芬太尼透皮贴剂临床合理用药指南（2026修订版）

doi:10.3760/cma.j.cn371439-20260625-00102

摘要/Abstract

摘要：

近年来，芬太尼透皮贴剂在癌痛领域的临床需求显著增长，但适应证把控不当、剂量滴定不规范、不良反应管理滞后等问题仍突出。为此，中国医疗保健与国际交流促进会舒缓治疗学分会和中国抗癌协会癌症康复与姑息治疗专业委员会组织专家对2021版《芬太尼透皮贴剂临床合理用药指南》进行修订。本指南参照国内外最新文献及临床研究证据，围绕适应证界定、优选人群、剂量转换与滴定、特殊类型癌痛联合用药策略、不良反应处置、药物相互作用、安全管理和患者教育等核心问题，形成了全流程、多维度的推荐意见。本指南旨在为临床医务人员提供切实可行的用药依据，推动芬太尼透皮贴剂在癌痛管理中的规范化应用，实现“规范镇痛、舒适抗癌”的临床目标。

关键词: 癌性疼痛, 芬太尼透皮贴剂, 诊疗指南, 合理用药

Abstract:

In recent years， the clinical demand for fentanyl transdermal patches in the field of cancer pain has markedly increased. Nevertheless， prominent clinical problems persist， including inappropriate indication control， irregular dose titration and lagging management of adverse reactions. To address these issues， the Branch of Palliative Care， China International Exchange and Promotive Association for Medical and Health Care together with the Committee of Rehabilitation and Palliative Care， China Anti-Cancer Association organized a panel of specialists to revise the 2021 edition of Guidelines for the Rational Clinical Use of Fentanyl Transdermal Patches. Referring to the latest domestic and foreign literature and clinical research evidence， this guideline develops comprehensive and multi-dimensional recommendations covering core issues such as indication definition， preferred patient populations， dose conversion and titration， combination regimens for special types of cancer pain， adverse reaction intervention， drug interactions， safety management and patient education. This guideline intends to provide practical medication references for clinical practitioners， standardize the application of fentanyl transdermal patches in cancer pain management， and achieve the clinical goal of "standardized pain relief and comfortable anti-cancer treatment".

Key words: Cancer pain, Fentanyl transdermal patches, Diagnostic and treatment guideline, Rational drug use

中国医疗保健与国际交流促进会舒缓治疗学分会, 中国抗癌协会癌症康复与姑息治疗专业委员会. 芬太尼透皮贴剂临床合理用药指南（2026修订版）[J]. 国际肿瘤学杂志, 2026, 53(11): 644-654.

Branch of Palliative Care， China International Exchange and Promotive Association for Medical and Health Care, Committee of Rehabilitation and Palliative Care， China Anti-Cancer Association. Guidelines for the rational clinical use of fentanyl transdermal patches （2026 revised edition）[J]. Journal of International Oncology, 2026, 53(11): 644-654.

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证据特征			CSCO专家共识度
类别	水平	来源	CSCO专家共识度
1A	高	严谨的Meta分析、大型随机对照临床研究	一致共识（支持意见≥80%）
1B	高	严谨的Meta分析、大型随机对照临床研究	基本一致共识（支持意见60%~80%）
2A	稍低	一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例-对照研究	一致共识（支持意见≥80%）
2B	稍低	一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例-对照研究	基本一致共识（支持意见60%~80%）
3	低	非对照的单臂临床研究、病例报告、专家观点	无共识，且争议大（支持意见<60%）

推荐等级	标准
Ⅰ级推荐	1A类证据和部分2A类证据 CSCO指南将1A类证据，以及部分专家共识度高且在中国可及性好的2A类证据作为Ⅰ级推荐。具体为：适应证明确、可及性好、肿瘤治疗价值稳定，纳入《国家基本医疗保险、工伤保险和生育保险药品目录》的诊治措施
Ⅱ级推荐	1B类证据和部分2A类证据 CSCO指南将1B类证据，以及部分在中国可及性欠佳，但专家共识度较高的2A类证据作为Ⅱ级推荐。具体为：国内外随机对照研究，提供高级别证据，但可及性差或者效价比不高；对于临床获益明显但价格较贵的措施，考虑患者可能获益，也可以作为Ⅱ级推荐
Ⅲ级推荐	2B类证据和3类证据对于某些临床上习惯使用，或有探索价值的诊治措施，虽然循证医学证据相对不足，但专家组意见认为可以接受的，作为Ⅲ级推荐

阿片类药物	临床应用	在严重肝功能不全患者中给药方式的调整
芬太尼	较为安全	通常不需要调整剂量
吗啡	谨慎应用，监测患者神志	给药间隔时间延长为原来的2倍
羟考酮	谨慎应用，监测不良反应	起始剂量可调整为原来的1/2~2/3，随后滴定剂量可降低至原来的1/3
可待因	禁用

肾小球滤过率（ml/min）	剂量调整为原剂量的百分比
肾小球滤过率（ml/min）	芬太尼	吗啡	羟考酮	可待因
>50	100%	100%	100%	禁用
10~50	75%~100%	50%~75%	50%	禁用
<10	50%	25%~50%	禁用	禁用

药物	口服	非胃肠道	转换关系
吗啡	30 mg	10 mg	非胃肠道∶口服=1∶3
芬太尼透皮贴剂		25 μg/h	芬太尼透皮贴剂（μg/h，72 h）∶口服吗啡（mg/d）=1∶2
芬太尼透皮贴剂		25 μg/h	芬太尼透皮贴剂（μg/h，72 h）∶口服盐酸羟考酮（mg/d）=1∶1
芬太尼注射液			芬太尼透皮贴剂∶芬太尼注射液=1∶1