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Galcanezumab add-on in refractory cluster headache. A case series. 加群单抗用于难治性丛集性头痛。病例系列。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-11-18 DOI: 10.1080/17581869.2024.2427564
Georgios Karagiorgis, Savvas Christofilos, Christina Deligianni, Ioanna Spanou, Sofia Vassilopoulou, Dimos-Dimitrios D Mitsikostas

Cluster headache (CH), a highly disabling condition, lacks disease-specific, mechanism-based prophylactic treatment. Galganezumab, a monoclonal antibody targeting the calcitonin gene-related peptide, reduced the weekly attacks of CH in one randomized, placebo-controlled trial for the prevention of episodic CH (eCH), but this effect was not detected in people with chronic CH (cCH). In this case series, we systematically monitored the efficacy and safety outcomes of adjunctive therapy in 11 people with refractory CH (failure of ≥ 3 prophylactic treatments; eCH n = 5, cCH, n = 6) who received galcanezumab (120-360 mg monthly) for 3 consecutive months. All participants received intermediate treatment with oral steroids or a great occipital nerve block ≥ 2 months before starting galcanezumab treatment. After galcanezumab treatment, the average number of weekly CH attacks and weekly days with any symptomatic treatment for CH decreased significantly from 16.0 ± 9.4 and 6.50 ± 3.59 before treatment to 1.8 ± 1.32 (p = 0.002) and 1.8 ± 3.36 (p = 0.001) at month 3 of treatment, respectively. Two participants with cCH showed no change in the number of attacks with galcanezumab. No serious adverse events were recorded. These data, along with those of previous real-world reports, suggest that galcanezumab may help people with refractory CH as an add-on treatment.

丛集性头痛(CH)是一种致残率很高的疾病,但缺乏针对疾病的、基于机制的预防性治疗。Galganezumab是一种靶向降钙素基因相关肽的单克隆抗体,在一项预防发作性头痛(eCH)的随机安慰剂对照试验中,Galganezumab可减少头痛的每周发作次数,但在慢性头痛(cCH)患者中未发现这种效果。在这个病例系列中,我们系统地监测了11名难治性CH患者(预防性治疗≥3次失败;eCH 5人,cCH 6人)的辅助治疗的疗效和安全性,这些患者连续3个月接受了加康珠单抗(每月120-360毫克)治疗。所有参试者在开始伽卡尼珠单抗治疗前≥2个月都接受了口服类固醇或枕大神经阻滞的中间治疗。接受加卡尼珠单抗治疗后,每周CH发作的平均次数和每周接受任何CH症状治疗的天数分别从治疗前的16.0 ± 9.4和6.50 ± 3.59显著降至治疗第3个月时的1.8 ± 1.32(p = 0.002)和1.8 ± 3.36(p = 0.001)。两名患有慢性阻塞性肺疾病的参试者使用加卡尼珠单抗后发作次数没有变化。没有严重不良事件记录。这些数据以及之前的真实世界报告表明,加卡尼珠单抗作为一种附加治疗方法,可以帮助难治性CH患者。
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引用次数: 0
A plain language summary describing changes in pain associated with uterine fibroids among women receiving relugolix combination therapy. 以通俗易懂的语言概述了接受瑞格列奈联合疗法的妇女在子宫肌瘤相关疼痛方面的变化。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-10-28 DOI: 10.1080/17581869.2024.2408114
Elizabeth A Stewart, Andrea S Lukes, Roberta Venturella, Juan-Camilo Arjona Ferreira, Yulan Li, Elke Hunsche, Rachel B Wagman, Ayman Al-Hendy

What is this summary about?: This is a summary of two research studies (known as clinical trials) called LIBERTY 1 and LIBERTY 2. These studies compared how well a medicine called relugolix combination therapy and placebo worked in reducing heavy menstrual bleeding (periods) in women with uterine fibroids (published in a separate article referenced in the section: Where can readers find more information on these studies?). Researchers also looked at whether women with moderate to severe pain from uterine fibroids saw improvement in their worst pain symptoms after 24 weeks of treatment (results described in the present summary).

What are the key takeaways?: Women with moderate to severe pain from uterine fibroids (menstrual or nonmenstrual pain) took either relugolix combination therapy or placebo (once daily by mouth) for 24 weeks. During the last 5 weeks of treatment, 65% of women taking relugolix combination therapy and 19% of women taking placebo reported having minimal or no menstrual pain. Similarly, 45% of women taking relugolix combination therapy and 22% of women taking placebo reported having minimal or no non-menstrual pain. During the same time period, 71% of the women taking relugolix combination therapy and 40% of women taking placebo reported their worst pain was reduced by about one third compared with the start of the study.

What were the main conclusions reported by the researchers?: Women with moderate to severe pain from uterine fibroids taking relugolix combination therapy were more likely to have minimal or no pain from uterine fibroids after treatment compared with women taking placebo.Clinical Trial Registration: NCT03049735 (LIBERTY 1), NCT03103087 (LIBERTY 2) (ClinicalTrials.gov).

本摘要介绍了什么? 本摘要介绍了两项名为 "LIBERTY 1 "和 "LIBERTY 2 "的研究(称为临床试验)。 这两项研究比较了一种名为瑞格列奈联合疗法的药物和安慰剂在减少患有子宫肌瘤的妇女大量月经出血(经期)方面的效果(发表在本节引用的另一篇文章中):读者从哪里可以找到有关这些研究的更多信息?)研究人员还考察了患有中度至重度子宫肌瘤疼痛的妇女在接受 24 周治疗后,其最严重的疼痛症状是否有所改善(结果见本摘要):患有中度至重度子宫肌瘤疼痛(经期或非经期疼痛)的妇女接受了 24 周的瑞格列奈联合疗法或安慰剂(每天口服一次)治疗。在治疗的最后 5 周,65% 的服用瑞格列士联合疗法的妇女和 19% 的服用安慰剂的妇女表示痛经症状轻微或没有痛经症状。同样,45%服用瑞格列士联合疗法的女性和 22% 服用安慰剂的女性也报告说,她们的非经期痛经症状轻微或没有。在同一时期,71%服用瑞格列奈联合疗法的妇女和40%服用安慰剂的妇女表示,与研究开始时相比,她们最严重的疼痛减轻了约三分之一。研究人员报告的主要结论是什么?与服用安慰剂的妇女相比,有中度至重度子宫肌瘤疼痛的妇女在接受relugolix联合疗法治疗后,子宫肌瘤疼痛减轻或消失的可能性更大:临床试验注册:NCT03049735(LIBERTY 1)、NCT03103087(LIBERTY 2)(ClinicalTrials.gov)。
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引用次数: 0
VX-548 in the treatment of acute pain. VX-548 用于治疗急性疼痛。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-11-18 DOI: 10.1080/17581869.2024.2421749
Aaron Yik Hang Kong, Hon Sen Tan, Ashraf S Habib

Acute pain management requires balancing analgesia with adverse effects risk. The voltage-gated sodium channel NaV1.8 plays an important role in pain physiology, and its inhibition was shown to have analgesic effects. VX-548 is a new oral NaV1.8-specific inhibitor that received United States Food and Drug Administration Fast Track and Breakthrough Therapy designations. Its efficacy was demonstrated in two Phase II trials of patients who underwent abdominoplasty and bunionectomy. These showed that VX-548, when given as an oral loading dose of 100 mg followed by 50 mg 12-hly, significantly decreased pain scores compared with placebo. Similarly, two Phase III trials of patients who underwent abdominoplasty and bunionectomy comparing VX-548 with hydrocodone bitartrate-acetaminophen and placebo reported significantly reduced pain scores compared with placebo, but no improvement compared with hydrocodone bitartrate-acetaminophen. Evidence from Phase II and III trials suggest that VX-548 is well-tolerated, with headache, nausea, constipation and dizziness being the most common adverse effects. However, the safety of prolonged VX-548 administration is uncertain; a Phase II trial of patients with diabetic neuropathy who received high-dose VX-548 over 12 weeks reported decreased creatinine clearance. Data pertaining to VX-548 safety and efficacy within the context of multimodal analgesia and pregnancy are also needed.

急性疼痛治疗需要在镇痛和不良反应风险之间取得平衡。电压门控钠通道 NaV1.8 在疼痛生理学中发挥着重要作用,抑制该通道具有镇痛效果。VX-548 是一种新型口服 NaV1.8 特异性抑制剂,已获得美国食品药品管理局的快速通道和突破性疗法认定。在对接受腹部整形术和拇趾外翻切除术的患者进行的两项二期试验中证明了其疗效。试验结果表明,与安慰剂相比,VX-548 在口服 100 毫克负荷剂量后,每 12 小时再口服 50 毫克,可显著降低疼痛评分。同样,两项针对腹部整形术和拇趾外翻切除术患者的 III 期试验将 VX-548 与酒石酸氢可酮-对乙酰氨基酚和安慰剂进行了比较,结果表明,与安慰剂相比,VX-548 能显著降低疼痛评分,但与酒石酸氢可酮-对乙酰氨基酚相比,疼痛评分没有改善。二期和三期试验的证据表明,VX-548 的耐受性良好,头痛、恶心、便秘和头晕是最常见的不良反应。然而,长期服用 VX-548 的安全性尚不确定;一项针对糖尿病神经病变患者的 II 期试验报告称,这些患者在 12 周内服用大剂量 VX-548 后,肌酐清除率下降。有关 VX-548 在多模式镇痛和妊娠中的安全性和疗效的数据也需要进一步研究。
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引用次数: 0
Combatting opioid misuse, overuse and abuse: a systematic review of pharmacists' services and outcomes. 打击阿片类药物的误用、过量使用和滥用:药剂师服务和成果系统回顾。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-10-22 DOI: 10.1080/17581869.2024.2411930
Bhuvan Kc, Alian A Alrasheedy, Mohamed Izham Mohamed Ibrahim, Vibhu Paudyal, Christina Malini Christopher, Sunil Shrestha, Shakti Shrestha

Aim: To examine the range of services pharmacists provide and their impact on patient outcomes, harm reduction, and appropriate opioid use.Methods: Six databases were searched (MEDLINE, EMBASE, Scopus, PsycINFO, CENTRAL and Cochrane Methodology Register) from inception to March 2023. The protocol was registered in PROSPERO (CRD42023401895).Results: Twenty-nine studies identified five key areas of pharmacist interventions in opioid management-naloxone programs and opioid de-escalation, patient and primary healthcare providers' education and motivational interview, prescription monitoring and opioid risk screening, clinical pharmacy interventions (pharmacotherapy, medication review, prescribing, adherence monitoring), and collaborative healthcare approaches to promote optimal opioid use. Outcomes assessment indicated harm reduction, improved safety, increased non-opioid analgesic use, decreased opioid consumption, and enhanced pain management.Conclusion: This review underscores pharmacists' vital role in tackling opioid misuse, overuse and abuse, providing a foundation for evidence-based policies to minimize harm and promote optimal opioid use.

目的:研究药剂师提供的服务范围及其对患者预后、减少伤害和适当使用阿片类药物的影响:检索了从开始到 2023 年 3 月的六个数据库(MEDLINE、EMBASE、Scopus、PsycINFO、CENTRAL 和 Cochrane Methodology Register)。研究方案已在 PROSPERO(CRD42023401895)上注册:29项研究确定了药剂师干预阿片类药物管理的五个关键领域--纳洛酮计划和阿片类药物降级、患者和初级医疗保健提供者的教育和动机访谈、处方监测和阿片类药物风险筛查、临床药学干预(药物治疗、药物审查、处方、依从性监测)以及促进阿片类药物最佳使用的合作医疗保健方法。结果评估显示,减少了伤害,提高了安全性,增加了非阿片类镇痛药的使用,减少了阿片类药物的消耗,加强了疼痛管理:本综述强调了药剂师在应对阿片类药物误用、过度使用和滥用方面的重要作用,为制定循证政策以最大限度地减少伤害和促进阿片类药物的最佳使用奠定了基础。
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引用次数: 0
Sustained relief with spinal cord stimulator despite anterior lead migration: a case report. 脊髓刺激器在前导联线移位的情况下仍能持续缓解症状:病例报告。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-10-04 DOI: 10.1080/17581869.2024.2407283
Soun Sheen, Kent Nouri

Lead migration is a common complication of spinal cord stimulation, although anterior migration is rare. While early studies suggested that anterior stimulation may produce analgesic effects, it is thought to be poorly tolerated due to abnormal paresthesia and muscle contractions due to its proximity to the corticospinal tract. This case report presents a unique case of sustained pain relief despite anterior lead migration, which suggests that anterior column stimulation may hold clinical significance for pain management. Further studies are needed to explore its analgesic mechanisms and potential therapeutic application. Strategies to prevent lead migration, particularly in the early postoperative period, are also crucial for optimizing outcomes.

导线移位是脊髓刺激的常见并发症,但前部移位很少见。虽然早期研究表明前路刺激可能会产生镇痛效果,但由于前路刺激靠近皮质脊髓束,会导致异常麻痹和肌肉收缩,因此人们认为前路刺激的耐受性很差。本病例报告提供了一个独特的病例,尽管前导联线移位,但疼痛仍得到持续缓解,这表明前柱刺激可能对疼痛治疗具有临床意义。还需要进一步的研究来探索其镇痛机制和潜在的治疗应用。预防导联移位的策略,尤其是在术后早期,对于优化治疗效果也至关重要。
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引用次数: 0
"Trying to explain the unexplainable": why research on contextual factors in musculoskeletal pain is needed. "试图解释无法解释的问题":为什么需要对肌肉骨骼疼痛的环境因素进行研究?
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-09-27 DOI: 10.1080/17581869.2024.2406224
Giacomo Rossettini, Alvisa Palese, Chad Cook
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引用次数: 0
Polmacoxib 2mg in patients with mild to moderate idiopathic osteoarthritis of hip/knee-a randomized, double-anonymous study. 针对轻度至中度特发性髋关节/膝关节骨关节炎患者的 2 毫克波马昔布--一项随机、双匿名研究。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-11-15 DOI: 10.1080/17581869.2024.2427944
Shubhadeep D Sinha, Tadikonda Bhavani Prasad, Bhaskar Konatham, Sreenivasa Chary Sriramadasu, Arnab Karmakar, Arun Kumar Sharma, Rakesh Verma, Srinivas Reddy Devireddy, Mohan Reddy Bandi, Muralidhar Panapakam

Aim: Polmacoxib, a new COX-2 inhibitor with carbonic anhydrase (CA) inhibitory action, is expected to help minimize the adverse effects associated with other NSAIDs, like GI (gastrointestinal) and CV (cardiovascular) system- related issues. The comparative efficacy and safety of polmacoxib 2 mg (manufactured by Hetero Labs Limited) versus celecoxib 200 mg (manufactured by Hetero Labs Limited) were assessed in this randomized, double-anonymous, clinical study in Indian adult patients diagnosed with idiopathic osteoarthritis (OA) of the.

Patients & methodology: 18 years and older patients of either sex, clinically and radiographically diagnosed idiopathic knee or hip OA were randomized to receive either polmacoxib or celecoxib in a 1:1 ratio. All patients were assessed with various pain measuring scales and recorded the scores at the end of weeks 3 and 6.

Conclusion: The data for all the pain assessment scores were analyzed, and polmacoxib was found to be a non-inferior therapeutic agent compared to celecoxib in terms of safety and efficacy.(https://ctri.nic.in/CTRI/2022/05/042923).

目的:波马昔布是一种具有碳酸酐酶(CA)抑制作用的新型COX-2抑制剂,有望帮助减少与其他非甾体抗炎药相关的不良反应,如与胃肠道和心血管系统相关的问题。在这项随机、双匿名临床研究中,对被诊断为特发性骨关节炎(OA)的印度成年患者进行了波马昔布 2 毫克(由 Hetero Labs Limited 生产)与塞来昔布 200 毫克(由 Hetero Labs Limited 生产)的疗效和安全性对比评估。患者和方法:18 岁及以上经临床和影像学诊断为特发性膝关节或髋关节 OA 的男女患者按 1:1 的比例随机接受波马昔布或塞来昔布治疗。所有患者均接受了各种疼痛测量量表的评估,并在第3周和第6周结束时记录了评分:对所有疼痛评估评分数据进行分析后发现,就安全性和有效性而言,波马昔布的治疗效果不优于塞来昔布。(https://ctri.nic.in/CTRI/2022/05/042923)。
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引用次数: 0
Comparison of responders and nonresponders with knee osteoarthritis after transcranial direct current stimulation. 经颅直流电刺激后膝关节骨关节炎有反应者与无反应者的比较。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-09-01 Epub Date: 2024-11-16 DOI: 10.1080/17581869.2024.2429943
Juyoung Park, Heling Tong, Yixin Kang, Hongyu Miao, Lifeng Lin, Rina S Fox, Ilknur Telkes, Geraldine Martorella, Hyochol Ahn

Aim: The study compared responders and nonresponders to transcranial direct current stimulation (tDCS) regarding clinical pain outcomes in knee osteoarthritis (OA) patients.

Patients and methods/materials: Sixty participants received home-based active tDCS, and clinical pain outcomes were compared between responders and nonresponders.

Results: Latent class growth analyses classified 41 participants as responders and 19 as nonresponders. Responders showed significantly greater decreases in pain intensity from baseline to post intervention than nonresponders (p < .001). Participants with higher BMI (p = .02) and weight (p = .005) were more likely to respond, while no significant sociodemographic differences were found.

Conclusions: Identifying characteristics of nonresponsive tDCS subgroups can tailor treatments for each group.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT04016272.

目的:该研究比较了经颅直流电刺激(tDCS)对膝关节骨性关节炎(OA)患者的临床疼痛结果有反应者和无反应者:60名参与者接受了基于家庭的主动tDCS治疗,并对有反应者和无反应者的临床疼痛结果进行了比较:结果:潜类增长分析将 41 名参与者归为应答者,19 名归为非应答者。有反应者从基线到干预后疼痛强度的下降幅度明显大于无反应者(p p = .02),体重(p = .005)更有可能有反应,而社会人口学方面没有发现明显差异:临床试验注册:www.clinicaltrials.gov 识别码为 NCT04016272。
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引用次数: 0
Epidural spread of surgical site infection from spinal cord stimulation trial. 脊髓刺激试验引起的手术部位感染的硬膜外扩散。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-06-02 Epub Date: 2024-07-08 DOI: 10.1080/17581869.2024.2373044
Taif Mukhdomi, Bennett Andrassy, Semih Gungor

We present a case of deep surgical site infection (SSI) at a spinal cord stimulator (SCS) trial implantation site, resulting from an allergic reaction to an unknown agent. A 38-year-old female with complex regional pain syndrome began an SCS trial, noting 100% pain relief for 5 days. Fluid drainage from the surgical site was reported on POD6 and trial leads were removed the following day. The patient was hospitalized with sepsis. Blood cultures revealed Staphylococcus aureus. MRIs showed skin breakdown and cellulitis of the paraspinal musculature extending into the epidural space. The patient was maintained with antibiotics and rigorous wound care for 9 days and the surgical site infection resolved. The patient proceeded to SCS implantation, and reported good pain relief with the implanted device.

我们介绍了一例脊髓刺激器(SCS)试验植入部位深部手术部位感染(SSI)病例,病因是对一种未知制剂的过敏反应。一名患有复杂性区域疼痛综合征的 38 岁女性开始接受 SCS 试验,5 天内疼痛缓解率达到 100%。据报告,POD6 时手术部位有液体排出,次日移除了试验导线。患者因败血症住院。血液培养显示为金黄色葡萄球菌。核磁共振成像显示皮肤破损和脊柱旁肌肉组织蜂窝织炎延伸至硬膜外腔。患者接受了 9 天的抗生素治疗和严格的伤口护理,手术部位感染得到缓解。患者继续接受了 SCS 植入手术,并表示植入设备后疼痛缓解良好。
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引用次数: 0
Self-management of primary dysmenorrhea-related pain: cross-sectional study on non-pharmacological interventions. 原发性痛经相关疼痛的自我管理:非药物干预横断面研究。
IF 1.4 Q4 CLINICAL NEUROLOGY Pub Date : 2024-06-02 Epub Date: 2024-07-23 DOI: 10.1080/17581869.2024.2376519
Jéssica Cordeiro Rodrigues, Guilherme Tavares de Arruda, Pâmela Calixto de Moraes, Caren Beatriz Firão, Mariana Arias Avila, Patricia Driusso

Aim: Different nonpharmacological strategies are adopted to decrease primary dysmenorrhea (PD)-related pain. The present study aimed to verify women's use of nonpharmacological methods for pain and compare them with evidence from the literature.Materials & methods: A two-step study was conducted, comprising an online survey with 9144 women to assess nonpharmacological strategies for relieving PD-related pain, and a literature review on PubMed of verify the evidence of nonpharmacological methods.Results: Many women reported using heat therapy (61.5%), tea (42.4%) and massage (30.9%) to alleviate menstrual pain. However, the literature on these methods is limited.Conclusion: Several nonpharmacological methods are used by women to relieve PD-related pain and studies with low bias risk are needed to prove their effectiveness.

目的:为减轻与原发性痛经(PD)相关的疼痛,人们采取了不同的非药物治疗策略。本研究旨在核实妇女使用非药物止痛方法的情况,并将其与文献证据进行比较。材料和方法:研究分为两个步骤,一是对 9144 名女性进行在线调查,评估缓解 PD 相关疼痛的非药物疗法;二是在 PubMed 上进行文献综述,核实非药物疗法的证据。调查结果显示许多女性表示使用热疗(61.5%)、茶疗(42.4%)和按摩(30.9%)来缓解痛经。然而,有关这些方法的文献资料十分有限。结论女性使用多种非药物方法来缓解与腹膜透析相关的疼痛,需要进行低偏倚风险的研究来证明这些方法的有效性。
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引用次数: 0
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Pain management
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