為疼痛開阿片類藥物——美國CDC 新的臨床實踐指引
資料來源：Deborah Dowell, M.D., M.P.H., Kathleen R. Ragan, M.S.P.H., Christopher M. Jones, Pharm.D., Dr.P.H., Grant T. Baldwin, Ph.D., M.P.H., and Roger Chou, M.D. / nengl j med nejm.org 新英格蘭醫學雜誌 / 財團法人台灣紅絲帶基金會編譯
疼痛影響著數百萬美國人的生活，並可能降低他們的功能水平、心理健康和生活品質。然而，疼痛治療的可及性有限——支持疼痛治療的證據使許多患有疼痛的人無法獲得所有可能有用的治療方法。此外，根據種族或族裔群體、性別、社會經濟地位和人口，疼痛管理持續存在差異密度等因素。阿片類藥物繼續常用於治療疼痛，儘管有證據顯示它們的短期益處很小，而且長期益處的證據也有限。
2016 年，疾病控制和預防中心 (CDC) 發布了慢性疼痛阿片類藥物處方指引，以幫助初級保健臨床醫生權衡阿片類藥物治療慢性疼痛的益處和風險。該指引的發布與慢性疼痛阿片類藥物的整體和潛在高風險處方的加速減少以及非阿片類止痛藥處方的增加有關。同時，新的法律、法規和政策，在某些情況下據稱源自 2016 年指引，超出了——並且與其建議不一致。這種誤用，包括不靈活地應用推薦劑量和持續時間閾值，導致患者受到傷害，包括未經治療和治療不足的疼痛、阿片類藥物的快速減量和突然停藥、急性戒斷症狀和心理困擾，在某些情況下導致自殺意念和行為。這些經驗強調了更新指引的靈活性之必要、個性化、以患者為中心的照護的重要性。此外，新的科學證據支持關於急性疼痛治療、阿片類藥物逐漸減量和各種類型疼痛的治療方法的擴展指導和特異性。
2022 年 CDC 臨床實踐指引適用於為患有疼痛的成人門診患者開具阿片類藥物處方的臨床醫生——在除鐮狀細胞病、癌症相關疼痛、姑息治療和臨終關懷之外的其他情況下——擴展了急性 (< 1 個月的持續時間）和亞急性（1 至 3 個月的持續時間）疼痛，以幫助初級保健和其他臨床醫生（例如，外科醫生、口腔保健醫生和急診醫生）權衡阿片類藥物和其他疼痛治療對門診患者或從醫院、急診室或其他機構出院接受治療的患者的益處和風險。
鑑於系統評價的新發現，非阿片類藥物療法在許多常見類型的急性疼痛（包括頭痛、腰痛、頸部疼痛以及與常見肌肉骨骼疾病、小手術、牙科手術或腎病相關結石的疼痛）方面至少與阿片類藥物一樣有效），該指引包括一項新建議，即臨床醫生根據患者的情況最大限度地使用非阿片類藥物療法（例如，局部或口服非類固醇消炎止痛藥 [nonsteroidal antiinflammatory drugs , NSAIDs] 或運動），並且僅當阿片類藥物治療對急性疼痛有益時才考慮使用阿片類藥物治療預計將超過其風險。該指引指出，當 非類固醇消炎止痛藥 (NSAIDs) 和其他療法禁忌或不太可能有效時（例如，嚴重外傷或大手術），阿片類藥物治療對中度至重度急性疼痛具有重要作用。
與 2016 年指引一樣，2022 年指引建議，當需要使用阿片類藥物治療急性疼痛時，應以最低有效劑量開具處方，且持續時間不得超過足以保證使用阿片類藥物的嚴重疼痛的預期持續時間。當阿片類藥物連續使用超過幾天后停止治療時，建議逐漸減量。對於接受阿片類藥物治療 1 至 3 個月（亞急性疼痛的時間範圍）的患者，2022 年指引建議臨床醫生避免在沒有仔細重新評估治療目標、益處和風險的情況下繼續阿片類藥物治療，以防止無意中開始長期阿片類藥物治療。
該指引的更新內容概述了非阿片類藥物疼痛治療的益處和風險。為 2022 年指引提供信息的審查強化了先前指引關於明智使用阿片類藥物治療慢性疼痛的建議。因此，新指引保留了 2016 年阿片類藥物處方原則對於慢性疼痛，包括臨床醫生應該最大限度地使用非阿片類藥物治療，並且只有在預期對疼痛和功能的預期益處超過風險時才考慮開始阿片類藥物治療，並且當需要阿片類藥物時，臨床醫生應該以最低有效劑量開始治療，在考慮增加劑量時仔細評估個體的益處和風險，並避免將劑量增加到可能導致收益相對於風險遞減的水平之上。這些原則並不意味著在提供阿片類藥物治療之前，非藥物和非阿片類藥物治療必須在每個患者身上都嘗試失敗。相反，在開始治療之前，應權衡特定於臨床情況的預期收益和風險。
一項新的建議進一步概述了臨床醫生如何與已經接受阿片類藥物治療的患者合作，以確定是否以及如何減少這些藥物的使用。以新數據為基礎的新指引建議臨床醫生仔細權衡逐漸減少阿片類藥物的益處和風險以及繼續使用阿片類藥物的益處和風險，並強調通常不應突然停止阿片類藥物治療，也不應迅速減少劑量。當患者服用阿片類藥物的時間較長（例如≥1 年）時，每月減量 10% 或更慢的劑量很可能比快速減量更容易耐受。儘管臨床醫生和患者可能並不總是能夠就是否有必要逐漸減量達成一致，但該指引描述了一種以患者為中心的方式實施治療改變的方法，同時避免放棄患者，而是利用臨床醫生的同理心和共同決策原則。
一個獨立的聯邦諮詢委員會、四名同儕評審員和公眾成員審查了更新指引的草案（我們編寫的），CDC 根據這一回饋對其進行了修改，其中強調了四個關鍵點：獲得疼痛照護和循證治療；患者和臨床醫生的共同決策至關重要；長期使用後停用阿片類藥物可能非常具有挑戰性並且可能有害，尤其是在劑量迅速減少或患者未獲得有效支持的情況下；新的建議需要仔細傳達和實施。一些評論者認為，引用特定阿片類藥物劑量和持續時間的語言很容易導致閾值被誤用為不靈活的標準，而其他評論者強烈認為臨床醫生需要這些特定信息，不應將其遺漏。
為了阻止這種閾值的誤用，新建議強調了一般原則（例如，避免將劑量增加到可能產生收益遞減的水平以上）而不是特定水平。在每項建議後的支持文本中，該指引提供了更具體的信息，包括與劑量相關的數據，為臨床決策制定和個體化患者照護提供信息。為了促進更公平的機會並減少獲得高品質照護上的障礙，建議的策略包括建立機制，使疼痛意外持續存在的患者能夠及時獲得重新評估。該指引還提醒臨床醫生在解釋處方藥監測計畫和毒理學測試數據時可能存在的偏見。添加了五項新的指導原則，以指導建議的實施並支持適當的個性化照護。
2022 年指引旨在促進公平獲得有效、知情、個性化和安全的疼痛管理，從而改善患者的功能和生活品質，同時闡明和減少與阿片類藥物使用相關的風險。理想情況下，新的建議應該導致更多和更公平地獲得全面的基於證據的疼痛治療，更明智地初始使用阿片類藥物，以及在已經長期接受治療的患者中，更仔細地考慮和管理與持續、逐漸減少或停用阿片類藥物相關的利益和風險。
CDC 將監測這些預期影響和意外影響，並將與公共和私人支付者合作，並分享可用於為更廣泛的疼痛治療覆蓋範圍做出決策的證據。指導可實現的最佳疼痛管理的證據仍然有限，研究應解決關鍵的剩餘差距，包括疼痛療法有效性的長期比較。患者與臨床醫生關於阿片類藥物相關益處和風險的溝通仍然是治療決策的核心。 2022 年指引可以幫助做出這些決定並幫助臨床醫生滿足患者的獨特需求。
本文僅代表作者觀點，不代表疾控中心官方立場。
作者提供的披露表可在 NEJM.org 獲取。
來自亞特蘭大疾病控制和預防中心國家傷害預防和控制中心藥物過量預防司 (D.D.、K.R.R.、G.T.B.) 和主任辦公室 (C.M.J.)； 和太平洋西北循證實踐中心，俄勒岡健康與科學大學，波特蘭（R.C.）。
本文於 2022 年 11 月 3 日發表在 NEJM.org
Prescribing Opioids for Pain — The New CDC Clinical Practice Guideline
Deborah Dowell, M.D., M.P.H., Kathleen R. Ragan, M.S.P.H., Christopher M. Jones, Pharm.D., Dr.P.H., Grant T. Baldwin, Ph.D., M.P.H., and Roger Chou, M.D. / nengl j med nejm.org The New England Journal of Medicine
Pain affects the lives of millions of Americans and potentially reduces their level of function, mental health, and quality of life. Yet limited access to pain treatment the evidence supporting pain treatments prevent many people with pain from accessing the full range of potentially helpful therapies.
Furthermore, there are persistent disparities in pain management according to race or ethnic group, gender, socioeconomic status, and population density, among other factors. Opioids continue to be commonly used to treat pain, despite evidence that their short-term benefits are small and despite limited evidence of long-term benefits.
In 2016, the Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain to help primary care clinicians weigh benefits and risks of opioid treatment for chronic pain. The guideline’s release was associated with accelerated reductions in overall and potentially high-risk prescribing of opioids and with increases in prescribing of nonopioid pain medications. Concurrently, new laws, regulations, and policies, in some cases purportedly derived from the 2016 guideline, went beyond — and were inconsistent with — its recommendations. Such misapplication, including inflexible application of recommended dosage and duration thresholds, contributed to patient harms, including untreated and undertreated pain, rapid opioid tapers and abrupt discontinuations, acute withdrawal symptoms, and psychological distress, in some cases leading to suicidal ideation and behavior. These experiences underlined the need for an updated guideline reinforcing the importance of flexible, individualized, patient-centered care. In addition, new scientific evidence supports expanded guidance and specificity regarding acute pain treatment, opioid tapering, and treatment methods for various types of pain.
The 2022 CDC Clinical Practice Guideline, which is intended for clinicians prescribing opioids for adult outpatients with pain — in situations other than those of sickle cell disease, cancer-related pain, palliative care, and endof-life care — expands guidance for acute (<1 month’s duration) and subacute (1 to 3 months’ duration) pain to help primary care and other clinicians (e.g., surgeons, oral health practitioners, and emergency clinicians) weigh benefits and risks of opioids and other pain treatments for outpatients or patients being discharged from hospitals, emergency departments, or other facilities.
Given new findings from systematic reviews that nonopioid therapies are at least as effective as opioids for many common types of acute pain (including headaches, low back pain, neck pain, and pain related to common musculoskeletal conditions, minor surgeries, dental procedures, or kidney stones), the guideline includes a new recommendation that clinicians maximize the use of nonopioid therapies (e.g., topical or oral nonsteroidal antiinflammatory drugs [NSAIDs] or exercise) as appropriate for the patient’s condition and consider opioid therapy for acute pain only if its benefits are anticipated to outweigh its risks. The guideline notes that there is an important role for opioid therapy for moderate-to-severe acute pain when NSAIDs and other therapies are contraindicated or are unlikely to be sufficiently effective (e.g., for severe traumatic injuries or major surgeries).
Like the 2016 guideline, the 2022 guideline recommends that when opioids are needed for acute pain, they should be prescribed at the lowest effective dose and for no longer than the expected duration of pain severe enough to warrant opioids. Tapering is recommended when opioid treatment is discontinued after being used continuously for more than a few days. For patients receiving opioids for 1 to 3 months (the timeframe for subacute pain), the 2022 guideline recommends that clinicians avoid continuing opioid treatment without carefully reassessing treatment goals, benefits, and risks in order to prevent unintentional initiation of long-term opioid therapy.
The updated content of the guideline outlines the benefits and risks of nonopioid pain treatments. The reviews that informed the 2022 guideline reinforced the previous guideline’s recommendations for judicious use of opioids for chronic pain. The new guideline therefore retains the 2016 principles for prescribing opioids for chronic pain, including that clinicians should maximize use of nonopioid therapies and consider initiating opioid therapy only if the expected benefits for pain and function are anticipated to outweigh the risks and that when opioids are needed, clinicians should initiate therapy at the lowest effective dosage, carefully evaluate individual benefits and risks when considering increasing dosages, and avoid increasing the dosage above levels likely to yield diminishing returns in benefits relative to risks. These principles do not imply that nonpharmacologic and nonopioid pharmacologic therapies must all be tried unsuccessfully in every patient before opioid therapy is offered. Rather, expected benefits specific to the clinical context should be weighed against risks before therapy is initiated.
A new recommendation further outlines how clinicians can work with patients who are already receiving opioids in determining whether and how to taper these medications. New guidance informed by emerging data advises clinicians to carefully weigh benefits and risks of tapering opioids along with benefits and risks of continuing opioids and emphasizes that opioid therapy should generally not be discontinued abruptly, nor should doses be reduced rapidly. When patients have been taking opioids for longer durations (e.g., ≥1 year), dosages that are tapered by 10% per month or slower will most likely be better tolerated than more rapid tapers. Although clinicians and patients might not always be able to agree on whether tapering is necessary, the guideline describes an approach to implementing treatment changes in a patientcentered manner, while avoiding abandoning the patient and instead drawing on clinicians’ empathy and principles of shared decision making.
An independent federal advisory committee, four peer reviewers, and members of the public reviewed the draft of the updated guideline (which we wrote), and the CDC revised it in response to this feedback, which emphasized four key points: there are persistent barriers to access to pain care and evidence-based treatment; shared decision making by patients and clinicians is critical; discontinuing opioids after extended use can be very challenging and potentially harmful, especially if doses are tapered rapidly or patients do not receive effective support; and the new recommendations need to be communicated and implemented carefully. Some commenters argued that language citing specific opioid dosages and durations could too readily lead to the misapplication of thresholds as inflexible standards, whereas others felt strongly that clinicians need this specific information and that it should not be omitted.
To discourage such misapplication of thresholds, the new recommendations emphasize general
principles (e.g., avoiding increasing dosages above levels likely to yield diminishing returns) rather than specific levels. In the supporting text following each recommendation, the guideline provides more specific information, including data related to dosages, to inform clinical decision making and individualized patient care. To promote more equitable access and reduce barriers to high-quality care, suggested strategies include the institution of mechanisms allowing patients whose pain unexpectedly persists to gain timely access to reevaluation. The guideline also cautions clinicians about potential bias in interpreting data from prescription drug monitoring programs and toxicology tests. Five new guiding principles have been added to inform implementation of the recommendations and support appropriate, individualized care.
The 2022 guideline aims to promote equitable access to effective, informed, individualized, and safe pain management that improves patients’ function and quality of life, while clarifying and reducing the risks associated with opioid use. Ideally, new recommendations should result in greater and more equitable access to the full range of evidence-based treatments for pain, more judicious initial use of opioids, and more careful consideration and management of benefits and risks associated with continuing, tapering, or discontinuing opioids in patients who are already receiving them long term.
The CDC will monitor for these intended effects as well as for unintended effects and will work with public and private payers and share evidence that can be used to inform decisions regarding coverage for a broader range of pain therapies. Evidence to guide the best achievable pain management remains limited, and research should address critical remaining gaps, including longterm comparative effectiveness of therapies for pain. Patient–clinician communication about benefits and risks associated with opioids remains central to treatment decisions. The 2022 guideline can help inform those decisions and assist clinicians in meeting patients’ unique needs.
The views expressed in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Disclosure forms provided by the authors are available at NEJM.org.
From the Division of Overdose Prevention (D.D., K.R.R., G.T.B.) and the Office of the Director (C.M.J.), National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta; and the Pacific Northwest Evidence-based Practice Center, Oregon Health and Science University, Portland (R.C.).
This article was published on November 3, 2022, at NEJM.org.