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

doi:10.6039/j.issn.1001-0408.2024.04.19

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Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease

更新时间：2025-09-25

- Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease
- ZHONGGUO YAOFANG Vol. 35, Issue 4, Pages: 481-487(2024)
- 作者机构：
  
  1.苏州大学附属第一医院药学部，江苏苏州　215006
  2.苏州大学附属第一医院消化科，江苏苏州　215006
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.04.19
  CLC： R969.3
- Received：27 June 2023，
  
  Revised：2024-01-22，
  
  Accepted：23 January 2024，
  
  Published：29 February 2024
- 稿件说明：
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金唐慧,朱濛昕,谢诚,等.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[J].中国药房,2024,35(04):481-487.

JIN Tanghui,ZHU Mengxin,XIE Cheng,et al.Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease[J].ZHONGGUO YAOFANG,2024,35(04):481-487.
金唐慧,朱濛昕,谢诚,等.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[J].中国药房,2024,35(04):481-487. DOI： 10.6039/j.issn.1001-0408.2024.04.19.

JIN Tanghui,ZHU Mengxin,XIE Cheng,et al.Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease[J].ZHONGGUO YAOFANG,2024,35(04):481-487. 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。

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 treatment results and make strategy adjustments in combination with the disease condition and TDM results. Additionally， the same test method is recommended for the same patient. Some guidelines/consensus hold that no differences were noted in the interpretation of results between biosimilar and original drug.

CONCLUSIONS

The overall quality of the included guidelines/consensus was fair， with relatively consistent recommendation. Clinicians need to understand the characteristics and limitations of TDM with this class of drugs， and interpret and apply results of TDM in combination with specific clinical treatment goals.

关键词

Keywords

references

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