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

金唐慧; 朱濛昕; 谢诚; 夏凡; 于迪; 李悦; 李芸; 奚沁华; 朱建国

doi:10.6039/j.issn.1001-0408.2024.04.19

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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

循证药学 | 更新时间：2024-02-23

- 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
- Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease
- 中国药房 2024年35卷第4期页码：481-487
- 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：
  
  主管药师，硕士。研究方向：医院药学。电话：0512-67780678。E-mail：jintanghui@163.com
  副主任药师，硕士。研究方向：临床药学。电话：0512-67780997。E-mail：lyxfyy@aliyun.com
- 基金信息：
  
  Δ 基金项目“十二五”国家临床重点专科建设项目(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(A202115);江苏省药学会正大天晴医院药学基金项目(Q202231);苏州市科技局项目(SKYD2023182)
- DOI：10.6039/j.issn.1001-0408.2024.04.19
  中图分类号： R969.3
- 纸质出版日期：2024-02-29，
  
  收稿日期：2023-06-27，
  
  修回日期：2024-01-22，
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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 ^Δ[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 ^Δ[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

炎症性肠病抗TNF-α制剂治疗药物监测指南共识

Keywords

anti-TNF-αtherapeutic drug monitoringguidelinesconsensus

references

CHOLAPRANEE A，HAZLEWOOD G S，KAPLAN G G，et al. Systematic review with meta-analysis：comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn’s disease and ulcerative colitis controlled trials[J]. Aliment Pharmacol Ther，2017，45（10）：1291-1302.

MA C，HUANG V，FEDORAK D K，et al. Adalimumab dose escalation is effective for managing secondary loss of response in Crohn’s disease[J]. Aliment Pharmacol Ther，2014，40（9）：1044-1055.

VANDE CASTEELE N，FEAGAN B G，GILS A，et al. Therapeutic drug monitoring in inflammatory bowel di-sease：current state and future perspectives[J]. Curr Ga-stroenterol Rep，2014，16（4）：378.

JOHNSTON E L，WARNER B D，DIGBY-BELL J L，et al. Utilisation of anti-TNF levels in a UK tertiary IBD centre[J]. Frontline Gastroenterol，2017，8（3）：189-195.

陈耀龙，罗旭飞，王吉耀，等. 如何区分临床实践指南与专家共识[J]. 协和医学杂志，2019，10（4）：403-408.

CHEN Y L，LUO X F，WANG J Y，et al. How to distinguish between clinical practice guidelines and expert consensus[J]. Med J Peking Union Med Coll Hosp，2019，10（4）：403-408.

盛永成，李莉，汪琴，等. 基于AGREE Ⅱ和AGREE-China的中国脆性骨折指南与共识的质量评价[J]. 中国循证医学杂志，2022，22（3）：351-359.

SHENG Y C，LI L，WANG Q，et al. Quality appraisal of clinical practice guidelines and consensus for the management of fragility fractures in China by AGREE Ⅱ and AGREE-China[J]. Chin J Evid Based Med，2022，22（3）：351-359.

周航宇，冯国双. 医学研究中的一致性评价方法[J]. 慢性病学杂志，2018，19（4）：361-362，365.

ZHOU H Y，FENG G S. Consistency evaluation method in medical research[J]. Chronic Pathematology J，2018，19（4）：361-362，365.

CHEIFETZ A S，ABREU M T，AFIF W，et al. A comprehensive literature review and expert consensus statement on therapeutic drug monitoring of biologics in inflammatory bowel disease[J]. Am J Gastroenterol，2021，116（10）：2014-2025.

GREUTER T，MAILLARD M H，JUILLERAT P，et al. Therapeutic drug monitoring to guide clinical decision making in inflammatory bowel disease patients with loss of response to anti-TNF：a Delphi technique-based consensus[J]. Digestion，2020，101（6）：683-691.

PAPAMICHAEL K，CHEIFETZ A S，MELMED G Y，et al. Appropriate therapeutic drug monitoring of biologic agents for patients with inflammatory bowel diseases[J]. Clin Gastroenterol Hepatol，2019，17（9）：1655-1668.e3.

KHAN A，BERAHMANA A B，DAY A S，et al. New Zealand Society of Gastroenterology guidelines on therapeutic drug monitoring in inflammatory bowel disease[J]. N Z Med J，2019，132（1491）：46-62.

中华医学会消化病学分会炎症性肠病学组.中国炎症性肠病治疗药物监测专家共识意见[J].中华消化杂志，2018，38（11）：721-727.

The Inflammatory Bowel Disease Group of the Gastroenterology Branch of the Chinese Medical Association. Consensus opinion of Chinese experts on drug monitoring for the treatment of inflammatory bowel disease[J].Chin J Dig，2018，38（11）：721-727.

MITREV N，VANDE CASTEELE N，SEOW C H，et al. Review article：consensus statements on therapeutic drug monitoring of anti-tumor necrosis factor therapy in in-flammatory bowel diseases[J]. Aliment Pharmacol Ther，2017，46（11/12）：1037-1053.

FEUERSTEIN J D，NGUYEN G C，KUPFER S S，et al. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease[J]. Gastroenterology，2017，153（3）：827-834.

MELMED G Y，IRVING P M，JONES J，et al. Appro-priateness of testing for anti-tumor necrosis factor agent and antibody concentrations，and interpretation of results[J]. Clin Gastroenterol Hepatol，2016，14（9）：1302-1309.

HENDY P，HART A，IRVING P. Anti-TNF drug and antidrug antibody level monitoring in IBD：a practical guide[J]. Frontline Gastroenterol，2016，7（2）：122-128.

朱良如，沈骏. 炎症性肠病医患共同决策：一个循序渐进的过程[J]. 中华炎性肠病杂志，2019，3（3）：261-263.

ZHU L R，SHEN J. Shared decision-making in inflammatory bowel disease：a step-by-step process[J]. Chin J Inflamm Bowel Dis，2019，3（3）：261-263.

STEENHOLDT C，BRYNSKOV J，THOMSEN O Ø，et al. Individualized therapy is a long-term cost-effective method compared to dose intensification in Crohn’s di-sease patients failing infliximab[J]. Dig Dis Sci，2015，60（9）：2762-2770.

GUIDI L，PUGLIESE D，PANICI TONUCCI T，et al. Therapeutic drug monitoring is more cost-effective than a clinically based approach in the management of loss of re-sponse to infliximab in inflammatory bowel disease：an observational multicentre study[J]. J Crohns Colitis，2018，12（9）：1079-1088.

PAPAMICHAEL K，CHACHU K A，VAJRAVELU R K，et al. Improved long-term outcomes of patients with inflammatory bowel disease receiving proactive compared with reactive monitoring of serum concentrations of infli-ximab[J]. Clin Gastroenterol Hepatol，2017，15（10）：1580-1588.e3.

VAUGHN B P，MARTINEZ-VAZQUEZ M，PATWARDHAN V R，et al. Proactive therapeutic concentration monitoring of infliximab may improve outcomes for patients with inflammatory bowel disease：results from a pilot observational study[J]. Inflamm Bowel Dis，2014，20（11）：1996-2003.

AMIOT A，HULIN A，BELHASSAN M，et al. Therapeutic drug monitoring is predictive of loss of response after de-escalation of infliximab therapy in patients with inflammatory bowel disease in clinical remission[J]. Clin Res Hepatol Gastroenterol，2016，40（1）：90-98.

VAN BEZOOIJEN J S，KOCH B C P，VAN DOORN M B A，et al. Comparison of three assays to quantify infli-ximab，adalimumab，and etanercept serum concentrations[J]. Ther Drug Monit，2016，38（4）：432-438.

MARTÍN S，DEL AGUA A R，TORRES N，et al. Comparison study of two commercially available methods for the determination of golimumab and anti-golimumab antibody levels in patients with rheumatic diseases[J]. Clin Chem Lab Med，2015，53（11）：e297-e299.

STEENHOLDT C，BENDTZEN K，BRYNSKOV J，et al. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn’s disease：post hoc analysis of a randomized controlled trial[J]. Am J Gastroenterol，2014，109（7）：1055-1064.

BRANDSE J F，MOULD D，SMEEKES O，et al. A real-life population pharmacokinetic study reveals factors associated with clearance and immunogenicity of infliximab in inflammatory bowel disease[J]. Inflamm Bowel Dis，2017，23（4）：650-660.

VERSTOCKT B，MOORS G，BIAN S M，et al. Influence of early adalimumab serum levels on immunogenicity and long-term outcome of anti-TNF naive Crohn’s disease patients：the usefulness of rapid testing[J]. Aliment Pharmacol Ther，2018，48（7）：731-739.

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