中国糖尿病足防治实践指南（Ⅱ）

·指南与共识·

本文亮点：

(1) 制订了适用于中国患者的糖尿病足临床实践指南,这对糖尿病足的预防及规范化治疗具有重要意义。

(1) 参与本指南制订的成员来自多个临床及学术领域,包括内分泌科、血管外科、烧伤与创面修复科、骨科、足踝外科、感染科、心血管科、康复科以及循证方法学科。所有成员均拥有博士或硕士研究生学历,并接受过系统的循证医学培训。此外,本指南的制订过程严格遵循国际指南制订规范,确保了指南制订过程的高度严谨性。

Highlights:

(1) The clinical practice guideline for diabetic foot suitable for Chinese patients was formulated, which is of great significance for the prevention and standardized treatment of diabetic foot.

(2) The members involved in the development of the guideline are from diverse clinical and academic disciplines, including endocrinology, vascular surgery, burn and wound repair surgery, orthopedics, foot and ankle surgery, infectious diseases, cardiology, rehabilitation, and evidence-based medicine. All members have doctoral or master's degrees and have received systematic training in evidence-based medicine. Furthermore, the guideline development process strictly adhered to international standards for guideline development, ensuring its highly rigorous approach.

# 中国糖尿病足防治实践指南(II)

中华医学会烧伤外科学分会 长三角一体化糖尿病足专病联盟 《中华烧伤与创面修复杂志》编辑委员会

通信作者:王爱萍,解放军东部战区空军医院内分泌科,南京210002,Email:wap454hospital@163.com;刘琰,上海交通大学医学院附属瑞金医院烧伤整形与创面修复科,上海200025,Email:rjliuyan@126.com;罗高兴,陆军军医大学(第三军医大学)第一附属医院全军烧伤研究所,创伤与化学中毒全国重点实验室,重庆市创面修复与组织再生重点实验室,重庆400038,Email:logxw@mmu.edu.cn

【摘要】 糖尿病足是糖尿病患者常见的严重并发症之一,足畸形、溃疡、缺血以及可能合并的感染等是导致患者截肢和/或死亡的重要原因。为进一步规范我国糖尿病足防治实践过程,提升医疗同质化水平,推动专病分级诊疗体系建设,中华医学会烧伤外科学分会、长三角一体化糖尿病足专病联盟和《中华烧伤与创面修复杂志》编辑委员会组织多学

科专家团队,确定糖尿病足诊断、治疗和预防等方面的临床问题,并运用推荐意见分级的评估、制订与评价系统评估相关证据的质量等级,制订了《中国糖尿病足防治实践指南》。该指南共形成了46条推荐意见,内容涵盖全面医学评估,控制血糖、血压、血脂及抗栓和抗感染等内科治疗,围手术期的风险评估和管理,清创、血管重建和组织修复手术等外科治

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疗,以及足病预防、多学科团队合作和分级诊疗体系建设等,旨在为中国糖尿病足的临床实践提供指导。

【关键词】 糖尿病足；感染；外周动脉病变；周围神经病变；创面修复

基金项目:2025年长三角生态绿色一体化发展示范区政府专项资金(区执会签[2025]0225号)

实践指南注册: 国际实践指南注册与透明化平台 (PREPARE-2024CN1219)

# Practical guideline on the prevention and management of diabetic foot in China

Chinese Burn Association, Yangtze River Delta Integrated Diabetic Foot Alliance, Editorial Committee of Chinese Journal of Burns and Wounds

Corresponding author: Wang Aiping, Department of Endocrinology, Air Force Hospital of Eastern Theater Command, Nanjing 210002, China, Email: wap454hospital@163.com; Liu Yan, Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China, Email: rjluyan@126.com; Luo Gaoxing, Institute of Burn Research, State Key Laboratory of Trauma and Chemical Poisoning, the First Affiliated Hospital of Army Medical University (the Third Military Medical University), Chongqing Key Laboratory for Wound Repair and Tissue Regeneration, Chongqing 400038, China, Email: gaoxing. luo@burnstrauma.com

【Abstract】 Diabetic foot is one of the common and serious complications among the patients with diabetes mellitus. The major causes of amputation and/or death in the patients are foot deformities, ulcers, ischemia, and possible concurrent infections. To further standardize diabetic foot prevention and treatment in China, improve its diagnostic and therapeutic consistency, and promote the development of a specialized tiered care system, Chinese Burn Association, Yangtze River Delta Integrated Diabetic Foot Alliance, and Editorial Committee of Chinese Journal of Burns and Wounds organized a multidisciplinary expert team. The team determined clinical issues related to the diagnosis, treatment, and prevention of diabetic foot and evaluated the quality grades of relevant evidence using the grading of recommendations assessment, development and evaluation system, and eventually developed the Practical guideline on the prevention and management of diabetic foot in China. There were 46 recommendations formed in the guideline, covering comprehensive medical assessment, internal medical treatments such as control of blood glucose, blood pressure, and blood lipid, antithrombotic and anti-infection therapy, perioperative risk assessment and management, surgical treatments such as debridement, vascular reconstruction, and tissue repair surgeries, as well as foot disease prevention, multidisciplinary cooperation, and the construction of a tiered care system, aiming to provide guidance for the clinical practice of diabetic foot in China.

【Key words】 Diabetic foot; Infections;

Peripheral arterial disease; Peripheral neuropathy; Wound repair

Fund program: 2025 Special Government Fund for the Yangtze River Delta Ecological Green Integration Development Demonstration Zone (No. QZHQ[2025] 0225)

Practice guideline registration: Practice Guideline Registration for Transparency (PREPARE-2024CN1219)

(上接本刊2025年11期第1029~1049页)

4.2 手术治疗

4.2.1 清创和骨重建手术

4.2.1.1 清创的方法 推荐意见26:应依据足溃疡特征和个人基础情况,同时考虑技术或设备因素,为DFU患者选择个体化的清创方案(推荐强度:强,证据等级:中等)。

证据摘要: 本条推荐意见的证据包括7篇荟萃分析和系统评价、2篇RCT,报告了糖尿病足的清创术。关键结局指标结果:锐性清创能促进非缺血性创面愈合,每周1次和每2周1次清创的效果无差异[149],但研究证据不充分[46]。加强清创手术培训能降低二次手术风险5倍(P=0.003)、降低住院时长[中位数由36d降到21.5d(P=0.02)[150]。激光清创后虽然贵炀炀创面大小变化不明显,但疼痛评分和细菌负荷均降低,52.9%患者倾向于选择[151];超声清创可明显促进糖尿病足创面愈合(P<0.001)[46,152];蛆虫清创对DFU愈合无优势,但能降低截肢率(P=0.02)[153];自溶性清创、酶制剂中木瓜蛋白酶组分和猕猴桃提取物等均有一定促进DFU愈合的作用,但普遍证据质量低、结果不稳定[72,154]。DFU清创频率和次数与感染控制、重复清创率、入院率、住院时间和住院费用相关[149,155]。

推荐说明:清创的目的是切开引流、去除坏死组织和异物,以促进组织生长。清创方法有多种,不同清创方法机制不同,各有优点和不足,其中机械性清创包括锐性清创、手术清创、湿-干法清创、超声清创、水动力清创和生物清创,通常作用迅速、特异性强,但常伴随疼痛、创面扩大或成本较高的不足;非机械性清创包括自溶性清创和酶学清创(胶原酶等),操作简便、选择性多,患者耐受性佳,但清创速度较慢,部分方法有感染或发生过敏反应的风险[149,153]。见表7。

4.2.1.2. 软组织清创推荐意见27:对于部分中度和所有重度感染的DFU,尤其是合并脓肿、湿性坏疽、气性坏疽或坏死性筋膜炎者,应紧急清创;若伴有严重缺血,应先切开引流并清除局部坏死组

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表7 不同清创方法的原理及优点和不足

Table 7 Principles, advantages, and limitations of various debridement techniques

|清创方法|作用原理|优点|不足| |---|---|---|---| |机械性清创|||| |锐性清创|用锐利工具,手动切开引流和清除坏死组织|快速、费用低、特异性强|疼痛、创面扩大| |手术清创|与锐性清创原理类似,需在手术室无菌环境中进行|清创彻底,可取标本进行活体组织检查,利于创面床的准备|技术要求高、疼痛、创面扩大、费用高| |湿-干法清创|先湿敷,移除干燥敷料时带走部分坏死组织|费用低、操作方便、非特异性|易损伤其他组织、疼痛| |超声清创|利用空化和微流效应,松动和去除坏死组织|快速、特异性|疼痛、费用高| |水动力清创|利用高压水流清除坏死组织|快速、非特异性|感染扩散、疼痛、费用高| |蛆虫清创|直接吞噬坏死组织和含酶分泌物或排泄物的化学作用|快速、特异性|蛆虫难获得,疼痛、发热或心理抗拒,大血管旁或可疑癌性创面禁用| |非机械性清创|用创面自身的酶和体液来软化并清除坏死组织|方便、不适感少、费用低、特异性|耗时长、增加感染风险| |自溶性清创|用外源性的酶类制剂直接降解坏死组织|操作方便、快速、特异性|耗时长、清创程度弱、成本高、存在过敏反应,严重感染禁用|

织(不扩大清创),等下肢血供改善后再行彻底清创(推荐强度:强,证据等级:中等)。

证据摘要:本条推荐意见的证据包括2篇系统综述和5篇回顾性队列研究,报告了DFI的清创方案。关键结局指标结果:相较于抗菌药物联合清创术,单纯抗菌药物治疗DFU患者的大截肢率高、住院时间延长[156]。及时清创的DFU患者大截肢率为0,而延迟清创[平均延迟(6.2±7.5)d]者大截肢率升至7.9%,且每延迟1天,Chopart截肢或踝上截肢风险升高1.6倍(P=0.015)[157]。相对于清创术,保守治的DFU患者的病死率高、创面愈合率低、抗菌药物使用时间长(中位数分别为17、55d),且61.5%的保守治疗患者最终被迫截肢[158]。延迟转诊显著增加中重度感染DFU患者大截肢的风险[159];早期血管重建联合广谱抗菌药物方案,对于缺血合并感染的DFU创面安全有效,不增加移植物或溃疡感染风险,更快改善组织灌注,缩短住院时间和减少成本,提高保肢率[160]。

推荐说明:糖尿病足的清创术需在患者镇静或麻醉条件下,由外科医师实施,适应证包括伴脓肿、湿性坏疽或气性坏疽或坏死性筋膜炎等中重度感染,慢性或难愈性溃疡(≥6周不愈合)伴纤维化或失活基底,以及骨髓炎合并骨质暴露;相对适应证包括血运尚可的感染并缺血性溃疡(必要时需联合血运重建手术)[9];禁忌证包括总体健康状况极不稳

定(尤其是呼吸和循环状态不稳定、超高龄、多种合并症)、姑息治疗或接近生命末期(预期生存期<3个月)、未纠正的重度凝血功能障碍(国际标准化比值>3.0);相对禁忌证包括严重下肢PAD(踝肱指数<0.4且末血运重建者)[161-162]。注意事项主要包括以下几个方面:(1)区分非威胁肢体的与威胁肢体的感染,早期清创可减少大截肢。(2)部分中度和所有重度感染,尤其是合并脓肿、湿性坏疽或气性坏疽或坏死性筋膜炎者,应急诊(24~48h内)清创[19]。(3)在下肢严重肢体缺血时,清创的时机、方法和范围等需个体化分析,IWGDF/ESVS/SVS指南强调感染与缺血需同步处理[19],缺血期避免盲目锐性清创(防止微血管血栓形成和创面加深),而血供恢复后需立即清创(防止清创延迟而导致感染加重)。(4)若怀疑为不稳定干痂(含坏死组织或脓液),应立即切开引流,任何抗菌药物使用都无法替代清创[159]。

4.2.1.3 骨性清创和重建

推荐意见28:当足部骨质破坏严重且保守治疗无效时,应根据局部破坏程度、血供与软组织条件及全身状况等来确定骨切除范围,并结合足部生物力学特点选择相应的重建方案(推荐强度:强,证据等级:GPS)。

证据摘要:本条推荐意见未查到相关的系统评价或原始研究证据。

推荐说明:在术前影像学检查的基础上,行合

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理清创手术能有效降低DFU患者大截肢风险。当足部骨质破坏严重且保守治疗无效时,应根据局部破坏程度、血供与软组织条件及全身状况等来确定骨切除范围。DFO治疗的核心目标是彻底清除病灶,包括行手术清创和抗菌药物治疗,清创+10d抗菌药物治疗方案和单纯90d抗菌药物治疗方案在DFO治疗效果和安全性方面均无差异[163],清创后连续3周和6周使用抗菌药物在治疗效果方面也无区别[164]。清创后使用含抗菌药物的填充材料(如抗生素骨水泥)覆盖溃疡创面,创面治愈率可达66%[165],但证据并不充分。在DFO彻底清除后,可通过结构性矫形重建,以稳定跖行足功能。不合并骨髓炎的DFU,在条件许可时,可直接进行骨矫形手术,例如CNO所致非感染性的足溃疡可行三关节融合术及软组织重建术[166]。本指南建议在综合评估手术适应证与成本-风险-收益比后,对于非感染DFU合并骨畸形(如拇外翻和CNO),可行手术稳定关节和矫正畸形;对于DFO导致的骨缺损,可先用骨替代材料填塞并采用合理疗程抗菌药物治疗,再择机行重建手术,以确保患者近期安全和远期功能获益最大化[167]。

推荐意见29:对于DFU患者前足骨质病变,根据病变位置和程度,可在清除病变组织后,行趾屈肌腱切断术和/或关节融合术等,必要时行多个跖骨头切除或截肢术(推荐强度:弱,证据等级:GPS)。

证据摘要：本条推荐意见未查到相关的系统评价或原始研究证据。

推荐说明:清创手术联合抗菌药物治疗前足DFO,可缩短抗菌药物疗程、促进创面愈合、降低溃疡复发率[168]。对于跖骨头下方溃疡,跖骨头切除术和跖骨截骨术均有良好疗效,且2种手术1年后的溃疡复发率相当[169];但若跖骨切除范围不足(<25%)可能会增加手术6个月后的溃疡复发风险[170]。在局限性截骨手术时,术前要通过影像学检查精准评估骨受累范围,术中要彻底切除感染骨,避免清创不充分[171-173]。目前尚无统一的累及前足骨质病变手术的方案,综合现有文献与本指南专家意见,在清除病变组织后,可进行以下手术:(1)足趾畸形(槌状趾、锤状趾爪形趾[7])合并溃疡,行单纯趾长屈肌腱切断术等;若无效,则需结合部分或全趾骨切除,尽量保留足趾长度; IWGDF新近指南还建议,无溃疡的足趾DFO还可单用抗菌药物治疗而不予外科手术处理[19]。(2)第1跖趾关节破坏时可行第

1. 跖趾关节切除成形术(又称Keller术,图2)或跖骨头“V”形骨切除术(又称Chevron术,图3),前者适用于严重病变,后者适用于拇外翻矫正。(3)第2~5跖趾关节破坏时,依据情况采取“髁”切除、单个跖骨头切除或跖骨头Weil截骨术(图4)等,必要时行关节融合术。(4)对于广泛软组织破坏或局部治疗失败的转移性DFU,手术切除部分趾骨或跖骨,尽可能保留残端长度,以减少负重面积丢失,在条件许可时,可采用多个跖骨头联合切除术(图5)或经跖骨截肢术(transmetatarsal amputation, TMA)。

 图2 第1跖趾关节切除成形术示意图。2A.术前跖趾关节破坏(阴影处);2B.跖趾关节切除成形(阴影处)术后

Figure 2 Schematic diagram of resection arthroplasty of the first metatarsophalangeal joint

 图3 跖骨头“V”形骨切除术示意图。3A.“V”形截骨线；3B.骨移位方向(箭头)

Figure 3 Schematic diagram of metatarsal head V-shaped osteotomy

推荐意见30:对于中足或后足骨与关节病变,可在彻底清创后,行骨与软组织联合重建术;若无法重建,可考虑不同平面的截肢术(推荐强度:弱,证据等级:GPS)。

证据摘要: 本条推荐意见的证据未见相关的系统评价或原始研究证据。

推荐说明：中足DFO多由前足感染向近端迁延

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 注:图4A中箭头表示骨移位方向,阴影表示骨切除部分,虚线表示截骨线

图4 跜骨头 Weil 截骨术及术后固定示意图。4A.跖骨头 Weil 截骨术方法;4B.跖骨头 Weil 截骨术后固定方式

Figure 4 Schematic diagram of metatarsal head Weil osteotomy and postoperative fixation

 注：阴影为切除部分，虚线为截骨线

图5 多跖骨头联合切除术示意图

Figure 5 Schematic diagram of multiple metatarsal head joint resection

所致,大截肢率>20.9%(远高于前足的6.1%)。经跗骨截肢适用于不适合行TMA或TMA术后溃疡未愈合的患者,超过70%经跗骨截肢的患者可达到功能性步行目标[175]。跟骨部分或全切除术后用生物复合材料填充的患者,足部溃疡愈合率达90%且并发症较少[176-177]。CNO致足底溃疡,可考虑环形中足外固定架术、后足关节融合术,必要时行内固定

手术等治疗,以重建病变中足或后足骨与关节的生物力学结构[178-179],CNO融合术成功率为84.2%、15.8%因骨髓炎仍需截肢[180]。目前尚无统一的累及中足或后足骨质病变手术的方案,综合现有文献与专家指南性意见,可进行以下治疗:(1)行手术清创,以彻底控制骨感染。(2)行外固定术,以进行足部减压[181];必要时行中足关节融合术、三关节融合术(图6)、全距关节融合术或距骨周围关节融合术等,以纠正畸形并维持跖行足;个别病例甚至可考虑骨(髂骨多见)移植填补空腔,并用游离皮瓣覆盖创面的联合重建方法,但此类手术目前尚缺乏足够证据支持且风险大,需要在经验丰富的诊疗中心实施[182-184]。(3)若骨破坏严重无法重建,考虑经跗骨截肢、Lisfranc截肢(图7)和Chopart截肢(图8)或大截肢。

 图6 三关节融合术示意图。6A.术前足结构(阴影部分为手术截除部分);6B.术后足结构

Figure 6 Schematic diagram of triple arthrodesis

4.2.2 PAD的治疗

推荐意见31:若DFU在超过4周的标准治疗后仍未见愈合,应分析影响愈合的因素并考虑重新进行下肢血管评估,必要时直接行下肢血管造影和/或重建术(推荐强度:强,证据等级:GPS)。

证据摘要:本条推荐意见未见相关的荟萃分析或原始研究证据。

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 图7 Lisfranc 截肢示意图。7A、7B、7C、7D. 分别为足侧位截骨线、足背截骨线、术中足部截面、术后足外观

Figure 7 Schematic diagram of Lisfranc amputation

 图8 Chopart 截肢示意图。8A、8B、8C、8D. 分别为足侧位截骨线、足背截骨线、术中足部截面、术后足外观

Figure 8 Schematic diagram of Chopart amputation

推荐说明:标准治疗4周后DFU面积减少≥50%是创面愈合的一个可靠指标[185];相反,则预示着创面完全愈合的可能性较低[186]。在给予充分的抗感染、血糖管理、创面护理和减压治疗后,若DFU创面无显著改善(4周内创面面积减少<50%),甚至恶化,应咨询血管专科医师并再次评估血管状况,以探讨进行血运重建的可能性[46-47,186]。血运重建手术应以重建溃疡部位的直接供养动脉为目标,选择直接血运重建(direct revascularization,DR);当目标血管重建困难时,选择间接血运重建(indirect revascularization,IR),力求开通与目标血管建立有代偿侧支循环的目标血管,恢复目标血管血运[47,187]。另外,积极评估局部微循环状况,筛查可能的免疫学和肿瘤等潜在影响DFU愈合的因素。

推荐意见32:对于合并PAD的DFU患者,下肢血运重建的目标是恢复至少1条从膝下至足部的动脉血流,最好为溃疡部位的直接供养动脉(推荐强度:强,证据等级:中等)。

证据摘要：本条推荐意见的证据包括6篇系统评价及荟萃分析，报告了在DFU治疗中，下肢血运重建的目标及作用[188-190]。关键结局指标结果：相较

于IR,DR能促进创面愈合、提高保肢率[191];行DR、IR和通过侧支循环的间接血运重建这3种手术的DFU患者的病死率无差异,行DR与IR的DFU患者的再手术率无差异[192]。

推荐说明:对于合并并严重PAD的DFU创面(如�WIFI分级系统评为3级和4级的创面),尤其是累及中足或后足的创面,若有合适的目标血管区域可用,应考虑采用血管区域导向的血运重建术,即“Angiosome”原则[192]。合并PAD的DFU患者,血运重建手术应恢复至少1条足部动脉顺行血流,且在可行情况下,考虑通过血管造影定位为溃疡解剖区域供血的目标动脉[193](图9)。在下肢血管手术前,应充分评估和权衡手术获益与风险,制订详细手术方案,并与患者及其家属充分沟通;同时,决策需个体化,应考虑血管解剖位置、技术可行性和其他合并症。

推荐意见33:根据DFU患者的整体情况、PAD体征(包括部位、程度和范围)以及技术可及性,为患者选择合适的血管重建方式(推荐强度:强,证据等级:高)。

证据摘要: 本条推荐意见的证据包括1篇荟萃

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 注:1为胫前动脉供血区域,2、3为腓动脉供血区域,4、5、6为胫后动脉供血区域

图9 足部血管支配示意图。9A.足背外侧;9B.足底内侧

Figure 9 Schematic diagram of foot vascular innervation

分析及4篇RCT,报告了下肢血管搭桥手术和经皮血管介入治疗(percutaneous vascular interventions,PVI)的效果。关键结局指标结果:相较于下肢血管搭桥手术组,PVI组DFU患者30d病死率、主要不良心脑血管事件及手术部位感染风险低,但I期和II期血管通畅失败、全因死亡等风险较高;2种手术的保肢生存率相似,但下肢血管搭桥手术成本更高[194]。相较于下肢血管搭桥手术,PVI具有更高的保肢生存率及更低的病死率,应被优先选择用于腹股沟下动脉病变。单段可用大隐静脉者(队列1)和需旁路替代移植物(人工血管)者(队列2)的平行队列研究显示,随访2.7年,相较于队列2,队列1主要肢体不良事件发生率低(P<0.001)[195]。在严重肢体缺血患者接受股-腘动脉PVI(无论是否包括膝下动脉)中,单纯球囊扩张+金属裸支架置入组、药物球囊扩张+金属裸支架置入组、药物洗脱支架的大截肢率分别为66%、60%和58%,药物洗脱支架或球囊并未在保肢生存率和严重不良事件方面显示出优势[196]。

推荐说明:鉴于下肢动脉闭塞症治疗的复杂性,严格掌握手术治疗适应证至关重要,通常Fontaine 分期为IIb期或Rutherford 分级为III级(即跋行距离<200 m)的间歇性跛行是手术的相对适应证,静息痛和肢端组织的缺血坏死等严重肢体缺血表现是绝对适应证[197]。PAD的手术方式选择如下:(1)PVI可降低围手术期主要不良心脑血管事件发生率及手术部位感染风险,但长期血管通畅率欠佳,是高龄、合并多种疾病的股腺动脉闭塞症患者首选。(2)行下肢血管搭桥手术患者的长期血管通畅率高、主要肢体不良事件或病死率显著低于行PVI的患者,但有切口感染或不愈合可能(膝下手术时更多发生,糖尿病及肾衰时预后更差),适合相对年轻、病变复杂者[198]。(3)股动脉分叉等特殊部位病变或腔内技术不完善时,可采用杂交手术方式(如

内膜剥脱术+PVI)。(4)不同节段血管病变的处理方式不同,如髂总或髂外动脉病变开通后可考虑直接置入金属裸支架或覆膜支架(其他新技术的效果有待验证),而股腘动脉病变首选药物洗脱治疗(也可用球囊扩张+支架植入或搭桥手术),PVI用于膝下动脉病变的治疗具有优势(胫腓干远端动脉或胫前、胫后以及腓动脉远端仅单纯球囊扩张,不用药物洗脱球囊和支架)[47]。当以上手术无血流再灌注可能的情况下,考虑深静脉经导管动脉化[47]。

推荐意见34:对于曾接受下肢血管重建手术的糖尿病足患者,若手术失败或术后再次出现缺血征象,无论距离上次手术多长时间,均应立即重新进行血管评估和或手术干预(推荐强度:强,证据等级:中等)。

证据摘要:本条推荐意见的证据包括2篇荟萃分析及1篇RCT,报告了下肢血管重建手术效果不佳或再缺血患者的进一步处理措施。关键结局指标结果:针对股腺动脉支架内再狭窄,首选介入治疗,药物涂层球囊在术后6、12个月降低靶病变血运重建风险、血管再狭窄发生率以及临床症状改善效果方面具有优势[199];应用覆膜支架被视为股腘动脉支架内再狭窄的最佳方案[200]。针对膝下血管再狭窄,首选PVI,也可选择搭桥手术,两者在术后30d内病死率、截肢率和再干预率等方面相近,但搭桥手术后心血管事件发生率和感染率更高[201-203];PVI失败更换为搭桥手术的血管再通成功率可高达92%且后期血管通畅率及保肢率也高,而搭桥手术失败更换为PVI的血管再通成功率仅为66%[204]。

推荐说明:对于接受过下肢血运重建的糖尿病足患者,若出现手术失败或再次出现缺血征象,无论距离上次手术多长时间,现有证据均支持立即重新评估血管状况并调整治疗策略[205-206]。缺血复发的症状包括间歇性跛行加重、踝肱指数下降≥0.15、溃疡恶化或新发静息痛,若影响生活质量且药物无效(如慢性肢体重度缺血复发、新发溃疡或坏疽等),可考虑选择性手术干预。二次血运重建的策略包括PVI及自体或人工血管搭桥手术,其中药物涂层球囊和药物涂层支架用于血管再狭窄的效果比普通球囊更好(膝下动脉段除外),搭桥手术或杂交手术(近端支架+远端搭桥手术)比PVI具有优势(均需考虑围手术期心血管事件和手术区域感染风险);对于广泛组织坏死合并感染或不具备血运重建条件的肢体,应进行截肢评估;对于无手术条件

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的患者,可仅调整抗栓和扩血管药物[101]。未来需要更多研究来证实的争议领域包括比较血管重建治疗效果不佳“立即再干预”与“密切监测后选择性干预”的结局差异、比较腔内或开放手术对血管长期通畅率和保肢率的影响,以及找出更多腔内新型器材的临床应用证据等。

4.2.3 创面修复手术

4.2.3.1 创基准备 糖尿病足创基准备,是针对不同原因和状态的糖尿病足创面进行评估并采取相应措施,营造一个无感染和血供良好的创基,从而刺激内源性创面愈合的进程,可为后期创面修复奠定基础。

推荐意见35:每1~4周评估DFU的大小和进展情况,按TIME(T:组织、I:感染/炎症、M:湿度平衡、E:边缘进展)原则或TIME-H(T:组织、I:感染/炎症、M:湿度平衡、E:边缘进展、H:宿主全身因素)原则准备创面(推荐强度:强,证据等级:GPS)。

证据摘要:本问题未查到相关的系统评价或原始研究证据。

推荐说明:慢性创面常因组织坏死、炎症失衡、渗出异常或上皮化受阻而难以愈合,增加治疗成本。创基准备的概念源于2000年,强调将患者整体状况视为最佳局部创面治疗的基础,TIME原则是Falanga[207]在2000年及Schultz等[208]在2003年提出,为慢性创面管理提供了系统化框架,随后得到了广泛认可和应用;若创面60d未愈合,则应用TIME-H原则,评估并处理阻碍创面愈合的因素[209]。DFU呈动态变化趋势,如果治疗1周内面积缩小10%~15%或4周内缩小>50%,则溃疡再感染和截肢的可能性低,说明单位时间内溃疡面积缩小百分比对预后有早期预测价值[210-211]。每周清创比每2周清创更能促进创面愈合、降低感染风险和住院需求[149]。

推荐意见36:合理使用敷料和创面处理技术,保持DFU创面湿润、控制渗出,营造促进上皮生长的环境(推荐程度:强,证据等级:中等)。

证据摘要:本问题共纳入11篇RCT和4篇系统综述,报告了敷料、氧和负压等在DFU治疗中的作用。关键结局指标结果:(1)敷料方面。①自体白细胞或血小板或纤维蛋白贴剂,能显著提高创面愈合率(P=0.0235)、缩短中位愈合时间(P=0.0343)[212]。其中,关于自体富血小板血浆(platelet-rich plasma, PRP)的11篇综述及2篇RCT表明其注射或外用均对DFU有效,但均存在研究异

质性高(PRP制备方式、给药方式、合并治疗、随访时长不同)、样本量有限及方法学质量偏低等不足[213-215]。②生长因子敷料,关于血小板衍生生长因子和表皮生长因子敷料各有7篇和4篇RCT,分别仅1篇RCT显示阳性结果;关于粒细胞集落刺激因子敷料的3篇RCT聚焦感染治疗,缺乏创面愈合相关内容;关于FGF敷料的2篇小型RCT显示其在创面愈合率或愈合时间上无显著优势,且唯一报告的阳性结果(溃疡面积缩小)存在方法学缺陷[18]。③蔗糖八硫酸盐敷料能提高创面愈合率(P=0.002)、减少平均愈合时间,具有成本-效益优势[216-217]。④脱水羊膜或绒毛膜移植物、冷冻保存的胎盘膜、脱水人脐带和粉末状脱水羊膜、脱水人羊膜等胎盘衍生产品,可提升创面愈合率[218]。⑤含银敷料,4篇RCT显示其具有短期抗感染和促进创面生长作用,但普遍存在方法学缺陷[219-222]。⑥胶原蛋白和海藻酸盐敷料,12篇RCT均存在中高度偏倚风险,阳性结果需谨慎解读[18]。⑦水凝胶,仅1篇RCT(31例患者)表明应用水凝胶16周后创面完全愈合率较高[223];⑧含到手香提取物与积雪草总苷敷料(又称ON101乳膏),仅1篇RCT和1篇事后研究分析表明,相较于亲水性纤维敷料(创面愈合率为35.1%),其在DFU(尤其是伴高HbA1c、肥胖、长病程等高风险因素者)的总体愈合率(60.7%)方面具有优势(P<0.001),且安全性良好[224-225]。(2)技术方面。①局部氧疗和高压氧治疗,两者均可加速创面愈合,12个月后溃疡愈合率为52%(高于无氧疗对照组的29%),但部分研究结论存在矛盾,其中1项研究因基线不均衡被提前终止[222,226-231]。②NPWT对于术后DFU愈合具有优势,但对于非手术治疗的DFU疗效不明确[153]。③胫骨横向骨搬运手术,6篇队列研究和1篇自身前后对照研究显示其可促进DFU愈合、降低截肢风险(胫骨横向骨搬运手术联合下肢介入手术的保肢疗效优于单纯介入手术),但纳入研究均有设计缺陷(非RCT设计、样本量不足、随访时间短、对照组缺失等)与方法学局限性[232-234]。④抗生素骨水泥局部应用,2篇系统综述和2篇RCT显示其可提高感染性DFU治愈率、缩短愈合时间并降低截肢风险且安全性良好,但纳入的研究也存在明显方法学缺陷(如随机化、隐藏、盲法不足)[235-236]。

推荐说明：(1)适宜的、湿润的创面愈合环境能加速上皮迁移，现代敷料在创造适宜的创面愈合环境方面较传统敷料（如纱布）具有优越性[153]。①自

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体白细胞或血小板或纤维蛋白贴剂,适合作为标准治疗无效的DFU的辅助疗法,需具备定期进行静脉穿刺的资源和技术[237]。其中,自体PRP可用于较浅表(Wagner分级1或2级)且无感染和缺血的难治性创面。②生长因子敷料,疗效不一致且存在安全风险,也不推荐常规用于DFU治疗。③蔗糖八硫酸盐敷料,适用于标准治疗≥2周无效的非感染性神经缺血性DFU[153]。④胎盘衍生产品,虽被IWGDF指南推荐用于标准治疗失败者,但证据多来自单中心研究,长期安全性和成本效益尚不明确,需谨慎应用[153]。⑤含银敷料,基于现有证据,不推荐常规用于促进创面愈合;但对于感染创面,其含有的银离子联合乙二胺四乙酸可抑制细菌生物膜形成,并通过结合细胞壁及酶破坏细菌结构,可能是一种可行选择,未来还需高质量 RCT 进一步验证其疗效[238-239]。⑥胶原蛋白和藻酸盐类敷料,缺乏足够证据支持。⑦水凝胶,仅与生理盐水纱布对比有效,缺乏与其他先进敷料的比较数据[240]。⑧含到手香提取物与积雪草总苷敷料,被采纳的研究是开放标签设计且受试者较少,价格较高,弱推荐用于DFU治疗。(2)DFU的治疗技术。①局部氧疗,居家可用且成本低;高压氧治疗,可用于标准治疗失败的神经缺血或缺血性DFU,有严重并发症(如尿毒症、低血糖)或合并症(如心力衰竭、幽闭综合征)患者禁用,需注意该技术低偏倚风险证据有限且结论有矛盾。②NPWT,适用于彻底清创术后的非缺血性DFU,避免负压设置过高或覆盖不当引起局部组织压迫缺血;不能用于清创不彻底的创面、以避免感染加重[241-242]。③胫骨横向骨搬运手术,是一种通过微创截骨并横向移动胫骨皮质骨块以刺激微血管新生的保肢技术,尚缺乏将其用于DFU的高质量RCT;临床仅限将其谨慎用于截骨部位血运良好、下肢远端循环障碍(如严重动脉粥样硬化、钙化防御病或自身免疫性疾病)且不能进行血运重建手术或无效的患者,但需严格掌握适应证和禁忌证、避免无指征的扩大应用。④抗生素骨水泥,是一种将抗生素与骨水泥混合制成的局部缓释材料,仅作为骨髓炎标准治疗的辅助手段,并需排除过敏、肿瘤和特殊感染等禁忌证。

4.2.3.2 创面修复 推荐意见37:对于糖尿病足患者足部软组织修复方式的选择,应根据足部组织缺损情况,并结合患者的全身情况、对运动和功能的需求等因素进行综合考量(推荐强度:强,证据

等级:高)。

证据摘要:本条推荐意见的证据包括4篇 RCT、2篇系统性综述和荟萃分析,报告了糖尿病足患者足部软组织修复方法的选择。关键结局指标结果:皮肤移植或组织替代能促进足溃疡愈合(相对危险度为1.55,95%置信区间为1.30~1.85)、降低截肢和感染风险[243];细胞、无细胞及类基质产品可显著提升足溃疡的愈合率[244]。局部固有肌瓣移植在糖尿病足踝重建中效果良好,但需更多高质量研究验证其长期效果[245]。软组织重建联合关节融合术治疗糖尿病患者中足CNO效果好[166]。游离皮瓣移植用于糖尿病患者下肢慢性溃疡治疗,皮瓣存活率达91.9%、保肢率为83.4%,是顽固性DFU治疗的有效选择,但需严格筛选患者并优化围术期管理[246-247]。

推荐说明:软组织修复技术由简单到复杂依次为:I 期缝合、II 期缝合、负压创面治疗、皮片移植、真皮基质移植、局部皮瓣移植、远处皮瓣移植、扩张皮瓣移植、局部筋膜皮瓣或肌筋膜皮瓣移植、岛状皮瓣或游离皮瓣移植(图10)[7]。关于皮瓣移植,需要注意的是:(1)皮瓣设计,皮瓣底部的血供决定了皮瓣移植的成功与否,而非皮瓣长宽比[248]。研究显示,局部足底皮瓣可设计成包括神经和血管的皮瓣,而无须在筋膜下剥离[249];皮瓣的切口线与松弛张力皮肤线平行(图11),可以使得皮肤的横向力最小,良好的皮瓣可以在一个方向上移动,无侧向或旋转(若同时进行骨手术,可不考虑皮瓣的侧向或旋转问题)。(2)导致皮瓣移植失败的原因主要是感染,尤其是金黄色葡萄球菌、假单胞菌和β溶血性链球菌感染,另外血清肿(浆液肿)和血肿形成等并发症也很多。

在糖尿病足创面修复中,需综合评估创面基底部骨结构的稳定性和损伤情况,同时还需要判断创面基底部受感染的骨质是否得到彻底清除,进而判断是否需要或者适合进行软组织重建以及重建的方式[250]。临床常根据溃疡的位置、深度和血供等特点采取不同的软组织重建方式:(1)皮片移植,适用于覆盖创面床准备良好、相对表浅、非承重或低承重区域的DFU创面,禁止用于严重缺血未纠正、深部组织暴露的DFU创面。(2)皮瓣移植,适用于覆盖深部缺损或负重区的溃疡,但需严格评估患者耐受性;禁止用于严重缺血未纠正,全身情况差而无法耐受长时间麻醉的患者。皮片移植与皮瓣移植手术成功的关键在于控制感染、优化创基(血供良好、

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 图10 皮瓣手术示意图。10A、10B、10C.分别为游离胫前皮瓣术、足背岛状皮瓣术、足内侧岛状皮瓣术

Figure 10 Schematic diagram of flap surgery

 注:图中腿部线条均为松弛张力皮肤线

图11 松弛张力皮肤线示意图

Figure 11 Schematic diagram of relaxed tension skin lines

无坏死)与全身状态(包括足部生物力学问题得到纠正),尤其需纠正缺血与血糖。

4.2.3.3 创面减压治疗 推荐意见38:根据溃疡部位、材料获取及患者情况,为前足、中足底溃疡选择合适的减压装置(推荐强度:弱,证据等级:中等)。

证据摘要:本条推荐意见的证据包括5篇 RCT 和6篇队列研究,报告了DFU患者减压装置的选择。关键结局指标结果:全接触石膏等不可拆卸的卸载装置(non-removable offloading device, NROD),可显著提高DFU愈合率、缩短愈合时间并降低复发风险,TCC组患者在愈合率(93.2%)、大截肢率(4.0%)以及依从性、成本效益和减少感染等方面均优于RCW组(创面愈合率为83.5%,大截肢率为7.3%)。而膝高可拆卸的卸载装置(removable offloading

device, ROD)和踝高 ROD 在 DFU愈合方面无差别[251]。另1项研究结果显示,全接触石膏在促进DFU愈合方面具有优势[252];相比于普通鞋具,RCW与全接触石膏均能降低全足压力,其中RCW降低中足峰值压力的效果更好,全接触石膏应用后溃疡愈合率更高[253-254];毡制泡沫结合适配鞋具,适用于资源受限或TCC禁忌者,其疗效有限但优于普通鞋具或标准治疗鞋[253]。近期1项研究认为允许CNO患者在TCC期间负重,不会对愈合过程产生负面影响[129]。上述部分研究未明确报道分组随机方法且对照组干预措施不完全一致,存在一定偏倚风险,但总体结果一致性较高。推荐说明:2023年 IWGDF指南建议,为促进糖尿病神经性前足或中足溃疡愈合,首选NROD;若存在禁忌或不耐受,可选用膝高或踝高ROD;如无可用装置,则采用合脚鞋具结合毡制泡沫作为三线措施。若非手术减压无效,可考虑跟腱延长术(achilles tendon lengthening, ATL)、跖骨头切除术、关节置换或跖骨截骨术;对于弯曲趾畸形所致的足底或趾尖溃疡,推荐行趾屈肌腱切断术[237,251]。是否选用半鞋存在争议,2016年 IWGDF指南推荐选用半鞋,但缺少更多循证医学证据支持;如果为避免无任何减压措施而负重行走考虑选用时,需谨慎选择人群和适应证,且做好一切防止跌倒措施,本指南不作特别推荐。对于后足溃疡减压措施,尚缺乏证据支持

4.2.4 截肢手术

推荐意见39:对于重症糖尿病足患者,作保肢还是截肢选择时,需权衡治疗风险与收益,并充分与患者沟通、尊重患者意愿,以确保决策透明(推荐强度:弱,证据等级:GPS)。

证据摘要: 本条推荐意见未见相关的荟萃分析或原始研究证据。

推荐说明:在临床实践中,部分重症患者虽然

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存在保肢可能,但又面临着反复手术(包括血管再通、清创和创面修复)最终还是要截肢的风险,制订合理的截肢、保肢决策至关重要。截肢可分为大截肢(如经股骨、胫骨、膝关节离断等)和小截肢(如足趾截肢、经肘骨截肢、TMA等),DFU患者行大截肢的适应证包括严重感染无法控制、不可逆的缺血导致组织坏死且血管重建无效、不可治愈的溃疡、恶性肿瘤累及肢体、创伤性损伤无法修复或重建,以及神经性关节病反复发作严重影响生活质量的情况;禁忌证包括可逆性疾病可以通过非手术方法有效控制,以及患者整体健康状况差使所有手术风险过高的情况[19]。17%的DFU患者最终会接受截肢[19];足部病变程度、外周血管病和高血压均是截肢的高危因素(P<0.01);截肢组患者较保肢组患者糖尿病病程长,HbA1c、白细胞计数、CRP高(P<0.05),而血红蛋白和血浆白蛋白水平低(P<0.01)[255]。有研究调查了41例膝下截肢患者,其中初期截肢者24例、匍行性截肢者17例,结果显示,匍行性截肢患者中有94.1%会选择多次挽救手术试图保肢,初期截肢患者中仅37.5%会选择挽救手术试图保肢(P=0.001)[256],故截肢前应尽量邀请血管外科、骨科及康复医学科医师共同评估病情,尤其是对于相对年轻患者,以确保手术成功,并为术后康复及部分患者的假肢安装提前做好准备。DFU患者保肢治疗的适应证包括早期干预(如清创、减压、改善血液循环)、有效的血管重建、感染控制、CNO得到有效治疗;禁忌证包括不可逆的组织坏死、严重感染扩散威胁生命,以及全身健康状况差使复杂保肢手术风险过高[19,257]。现有证据支持临床获益与风险评估后的个体化决策,优先保肢,而以TMA为代表的经足骨截肢是保肢治疗的重要手段[258]。

推荐意见40:对于截术后DFU患者,应制订包含残肢护理、个体化假肢适配及渐进性训练的康复计划,并提供贯穿全程的心理支持(推荐强度:弱,证据等级:GPS)。

证据摘要:本条推荐意见未见相关的荟萃分析或原始研究证据。

推荐说明：相较于常规护理组，联合康复或心理护理组糖尿病足截技术后的患者并发症发生率低、汉密尔顿焦虑量表评分低、糖尿病特异性生活质量量表评分高($P$值均$<0.05$)[259-260]，但因证据质量等级较低，研究结论的临床真实性尚待证实。

2020年的一篇关于下肢截肢的多学科指南指出,在假肢适配过程中,可以通过物理治疗师一对一的训练、利用虚拟现实或增强现实的模拟训练,提升步行速度,适应假肢支撑面,但证据质量等级较低[261]。对于首次安装假肢的患者,应根据患者的偏好和目标,制订以提高行走能力为目标的渐进性康复训练计划(包括确定训练目标、内容、强度和持续时间)。总之,糖尿病足截肢后的康复需融合精准假肢技术、阶段性训练及跨学科管理,核心目标是减少二次溃疡、提升生活品质。

5 糖尿病足的预防

5.1 足病的风险评估和分层

推荐意见41:在糖尿病患者初次诊断或初次就诊时,应该评估其足病的风险,并按照风险分层结果,至少每年1次进行足部神经、血管等状况的全面评估(推荐强度:强,证据等级:GPS)。

证据摘要：本条推荐意见未查到相关的系统评价或原始研究证据。

推荐说明:在糖尿病患者初次诊断或初次就诊时,应用IWGDF风险分层系统对其进行足病风险评估及分层管理(表8),能优化糖尿病患者的足部护理行为[262],具有成本效益,也可有效识别高风险患者,使新发足溃疡概率降低28.6%,而糖尿病足中低风险患者新发足溃疡概率仅下降3.2%[263-264]。5篇横断面研究均强调应用IWGDF风险分层系统或筛查工具可有效识别高风险患者[265-269]。另外,糖尿病足筛查应该由训练有素的医疗专业人员进行[18]。目前相关研究多为观察性研究,基于RCT证据很少且证据质量等级低,糖尿病足的早期识别和预防收益仍需更多研究加以证实。

5.2 健康教育

推荐意见42:结构化健康教育能有效预防糖尿病足高危患者的足溃疡发生和发展(推荐强度:强,证据级别:中等)。

证据摘要:本条推荐意见的证据包括11篇RCT,报告了对糖尿病患者进行结构化健康教育的效果。关键结局指标结果:是否进行健康教育对足溃疡发生率(相对危险度=0.62,95%置信区间为0.37~1.03,P<0.05)、截肢率(相对危险度=0.51,95%置信区间为0.27~0.96,P<0.05)均有影响,但不会明显影响全因病死率和足畸形发生率;次要结局指标结果显示,健康教育能改善糖化血红蛋白水平和自

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表8 IWGDF风险分层系统和相应的临床表现及筛查频率

Table 8 IWGDF risk stratification system and corresponding clinical manifestations and screening frequencies

|分级|DFU 风险等级|临床表现|筛查频率| |---|---|---|---| |0|非常低|无LOPS且无PAD迹象|每年1次| |1|低|LOPS或PAD|每6~12个月1次| |2|中等|LOPS+PAD或LOPS+足畸形或PAD+足畸形|每3~6个月1次| |3|高|LOPS或PAD合并以下1项或多项:足溃疡、下肢截肢术后(小截肢或大截肢)、终末期肾病|每1~3个月1次|

注:IWGDF为国际糖尿病足工作组,LOPS为保护性感觉丧失,PAD为外周动脉疾病

我护理效能,尤其是足部护理知识和行为管理均得到明显提升[270-280]。

推荐说明:开展结构化健康教育能提高DFU高危患者的自我护理效能和知识水平,形成良好的足部护理行为,降低截肢的发生率,成本效益好且操作难度低。结构化教育的内容包括加强对有足溃疡风险(IWGDF风险分层系统分级为1~3级)的糖尿病患者的足部保护,避免赤脚行走、不穿薄底拖鞋或光脚穿鞋、每日洗脚并彻底擦干、使用润肤剂保湿、正确修剪趾甲;对于DFU中高风险(IWGDF风险分层系统2~3级)患者,建议每日监测双侧足的皮肤温度,若连续2d温差超过2.2°C,应减少活动并寻求专业指导[18]。

推荐意见43:对于存在足溃疡史、截肢史或足畸形等DFU高风险因素的糖尿病患者,建议使用减压治疗鞋具,以预防足溃疡的发生或复发;而对于无结构性足畸形或DPN的DFU低风险糖尿病患者,可选择普通鞋具(推荐强度:强,证据等级:中等)。

证据摘要: 本条推荐意见的证据包括5篇回顾性队列研究和4篇系统评价,报告了DFU低风险人群和高风险人群鞋具的选择。关键结局指标结果:在糖尿病足低风险人群中,普通鞋具并未显著增加足溃疡风险,也无证据支持减压矫形治疗鞋较普通鞋更能预防溃疡发生[281]。在有足溃疡史、截肢史或足畸形等高风险因素的患者中,与普通鞋或标准治疗鞋相比,减压矫形治疗鞋能显著降低足溃疡发生率(相对危险度为0.49,95%置信区间为0.28~0.84)且无发表偏倚的证据。鞋具预防溃疡的有效性与干预时间呈负相关[282],其他几项前瞻性队列研究也支持上述结论,总体研究设计质量中等,部分研究存在盲法等问题。

推荐说明:对有足溃疡史、截肢史或足畸形等 DFU高风险人群,优先推荐使用减压治疗鞋具,如个性化定制的鞋垫和摇摆底鞋,不仅能使溃疡新发风险降低,复发的风险也能下降50%以上。对于无结构性足畸形或DPN的DFU低风险人群,可选择普

通鞋具,但要选择包裹性好和缓冲适度的运动鞋,避免选择拖鞋、高跟鞋或其他不合脚鞋具,多项研究证实普通鞋具的安全性与可接受性均较高[237]。该策略在各级医疗机构均具可行性,且在中国DFU高治疗费用的背景下,具有重要的推广价值。

5.3 足溃疡前兆病变的处理

推荐意见44:所有糖尿病患者应积极治疗足底 胼胝、鸡眼、嵌甲、脚气、水疱、皲裂等可能导致足溃 疡的前期病变,以有效预防足溃疡的发生与复发 (推荐强度:强,证据等级:GPS)。

证据摘要: 本条推荐意见未查到相关的系统评价或原始研究证据。

推荐说明:诸多临床研究显示,40.6%的1型糖尿病患者和39.5%的2型糖尿病患者有足溃疡前期病变,其中胼胝、嵌甲和真菌感染的发生率在1型糖尿病患者中达16.8%、10.5%、15.8%,在2型糖尿病患者中达18.5%、21.9%、24.7%[283];足跟皲裂和鸡眼也与足溃疡的发生有关[267]。胼胝切除能降低足底总压力和冲量、局部压力和冲量,且患者的疾病、生理、心理和社会维度评分均有改善,Wagner分级优于术前[284]。接受足病医师对生活方式和溃疡前期病变干预指导1年,能显著降低足溃疡的发生率(未接受干预、接受干预的发生率分别为20.7%、6.7%,P<0.001)且干预次数与溃疡发生次数呈负相关(Spearman 相关系数为-0.496, P<0.001);有DFU史的患者,对生活方式和溃疡前期病变干预后溃疡复发率也明显下降(未接受干预、接受干预复发率分别为89.7%、27.9%, P<0.001)[285]。另外,足趾畸形,如拇外翻、第2跖骨过长等,存在于近半数的糖尿病患者中,易导致足底异常压力区形成、胼胝生成,常无疼痛感,但足底额外承重(约18600kg/d)[286]。过小的趾间缝隙,加上不合适的鞋具,也会在非承重区形成鸡眼,并伴有疼痛感。胼胝和鸡眼在早期对局部皮肤均有一定的保护作用,但随着疾病进展,局部过度厚、硬的皮肤反而会成为异物,导致皮下出血、溃疡发生(在部分骨突出部位,甚至累及骨

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质)。手术刀削除胼胝和鸡眼已被广泛认可是有效预防足溃疡的措施;胼胝和鸡眼的修剪频率应依据鞋内足底动态压力变化调整,而非单纯根据胼胝厚度决定[287]。对于嵌甲、真菌感染或水疱患者,应及时就医进行部分趾甲拔除、使用局部抗真菌药物或进行水疱引流等处理,不建议自行使用含酸类药膏或药水。

5.4 外科干预

推荐意见45:对于DFU高风险患者,若溃疡前期病变经保守治疗愈合困难或无效,建议在全面医学评估的基础上,考虑合适的外科干预措施(推荐强度:强,证据等级:中等)。

证据摘要:本条推荐意见的证据包括1篇RCT和6篇系统评价,报告了手术干预在糖尿病足预防中的应用。关键结局指标结果:足趾屈肌腱切断术(图12),可使足底压力(平均差降低398kPa, P<0.00001)和溃疡愈合后复发风险均大幅下降,且使趾尖胼胝、锤状趾或指甲增厚患足的压力值降低、溃疡发生减少[288];足底筋膜松解(针对前足溃疡)和拇长屈肌腱转移(针对足跟溃疡),使24个月内溃疡复发率都为0[289];ATL,使前足足底压力(平均差降低218kPa, P=0.03)和DFU复发风险(17~48个月内复发率为0~20%)均降低,而愈合率升高(P=0.006)[251];跖骨头切除术,使得足底压力(平均差降低511kPa, P<0.00001)和术后1年时DFU复发率均降低[290-291];截骨术联合关节融合术,使足底溃疡的复发率和截肢率显著降低;第1跖趾关节成形术患者术后6个月时的DFU复发率较低;此外第1跖趾关节切除成形术和趾间关节置换术联合治疗拇外翻,加权愈合率为94%、愈合时间为(3.1±0.4)周、溃疡复发率为6%、溃疡转移率为4.5%[292],明显优于选择其中单一手术方案;足内侧柱融合术和多水平外固定术是保守治疗无效的无溃疡性CNO最常用的手术方式[293]。

推荐说明:DFU发病率高,复发率也高(4个月内复发率能达40%、3年内复发率更是高达60%)。2023年IWGDF指南对手术预防DFU的有效性和安全性做出明确声明,手术能预防糖尿病足高危患者的足溃疡发生,尤其适用于去解决因骨性突出所致的局部高压问题。足趾屈肌腱切断术(图12)适用于足趾畸形,手术安全有效,可松解非僵硬畸形足趾。跟腱延长术(图13)适用于踝关节背屈受限或TMA/经跗骨截术后愈合创面,有助于降低前足压

 图12 足趾屈肌腱切断术示意图

Figure 12 Schematic diagram of toe flexor tendon tenotomy

力。背屈跖骨截骨术(图14)适用于预防慢性或复发性神经性前足溃疡。远端跖骨干骺端截骨术、远端跖骨骨干截骨术(图15)适用于各类型跖骨头下压力性溃疡的预防。改良第1跖趾关节切除成形术适用于拇趾底面溃疡的预防,拇外翻手术、Silver拇囊炎切除术(图16)适用于轻度拇外翻畸形,跖骨头“V”形骨切除术(图3)适用于中度拇外翻畸形,跖骨近端截骨+拇趾 Akin术适用于重度拇外翻畸形(图17),第5趾内翻畸形的手术方式类似拇外翻手术方式(图18)。CNO相关手术,包括骨窄切除术、足内侧柱融合术(图19)、多平面重排术及中后足关节融合术(如三关节融合术)。DFU的新发与复发多与局部高压有关,手术减压已被多项研究证实能有效预防糖尿病足患者的溃疡发生,但高质量RCT仍较少,且临床需要仔细权衡手术的风险和获益比。

 图13 跟腱延长术示意图。13A.手术切口(虚线);13B.术后肌腱

Figure 13 Schematic diagram of achilles tendon lengthening surgery

6 搭建多学科诊疗团队及构建分级诊疗体系

推荐意见46:成立多学科的保肢团队,及时向上级糖尿病足中心请求会诊和/或转诊,以降低DFU患者的截肢率和病死率(推荐强度:强,证据等级:

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 注:箭头表示骨移除

图14 背屈跖骨截骨术示意图

Figure 14 Schematic diagram of dorsiflexion metatarsal osteotomy

 图15 远端跖骨干骺端截骨术及远端跖骨骨干截骨术示意图。15A.远端跖骨干骺端截骨术,左图为“V”形截骨线,右图为骨移位方向;15B.远端跖骨骨干截骨术,左图为截骨线,右图为骨移位方向

Figure 15 Schematic diagram of distal metatarsal metaphyseal osteotomy and distal metatarsal diaphyseal osteotomy

中等)。

证据摘要:本条推荐意见的证据包括3篇系统评价和2篇观察性研究,报告了多学科治疗和及时转诊对糖尿病足患者预后的影响。关键结局指标结果:采用多学科治疗及会诊或转诊后,DFU患者的大截肢率下降到<5%、截肢风险降低24%[294]、死亡风险降低69%、全因病死率降低(比值比为0.31,95%置信区间为0.18~0.53)[295],创面愈合时间显著缩短(逆方差为-46)[294],平治疗均时间大幅缩短

 注:图16A阴影部分示切除增生骨赘

图16 Silver拇囊炎切除术示意图。16A.切断拇短屈肌和拇收肌;16B.紧缩缝合内侧关节囊

Figure 16 Schematic diagram of silver bunionectomy

 注:图17B左侧虚线图为术前,右侧实线图为术后,阴影部分为骨切除部分

图17 跖骨近端截骨+拇指Akin术示意图。17A.跖骨近端截骨术;17B.拇趾Akin术;17C.跖骨近端截骨+拇趾Akin术后

Figure 17 Schematic diagram of proximal metatarsal osteotomy+hallux Akin procedure

($P<0.001$)、血流感染率降低($P=0.04$)、血管介入率提高($P<0.01$)、门诊随访率提高($P<0.001$) [296-297]。

推荐说明:糖尿病患者一旦出现下列情况,应立即请外科医师会诊,并将患者转诊至有能力救治的科室或医院。(1)肢体皮肤颜色急剧变化(变红或变白)、皮肤温度急剧变化(变冷或变热)、疼痛加剧、不明原因进行性加重的肿胀、脓毒血症(甚至休克、意识丧失)、播散性蜂窝组织炎、坏死性筋膜炎、气性坏疽,出现以上这些情况需要在24h内将患者转诊。(2)新发深大溃疡、原有浅表溃疡恶化并累及骨质或关节、慢性骨髓炎逐渐加重、部分反复发作的有严重足畸形的足溃疡等[56]。同时,建议有多学科合作团队的糖尿病足中心,建立明确的糖尿病足诊断和处置流程,并设立急诊转诊快速通道。

目前中国尚无统一的糖尿病足分级诊疗标准。以长三角地区(以长三角一体化示范区为核心)为例,采用“长三角五级协管模式”——构建由区域中心和省、市、县三级中心及基层单位(如社区服务中心)组成的五级专病防治组织体系:患者按SINBAD

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 图18 第5趾内翻畸形及其矫正手术示意图。18A.第5趾内翻畸形示意图;18B.髁突切除术示意图(虚线为截骨线);18C.远端截骨术示意图,左图为术前(阴影部分为骨切除部分),右图为术后;18D.近端截骨术示意图,左图为截骨后螺钉固定

Figure 18 Schematic diagram of the fifth toe varus deformity and its corrective surgery

 图19 足内侧柱融合示意图

Figure 19 Schematic diagram of medial column arthrodesis of the foot

系统分级,医院按WIFI分级系统评定诊治能力,并通过信息化系统实现自动分级与分层管理,已被纳入《中国糖尿病足诊治临床路径(2023版)》[56,298]。

7 总结

总之,本指南基于PICO和GRADE系统,针对糖尿病足的预防与治疗提出46条推荐意见(推荐意见流程图见图20)。强调通过病史、体格检查和辅助检查进行综合评估,并依据感染程度、血管及神经状况制订个体化糖尿病足治疗方案,其治疗涵盖血糖、血压、血脂管理及抗感染、清创、血管重建、创面修复,同时推荐减压治疗、健康教育和外科干预以预防溃疡,并倡导多学科诊疗和分级诊疗,为临床实践提供系统指导。

《中国糖尿病足防治实践指南》编写组

见本刊2025年第11期第1042、1043页

利益冲突 本指南得到“2025年长三角生态绿色一体化发展示范区政府专项资金(区执会签[2025]0225号)”的支持,用于承担指南制订过程中的科研费、宣传费及项目组织实施等费用,且推荐意见未

受资助影响。所有编写组成员均如实填写了利益冲突声明表,不存在与指南相关的利益冲突

参考文献

(文献第1~148条见本刊2025年第11期第1043~1049页

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[154] Ning P,Liu Y,Kang J,et al.Comparison of healing effectiveness of different debridement approaches for diabetic foot ulcers: a network meta-analysis of randomized controlled trials[J].Front Public Health,2023,11:1271706.DOI:10.3389/fpubh.2023.1271706.

[155] Vas P, Rayman G, Dhatariya K, et al. Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review[J]. Diabetes Metab Res Rev, 2020,36 Suppl 1:e3284 DOI:10.1002/dmrr.3284.

[156] Tan JS,Friedman NM,Hazelton-Miller C,et al.Can aggressive treatment of diabetic foot infections reduce the need for above-ankle amputation? [J]. Clin Infect Dis, 1996, 23(2):286-291.DOI:101.1093/clinids/23.2.286.

[157] Faglia E, Clerici G, Caminiti M, et al. The role of early surgical debridement and revascularization in patients with diabetes and deep foot space abscess: retrospective review

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 注:《中国糖尿病足防治实践指南》编写组见本刊2025年第11期第1042、1043页

图20 《中国糖尿病足防治实践指南》推荐意见流程图

Figure 20 Flow chart of recommendations from the Practical guideline on the prevention and management of diabetic foot in China

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