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5-氨基酮戊酸超说明书用于光动力疗法的循证评价与分级管理
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| 篇名： | 5-氨基酮戊酸超说明书用于光动力疗法的循证评价与分级管理 |
| TITLE： | Evidence-based evaluation and hierarchical management of off-label use of 5-aminolevulinic acid in photodynamic therapy |
| 摘要： | 目的 为医疗机构基于证据等级建立5-氨基酮戊酸（ALA）超说明书用于光动疗法的备案管理模式与审核规则提供参考。方法回顾性收集本院2024年1月1日至2025年12月31日合理用药系统中全部含ALA的门诊处方，根据药品说明书识别ALA超说明书用于光动力疗法的现状。系统检索Micromedex、PubMed、中国知网、万方数据等数据库中的相关文献，作为ALA超说明书用药的相关循证证据。参照本院《超说明书用药备案标准》，采用循证评价方法对ALA超说明书用药进行循证证据评价并进行分级管理。结果共纳入1803张有效处方，其中超说明书用药处方676张（37.49%），分布在皮肤科（564张，83.43%）和整形美容科（112张，16.57%）。676张处方均为超适应证用药，涉及10种皮肤疾病，以中重度痤疮（39.94%）、皮肤疣（25.44%）、鲍恩病（11.98%）等为主。根据循证证据，中重度痤疮、光线性角化病、鲍恩病等超说明书用药按证据类别Ⅰ级或Ⅱ级进行管理，乳房外Paget病、玫瑰痤疮按证据类别Ⅲ级进行管理，硬化性苔藓、瘢痕疙瘩按证据类别Ⅳ级进行管理。循证评价结果显示，本院92.01%的超说明书用药具有高级别循证证据支持（证据级别为Ⅰ～Ⅱ级）。结论对于中重度痤疮、鲍恩病等具有高级别证据支持的超说明书用药，可按证据级别Ⅰ、Ⅱ级进行备案管理；而对于硬化性苔藓、瘢痕疙瘩用法，循证证据不足，应严格限制使用。本院绝大多数ALA超说明书用药具有较充分的循证依据。 |
| ABSTRACT： | OBJECTIVE To provide reference for medical institutions to establish the record management mode and review rules of off-label use of 5-aminolevulinic acid （ALA） in photodynamic therapy based on the level of evidence. METHODS All ALA-containing outpatient prescriptions in the rational drug use system in our hospital from January 1， 2024 to December 31， 2025 were retrospectively collected. Based on the drug instructions， the current status of off-label use of ALA in photodynamic therapy was identified . The relevant studies in Micromedex， PubMed， CNKI， Wanfang Data and other databases were systematically searched as the relevant evidence-based evidence of ALA off-label use. According to the Off-label Drug Use Filing Standard of the hospital，the evidence-based evaluation method was used to evaluate the evidence-based evidence of ALA off-label use and carry out hierarchical management. RESULTS A total of 1 803 effective prescriptions were included， of which 676 （37.49%） were off-label use， distributed in the dermatology department （564 prescriptions，83.43%） and the plastic surgery department （112 prescriptions，16.57%）. All 676 prescriptions were off-indications medication， involving ten types of skin diseases， primarily including moderate to severe acne （39.94%）， skin warts （25.44%）， Bowen’s disease （11.98%）， and others. According to evidence-based evidence，off-label uses such as moderate to severe acne， actinic keratosis， and Bowen’s disease were managed according to the evidence categoryⅠ orⅡ.The uses of extramammary Paget’s disease and rosacea were managed according to the evidence category Ⅲ.The uses of lichen sclerosus and keloids were managed according to the evidence category Ⅳ.The results of evidence-based evaluation showed that 92.01% of off-label use in our hospital had high-level evidence-based support （ evidence category was gradeⅠ-Ⅱ）. CONCLUSIONS Off-label uses supported by high-level evidence， such as moderate to severe acne， skin warts， and Bowen’s disease， can be managed under filing category Ⅰ or Ⅱ. For the use of lichen sclerosus and keloids， evidence-based evidence is insufficient and should be strictly restricted.The vast majority of ALA off-label use in our hospital has sufficient evidence-based basis. |
| 期刊： | 2026年第37卷第08期 |
| 作者： | 马靖；刘婷婷；苟小霜；杨雪；李晨；刘芳；刘耀 |
| AUTHORS： | MA Jing，LIU Tingting，GOU Xiaoshuang，YANG Xue，LI Chen，LIU Fang，LIU Yao |
| 关键字： | 5-氨基酮戊酸；超说明书用药；循证评价；光动力疗法；皮肤疾病 |
| KEYWORDS： | 5-aminolevulinic acid； off-label use； evidence-based evaluation； photodynamic therapy； skin diseases |
| 阅读数： | 7 次 |
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