Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.
Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.
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负责任、安全、有效的阿片类药物处方治疗慢性非癌症疼痛：美国介入疼痛医师协会 (ASIPP) 指南。
作者：
L. Manchikanti;A. Kaye;N. Knezevic;Heath B. McAnally;K. Slavin;A. Trescot;S. Blank;V. Pampati;S. Abdi;J. Grider;A. Kaye;Kavita N. Manchikanti;Harold J. Cordner;C. Gharibo;Michael E. Harned;Sheri L. Albers;S. Atluri;S. Aydin;S. Bakshi;R. Barkin;Ramsin M. Benyamin;M. Boswell;R. Buenaventura;Aaron Calodney;David L. Cedeño;Sukdeb Datta;T. Deer;B. Fellows;V. Galan;V. Grami;Hans C. Hansen;Standiford Helm Ii;R. Justiz;D. Koyyalagunta;Y. Malla;A. Navani;Kent H. Nouri;R. Pasupuleti;N. Sehgal;S. Silverman;Thomas T Simopoulos;V. Singh;D. Solanki;P. Staats;R. Vallejo;Bradley W. Wargo;Art Watanabe;J. Hirsch
背景
自 20 世纪 90 年代以来，阿片类药物的使用、滥用和不良后果（包括死亡）以惊人的速度升级。为了控制阿片类药物滥用，各个组织制定了许多关于负责任的阿片类药物处方的法规和指南。然而，美国阿片类药物流行病仍在持续，1999 年至 2015 年间药物剂量死亡人数增加了两倍。最近的数据显示，天然和半合成阿片类药物导致的死亡人数持续增加，美沙酮死亡率下降，而涉及其他阿片类药物（特别是海洛因和非法合成芬太尼）的死亡率急剧上升。与疗效的科学证据和负面建议相反，很大一部分医生和患者 (92%) 认为阿片类药物可以减轻疼痛，而较小比例 (57%) 则报告生活质量更好。在制定当前指南的过程中，我们重点关注减少阿片类药物滥用和转移的方法，同时不危及那些患有非癌症疼痛且具有阿片类药物使用适当医学指征的患者的使用。
目标
为治疗慢性非癌症疼痛的阿片类药物处方提供指导，在对阿片类药物使用感兴趣的许多不同群体中就如何适当开阿片类药物制定一致的理念，改善慢性非癌症疼痛的治疗并减少药物滥用和转移的可能性。这些指南旨在为这一复杂而困难的实践领域提供系统和标准化的方法，同时认识到每种临床情况都是独特的。
方法
使用的方法包括制定目标和关键问题。该方法还利用了值得信赖的标准、适当的利益冲突披露以及来自不同专业和团体的专家小组。对有关阿片类药物使用、滥用、有效性和不良后果的文献进行了审查，对现有文献进行了最佳证据综合，并利用医疗保健研究和质量机构 (AHRQ) 所描述的分级进行推荐。 建议摘要：i．阿片类药物治疗的初始步骤 1. 综合评估和记录。 （证据：I 级；建议强度：强） 2. 筛查阿片类药物滥用情况，以识别阿片类药物滥用者。 （证据：II-III 级；建议强度：中等） 3. 处方药监测计划 (PDMP) 的利用。 （证据：I-II 级；推荐强度：中度至强） 4. 利用尿液药物检测（UDT）。 （证据：II 级；建议强度：中等） 5. 如果有的话，建立适当的身体诊断和心理诊断。 （证据：I 级；推荐强度：强） 6. 考虑适当的影像学、身体诊断和心理状态以配合主观主诉。 （证据：III 级；建议强度：中等） 7. 根据平均中度至重度（≥ 4 分，0 - 10 级）疼痛和/或残疾来确定医疗必要性。 （证据：II 级；推荐强度：中等） 8. 根据风险对患者进行分层。 （证据：I-II 级；推荐强度：中等） 9. 制定阿片类药物治疗的缓解疼痛和功能改善的治疗目标。 （证据：I-II 级；建议强度：中等） 10. 获得所有各方都遵守的强有力的阿片类药物协议。 （证据：III 级；建议强度：中等）ii．长期阿片类药物治疗的有效性评估 11. 在适当的监测下，开始使用低剂量、短效药物的阿片类药物治疗。 （证据：II 级；建议强度：中等） 12. 将 40 吗啡毫克当量 (MME) 视为低剂量，41 至 90 MME 视为中等剂量，大于 91 MME 视为高剂量。 （证据：II 级；推荐强度：中等） 13. 在开始阿片类药物治疗时避免使用长效阿片类药物。 （证据：I 级；建议强度：强） 14. 建议仅在其他阿片类药物治疗失败后使用美沙酮，并且仅由接受过风险和用途专门培训的临床医生在 FDA 推荐剂量范围内使用。 （证据：I 级；推荐强度：强） 15. 了解并教育患者有效性和不良后果。 （证据：I 级；建议强度：强） 16. 长效和短效阿片类药物的疗效相似，但长效阿片类药物的不良后果增加。 （证据：I-II 级；推荐强度：中到强） 17. 定期评估疼痛缓解和/或功能状态改善 ≥ 30%，且无不良后果。 （证据：II 级；推荐强度：中等） 18. 仅在患有严重顽固性疼痛的特定情况下推荐长效或高剂量阿片类药物。 （证据：I 级；推荐强度：强）iii．监测依从性和副作用 19. 监测 UDT 和 PDMP 的依从性、滥用和不遵守情况。 （证据：I-II 级；建议强度：中度至强） 20. 定期用心电图监测服用美沙酮的患者。 （证据：I 级；推荐强度：强）。 21. 监测包括便秘在内的副作用并进行适当处理，包括在有需要时停止使用阿片类药物。 （证据：I 级；推荐强度：强）iv．最后阶段 22。可能会根据持续的医疗需要继续进行监测，并取得适当的结果。 （证据：I-II 级；建议强度：中等） 23. 由于缺乏反应、不良后果和滥用康复而停止阿片类药物治疗。 （证据：III 级；推荐强度：中等） 结论：这些指南的制定基于对文献的全面回顾、小组成员的共识、符合患者偏好、共同决策和证据有限的实践模式，基于随机对照试验 (RCT)，旨在长期改善慢性非癌性疼痛的疼痛和功能。因此，慢性阿片类药物治疗应仅提供给经证实具有医疗必要性和稳定性、改善疼痛和功能的患者，单独或与其他低剂量治疗方式联合使用，并进行适当的依从性监测和对不良事件的了解。关键词：慢性疼痛、持续性疼痛、非癌性疼痛、受控物质、药物滥用、处方药滥用、依赖性、阿片类药物、处方监测、药物测试、依从性监测、转移免责声明：本指南基于现有最佳证据，并不构成僵化的治疗建议。由于证据不断变化，本文件无意成为“护理标准”。
BACKGROUND
Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use.
OBJECTIVES
To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique.
METHODS
The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."
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DOI：
10.1001/jama.2015.13766
发表时间：
2015-11-03
期刊：
JAMA
影响因子：
--
作者：
Kantor ED;Rehm CD;Haas JS;Chan AT;Giovannucci EL
通讯作者：
Giovannucci EL
影响因子：
--
作者：
Freburger, Janet K.;Holmes, George M.;Agans, Robert P.;Jackman, Anne M.;Darter, Jane D.;Wallace, Andrea S.;Castel, Liana D.;Kalsbeek, William D.;Carey, Timothy S.
通讯作者：
Carey, Timothy S.
扭转阿片类药物过度处方的策略。
影响因子：
39
作者：
Wright,AileenP;Becker,WilliamC;Schiff,GordonD
通讯作者：
Schiff,GordonD
DOI：
10.1001/jama.2016.16885
发表时间：
2016-12-27
期刊：
JAMA
影响因子：
--
作者：
Dieleman JL;Baral R;Birger M;Bui AL;Bulchis A;Chapin A;Hamavid H;Horst C;Johnson EK;Joseph J;Lavado R;Lomsadze L;Reynolds A;Squires E;Campbell M;DeCenso B;Dicker D;Flaxman AD;Gabert R;Highfill T;Naghavi M;Nightingale N;Templin T;Tobias MI;Vos T;Murray CJ
通讯作者：
Murray CJ
影响因子：
120.7
作者：
Gureje, O;Von Korff, M;Gater, R
通讯作者：
Gater, R