鞋具对糖尿病足溃疡高危患者预防的有效性：国际糖尿病足工作组2023年糖尿病足诊疗指南足溃疡预防部分解读

工作组2023年糖尿病足诊疗指南足溃疡预防部分解读际糖尿病足工作组的首要事项。该文对国际糖尿病足工作组2023年糖尿病足诊鞋具对溃疡发生率/复发率、足底压力的影响，同时关注死亡率、不良事件、依鞋用率和高复发率等特征[1]。国际糖尿病足工作组(InternationalWorkingGroupontheDiabeticFoot,IWGDF)始终把足溃疡的预防视为首要事项。足溃疡的危险因素包括保护性感觉丧失(lossofprotectivese足畸形、外周动脉疾病(peripheralS或PAD加以下任何1项：足溃疡史、下肢截肢史、晚期肾脏疾病。病变、预防性手术、心理指导等，效果并不确切。本文对2023年糖尿病足诊疗分组方法进行分类总结，重点关注不同鞋具对溃索到3项随机对照试验(randomizedcontrolledtrial,RCT)[2-4]和3项队列研究[5-7]。3项RCT符合Meta分析纳入标准，应用Meta分析评估3鞋具有保护性作用，但差异无统计学意义且异质性高。3项队列研究中，1项未发现治疗性鞋具与普通鞋具的差异，2项证实足底压力方面，1项队列研究[7]和18项非RCT[8-26]均提示，与普通准鞋垫指已临床应用于相关类型溃疡预防的鞋垫。该条目共检索到5项RCT[27-31]和20项非RCT[32-51]。结果显示，与标准鞋垫相比，降低剪切力的足底压力方面，目前有2项RCT和20项非RCT报告了足底压力。由于鞋垫元素及其效果存在很大差异(例如，同一元素可能效果[44]),无相关证据陈述。至于其他结果，不良事件(1项RCT)、健康相关生命质量(HRQoL,1项RCT)和依从性(2项RCT)方面差异没有统计学意义。指制式统一的治疗性鞋具。该条目在预防溃疡方面共检索到4项RCT[52-55]和3项RCT[56-58],对其中2项符合Meta分析纳入标准的RCT进行Meta发现，溃疡复发的相对危险度为0.62,与标准组相比，压力优化组有保护性趋势，但差异无统计学意义且异质性高。其他2项RCT未发现二者溃疡发生率的差异。关注足底压力的3项RCT和3项非RCT均显示，与标准治疗鞋相比，压力优间加厚，两头微翘起)的治疗鞋。试验组根据3D扫描患者足部尺寸、模型和体尿病患者中，与标准治疗鞋相比，基于足部3D扫描选择的治疗性鞋具对足溃疡硅趾矫形器是指应用硅胶材料定制的分趾矫形器。1项RCT[60]比较了硅趾矫形器与其他矫形器在低中溃疡风险(IWGDF风险1或2)人群中的预防效果，人群(IWGDF风险1)步态康复的效果。结果发现，与步态康复期间不穿震动鞋垫的患者相比，在8周步态康复计划后，震动鞋垫2项RCT[28,52]和1项队列研究[62]比较了治疗性鞋具依从性好的参与者与依从性差的参与者之间的差异，3项研2项非RCT描述了使用专为溃疡高风险人群(IWGDF风险3)设计的室内治疗鞋的对患者依从性的影响[62-63]。结果显示，基线时依从性差的参与者在使用专用鞋具1个月和12个月后依从性显著提高(基线时中位数为65%;1个月后为77%;12个月后为87%),基线时依从性好的参与者无明显变化[62]。该队列整体1年内溃疡复发率为26%。与常规定制性鞋具相比，专用治疗性鞋具对关文献中对照研究18项，非对照研究超过40项，从一定程度上证实了鞋具对降难以推广。随着定制化鞋具的有效性证据的不断积累和方法的不断成熟[4,64],有效性的关键环节和重要挑战[28,52,62],进一步的研究还在进行中。ecurrence[J].NEnglJMed,2017,epreventionofdiabeticfootulcers[J].DiabetesCare,1995,18trolledtrial[J].JAMA,2002,287(19):2552-2558.DOI:10.1001/jama.[4]RizzoL,TedeschiA,FallaniE,eropathiculcersinhigh-riskdiabeticfootpatients[J].IntJLowExtremWounds,2012,11(1):59-64.DOI:10.1177/1534734612438729.[5]ReikeH,BruningA,Rischdedorthoticdevice[J].Diabetes[6]BuschK,ChantelauE.Effectivenessofanewbrandofstock'diabetic'shoestoprotectagainstectivecohortstudy[J].DiabetMed,2[7]ViswanathanV,Madhavaofdifferenttypesoffootwearinsolesforthediabeticneuropatoot:afollow-upstudy[J].DiabetesCare,2004abetMed,1990,7(4):355-359.DOI:10.1111/j.1464-5491.1990.tb01[9]BaumannR.Efficacyofindustriallyprodu[10]BorssénB,BergenheimT,Lithnerdemiologicalandprospective9-225.DOI:10.1046/j.1365-2796.1996[11]StriesowF.[Specialmanufacturedshoesentulcerindiabeticfootsyndrome][J].MedKlin(Mu[12]FriggA,PagenstertG,SchäferDonofdiabeticfootulcersaftertotalcontactcasting[J].FootAnkleInt,2007,28(1):64-69.DOI:10.3113/FAI.20nbyanewmethodofcustom-madeshoesinhreshoesfordiabetics.009,38(12):1209-1214.DOI:10.1007/[15]FernandezML,LozanoRM,Diafinthediabeticfootusingforefootofflpressuresinneuropathicfeet[J].D[18]KavrosSJ,VanStraatenntarpressurereductionofoff-the-shelfrockerbottomprovisionalfootwear[J].ClinBiomech(Bristol,Avon),2011,26(7):778-782.DOI:[19]ChapmanJD,PreeceS,BraunsteinB,edesignfeaturesonforefootplantarpressuresinpeoplewithandwithoutdiabetes[J].ClinBiomech(Bristol,Avon),2013,28(6):679-685.DOI:10.1016/j.clinbiomech.2013.05.005.BronzeAward.Comparisonofstrategiesforreducingpressureatthesiteofneuropathiculcers[J].JAmPodiatrMedAssoc,1997,87(10):[21]RaspovicA,LandorfKB,GazarekJ,etal.Reductionofpeakplantarpressureinpeoplewithdiabete2012,5(1):25.DOI:10.1186/1757-1146-5-25.[22]LinTL,SheenHM,ChungCT,etal.peoplewithdiabeticperipheralneuropathy[J].JFootAnkleRes,2013,6(1):29.DOI:10.1186/1757-1146-6-29.reintheneuropathicfoot.Acomparisonof[24]ZwaferinkJ,CustersW,PaardekooperI,etal.Effectofacarbooffootulceration[J].GaitPosture,2021,86:341-345.DOI:10.101[25]López-MoralM,Momportanceoffootwearoutsoleri[26]KarimiMT.Theevaluationoffootrockersonthekinematicparametersofindividualswithdiabetes[J].FootAnkleSpec,2018,11(4):lestopreventfootulcerationinhigh-riskdvSkinWoundCare,2012,25[28]López-MoralM,Lázaro-Martinezthepreventionofrecurrenceinpatientswithdiabetesmelliiabeticpolineuropathy:arandomizedclinicaltrial[J].[29]ColagiuriS,MarsdenLL,NaiduV,etal[30]PatonJS,StenhouseEA,BruceG,etal.Acompaiabeticfootulceration:aparticipant-blinded 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