Page 107 - 《中国药房》2024年4期

·循证药学·

对炎症性肠病患者开展抗 TNF-α 制剂 TDM 的国内外指南/共识
的质量评价
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金唐慧 ，朱濛昕 ，谢 诚 ，夏 凡 ，于 迪 ，李 悦 ，李 芸 ，奚沁华 ，朱建国（1.苏州大学附属第一医院
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药学部，江苏 苏州 215006；2.苏州大学附属第一医院消化科，江苏 苏州 215006）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2024）04-0481-07
DOI 10.6039/j.issn.1001-0408.2024.04.19
摘 要 目的 评价对炎症性肠病（IBD）患者开展抗肿瘤坏死因子 α（TNF-α）制剂治疗药物监测（TDM）的指南/共识的质量。
方法 检索PubMed、Embase、中国知网、万方数据和维普网以及国内外指南/共识发布网站，收集针对IBD患者开展抗TNF-α制剂
TDM的指南/专家共识。检索时限均为建库至2023年6月。由2名研究者独立筛选文献、提取资料后，采用指南研究与评价工具
Ⅱ对纳入指南/共识的方法学质量进行评价，并汇总纳入指南/共识的主要推荐意见。结果 共纳入9篇文献，3篇为指南，6篇为共
识。9篇指南/共识在范围和目的、参与人员、制定的严谨性、表达的清晰性、应用性和编辑独立性6个维度的标准化百分比分别为
90.43%、41.98%、52.55%、85.49%、19.00%、76.85%。8篇指南/共识的推荐级别为B级，1篇共识的推荐级别为C级。主要推荐意见
涉及TDM应用场景、阈值范围、策略调整、检测方法以及结果解读。大部分指南/共识均推荐对失应答患者应进行被动TDM；建议
根据预期的治疗结果设定TDM浓度范围，并结合疾病状况和TDM结果进行策略调整，且建议同一患者采用相同的检测方法。部
分指南/共识认为，生物类似药和原研药不存在结果解读差异。结论 纳入的指南/共识总体质量一般，推荐意见较为统一。临床工
作者需要了解该类药物TDM的特点和局限性，并结合具体的临床治疗目标去解读和运用监测结果。
关键词 炎症性肠病；抗TNF-α制剂；治疗药物监测；指南；共识

Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients
with inflammatory bowel disease
JIN Tanghui ，ZHU Mengxin ，XIE Cheng ，XIA Fan ，YU Di ，LI Yue ，LI Yun ，XI Qinhua ，ZHU Jianguo 1
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（1. Dept. of Pharmacy， the First Affiliated Hospital of Soochow University， Jiangsu Suzhou 215006；2. Dept. of
Gastroenterology， the First Affiliated Hospital of Soochow University， Jiangsu Suzhou 215006， China）
ABSTRACT OBJECTIVE To evaluate the quality of guidelines/consensus on therapeutic drug monitoring （TDM） of anti-tumor
necrosis factor- α （TNF- α） in patients with inflammatory bowel disease （IBD） in China and globally. METHODS PubMed，
Embase， CNKI， Wanfang data， VIP， and release websites of guidelines/consensus in China and globally were searched to collect
guidelines/expert consensus on TDM with anti-TNF-α for IBD patients. The search period was from database establishment to June
2023. After two investigators independently screened the literature and extracted the data， the methodological quality of the included
guidelines/consensuses was evaluated using the Appraisal of Guidelines for Research and Evaluation Ⅱ. The main recommendations
of the included guidelines/consensuses were summarized. RESULTS A total of 9 articles were included， 3 were guidelines and 6
were expert consensus. The standardized percentages of the 9 guidelines/consensus in the 6 dimensions （scope and aims，
participants， rigor of formulation， clarity of expression， application， and editorial independence） were 90.43%， 41.98%， 52.55%，
85.49%， 19.00%， and 76.85%， respectively. Eight guidelines/consensus had a recommendation of grade B and one consensus of
grade C. The main recommendations involve TDM application scenarios， threshold ranges， strategy adjustments， detection
methods， and interpretation of results. Most guidelines/consensus recommend passive TDM for non-responders. It is recommended
to set the TDM concentration range according to the expected
Δ 基金项目 国家临床重点专科（临床药学）建设项目（No.国卫办
医函〔2018〕292 号）；江苏省药学会-奥赛康医院药学基金项目（No. treatment results and make strategy adjustments in combination
A202115）；江苏省药学会正大天晴医院药学基金项目（No.Q202231）； with the disease condition and TDM results. Additionally， the
苏州市科技局项目（No.SKYD2023182） same test method is recommended for the same patient. Some
＊第一作者 主管药师，硕士。研究方向：医院药学。电话：0512- guidelines/consensus hold that no differences were noted in the
67780678。E-mail：jintanghui@163.com
# 通信作者 副主任药师，硕士。研究方向：临床药学。电话： interpretation of results between biosimilar and original drug.
0512-67780997。E-mail：lyxfyy@aliyun.com CONCLUSIONS The overall quality of the included

中国药房 2024年第35卷第4期 China Pharmacy 2024 Vol. 35 No. 4 · 481 ·