2012美国感染病学会发布糖尿病足感染诊疗指南

I D S A G U I D E L I N E S 2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infectionsa Benjamin A. Lipsky,1 Anthony R. Berendt,2 Paul B. Cornia,3 James C. Pile,4 Edgar J. G. Peters,5 David G. Armstrong,6 H. Gunner Deery,7 John M. Embil,8 Warren S. Joseph,9 Adolf W. Karchmer,10 Michael S. Pinzur,11 and Eric Senneville12 1Department of Medicine, University of Washington, Veterans Affairs Puget Sound Health Care System, Seattle; 2Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust, Oxford; 3Department of Medicine, University of Washington, Veteran Affairs Puget Sound Health Care System, Seattle; 4Divisions of Hospital Medicine and Infectious Diseases, MetroHealth Medical Center, Cleveland, Ohio; 5Department of Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands; 6Southern Arizona Limb Salvage Alliance, Department of Surgery, University of Arizona, Tucson; 7Northern Michigan Infectious Diseases, Petoskey; 8Department of Medicine, University of Manitoba, Winnipeg, Canada; 9Division of Podiatric Surgery, Department of Surgery, Roxborough Memorial Hospital, Philadelphia, Pennsylvania; 10Department of Medicine, Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts; 11Department of Orthopaedic Surgery and Rehabilitation, Loyola University Medical Center, Maywood, Illinois; and 12Department of Infectious Diseases, Dron Hospital, Tourcoing, France Foot infections are a common and serious problem in persons with diabetes. Diabetic foot infections (DFIs) typically begin in a wound, most often a neuropathic ulceration. While all wounds are colonized with microorganisms, the presence of infection is defined by ≥2 classic findings of inflammation or purulence. Infections are then classified into mild (superficial and limited in size and depth), moderate (deeper or more extensive), or severe (accompanied by systemic signs or metabolic perturbations). This classification system, along with a vascular assessment, helps determine which patients should be hospitalized, which may require special imaging procedures or surgical interventions, and which will require amputation. Most DFIs are polymicrobial, with aerobic gram-positive cocci (GPC), and especially staphylococci, the most common causative organisms. Aerobic gram-negative bacilli are frequently copathogens in infections that are chronic or follow antibiotic treatment, and obligate anaerobes may be copathogens in ischemic or necrotic wounds. Wounds without evidence of soft tissue or bone infection do not require antibiotic therapy. For infected wounds, obtain a post-debridement specimen (preferably of tissue) for aerobic and anaerobic culture. Empiric antibiotic therapy can be narrowly targeted at GPC in many acutely infected patients, but those at risk for infection with antibiotic-resistant organisms or with chronic, previously treated, or severe infections usually require broader spectrum regimens. Imaging is helpful in most DFIs; plain radiographs may be sufficient, but magnetic resonance imaging is far more sensitive and specific. Osteomyelitis occurs in many diabetic patients with a foot wound and can be difficult to diagnose (optimally defined by bone culture and histology) and treat (often requiring surgical debridement or resection, and/or prolonged antibiotic therapy). Most DFIs require some surgical intervention, ranging from minor (debridement) to major (resection, amputation). Wounds must also be properly dressed and off-loaded of pressure, and patients need regular follow-up. An ischemic foot may require revascularization, and some nonresponding patients may benefit from selected adjunctive measures. Employing multidisciplinary foot teams improves outcomes. Clinicians and healthcare organiz- ations should attempt to monitor, and thereby improve, their outcomes and processes in caring for DFIs. Received 21 March 2012; accepted 22 March 2012. aIt is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances. Correspondence: Benjamin A. Lipsky, MD, University of Washington, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA 98108 (balipsky@uw.edu). Clinical Infectious Diseases 2012;54(12):132–173 Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2012. DOI: 10.1093/cid/cis346 e132 • CID 2012:54 (15 June) • Lipsky et al by guest on June 4, 2012 http://cid.oxfordjournals.org/ D ow nloaded from ? ? ? w w w . m edl i v e. cn EXECUTIVE SUMMARY Diabetic foot infections (DFIs) are a frequent clinical problem. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnos- tic and therapeutic approaches. Infection in foot wounds should be defined clinically by the presence of inflammation or purulence, and then classified by severity. This approach helps clinicians make decisions about which patients to hospi- talize or to send for imaging procedures or for whom to rec- ommend surgical interventions. Many organisms, alone or in combinations, can cause DFI, but gram-positive cocci (GPC), especially staphylococci, are the most common. Although clinically uninfected wounds do not require anti- biotic therapy, infected wounds do. Empiric antibiotic regi- mens must be based on available clinical and epidemiologic data, but definitive therapy should be based on cultures of infected tissue. Imaging is especially helpful when seeking evidence of underlying osteomyelitis, which is often difficult to diagnose and treat. Surgical interventions of various types are often needed and proper wound care is important for successful cure of the infection and healing of the wound. Patients with a DFI should be evaluated for an ischemic foot, and employing multidisciplinary foot teams improves outcomes. Summarized below are the recommendations made in the new guidelines for diabetic foot infections. The expert panel followed a process used in the development of other Infectious Diseases Society of America (IDSA) guidelines, which in- cluded a systematic weighting of the strength of recommen- dation and quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system [1–6] (Table 1). A detailed description of the methods, background, and evidence summaries that support each of the recommendations can be found online in the full text of the guidelines. RECOMMENDATIONS FOR MANAGING DIABETIC FOOT INFECTIONS I. In which diabetic patients with a foot wound should I suspect infection, and how should I classify it? Recommendations 1. Clinicians should consider the possibility of infection oc- curring in any foot wound in a patient with diabetes (strong, low). Evidence of infection generally includes classic signs of inflammation (redness, warmth, swelling, tenderness, or pain) or purulent secretions, but may also include additional or sec- ondary signs (eg, nonpurulent secretions, friable or discolored granulation tissue, undermining of wound edges, foul odor) (strong, low). 2. Clinicians should be aware of factors that increase the risk for DFI and especially consider infection when these factors are present; these include a wound for which the probe-to-bone (PTB) test is positive; an ulceration present for >30 days; a history of recurrent foot ulcers; a traumatic foot wound; the presence of peripheral vascular disease in the af- fected limb; a previous lower extremity amputation; loss of protective sensation; the presence of renal insufficiency; or a history of walking barefoot (strong, low). 3. Clinicians should select and routinely use a validated classification system, such as that developed by the International Working Group on the Diabetic Foot (IWGDF) (abbreviated with the acronym PEDIS) or IDSA (see below), to classify infec- tions and to help define the mix of types and severity of their cases and their outcomes (strong, high). The DFI Wound Score may provide additional quantitative discrimination for research purposes (weak, low). Other validated diabetic foot classification schemes have limited value for infection, as they describe only its presence or absence (moderate, low). II. How should I assess a diabetic patient presenting with a foot infection? Recommendations 4. Clinicians should evaluate a diabetic patient presenting with a foot wound at 3 levels: the patient as a whole, the af- fected foot or limb, and the infected wound (strong, low). 5. Clinicians should diagnose infection based on the pres- ence of at least 2 classic symptoms or signs of inflammation (erythema, warmth, tenderness, pain, or induration) or puru- lent secretions. They should then document and classify the severity of the infection based on its extent and depth and the presence of any systemic findings of infection (strong, low). 6. We recommend assessing the affected limb and foot for arterial ischemia (strong, moderate), venous insufficiency, presence of protective sensation, and biomechanical problems (strong, low). 7. Clinicians should debride any wound that has necrotic tissue or surrounding callus; the required procedure may range from minor to extensive (strong, low). III. When and from whom should I request a consultation for a patient with a diabetic foot infection? Recommendations 8. For both outpatients and inpatients with a DFI, clini- cians should attempt to provide a well-coordinated approach by those with expertise in a variety of specialties, preferably by a multidisciplinary diabetic foot care team (strong, moderate). Where such a team is not yet available, the primary treating clinician should try to coordinate care among consulting specialists. IDSA Guideline for Diabetic Foot Infections • CID 2012:54 (15 June) • e133 by guest on June 4, 2012 http://cid.oxfordjournals.org/ D ow nloaded from ? ? ? w w w . m edl i v e. cn 9. Diabetic foot care teams can include (or should have ready access to) specialists in various fields; patients with a DFI may especially benefit from consultation with an infec- tious disease or clinical microbiology specialist and a surgeon with experience and interest in managing DFIs (strong, low). 10. Clinicians without adequate training in wound debridement should seek consultation from those more qualified for this task, especially when extensive procedures are required (strong, low). 11. If there is clinical or imaging evidence of significant ischemia in an infected limb, we recommend the clinician Table 1. Strength of Recommendations and Quality of the Evidence Strength of Recommendation and Quality of Evidence Clarity of Balance Between Desirable and Undesirable Effects Methodological Quality of Supporting Evidence (Examples) Implications Strong recommendation, high-quality evidence Desirable effects clearly outweigh undesirable effects, or vice versa Consistent evidence from well-performed RCTs or exceptionally strong evidence from unbiased observational studies Recommendation can apply to most patients in most circumstances. Further research is unlikely to change our confidence in the estimate of effect Strong recommendation, moderate-quality evidence Desirable effects clearly outweigh undesirable effects, or vice versa Evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from unbiased observational studies Recommendation can apply to most patients in most circumstances. Further research (if performed) is likely to have an important impact on our confidence in the estimate of effect and may change the estimate Strong recommendation, low-quality evidence Desirable effects clearly outweigh undesirable effects, or vice versa Evidence for at least 1 critical outcome from observational studies, RCTs with serious flaws or indirect evidence Recommendation may change when higher-quality evidence becomes available. Further research (if performed) is likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Strong recommendation, very low-quality evidence (very rarely applicable) Desirable effects clearly outweigh undesirable effects, or vice versa Evidence for at least 1 critical outcome from unsystematic clinical observations or very indirect evidence Recommendation may change when higher-quality evidence becomes available; any estimate of effect for at least 1 critical outcome is very uncertain Weak recommendation, high-quality evidence Desirable effects closely balanced with undesirable effects Consistent evidence from well- performed RCTs or exceptionally strong evidence from unbiased observational studies The best action may differ depending on circumstances or patients or societal values. Further research is unlikely to change our confidence in the estimate of effect Weak recommendation, moderate-quality evidence Desirable effects closely balanced with undesirable effects Evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from unbiased observational studies Alternative approaches likely to be better for some patients under some circumstances. Further research (if performed) is likely to have an important impact on our confidence in the estimate of effect and may change the estimate Weak recommendation, low-quality evidence Uncertainty in the estimates of desirable effects, harms, and burden; desirable effects, harms, and burden may be closely balanced Evidence for at least 1 critical outcome from observational studies, RCTs with serious flaws, or indirect evidence Other alternatives may be equally reasonable. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Weak recommendation, very low-quality evidence Major uncertainty in the estimates of desirable effects, harms, and burden; desirable effects may or may not be balanced with undesirable effects or may be closely balanced Evidence for at least 1 critical outcome from unsystematic clinical observations or very indirect evidence Other alternatives may be equally reasonable. Any estimate of effect, for at least 1 critical outcome, is very uncertain Abbreviation: RCT, randomized controlled trial. e134 • CID 2012:54 (15 June) • Lipsky et al by guest on June 4, 2012 http://cid.oxfordjournals.org/ D ow nloaded from ? ? ? w w w . m edl i v e. cn consult a vascular surgeon for consideration of revasculariza- tion (strong, moderate). 12. We recommend that clinicians unfamiliar with pressure off-loading or special dressing techniques consult foot or wound care specialists when these are required (strong, low). 13. Providers working in communities with inadequate access to consultation from specialists might consider devising systems (eg, telemedicine) to ensure expert input on managing their patients (strong, low). IV. Which patients with a diabetic foot infection should I hospitalize, and what criteria should they meet before I discharge them? Recommendations 14. We recommend that all patients with a severe infection, selected patients with a moderate infection with complicating features (eg, severe peripheral arterial disease [PAD] or lack of home support), and any patient unable to comply with the required outpatient treatment regimen for psychological or social reasons be hospitalized initially. Patients who do not meet any of these criteria, but are failing to improve with out- patient therapy, may also need to be hospitalized (strong, low). 15. We recommend that prior to being discharged, a patient with a DFI should be clinically stable; have had any urgently needed surgery performed; have achieved acceptable glycemic control; be able to manage (on his/her own or with help) at the designated discharge location; and have a well- defined plan that includes an appropriate antibiotic regimen to which he/she will adhere, an off-loading scheme (if needed), specific wound care instructions, and appropriate outpatient follow-up (strong, low). V. When and how should I obtain specimen(s) for culture from a patient with a diabetic foot wound? Recommendations 16. For clinically uninfected wounds, we recommend not collecting a specimen for culture (strong, low). 17. For infected wounds, we recommend that clinicians send appropriately obtained specimens for culture prior to starting empiric antibiotic therapy, if possible. Cultures may be unnecessary for a mild infection in a patient who has not recently received antibiotic therapy (strong, low). 18. We recommend sending a specimen for culture that is from deep tissue, obtained by biopsy or curettage after the wound has been cleansed and debrided. We suggest avoiding swab specimens, especially of inadequately debrided wounds, as they provide less accurate results (strong, moderate). VI. How should I initially select, and when should I modify, an antibiotic regimen for a diabetic foot infection? (See question VIII for recommendations for antibiotic treatment of osteomyelitis) Recommendations 19. We recommend that clinically uninfected wounds not be treated with antibiotic therapy (strong, low). 20. We recommend prescribing antibiotic therapy for all infected wounds, but caution that this is often insuffi- cient unless combined with appropriate wound care (strong, low). 21. We recommend that clinicians select an empiric anti- biotic regimen on the basis of the severity of the infection and the likely etiologic agent(s) (strong, low). a. For mild to moderate infections in patients who have not recently received antibiotic treatment, we suggest that therapy just targeting aerobic GPC is sufficient (weak, low). b. For most severe infections, we recommend starting broad-spectrum empiric antibiotic therapy, pending culture results and antibiotic susceptibility data (strong, low). c. Empiric therapy directed at Pseudomonas aeruginosa is usually unnecessary except for patients with risk factors for true infection with this organism (strong, low). d. Consider providing empiric therapy directed against methicillin-resistant Staphylococcus aureus (MRSA) in a patient with a prior history of MRSA infection; when the local prevalence of MRSA colonization or infection is high; or if the infection is clinically severe (weak, low). 22. We recommend that definitive therapy be based on the results of an appropriately obtained culture and sensitivity testing of a wound specimen as well as the patient’s clinical response to the empiric regimen (strong, low). 23. We suggest basing the route of therapy largely on infec- tion severity. We prefer parenteral therapy for all severe, and some moderate, DFIs, at least initially (weak, low), with a switch to oral agents when the patient is systemically well and culture results are available. Clinicians can probably use highly bioavailable oral antibiotics alone in most mild, and in many moderate, infections and topical therapy for selected mild superficial infections (strong, moderate). 24. We suggest continuing antibiotic therapy until, but not beyond, resolution of findings of infection, but not through complete healing of the wound (weak, low). We suggest an initial antibiotic course for a soft tissue infection of about 1–2 weeks for mild infections and 2–3 weeks for moderate to severe infections (weak, low). IDS