作者投稿
专家审稿
编辑办公
邮件订阅
RSS
2024 Consensus Guidelines on Spinal Cord Stimulation for Chronic Pain Management Among Practicing Pain Physicians in China and the United States
-
摘要: 脊髓电刺激(spinal cord stimulation, SCS)是一种新兴的神经调控疗法，近年来在慢性疼痛治疗中发挥了重要作用。为进一步规范、优化SCS在慢性疼痛管理中的应用，同时为疼痛科医生提供SCS治疗相关的最新循证医学证据与建议，2024中美SCS管理慢性疼痛共识工作组参考RIGHT指南制定方法，对SCS在慢性疼痛管理领域的文献进行系统回顾，并结合最新研究证据，在SCS适应证与禁忌证，患者选择、筛查及宣教，测试期与植入期注意事项，并发症及其处理方法等方面达成了一致意见，形成《脊髓电刺激管理慢性疼痛中美专家共识(2024)》。本共识根据美国预防服务工作组分级指南，给出了相应的净获益证据等级和推荐强度，为SCS在慢性疼痛治疗中的应用提供了最新依据。Abstract: In recent years, Spinal Cord Stimulation (SCS) has emerged as a pivotal intervention in chronic pain management. The judicious utilization of SCS is paramount for effective clinical outcomes. The 2024 Consensus Working Group on SCS Management of Chronic Pain, spanning experts from China and the United States, undertook a comprehensive literature review guided by the RIGHT framework. This review addressed SCS's role in chronic pain management, focusing on indications and contraindications, patient selection processes, education, considerations during trial and implantation phases, and strategies for managing complications. Leveraging the United States Preventive Services Task Force's grading guidelines, this consensus offers evidence-based recommendations aimed at enhancing SCS application in chronic pain management. This guideline seeks to equip pain physicians across all levels with the most current evidence, thereby refining SCS practices for optimal patient outcomes.作者贡献：本共识由2024中美脊髓电刺激管理慢性疼痛共识工作组发起；许继军组织建立共识工作组，并进行共识讨论协调工作；李静、许继军共同起草共识初稿并针对专家意见予以修订；陶高见、肖红、肖礼祖、金晓红、刘爱军、冯智英、陈付强、黄乔东、姚明、王志萍、许力、林嘉祥、徐威廉、蒋晓刚、王文宝、孙卓、程建国、黄宇光共同参与推荐意见商讨与修订工作。所有参与者均对共识终稿表示认同。利益冲突：所有参与共识制订的专家组成员均声明不存在利益冲突共识工作组组长：许继军秘书：李静成员(按姓氏首字母排序)：陈付强(青岛市市立医院疼痛科)，程建国(美国克利夫兰医学中心疼痛科)，冯智英(浙江大学医学院附属第一医院疼痛科)，黄乔东(广东省第二人民医院疼痛科)，黄宇光(中国医学科学院北京协和医院麻醉科)，蒋晓刚(美国俄亥俄州阿德纳骨科和脊柱研究所)，金晓红(苏州大学附属第一医院疼痛科)，李静(南京大学医学院附属鼓楼医院疼痛科)，林嘉祥(台湾省台北医学大学-双和医院疼痛中心)，刘爱军(中国人民解放军总医院神经外科医学部)，孙卓(美国乔治亚州立医学院麻醉与围手术期医学系)，陶高见(南京大学医学院附属鼓楼医院疼痛科)，王文宝(美国贝勒大学康复研究所)，王志萍(徐州医科大学附属医院麻醉科)，肖红(四川大学华西医院疼痛科)，肖礼祖(深圳市南山医院疼痛科)，徐威廉(美国乔治亚查理·诺伍德退伍军人医院外科疼痛医学部)，许继军(美国克利夫兰医学中心疼痛科)，许力(中国医学科学院北京协和医院麻醉医学科)，姚明(嘉兴大学附属医院疼痛科)
-
表 1 净获益证据等级定义
Table 1. Definition of evidence level of net benefit
证据等级 定义 高 现有证据通常来自对具有代表性的初级保健人群进行精心设计的研究方案，通过严格执行获得的研究结果，且不同研究之间的结论具有高度一致性；这些研究评估了医疗服务对健康结果的影响，结论不太可能受未来研究结果的强烈影响 中 现有证据可确定该医疗服务对健康结局的影响，但受下列因素的影响：①单个研究的数量、规模及质量；②不同研究之间结论不一致；③研究结论在初级医疗实践中适用性有限；④证据链缺乏连贯性随着研究资料的积累，医疗服务实际效果的强度或方向可发生变化，而此种变化可能改变目前的结论 低 现有证据不足以评估该医疗服务对健康结局的影响，下列因素可能导致证据不足：①研究数量或规模受限；②研究设计或方法存有重大缺陷；③不同研究之间结论不一致；④证据链缺陷；⑤研究结果在初级医疗保健中不适用；⑥缺乏关于重要健康结局的信息。更多的研究数据可能有助于评估该医疗服务对健康结局的影响 
下载: 导出CSV
表 2 推荐强度定义和实践建议
Table 2. Definition of recommendation strength and practical suggestions
等级 定义 实践建议 A 推荐该医疗服务，高级别证据表明有显著净获益 提供该医疗服务 B 推荐该医疗服务，高级别证据表明有中等程度净获益或中等级别证据表明有中等至显著的净获益 提供该医疗服务 C 建议根据医师经验和患者意愿有选择性地向患者提供该医疗服务，至少有中等级别证据表明存在少量净获益 根据具体情况为特定的患者提供该医疗服务 D 建议不使用该医疗服务，有中等或高级别证据表明该医疗服务无净获益或风险大于获益 不建议使用该医疗服务 I 由于证据缺乏、质量差或相互矛盾，目前的证据不足以评估该医疗服务获益与风险间的关系 如提供该医疗服务，患者应了解其获益和风险的不确定性
下载: 导出CSV
表 3 SCS装置感染的预防和管理建议
Table 3. Recommendations for prevention and management of SCS devices infections
术前 术中 术后 (1)SCS测试和植入术前，识别并治疗患者存在的所有远期感染
(2)优化SCS植入术患者的血糖控制
(3)劝导患者戒烟
(4)通过鼻用莫匹罗星软膏和氯己定药浴对MSSA和MSRA携带患者进行去定植
(5)SCS测试和植入术前1 h内预防性使用抗生素(除万古霉素外)，并根据患者体质量确定抗生素用量
(6)必要时于术前采用电动剪刀剃除患者头发
(7)SCS测试和植入术前，术者使用合适的杀菌剂进行至少2~5 min的手消毒
(8)术者保持指甲修剪短，不建议佩戴手部或臂部饰物(包括美甲)进行SCS测试和植入术(1)SCS测试和植入术期间术者穿无菌服，戴手套(如有可能，可戴双层手套)和外科口罩，戴帽子或头巾以完全遮挡头发
(2)使用有效的皮肤杀菌剂对术区进行消毒
(3)如使用切口保护膜，则建议在SCS植入术时使用含碘的保护膜
(4)在含层流和高效过滤器的手术间行SCS植入术
(5)SCS测试和植入术期间保持手术室门关闭，并限制人员流动
(6)减少组织创伤，充分止血，消除死腔，避免组织表面电灼
(7)在缝合切口前，使用生理盐水充分冲洗
(8)应尽可能缩短手术持续时间(1)SCS测试和植入术后应用封闭性敷料24~48 h
(2)不建议在正常愈合的手术创口上常规使用局部抗生素
(3)了解植入式器械手术部位深部感染的最长时间(植入后1年)
(4)SCS测试和植入术后24 h停用抗生素
(5)向患者和家属进行正确的切口护理宣教，使其了解SSI症状及报告症状的重要性
(6)使用无菌技术更换敷料，且在更换敷料前进行手清洁
(7)当怀疑有SSI时，应采用能覆盖可能致病菌的抗生素；在选择抗生素时应考虑细菌耐药情况，必要时进行细菌培养SCS(spinal cord stimulation)：脊髓电刺激；MSSA(Methicillin-susceptible Staphylococcus aureus)：甲氧西林敏感的金黄色葡萄球菌；MRSA(Methicillin-resistant Staphylococcus aureus)：甲氧西林耐药的金黄色葡萄球菌；SSI(surgical site infection)：手术部位感染
下载: 导出CSV
-
[1] De La Rosa J S, Brady B R, Ibrahim M M, et al. Co-occurrence of chronic pain and anxiety/depression symptoms in U.S. adults: prevalence, functional impacts, and opportunities[J]. Pain, 2024, 165(3): 666-673. doi: 10.1097/j.pain.0000000000003056 [2] Shanthanna H, Eldabe S, Provenzano D A, et al. Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain[J]. Reg Anesth Pain Med, 2023, 48(6): 273-287. doi: 10.1136/rapm-2022-104097 [3] Petersen E A, Stauss T G, Scowcroft J A, et al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial[J]. JAMA Neurol, 2021, 78(6): 687. doi: 10.1001/jamaneurol.2021.0538 [4] Mekhail N, Levy R M, Deer T R, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial[J]. Lancet Neurol, 2020, 19(2): 123-134. doi: 10.1016/S1474-4422(19)30414-4 [5] Mekhail N, Visnjevac O, Azer G, et al. Spinal Cord Stimulation 50 Years Later: Clinical Outcomes of Spinal Cord Stimulation Based on Randomized Clinical Trials—A Systematic Review[J]. Reg Anesth Pain Med, 2018, 43(4): 391-406. doi: 10.1097/AAP.0000000000000744 [6] Xu J, Liu A, Cheng J. New advancements in spinal cord stimulation for chronic pain management[J]. Curr Opin Anaesthesiol, 2017, 30(6): 710-717. doi: 10.1097/ACO.0000000000000531 [7] 脊髓电刺激治疗慢性疼痛专家共识编写组. 脊髓电刺激治疗慢性疼痛专家共识[J]. 中国疼痛医学杂志, 2021, 27(6): 406-409. doi: 10.3969/j.issn.1006-9852.2021.06.002 Expert Consensus Writing Group for Spinal Cord Electrical Stimulation Therapy for Chronic Pain. Expert consensus on spinal cord electrical stimulation for the treatment of chronic pain[J]. Chin J Pain Med, 2021, 27(6): 406-409. doi: 10.3969/j.issn.1006-9852.2021.06.002 [8] 陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版)[J]. 中华医学杂志, 2022, 102(10): 697-703. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGUD202210051.htm Chen Y L, Yang K H, Wang X Q, et al. Guiding principles for formulating/revising clinical diagnosis and treatment guidelines in China (2022 Edition)[J]. Natl Med J Chin, 2022, 102(10): 697-703. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGUD202210051.htm [9] Chen Y, Yang K, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement[J]. Ann Intern Med, 2017, 166(2): 128-132. doi: 10.7326/M16-1565 [10] U.S. Preventive Services Task force. Grade definitions[EB/OL]. [2024-01-17]. https://www.uspreventiveservicestask-force.org/uspstf/about-uspstf/methods-and-processes/grade-definitions .[11] Sun W, Jin Y, Liu H, et al. Short-term spinal cord stimulation is an effective therapeutic approach for herpetic-related neuralgia—A Chinese nationwide expert consensus[J]. Front Aging Neurosci, 2022, 14: 939432. doi: 10.3389/fnagi.2022.939432 [12] Isagulyan E, Tkachenko V, Semenov D, et al. The effective-ness of various types of electrical stimulation of the spinal cord for chronic pain in patients with postherpetic neuralgia: a literature review[J]. Pain Res Manag, 2023, 2023: 6015680. [13] Wan C F, Song T. Efficacy of Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation for Acute/Subacute Zoster-Related Pain: A Randomized, Double-Blinded, Controlled Trial[J]. Pain Physician, 2021, 24(3): 215-222. [14] The Neuromodulation Foundation[EB/OL]. [2024-01-17]. https://www.neuromodfound.org/treatment_of_chronic_neuropathic_pain/patient_selection/contraindication/ .[15] The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices[J]. Neuromodulation, 2017, 20(4): 407. doi: 10.1111/ner.12619 [16] Mekhail N, Mehanny D, Armanyous S, et al. The impact of obesity on the effectiveness of spinal cord stimulation in chronic spine-related pain patients[J]. Spine J, 2019, 19(3): 476-486. doi: 10.1016/j.spinee.2018.08.006 [17] Mekhail N, Azer G, Saweris Y, et al. The impact of tobacco cigarette smoking on spinal cord stimulation effectiveness in chronic spine-related pain patients[J]. Reg Anesth Pain Med, 2018, 43(7): 768-775. [18] Adil S M, Charalambous L T, Rajkumar S, et al. Machine Learning to Predict Successful Opioid Dose Reduction or Stabilization After Spinal Cord Stimulation[J]. Neurosurgery, 2022, 91(2): 272-279. doi: 10.1227/neu.0000000000001969 [19] Lu Y, Mao P, Wang G, et al. Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)[J]. Trials, 2020, 21(1): 834. doi: 10.1186/s13063-020-04768-3 [20] Kapural L, Patterson D G, Li S, et al. Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial[J]. Neuromodulation, 2023, 26(7): 1400-1411. doi: 10.1016/j.neurom.2023.05.006 [21] Petraglia F W 3rd, Farber S H, Gramer R, et al. The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation[J]. Neuromodulation, 2016, 19(1): 85-90. doi: 10.1111/ner.12370 [22] Mullins C F, Royds J, Al-Kaisy A. Radiographic lead migration in percutaneous spinal cord stimulator trials[J]. Reg Anesth Pain Med, 2023. doi: 10.1136/rapm-2023-104347. [23] Das A, Gopinath S D, Arimbasseri G A. Systemic ablation of vitamin D receptor leads to skeletal muscle glycogen storage disorder in mice[J]. J Cachexia Sarcopenia Muscle, 2022, 13(1): 467-480. doi: 10.1002/jcsm.12841 [24] Sayed D, Chakravarthy K, Amirdelfan K, et al. A Comprehensive Practice Guideline for Magnetic Resonance Imaging Compatibility in Implanted Neuromodulation Devices[J]. Neuromodulation, 2020, 23(7): 893-911. [25] Deer T R, Russo M A, Grider J S, et al. The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulations[J]. Neuromodulation, 2022, 25(1): 1-34. -
点击查看大图
表(3)
计量
- 文章访问数: 1690
- HTML全文浏览量: 23
- PDF下载量: 484
- 被引次数: 0
