offloading interventions to heal most plantar DFU. Digital flexor tenotomies and Achilles tendon lengthening in combination with offloading devices are likely superior for some specific plantar DFU locations. Otherwise, any offloading device is probably superior to therapeutic footwear and other non-surgical
offloading interventions to heal most plantar DFU. However, all these interventions have low-to-moderate certainty of evidence supporting their outcomes and more high-quality trials are needed to improve our certainty for the effectiveness of most offloading interventions.