大湾区慢性创面医护康标准化体系建设联盟,《中国科技论文》体表外科卷编辑委员会,黄广涛1,吴 军1,郇京宁1,2
(1.深圳大学第一附属医院(深圳市第二人民医院)烧伤整形科,广东深圳518000;2.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200011)
摘要:负压封闭引流技术(negative pressure wound therapy, NPWT)自2017年国内首部烧伤外科应用专家共识发布以来,其技术类型与临床应用范围均取得了显著拓展。特别是在促进各类急慢性创面愈合及预防外科手术部位感染方面,已累积了大量高质量循证证据。为整合国内外最新研究成果与临床实践经验,规范操作标准,提升治疗水平,国内创面修复相关多学科领域的专家共同撰写了本更新版共识。本共识汇聚了国内多位在创面相关的多学科领域的专家,结合国内外最新研究成果,遵循严谨的循证医学原则,采用系统综述方法,聚焦于NPWT的技术分类、适应症、参数优化及并发症处理等核心议题。工作小组系统检索了PubMed、Web of Science、IEEE Xplore及中国知网等数据库中2015—2025年相关文献,共获得791篇。经去重、筛选,并根据纳入标准(临床研究、随机对照试验、meta分析及相关共识等)最终纳入210篇文献进行证据综合与评价。本共识旨在为创面修复相关学科的临床医生提供基于最新证据、统一且可操作的治疗方案与技术规范。共识内容充分结合了我国临床实践的现状与需求,以期推动NPWT在国内的合理、规范及高效应用,最终惠及广大患者。
关键词:负压封闭引流技术;手术部位感染;创面修复;手术切口并发症
Surgical wound dehiscence (SWD), a complication of surgery, can delay wound healing, increase the economic burden of the healthcare provider, and have a negative impact on the patient’s wellbeing. The fundamental goal for the treatment of SWD is wound closure. This article describes the use of Avance® Solo, a negative pressure wound therapy system, selected as a therapy for both the prevention and treatment of dehisced closed surgical incision wounds in a patient with complex and social needs.
KEY WORDS
Negative pressure wound therapy (NPWT)
Patient wellbeing
Surgical wound dehiscence
Wound healing
LISA SUTHERLAND
MSC RN LLB(HONS), Nurse Consultant for Wound Management and Tissue Viability, Norfolk anad Norwich University Hospital; Honorary Lecturer, University of East Anglia, Norwich, UK
N Rezai
The Covid-19 pandemic, with its disruption of services and higher mortality risk has had far-reaching consequences for people with diabetes, contributing toward increased risk of rapid deterioration, ICU admissions and a worse prognosis. Covid-19 also affected access to diabetes related foot care and multidisciplinary services, with long-term implications for people who were unable to access care and attend clinic appointments during the pandemic. This review examines studies on the effect of Covid-19 on people with diabetes, foot complications associated with diabetes and service delivery.
Citation: Rezai N (2023) What are the effects of Covid-19 on diabetes and diabetic foot-related complications?. The Diabetic Foot Journal 26(1): 40–5
Key words
- Covid-19
- Foot care access
- Service provision
- Telemedicine
Article points
1. People with diabetes are more likely to be more unwell with Covid-19.
2. Foot care services were severely disrupted during the pandemic.
3. Lessons learned from the pandemic give avenues to investigate for footcare services in future.
Author
Miss Nealoofar Rezai, BSc (Hons) MRCPod, is Clinical Lead Podiatrist, Royal Free Hospital, London, UK
The SURMOUNT-2 trial was simultaneously presented at the ADA 2023 Scientific Sessions and published in the Lancet, and demonstrated that use of the dual GLP-1/GIP receptor agonist tirzepatide resulted in a mean body weight reduction of up to 14.7% after 72 weeks in people living with type 2 diabetes and comorbid obesity or excess weight. This level of weight loss has previously been associated with type 2 diabetes remission, and was also accompanied by clinically meaningful improvements in a number of cardiometabolic risk factors, including lipids, blood pressure and liver enzymes. With tirzepatide and semaglutide, we now have two compelling evidence-based pharmacological therapies with superior efficacy and safety profiles compared to previous obesity medications. However, there remains uncertainty about durability of effect and impact of withdrawal of treatment on weight loss maintenance. Amid calls to use percentage weight loss as a target biomarker in obesity (like HbA1c in diabetes, LDL-cholesterol in atherosclerotic cardiovascular disease and albuminuria in chronic kidney disease), a seismic shift in how we approach the management of obesity, with significant financial implications for healthcare systems globally, may be required.
Kevin Fernando
GP in North Berwick
Citation: Fernando K (2023) Diabetes Distilled: Treating obesity is no longer inSURMOUNTable. Diabetes & Primary Care 25: [early view publication]
The SURMOUNT-2 trial was simultaneously presented at the ADA 2023 Scientific Sessions in San Diego and published in the Lancet. The trial demonstrated that use of the dual GLP-1 and GIP receptor agonist tirzepatide resulted in a mean body weight reduction of up to 14.7% after 72 weeks in people living with type 2 diabetes and comorbid obesity or excess weight.
Moreover, around one third of participants lost over 20% of their baseline body weight. The average weight reduction with tirzepatide after 72 weeks was 14–16 kg, a level that has previously been associated with remission of type 2 diabetes (Lean et al, 2018).
With respect to glucose-lowering efficacy (a pre-specified key secondary endpoint of the trial), use of tirzepatide reduced HbA1c by 23 mmol/mol (2.1%) after 72 weeks. The mean HbA1c of trial participants at trial end was 41 mmol/mol (5.9%), reflecting, in other words, normalisation of glucose levels.
Additional benefits observed included reductions in fasting glucose and insulin levels (indicating a significant increase in insulin sensitivity); improvements in lipid profile, particularly fasting triglyceride and non-HDL cholesterol levels; a reduction in systolic blood pressure of 6–7 mmHg; and reductions in liver enzymes (notably a 35% improvement in ALT) – all clinically meaningful improvements in cardiometabolic risk factors.
SURMOUNT-2 also explored the safety profile of tirzepatide; reassuringly, the overall rate of serious adverse events was similar between the tirzepatide and placebo groups. Most treatment-emergent adverse effects with tirzepatide were, predictably, gastrointestinal in nature: most commonly nausea, diarrhoea and vomiting. However, these gastrointestinal adverse effects occurred primarily during the dose escalation period, were mostly mild to moderate in severity and decreased over time.
Importantly, there was no imbalance observed with diabetic retinopathy events, liver and gallbladder events, malignancies (including pancreatic cancer and medullary thyroid cancer) and pancreatitis, which have previously shadowed certain incretin molecules. There were also no cases of severe hypoglycaemia detected, despite the potent glucose-lowering efficacy of tirzepatide. Mean pancreatic enzyme levels were increased but remained within the normal range, which is consistent with other incretin therapies used for obesity, such as semaglutide. Overall, mean pulse rate increased by 1 bpm over 72 weeks; there was an initial rise of 4 bpm observed, which subsequently decreased.
A seismic shift is required
It is well known that people living with obesity and type 2 diabetes lose less weight than those living with obesity alone, so SURMOUNT-2 is a prodigious advance for the management of obesity and type 2 diabetes. The results of SURMOUNT-2 also surpass the compelling results with semaglutide 2.4 mg in the STEP-2 trial (Davies et al, 2021).
Obesity is now recognised as a chronic disease with multiple pathophysiological aspects; it involves more than just an increase in body mass. Like other chronic diseases, obesity is relapsing in nature and can lead to a range of complications, including cardiometabolic disease and malignancy.
Different complications require different amounts of weight loss for treatment; for example, in non-alcoholic fatty liver disease (NAFLD), 3–5% weight loss reduces hepatic steatosis, while ≥5–7% weight loss can lead to resolution of non-alcoholic steatophepatitis and ≥10% weight loss improves hepatic fibrosis (Hannah and Harrison, 2016). The 2022 ADA/EASD Consensus Report suggests that 5–10% weight loss confers metabolic improvement in type 2 diabetes, and weight loss of >10–15% can lead to remission of type 2 diabetes (Davies et al, 2022).
Percentage weight loss should now be used as a target biomarker in obesity (like HbA1c in diabetes, LDL-cholesterol in atherosclerotic cardiovascular disease and albuminuria in chronic kidney disease) to mitigate the specific complications of obesity (Garvey, 2022).
Much of current thinking for preventing and treating obesity centres around hedonic eating in combination with a sedentary lifestyle; “Eat less, move more” is commonly delivered advice to people living with obesity. However, while these are contributing factors, it is well known that pathophysiological mechanisms affecting appetite and satiety are pivotal in the development of obesity. Optimising satiety needs to be addressed early in the management of obesity, as calorie restriction alone is unlikely to be a long-term solution if there is ongoing abnormal hunger.
A seismic shift is required in how we approach the management of obesity, with increased access to weight management services and evidence based pharmacological therapies that directly impact appetite and satiety, such as semaglutide and tirzepatide.
Ongoing questions
As with all good studies, SURMOUNT-2 raises more questions than answers. What is the durability of effect of tirzepatide after 72 weeks and, crucially, what is the effect of withdrawal of tirzepatide on weight loss maintenance? The STEP-4 weight maintenance trial and STEP-1 off-treatment extension study both demonstrated weight regain after discontinuation of semaglutide, suggesting that incretin therapy is required over the long term for sustained weight loss (Rubino et al, 2021; Wilding et al, 2022). This has significant financial implications for healthcare systems globally. One solution would be a phased approach to the management of obesity, with early phases using highly efficacious obesity drugs such as tirzepatide or semaglutide and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance. Several such obesity maintenance drugs are in the early stages of development.
This approach is analogous to the treatment of rheumatoid arthritis, where often potent targeted biological therapy is used early on to achieve remission of arthritis, followed by a switch to a conventional DMARD for maintenance therapy, for reasons of long-term safety and health economics. Using this approach for obesity management might help the sustainability of healthcare systems.
Finally, what are the cardiovascular, renal and liver benefits of tirzepatide? These questions will hopefully be answered on completion of the SURPASS-CVOT, SURMOUNT-MMO and SYNERGY-NASH trials, which, unfortunately, are not due to report soon. However, positive results would facilitate targeted use of tirzepatide for people living with obesity and specific co-morbidities such as atherosclerotic cardiovascular disease, chronic kidney disease and NAFLD.
In conclusion, treatment of obesity is no longer insurmountable, with two compelling evidence-based pharmacological therapies with superior efficacy and safety profiles compared to previous obesity medications. However, there remains uncertainty about durability of effect and impact of withdrawal of treatment on weight loss maintenance. Much-needed real-world data will help resolve some of this uncertainty.
References
1. Davies M, Færch L, Jeppesen OK et al; STEP 2 study group (2021) Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): A randomised, doubleblind, double-dummy, placebo-controlled, phase 3 trial. Lancet 397: 971–84
2. Davies MJ, Aroda VR, Collins BS et al (2022) Management of hyperglycemia in type 2 diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 45: 2753–86
3. Garvey WT (2022) New horizons. A new paradigm for treating to target with second-generation obesity medications. J Clin Endocrinol Metab 107: e1339–47
4. Hannah WN Jr, Harrison SA (2016) Lifestyle and dietary interventions in the management of nonalcoholic fatty liver disease. Dig Dis Sci 61: 1365–74
5. Lean ME, Leslie WS, Barnes AC et al (2018) Primary care-led weight management for remission of type 2 diabetes (DiRECT): An open-label, cluster-randomised trial. Lancet 391: 541–51
6. Rubino D, Abrahamsson N, Davies M et al; STEP 4 investigators (2021) Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: The STEP 4 randomized clinical trial. JAMA 325: 1414–25
7. Wilding JPH, Batterham RL, Davies M et al; STEP 1 study group (2022) Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab 24: 1553–64
This article is excerpted from the Diabetes & Primary Care Vol 25 No 4 2023 by Wound World.
(10)申请公布号 CN 115812675 A
(43)申请公布日 2023.03.21
(21)申请号 202211475178 .2
(22)申请日 2022 .11 .23
(71)申请人 南方医科大学
地址 510515 广东省广州市白云区沙太南 路1023号
(72)发明人 张琳 张璐 张敏 王雪儿 卢魁 陈银燕
(74)专利代理机构 广州嘉权专利商标事务所有限公司 44205
专利代理师 齐键
(51)Int .Cl .
A01K 67/027 (2006 .01)
A61K 49/00(2006 .01)
伤口世界平台生态圈,以“关爱人间所有伤口患者”为愿景,连接、整合和拓展线上和线下的管理慢性伤口的资源,倡导远程、就近和居家管理慢性伤口,解决伤口专家的碎片化时间的价值创造、诊疗经验的裂变复制、和患者的就近、居家和低成本管理慢性伤口的问题。
2019广东省医疗行业协会伤口管理分会年会
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