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Reprocessed Single-Use Semicritical and Critical Medical Devices 再加工的一次性半关键和关键医疗器械
Pub Date : 2024-03-11 DOI: 10.51731/cjht.2024.854
Kellee Kaulback, Jennifer Horton
What Is the Issue? Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs). Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs. Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection. What Did We Do? To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources. This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices. What Did We Find? We identified 8 studies, including one study based in Canada, that evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups. Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols. Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings. What Does it Mean? Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs. While the evidence base in this review was insufficient to conclude whether
问题出在哪里? 医疗器械的再处理包括清洁、翻新、检测和消毒,以确保器械可以安全地重复使用。与可重复使用的医疗器械不同,制造商无需提供正确清洗和消毒一次性医疗器械(SUMD)的说明。加拿大卫生部对第三方器械再处理商进行监管,要求他们满足与新器械制造商相同的要求。加拿大卫生部不对医院现场再处理进行监督,而是由省和地区一级进行监督。考虑到使用再处理 SUMDs 可能带来的经济和环境效益,人们对确定再处理 SUMDs 的临床安全性越来越感兴趣。目前的再处理医疗器械标准使用的是基于生物负荷测量的灭菌和消毒定义,但不一定包括感染等临床结果。 我们做了什么? 为了给适当使用再处理关键和半关键 SUMD 的决策提供信息,CADTH 试图识别和总结评估再处理 SUMD 临床安全性的文献,与未经再处理(新)的 SUMD 相比,再处理 SUMD 的临床安全性定义为感染、死亡率或其他不良事件。细菌菌落计数等微生物学结果未包括在内。信息专家搜索了同行评议和灰色文献资料。本报告未提供加拿大器械再处理商的完整列表,也未推荐任何特定的医疗器械再处理方法。 我们发现了什么? 我们确定了 8 项研究(包括一项位于加拿大的研究),这些研究评估了再处理 SUMD 与新 SUMD 相比的使用情况;大多数研究并未报告不同组别之间在患者预后方面存在统计学意义上的显著差异。所纳入的大多数研究的质量为极低至中等,这限制了对因重复使用这些设备而观察到的结果的信心。半数纳入的研究发表于 2005 年之前,考虑到随着时间的推移,再处理标准、手术方法、器械规格和患者护理方案可能会有所改进和变化,这可能会限制研究的适用性。大多数研究针对不同的手术人群评估了不同类型的再处理一次性医疗器械,因此在特定人群或相关干预中使用特定器械的证据非常有限。所有纳入的研究都评估了被归类为临界的 SUMD,而且所有研究都是在手术环境中进行的;但是,尚不清楚半临界器械或非手术环境中的患者风险水平是否会有所不同。 这意味着什么? 由于器械、临床应用和再处理方法各不相同,因此很难就再处理 SUMD 是否合适得出广泛的结论。虽然本综述的证据基础不足以断定手术环境中再处理的关键 SUMD 是否会影响患者的预后,但加拿大的标准和其他资源有助于根据感染风险为医疗器械再处理决策提供信息。为确保患者安全,SUMD 的任何再处理都应符合加拿大卫生部规定的安全性、有效性和标签标准。
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引用次数: 0
Aerosol Therapy With Inhalers During Mechanical Ventilation 机械通气时使用吸入器进行气溶胶治疗
Pub Date : 2024-03-11 DOI: 10.51731/cjht.2024.853
Robyn Haas, Jennie Horton
What Is the Issue? Mechanical ventilation helps individuals breathe when they cannot do so on their own. During mechanical ventilation, aerosol therapy is used to deliver medication to the lungs of the person who is using the ventilator. High doses of aerosol therapy administered via metered dose inhaler for adults and older adults who are mechanically ventilated is common clinical practice. However, the reasoning behind this practice, and whether it has clinical benefits compared to no doses and standard doses, is unclear. What Did We Do? To inform decisions about high doses of aerosol therapy delivered with metered dose inhalers in adults and older adults receiving mechanical ventilation, we sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus no aerosol therapy. We also sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus standard doses. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2004, and January 25, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included study, and narratively summarized the findings. What Did We Find? We found 1 retrospective chart review that compared the clinical effectiveness of 2 different doses of inhaled high doses of aerosol therapy. The findings from this study suggest that, compared to lower doses, higher doses of salbutamol are associated with more days alive and free of acute lung injury and more days alive and free of indicators of acute respiratory distress and respiratory failure. We did not find any studies that compared the clinical effectiveness of inhaled high doses of aerosol therapy to no aerosol therapy for adults and older adults receiving mechanical ventilation that met inclusion criteria for our review. What Does It Mean? The available evidence with methodological limitations suggests that high doses of aerosol therapy with salbutamol may be associated with better clinical respiratory outcomes when compared to low doses in patients with acute lung injury who are mechanically ventilated. To inform future clinical practice, decision-makers may want to consider the potential risks and benefits and environmental implications of aerosol therapy, as well as implementation factors (e.g., resource needs, risk of contamination). Additional clinical studies would help provide a better understanding of the optimal dosage and clinical effectiveness of aerosol therapy for patients who are mechanically ventilated.
问题出在哪里? 机械通气可以在患者无法自主呼吸时帮助他们呼吸。在机械通气期间,气雾疗法用于向使用呼吸机的患者的肺部输送药物。通过计量吸入器为接受机械通气的成年人和老年人提供大剂量的气溶胶治疗是临床上常见的做法。然而,这种做法背后的原因以及与无剂量和标准剂量相比是否具有临床益处尚不清楚。 我们做了什么? 为了给成人和接受机械通气的老年人使用定量吸入器进行大剂量气雾剂治疗的决策提供依据,我们试图找出并总结比较吸入大剂量气雾剂治疗与无气雾剂治疗临床疗效的文献。我们还试图找出并总结比较吸入大剂量气雾剂治疗与标准剂量治疗临床效果的文献。研究信息专家对 2004 年 1 月 1 日至 2024 年 1 月 25 日期间发表的同行评审文献和灰色文献进行了文献检索。检索仅限于英文文献。一位审稿人根据预先设定的标准筛选纳入文章,对纳入的研究进行批判性评估,并对研究结果进行叙述性总结。 我们发现了什么? 我们发现了一篇回顾性图表综述,该综述比较了两种不同剂量的吸入式大剂量气雾疗法的临床效果。这项研究的结果表明,与低剂量相比,高剂量沙丁胺醇与更多的存活天数和无急性肺损伤相关,与更多的存活天数和无急性呼吸窘迫和呼吸衰竭指标相关。对于接受机械通气的成人和老年人,我们没有找到任何符合纳入标准的研究,来比较吸入大剂量气雾剂治疗和不使用气雾剂治疗的临床效果。 这意味着什么? 受方法学限制的现有证据表明,对于接受机械通气的急性肺损伤患者,与小剂量沙丁胺醇相比,大剂量沙丁胺醇气雾剂治疗可能具有更好的临床呼吸效果。为指导未来的临床实践,决策者可能需要考虑气雾疗法的潜在风险和益处、对环境的影响以及实施因素(如资源需求、污染风险)。更多的临床研究将有助于更好地了解气雾疗法对机械通气患者的最佳剂量和临床效果。
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引用次数: 0
Fidanacogene Elaparvovec (Beqvez) Fidanacogene Elaparvovec (Beqvez)
Pub Date : 2024-03-06 DOI: 10.51731/cjht.2024.851
Cadth
CADTH recommends that Beqvez be reimbursed by public drug plans for the treatment of adults with moderately severe to severe hemophilia B (congenital factor IX deficiency) who are negative for neutralizing antibodies to variant adeno-associated virus (AAV) serotype Rh74 , if certain conditions are met. Beqvez should only be covered to treat adult patients (aged 18 years or older) with circulating coagulation factor IX (FIX:C) activity of 2% or less and bleeding that requires ongoing prophylactic treatment. Beqvez should not be covered if the patient has FIX inhibitors or has previously received gene therapy for hemophilia B. Beqvez should only be reimbursed if prescribed by specialists who have expertise in treating hemophilia B and if the cost of Beqvez is reduced. Beqvez is a 1-time therapy.
CADTH 建议,Beqvez 用于治疗中重度至重度血友病 B(先天性 IX 因子缺乏症)成人患者,且变异腺相关病毒 (AAV) 血清型 Rh74 中和抗体阴性,但需满足特定条件。Beqvez 只能用于治疗循环凝血因子 IX (FIX:C) 活性为 2% 或更低且出血需要持续预防性治疗的成年患者(18 岁或以上)。如果患者患有 FIX 抑制剂或曾接受过 B 型血友病基因治疗,则 Beqvez 不在承保范围内。Beqvez 只有在由具有治疗 B 型血友病专业知识的专科医生处方且 Beqvez 的费用降低的情况下才能获得报销。Beqvez 为一次性疗法。
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引用次数: 0
Belumosudil (Rezurock) 贝卢莫司地(Rezurock)
Pub Date : 2024-03-05 DOI: 10.51731/cjht.2024.848
Cadth
CADTH recommends that Rezurock be reimbursed by public drug plans for the treatment of chronic graft-versus-host disease (cGVHD) if certain conditions are met. Rezurock should only be covered to treat patients aged 12 years and older who have clinically diagnosed moderate to severe cGVHD and whose disease has not shown an adequate response to at least 2 prior lines of systemic therapy (1 of which is corticosteroids with or without calcineurin inhibitors). Rezurock should only be reimbursed if prescribed by clinicians who have experience in the diagnosis and management of patients with cGVHD, and the cost of Rezurock is reduced.
CADTH 建议,在满足特定条件的情况下,Rezurock 可由公共药品计划报销,用于治疗慢性移植物抗宿主病 (cGVHD)。Rezurock 只能用于治疗年龄在 12 岁及以上、临床诊断为中度至重度 cGVHD 的患者,而且这些患者的疾病对之前至少 2 种系统疗法(其中 1 种是皮质类固醇加或不加钙化蛋白抑制剂)的反应不充分。Rezurock 只能由在诊断和治疗 cGVHD 患者方面具有丰富经验的临床医生处方,且 Rezurock 的成本较低,方可获得报销。
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引用次数: 0
2024 Watch List: Top 10 Technologies and Issues Related to Caring for Children and Youth With Medical Complexity 2024 年观察清单:与护理医疗复杂的儿童和青少年相关的十大技术和问题
Pub Date : 2024-03-05 DOI: 10.51731/cjht.2024.850
Cadth
What Is the 2024 Watch List? The Watch List annual Horizon Scan report presents emerging technologies and issues that have the potential to shape the future of health care in Canada. CADTH’s 2024 Watch List focuses on care for children and youth with medical complexity. This top 10 has been divided in 2 parts — the top 5 technologies and top 5 issues related to children and youth with medical complexity that have the potential to make a significant and meaningful impact in transforming health systems in Canada over the next 5 years. These technologies and issues could shape the future of health care for not only children and youth with medical complexity, but also for others with chronic health conditions. Why Is This an Issue? Children and youth (people aged 24 years and younger) with medical complexity are a diverse group with a range of needs (e.g., single or multiple conditions, rare diseases). Although there is no single definition, common characteristics include significant functional limitations often causing the child or youth to be reliant on technology; high health care utilization, often requiring specialized care and services from different providers in multiple settings; and high health care service needs, such as care provision in the home and care coordination, which can have significant social and financial impacts on caregivers and the family. Children and youth with medical complexity account for less than 1% of all children and youth in Canada, but they account for 37% of hospital stays and 17% of emergency department visits. Due in part to the high number of health care interactions, this group experiences the effects of challenges within the health care system more acutely than their less medically complex peers. What Is the Potential Impact? The Watch List highlights areas for innovation, systems change, and investment. Advances in medical care have resulted in more children living with conditions that previously would not have been survivable in infancy and childhood. Now there are more children and youth with medical complexity, and they are living longer. Our current health systems were not designed to meet the complex needs of this group of people and their caregivers, including that many of them face challenges in accessing needed care. This year’s Watch List spotlights new and emerging technologies and key issues that could have a major impact on how patient care is provided to children and youth with medical complexity. What Else Do We Need to Know? In the 2024 Watch List, we identify and describe the top 5 new and emerging technologies that could shape the future of health care for children and youth with medical complexity in Canada, including new models of care and technologies and systems to improve communication. We also explore some considerations for health care decision-makers about the potential impact of these technologies on care pathways, health care human resources, health care inf
什么是 2024 年观察清单? 观察清单》年度地平线扫描报告介绍了有可能塑造加拿大未来医疗保健的新兴技术和问题。加拿大卫生部的 2024 年观察清单重点关注医疗复杂性儿童和青少年的护理。前十名分为两部分--未来 5 年内有可能对加拿大医疗系统的变革产生重大影响的 5 大技术和 5 大问题。这些技术和问题不仅会影响有复杂病症的儿童和青少年的未来医疗保健,也会影响其他慢性病患者的未来医疗保健。 为什么这是一个问题? 患有复杂病症的儿童和青少年(24 岁及以下)是一个多样化的群体,他们有各种不同的需求(如单一或多种病症、罕见疾病)。虽然没有统一的定义,但其共同特征包括:功能严重受限,通常导致儿童或青少年对技术的依赖;医疗保健使用率高,通常需要在多种环境下由不同的医疗服务提供者提供专门的护理和服务;医疗保健服务需求高,如在家中提供护理和护理协调,这可能会对护理者和家庭产生重大的社会和经济影响。在加拿大,病情复杂的儿童和青少年不到儿童和青少年总数的 1%,但他们却占住院人数的 37%,占急诊就诊人数的 17%。部分由于与医疗保健系统的互动较多,这一群体比医疗复杂性较低的同龄人更容易受到医疗保健系统挑战的影响。 潜在影响是什么? 观察清单强调了需要创新、系统变革和投资的领域。医疗保健的进步使更多的儿童在婴幼儿时期就患上了以前无法治愈的疾病。现在,有更多的儿童和青少年患有复杂的疾病,而且他们的寿命更长。我们目前的医疗系统在设计上无法满足这群人及其照顾者的复杂需求,包括他们中的许多人在获得所需的医疗服务方面面临挑战。今年的 "观察清单 "重点关注可能对如何为病情复杂的儿童和青少年提供病人护理产生重大影响的新兴技术和关键问题。 我们还需要了解什么? 在《2024 年观察清单》中,我们确定并描述了可能影响加拿大有复杂病症的儿童和青少年未来医疗保健的五大新兴技术,包括新的护理模式以及改善沟通的技术和系统。我们还为医疗决策者探讨了这些技术对医疗途径、医疗人力资源、医疗基础设施和医疗公平的潜在影响。2024 年观察清单还指出了限制医疗系统为病情复杂的儿童和青少年提供最佳医疗质量的 5 大问题。需要提高医疗系统之间的互操作性、需要改善可持续性的战略等关键问题值得更多关注,并将影响医疗复杂性儿童和青少年新兴技术的更广泛采用、推广和实施。监测与《2024 年观察清单》中强调的顶尖技术和问题相关的持续发展和证据,有助于指导加拿大的医疗系统规划,并改善高质量医疗服务的获取。
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引用次数: 0
Opioid-Sparing Effects of IV Acetaminophen for Patients Undergoing Surgery 静脉注射对乙酰氨基酚对手术患者的阿片类药物保护作用
Pub Date : 2024-03-05 DOI: 10.51731/cjht.2024.849
Camille Santos, C. Lachance, Sharon Bailey
What Is the Issue? Opioids are often used to help manage postoperative pain. However, their consumption can cause side effects, in addition to the risk of developing dependence with long-term use. Acetaminophen is an alternative analgesic that may provide opioid-sparing benefits for patients undergoing surgery (e.g., the need for patients to use opioids later), but there is a lack of synthesized evidence to confirm. Acetaminophen is available in different formulations, such as IV, oral, and rectal. However, there is uncertainty around the benefits of using 1 formulation over another perioperatively. What Did We Do? To inform decisions about IV acetaminophen, we sought to identify and summarize literature comparing the effectiveness of IV acetaminophen to alternative analgesics (i.e., nonsteroidal anti-inflammatory drugs [NSAIDs]), alternative formulations (i.e., oral or rectal acetaminophen), or placebo for reducing opioid consumption in patients undergoing surgery. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019, and January 9, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria. To investigate the true effect of IV acetaminophen, we excluded studies with any intraoperative opioid use. What Did We Find? For adult patients undergoing elective hip surgery, there may be no significant differences in cumulative opioid use between postoperative IV and oral acetaminophen (1 randomized controlled trial). For patients undergoing elective cesarian delivery, postoperative IV acetaminophen may result in a decrease in total morphine consumption after surgery compared to placebo (1 randomized controlled trial). For adult patients undergoing lumbar disc surgery, there may be no significant differences in total morphine consumption for patients receiving intraoperative IV acetaminophen compared to placebo (1 systematic review with 1 relevant RCT). We did not find any studies comparing the opioid-sparing effects of IV acetaminophen to NSAIDs that met our criteria for this review. What Does It Mean? Limited evidence from this review suggests that the opioid-sparing effect of IV acetaminophen may vary across types of surgery when compared to placebo. Additionally, IV acetaminophen may not offer additional opioid-sparing benefits compared to oral administration. However, we require more comprehensive research with rigorous methodological approaches to understand this topic better. Relative to opioids, IV acetaminophen has a preferable side effect profile, including a low risk of dependence; therefore, decision-makers may wish to consider using this formulation in the surgical or postsurgical setting.
问题出在哪里? 阿片类药物通常用于帮助控制术后疼痛。然而,服用阿片类药物可能会产生副作用,长期使用还有可能产生依赖性。对乙酰氨基酚是一种替代性镇痛药,可为接受手术的患者提供阿片类药物的优势(例如,患者以后不再需要使用阿片类药物),但目前还缺乏综合证据来证实这一点。对乙酰氨基酚有不同的剂型,如静脉注射、口服和直肠。然而,围手术期使用一种制剂比使用另一种制剂的益处尚不确定。 我们做了什么? 为了给关于静脉注射对乙酰氨基酚的决策提供信息,我们试图找出并总结文献,比较静脉注射对乙酰氨基酚与替代镇痛药(即非甾体类抗炎药 [NSAIDs])、替代制剂(即口服或直肠注射对乙酰氨基酚)或安慰剂在减少手术患者阿片类药物用量方面的有效性。一位研究信息专家对2019年1月1日至2024年1月9日期间发表的同行评审文献和灰色文献进行了文献检索。检索仅限于英文文献。一位审稿人根据预先设定的标准筛选纳入文章。为了调查静脉注射对乙酰氨基酚的真实效果,我们排除了术中使用任何阿片类药物的研究。 我们发现了什么? 对于接受择期髋关节手术的成年患者,术后静脉滴注和口服对乙酰氨基酚在阿片类药物的累积用量上可能没有显著差异(1 项随机对照试验)。对于接受择期剖宫产手术的患者,与安慰剂相比,术后静脉滴注对乙酰氨基酚可能会减少术后吗啡的总用量(1 项随机对照试验)。对于接受腰椎间盘手术的成年患者,与安慰剂相比,术中静脉滴注对乙酰氨基酚的患者在吗啡总消耗量方面可能没有显著差异(1 篇系统综述和 1 篇相关的随机对照试验)。我们没有发现任何符合本综述标准的研究对静脉注射对乙酰氨基酚和非甾体抗炎药的阿片类药物节省效果进行比较。 这意味着什么? 本综述中的有限证据表明,与安慰剂相比,静脉注射对乙酰氨基酚对阿片类药物的节省作用可能因手术类型而异。此外,与口服药物相比,静脉注射对乙酰氨基酚可能不会提供更多的阿片类药物节省优势。然而,我们需要更全面的研究和严格的方法来更好地理解这一课题。与阿片类药物相比,静脉注射对乙酰氨基酚具有更好的副作用,包括较低的依赖性风险;因此,决策者不妨考虑在手术或术后环境中使用这种制剂。
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引用次数: 1
Intra-Articular Hyaluronic Acid for Osteoarthritis of the Hip, Shoulder, and Ankle 关节内透明质酸治疗髋关节、肩关节和踝关节骨性关节炎
Pub Date : 2024-03-04 DOI: 10.51731/cjht.2024.847
Angela M. Barbara, Lindsay Ritchie, Melissa Severn
What Is the Issue? Osteoarthritis (OA) is a chronic disease of the joints, such as the hip, shoulder, and ankle. OA causes the joints to be painful, unstable, and less functional. In adults 55 years and younger, joint trauma is a common cause of OA. Hyaluronic acid (HA) is a naturally occurring molecule found in human cells that provides lubrication when injected into the joint. HA injections are a less invasive option than surgery, with potentially fewer complications. To support decision-making about treating hip, shoulder, or ankle OA in adults 55 years and younger, it is important to understand the potential benefits and harms of using HA in this population. What Did We Do? We reviewed the clinical effectiveness of high molecular weight (MW) injection of HA in adults between the ages of 18 and 55 years with OA of the hip, shoulder, or ankle joints to guide decisions on the use of high MW HA injection. An information specialist searched for peer-reviewed and grey literature sources published on January 1, 2013 to December 12, 2023. One reviewer screened citations and selected and critically appraised the included studies. What Did We Find? The evidence for this report was based on observational before-and-after studies. We found no relevant comparative studies examining the effect of high MW HA versus placebo or no treatment. While most studies reported post-treatment outcome improvements, it is uncertain whether high MW injection of HA improves pain, function, and disability in adults 55 years and under with hip, shoulder, or ankle OA. This is due to the low-quality evidence, small sample sizes, and methodological problems. Serious side effects of high MW HA were not reported. What Does This Mean? Due to the uncertainty of the clinical effectiveness evidence, health care providers and decision-makers may consider other factors when considering high MW IA-HA for patients with hip, shoulder, or ankle OA; these factors could include acceptability, feasibility, costs, health equity, and patient values and preferences. Future research from randomized studies in large populations is needed to understand the effectiveness and safety of high MW HA injections for hip, shoulder, and ankle OA.
问题是什么? 骨关节炎(OA)是髋关节、肩关节和踝关节等关节的一种慢性疾病。OA 会导致关节疼痛、不稳定和功能减退。在 55 岁及以下的成年人中,关节创伤是导致 OA 的常见原因。透明质酸(HA)是一种存在于人体细胞中的天然分子,注入关节后可起到润滑作用。与手术相比,注射透明质酸是一种创伤较小的选择,并发症也可能较少。为了帮助 55 岁及以下的成年人做出治疗髋关节、肩关节或踝关节 OA 的决策,了解在这一人群中使用 HA 的潜在益处和弊端非常重要。 我们做了什么? 我们回顾了高分子量(MW)HA注射剂对18至55岁患有髋关节、肩关节或踝关节OA的成年人的临床疗效,以指导使用高分子量HA注射剂的决策。一位信息专家检索了2013年1月1日至2023年12月12日发表的同行评议和灰色文献资料。一位审稿人筛选了引文,并对纳入的研究进行了筛选和严格评估。 我们发现了什么? 本报告的证据基于观察性前后对比研究。我们没有发现任何相关的比较研究,对高分子量 HA 与安慰剂或不治疗的效果进行检查。虽然大多数研究报告了治疗后的效果改善情况,但目前尚不确定高分子量注射HA是否能改善55岁及以下患有髋关节、肩关节或踝关节OA的成年人的疼痛、功能和残疾状况。这主要是由于证据质量低、样本量小以及方法问题。没有关于高MW HA严重副作用的报道。 这意味着什么? 由于临床有效性证据的不确定性,医疗服务提供者和决策者在考虑为髋关节、肩关节或踝关节OA患者提供高分子量IA-HA时可能会考虑其他因素;这些因素可能包括可接受性、可行性、成本、健康公平性以及患者的价值观和偏好。未来需要对大量人群进行随机研究,以了解高分子量 HA 注射治疗髋关节、肩关节和踝关节 OA 的有效性和安全性。
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引用次数: 0
Odevixibat (Bylvay) 奥德维希巴特(Bylvay)
Pub Date : 2024-03-01 DOI: 10.51731/cjht.2024.846
Cadth
CADTH recommends that Bylvay should be reimbursed by public drug plans for pruritus (itching) in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC) if certain conditions are met. Bylvay should only be covered to treat patients aged 6 months or older who have been diagnosed with PFIC type 1 (PFIC1) or PFIC type 2 (PFIC2), have severe itching, and have elevated serum bile acids. The first time Bylvay is prescribed, it should be for a trial period of 3 months to ensure that it improves the patient’s itching before it is renewed. Bylvay should only be reimbursed if it is prescribed by specialists in managing PFIC, if patients experience an improvement in their itching after using Bylvay for 3 months, and if the cost of Bylvay is reduced. Bylvay should be stopped if the patient receives a liver transplant.
CADTH 建议,对于 6 个月或以上的进行性家族性肝内胆汁淤积症 (PFIC) 患者的瘙痒(瘙痒)治疗,如果满足特定条件,Bylvay 应获得公共药品计划的报销。Bylvay 只能用于治疗确诊为 PFIC 1 型 (PFIC1) 或 PFIC 2 型 (PFIC2)、严重瘙痒且血清胆汁酸升高的 6 个月或以上患者。首次处方 Bylvay 时,应试用 3 个月,以确保改善患者的瘙痒症状后再续约。只有在以下情况下,Bylvay 才能获得报销:由管理 PFIC 的专家开具处方;患者在使用 Bylvay 3 个月后瘙痒症状有所改善;以及 Bylvay 的费用有所降低。如果患者接受肝移植,则应停用 Bylvay。
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引用次数: 0
Ketamine for Adults With Substance Use Disorders 氯胺酮治疗成人药物使用失调症
Pub Date : 2024-02-28 DOI: 10.51731/cjht.2024.845
Khai Tran, Daniel W. MacDougall
What Is the Issue Accumulating research has demonstrated that subanesthetic doses of ketamine have rapid and sustained antidepressant effects. In 2019, the US FDA approved the S-enantiomer of ketamine (esketamine) for the treatment of patients with treatment-resistant depression. Since then, there has been interest in the development of ketamine for the treatment of a broad range of mental health conditions beyond depression, including substance use disorders (SUDs). Decision-makers want to know if there is any evidence to support the use of ketamine for treating SUDs in adults. What Did We Do? To inform decisions about using ketamine for treating SUDs, we sought to identify and summarize the literature comparing the clinical and cost-effectiveness of ketamine with placebo or no treatment, with alternative interventions, or among ketamine administered via different routes for SUDs. We also searched for evidence-based recommendations for the use of ketamine for SUDs. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2018, and November 28, 2023. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? We found 2 systematic reviews (SRs) and 1 randomized controlled trial (RCT) on the use of ketamine for the treatment of patients with alcohol use disorder (AUD), cocaine use disorder (CUD), and opioid use disorder (OUD). Evidence from 2 SR suggests that a combination of ketamine infusion and psychotherapy treatment may be effective in promoting abstinence and reduced consumption of alcohol and cocaine use. There were mixed results regarding the effect of ketamine on withdrawal and craving. The effects of ketamine on OUD were inconclusive as the results were derived from a single study with a small sample size. Similarly, the effects of ketamine on health care utilization (e.g., hospital readmission, emergency department visit) in patients with severe AUD reported in a RCT were also inconclusive due to the small sample size. Adverse events associated with ketamine treatment included the dissociative and psychotomimetic effects and nondissociative effects. The authors of the included SR reported that these events were mild and transient. We did not find any studies on the cost-effectiveness or evidence-based guidelines of ketamine for treating SUDs that met our criteria for this review. What Does It Mean? The conclusions on the positive effects of ketamine for AUD and CUD should be interpreted with caution due to the high risk of bias of the studies included in the SRs. There is a need for more robust clinical trials with larger sample sizes, blinding, and low risk of bias to provide more accurate findings on clinical efficacy, dosing strategies, and safety profile of ketamine for the treatment of AUD, CUD, and OUD. Ad
问题所在 越来越多的研究表明,亚麻醉剂量的氯胺酮具有快速、持续的抗抑郁作用。2019 年,美国 FDA 批准将氯胺酮的 S-对映体(esketamine)用于治疗耐药抑郁症患者。从那时起,人们开始关注开发氯胺酮用于治疗抑郁症以外的多种精神疾病,包括药物使用障碍 (SUD)。决策者想知道是否有证据支持氯胺酮用于治疗成人 SUD。 我们做了什么? 为了给使用氯胺酮治疗药物依赖性障碍的决策提供信息,我们试图确定并总结文献资料,比较氯胺酮与安慰剂或不治疗、与替代干预措施或通过不同途径给予氯胺酮治疗药物依赖性障碍的临床和成本效益。我们还搜索了使用氯胺酮治疗精神分裂症的循证建议。一位研究信息专家对2018年1月1日至2023年11月28日期间发表的同行评审文献和灰色文献资料进行了文献检索。一位审稿人根据预先定义的标准对引文进行了筛选,对纳入的研究进行了批判性评估,并对研究结果进行了叙述性总结。 我们发现了什么? 我们发现了 2 篇系统综述 (SR) 和 1 篇随机对照试验 (RCT),内容涉及氯胺酮用于治疗酒精使用障碍 (AUD)、可卡因使用障碍 (CUD) 和阿片类药物使用障碍 (OUD) 患者。2 项研究结果表明,氯胺酮输注与心理治疗相结合可有效促进戒酒并减少酒精和可卡因的使用。氯胺酮对戒断和渴求的影响结果不一。氯胺酮对戒断和渴求的影响尚无定论,因为其结果来自于样本量较小的单项研究。同样,由于样本量较小,氯胺酮对重度 AUD 患者使用医疗服务(如再次入院、急诊就诊)的影响也没有定论。与氯胺酮治疗相关的不良事件包括解离效应、拟精神效应和非解离效应。纳入的研究报告的作者称这些不良反应是轻微和短暂的。我们没有发现任何关于氯胺酮治疗精神分裂症的成本效益或循证指南的研究符合本综述的标准。 这意味着什么? 由于纳入SR的研究存在较高的偏倚风险,因此在解释氯胺酮对AUD和CUD的积极作用时应谨慎。需要进行样本量更大、有盲法和低偏倚风险的更可靠的临床试验,以便就氯胺酮治疗 AUD、CUD 和 OUD 的临床疗效、剂量策略和安全性提供更准确的结论。对其他滥用物质(如尼古丁、苯丙胺和大麻)的更多研究可能会对氯胺酮治疗 SUDs 的总体疗效提供重要的启示。
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引用次数: 0
Working Together for Better Health: A United Effort to Support the National Strategy for Drugs for Rare Diseases in Canada 共同努力,改善健康:共同努力支持加拿大罕见病药物国家战略
Pub Date : 2024-02-28 DOI: 10.51731/cjht.2024.844
Helen Mai, Trish Caetano, Carli Wallington
February 29 is Rare Disease Day — an occasion that inspires action and solidarity to address the challenges and opportunities of rare diseases. To address the issues faced by patients with rare diseases, in March 2023, the Government of Canada announced a national strategy for drugs for rare diseases, with an investment of up to $1.5 billion over 3 years. The strategy aims to increase the accessibility and affordability of drugs for rare diseases for patients across Canada. CADTH-led initiatives are primarily related to improving the collection, use, and quality of evidence to inform and support decision-making.
2 月 29 日是 "罕见病日"(Rare Disease Day)--这是一个激励人们采取行动、团结一致应对罕见病挑战和机遇的日子。为解决罕见病患者面临的问题,加拿大政府于 2023 年 3 月宣布了一项罕见病药物国家战略,在 3 年内投资高达 15 亿加元。该战略旨在提高加拿大全国罕见病患者对罕见病药物的可及性和可负担性。加拿大卫生部牵头的倡议主要涉及改进证据的收集、使用和质量,为决策提供信息和支持。
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引用次数: 0
期刊
Canadian Journal of Health Technologies
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