Pain, Intractable

本病例由北京世纪坛医院的魏德华教授提供，该患者为糖尿病足（wagner 1级）患者，经过清创术、常规血糖控制及护理，在使用一种外用中成药膏无明显效果的情况下，换用香雷糖足膏治疗后，足溃疡痊愈。 病例分享专家 魏德华 硕士研究生，医师 研究方向：糖尿病足，慢性创面治疗 单位：首都医科大学附属北京世纪坛医院 矫形外科（糖尿病足中心） 01 基本信息 患者，侯某，性别：男性，年龄：57岁 主诉 右足第5趾和右足跟破溃、渗液3个月余 现病史 患者于3个月前无明显诱因出现右足第5趾和右足跟破溃、渗液，后右足第5趾远端出现发黑，当时未重视，家中予碘伏换药治疗后症状无明显缓解，来我院急诊就诊，以“糖尿病性足坏疽，2型糖尿病足（wagner 1级）”收住院。 既往史 既往有2型糖尿病、高血压、高脂血症、冠心病病史10余年，具体用药不详，足部慢性顽固性疼痛，10年前行冠脉支架置入术，半年余前行双下肢动脉扩张成形术支架置入术，否认传染病史，否认外伤史，否认输血史，否认食物、药物过敏史。 体格检查 右足第5趾发黑，基底部挤压见少量黄褐色脓液流出，局部肿胀；右足跟外侧见大小约3cm*2cm创面，表面见脓性分泌物附着，深达真皮层，周围明显红肿，皮温高。右侧足背动脉、胫后动脉未扪及，趾端血运可，左侧足背动脉、胫后动脉搏动弱，左足皮温低，双小腿及足部感觉减退。 入院诊断 1. 2型糖尿病性周围血管病及坏疽 2. 2型糖尿病足（wagner 1级） 3. 2型糖尿病 4. 下肢动脉粥样硬化闭塞症 5. 冠状动脉粥样硬化性心脏病 6. 高血压病2级（极高危） 7. 冠状动脉支架植入术后 8. 慢性顽固性疼痛 治疗经过 常规血糖控制、营养支持、抗感染及护理基础上，进行足跟部创面局部清创，加用创口恢复药物治疗，在使用外用中成药膏治疗2天后，患者反馈伤口略微恶化，更换为香雷糖足膏治疗，每日一次，整个疗程使用量为三分之一支（约15g），约2周后，患者痊愈，未发现不良反应，患者反馈良好，予以出院。 左右滑动查看｜治疗前后状况 使用香雷糖足膏后溃疡面积随时间的变化 使用香雷糖足膏后溃疡面积随治疗周期的变化 02 专家分析1 糖尿病患者容易发生多种并发症，其中糖尿病足溃疡(DFU)是导致患者截肢和死亡的重要因素。Wagner分级是一种常用的糖尿病足病评估系统，用于评估糖尿病患者足部溃疡和糖尿病足部感染的严重程度。目前治疗DFU的常规方法包括局部清创引流、扩张血管、控制感染以及促进创面溃疡愈合，但创面保护、避免恶化及促进溃疡愈合仍是目前治疗的重难点1。 该患者为57岁男性，已有糖尿病史10年，因右足小趾和右足跟溃烂就诊，诊断为W1级糖尿病足。常规血糖控制及护理基础上，起初使用外用中成药膏，患者反馈不佳，创口未有明显改善，换用香雷糖足膏两周后痊愈，未发现不良反应。 香雷糖足膏成份为到手香提取物、积雪草总苷，研究2证实，到手香提取物通过阻断p65NF-κB激活来抑制脂多糖（LPS）诱导步骤，同时还抑制LPS诱导的细胞中ATP诱导的信号通路，包括对ACS二聚和寡聚、K+外排反应，以及半胱天冬酶-1、白细胞介素（IL）-1β和IL-18的释放反应的抑制。通过调节 M1/M2 巨噬细胞间的平衡达到治疗糖足溃疡效果。该病例中，整个治疗过程中患者反馈良好，临床评价较好。 03 专家分析2 糖尿病足致残、致死率高，治疗的医疗费用高，会造成沉重的家庭及社会负担3。而传统治疗在促进DFU伤口愈合方面的效果较差，DFU患者常病情反复、伤口迟延愈合，易导致截肢等不良后果4。 该病例为老年男性患者，糖尿病史为10年，因W1级糖尿病足入院，右足跟溃疡清创术后为开放伤口，治疗的难点在于患者病史较长且血糖控制欠佳，溃疡面恢复较慢，经一种外用药物治疗后无明显改善。 香雷糖足膏是1.1类天然药物，是DFU的一种难愈性创面突破性疗法，《糖尿病足溃疡创面治疗专家共识(2024)》5指出，香雷糖足膏通过抑制NOD样受体热蛋白结构域相关蛋白3（NLRP3）炎症小体与下游炎症因子［白细胞介素（IL）-6、肿瘤坏死因子（TNF）-α、IL-1β］表达，抑制M1型巨噬细胞极化，并活化脂肪祖细胞分泌粒细胞集落刺激因子(G-CSF) 与CXC基序趋化因子配体3（CXCL3），促进M2a / M2c型巨噬细胞极化，从而控制创面炎症并快速进入增生期，达到促进溃疡愈合的作用。在本病例中，患者右足跟处行清创术，在常规血糖控制及护理基础上，换用香雷糖足膏治疗显示出显著的疗效。当然，应注意的是，香雷糖足膏的使用频次按照说明书为每日两次。 04 专家简介 第一位点评专家  王江宁 教授 教授、博士生导师 首都医科大学博士研究生导师，辽宁中医药大学博士研究生导师，首都医科大学附属北京世纪坛医院矫形外科主任 首都医科大学附属北京世纪坛医院中西医结合糖尿病足治疗中心主任 首都医科大学(科技园)临床医学工程转化研究所所长 学术任职: 享受国务院特殊津贴（国务院特殊贡献专家）；          卫生部首批科普专家（全国骨科共十二位专家）；          世界国际医学保肢协会副主席；           世界国际医学保肢协会中国区主席；          中华预防医学会组织感染与损伤防治与控制专业委员会全国主任委员；          教育部及北京市科技进步奖行评专家；          国家自然科学基金评审专家；          北京市卫计委糖尿病足知名专家团队首席专家。 发表国家级医学核心期刊论文100余篇，以第一作者及通讯作者发表SCI收录文章60余篇。主编书籍6部，主译书籍2部，承担国家科技部重点研发计划2项，国家自然基金项目3项，首都临床特色应用研究与成果推广项目3项，拥有发明专利5项，实用新型专利10项。从医40余年，有二项手术填补国际空白，有二项科研成果填补国内空白，是中国治疗糖尿病足、褥疮难愈合创面及小儿麻痹后遗症、脑瘫后遗症畸形矫正的顶级专家。 第二位点评专家 王方明 教授 医学硕士，主任医师 解放军总医院工作20余年 曾经到武汉第三医院、积水潭医院整、北医三医院、宣武医院进修烧伤整形、显微外科、血管外科 从事烧伤整形、创面修复、周围血管外科临床一线工作30余年，积累了丰富临床经验，善于应用各种皮瓣修复复杂难愈合创面；善于进行外周血管的介入治疗，对糖尿病足的治疗具有丰富经验。 擅长主治： 1、糖尿病及并发双下肢麻木、疼痛、畏冷及糖尿病足等； 2、压疮（褥疮）。 3下肢静脉性溃疡（静脉曲张性溃疡）、脉管炎、下肢混合性溃疡（老烂腿）。 4、各种原因导致的慢性创面不愈合； 5、动脉性疾病：动脉硬化性闭塞症、糖尿病足、肾动脉狭窄、颈动脉狭窄、血栓闭塞性脉 管炎、急性动脉栓塞、多发性大动脉炎、皮肤血管炎、雷诺氏病(症)等； 6、静脉疾病：深静脉血栓形成、下肢静脉功能不全、静脉曲张、浅静脉炎等 参考文献 1、王艳,李岩岩,孙照阳.VSD技术联合rb-bFGF治疗Wagner2级糖尿病足溃疡的效果[J].临床医学,2024,44(07):39-41.DOI:10.19528/j.issn.1003-3548.2024.07.012. 2、Leu WJ, Chen JC, Guh JH. Extract From Plectranthus amboinicus Inhibit Maturation and Release of Interleukin 1β Through Inhibition of NF-κB Nuclear Translocation and NLRP3 Inflammasome Activation. Front Pharmacol. 2019 May 28;10:573. doi: 10.3389/fphar.2019.00573. PMID: 31191313; PMCID: PMC6546882. 3、中华医学会糖尿病学分会, 中华医学会感染病学分会, 中华医学会组织修复与再生分会. 中国糖尿病足防治指南(2019版)(I). 中华糖尿病杂志 2019, 11(2):92-108. 4、陈耀楠, 等. 糖尿病足溃疡慢性伤口的形成机制及新型敷料的研究进展 [J] . 中华糖尿病杂志, 2023, 15(2) : 199-203. 5、中华医学会内分泌学分会,中国内分泌代谢病专科联盟.糖尿病足溃疡创面治疗专家共识(2024)[J].中华内分泌代谢杂志, 2024, 40(07):565-569.DOI:10.3760/cma.j.cn311282-20240625-00281. 免责声明：本文仅作最新前沿信息交流之目的，文中所有观点不代表梅斯医学立场，亦不代表梅斯医学支持或反对文中观点。如需获得治疗方案指导，请前往正规医院就诊！

HFX AdaptivAI combines insights from over 100,000 patients and more than 100 million data points¹ and leverages artificial intelligence (AI) to deliver responsive and personalized pain relief in real time* REDWOOD CITY, Calif., Sept. 24, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the U.S. Food and Drug Administration (FDA) approval and limited market release of HFX iQ™ with HFX AdaptivAI™ – a responsive, personalized pain management platform powering the HFX iQ spinal cord stimulation (SCS) system. Continue Reading HFX AdaptivAI™ powering HFX iQ™, the only AI-enabled spinal cord stimulation system. Image courtesy of Nevro Corp. Building on a foundation of landmark evidence2, clinical research and big data, HFX AdaptivAI is the only technology with artificial intelligence (AI) to provide patients suffering from chronic pain with an unprecedented level of personalized, responsive pain relief. "Nevro is further establishing its position as the leading developer of data-driven solutions for pain management through the launch of HFX iQ with HFX AdaptivAI," said Kevin Thornal, Nevro's CEO and president. "HFX AdaptivAI delivers personalized pain relief, utilizing AI and leveraging millions of data points and ten years of innovation and patient care. We believe this new solution is a major milestone, and it demonstrates our dedication to freeing patients from the burden of chronic pain through evidence-based therapies that transform patients' lives. Importantly, HFX AdaptivAI puts patients in control of their pain relief while, at the same time, providing physicians the ability to monitor their patient's pain journey – closing the loop that matters." "HFX AdaptivAI is a significant leap forward in pain management," said Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist at The University of Kansas Health System. "Drawing from landmark evidence and big data, this technology has the potential to offer patients a faster and more sustainable approach to pain relief. HFX AdaptivAI is on the right path to make a lasting impact on how we manage chronic pain and improve patient outcomes." HFX AdaptivAI Offers: Relief and Beyond: HFX AdaptivAI is engineered to maximize pain relief over time by continuing to optimize therapy even when pain relief over 50% has been achieved1. Bipole Interlacing™: Proprietary technology creates customized therapy programs in real-time using direct patient input1**. Smart Power: Through therapy optimization, advanced Smart Power technology allows patients to charge their device as little as six times per year3. Enhanced Real-Time Insights: HFX AdaptivAI technology gathers real-time quality of life (QoL) metrics and device data, enabling more impactful patient-clinician interactions. This real-time information helps patients report pain relief in significantly less time than with traditional programming¹. Advanced Proactive Remote Monitoring: With the launch of HFX AdaptivAI, physicians will have the ability to remotely monitor each of their patient's pain journey in real time through Nevro's healthcare provider portal. "Chronic pain is a dynamic, biopsychosocial human condition unique to each individual4," said Dr. David Caraway, MD, PhD, Nevro's chief medical officer. "To effectively treat suffering – as perceived by each patient – therapies must be personalized based on the changing experience of pain. Only HFX AdaptivAI seeks to engage with the patient and personalize the SCS therapy in real time using evidence based on algorithms and multi-dimensional metrics of pain relief, function and satisfaction." Nevro noted that it expects to launch its full market release of HFX iQ with HFX AdaptivAI in the U.S. in the fourth quarter of 2024. For more information on HFX AdaptivAI, please visit . Internet Posting of Information Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at . The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro. About Nevro Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy. Senza®, Senza II®, Senza Omnia™, and HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with Nevrocloud™ insights for enhanced patient and practice management. SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX AdaptivAI, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. Bluetooth® and the Bluetooth symbol are registered trademarks of their respective owners. *HFX AdaptivAI™ technology includes an advanced algorithm with an ability to interlace bipoles. Senza HFX iQ uses a fixed set of instructions to provide optimized treatment recommendations that utilize direct patient input from assessments on pain and quality of life measures. Big data refers to Nevro's internal cloud database. **HFX AdaptivAI™ customized programs are pre-defined parameters programmed by the physician. To learn more about Nevro, please visit our website at and connect with us on  LinkedIn,  Twitter,  Facebook and  Instagram. 1 Data on file. 2 Kapural, L., et al. (2016). Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery, 79(5), 667–677. Patel, N.P., et al. (2023). Durable responses at 24 months with high-frequency spinal cord stimulation for nonsurgical refractory back pain. J Neurosurg Spine:1-11. Petersen, E., et al. (2023). Long-Term Efficacy of High-Frequency (10 kHz) Spinal Cord Stimulation for the Treatment of Painful Diabetic Neuropathy: 24-Month Results of a Randomized Controlled Trial. Diabetes Research and Clinical Practice, 110865. To learn more about Nevro's landmark publications, please visit the company's Publications page on its website. 3 Data on file, 3% PD 10 KHz 30 μs 2.0 mA 20 secs 10mins 800 Ohms. 4 Deer T.R., Caraway D.L., Wallace M.S. 2014. A Definition of Refractory Pain to Help Determine Suitability for Device Implantation. Neuromodulation 2014; 17: 711–715 Forward-Looking Statements In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that HFX AdaptivAI™ is the future of SCS therapy and keeps Nevro firmly at the forefront of innovation. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on February 23, 2024, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. Investors and Media: Angie McCabe Vice President, Investor Relations & Corporate Communications [email protected] SOURCE Nevro Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

For millions suffering from chronic pain, relief often comes with a host of complications. But a new generation of spinal cord stimulators aims to change that. BackStop Neural is developing thin, softening epidural leads for chronic arm and neck pain and won a two-year, $485k Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support continued development. A softer touch for spinal cord stimulation Founded in 2018, BackStop Neural specializes in spinal cord stimulation systems. The company’s recent NIH funding will back the development of stimulators that use tiny electrodes to interrupt pain signals before they hit the brain. The company’s website describes them as “stable, high charge-injection capacity titanium nitride electrodes.” One novel element in the design is the lead, the component that delivers the electrical stimulation. The company said its paddle-type epidural stimulation lead is 10 times thinner than commercially available products. “This lead is made with a proprietary polymer that is stiff for implantation but softens once implanted, ensuring close contact with the spinal cord for stable and efficient stimulation and insertion into the narrower cervical space,” the company said in a news release. “Spinal cord stimulation (SCS) is effective in the treatment of chronic, intractable pain of the trunk and/or limbs due to a variety of neuropathic pain conditions including failed back surgery syndrome, complex regional pain syndrome, and painful diabetic neuropathy,” the company later continued. “However, it is still underutilized as a therapy partly due to SCS leads not being well suited to placement in the cervical epidural space. BackStop Neural’s softening lead may improve the risk profile of placement in regions with less epidural space, such as the cervical region, to increase patient eligibility and expand the use of SCS in the current standard of care for chronic pain patients.” Balancing rigidity and flexibility “Our team has worked tirelessly to develop a lead that combines the best of both worlds—rigidity for implantation and flexibility for long-term use,” Chief Medical Officer Dr. Jason Carmel said in the news release, adding that the lead has “the potential to reduce the risk of the surgical procedure but also enhances the overall effectiveness of the therapy.” Neurosurgeon Dr. Steven Falowski, a member of BackStop Neural’s advisory board, said the technology “could transform how we approach chronic pain management.” “The ability to maintain consistent contact with the spinal cord could lead to more reliable pain relief and potentially reduce the need for repeated adjustments or revisions,” he said in the release. The NIH grant will enable BackStop Neural to conduct testing of the new lead, including evaluating its mechanical and electrical stability, biocompatibility, and effectiveness in a pre-clinical animal study. BackStop is eligible for Phase II of the grant, which would provide an additional $2 to $3 million if granted. The company was founded by experts with diverse backgrounds. CEO Connie Manz previously conducted research at MIT, Draper and UT Dallas. President Walter Voit is a serial entrepreneur and tenured professor at UT Dallas. Carmel is a neurologist and motor systems neuroscientist at Columbia University.