Division of Gastroenterology and Liver Disease, Department of Internal Medicine, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
J Crohns Colitis. 2020 Sep 7;14(8):1057-1065. doi: 10.1093/ecco-jcc/jjaa029.
Using therapeutic drug monitoring [TDM] in adult patients with inflammatory bowel disease [IBD] remains controversial. We conducted a systematic review and meta-analysis to answer four clinical PICO [Population, Intervention, Comparator, Outcome] questions.
We searched MEDLINE, Embase, Web of Science, and Cochrane Central from inception to June 30, 2019. Remission was defined by the manuscripts' definitions of clinical remission. Data were analysed using RevMan 5.3. Quality of evidence was assessed with GRADE methodology.
We identified and screened 3365 abstracts and 11 articles. PICO 1 Reactive vs No TDM: six studies pooled showed 57.1% [257/450] failed to achieve remission following reactive TDM vs 44.7% [268/600] in the no TDM group (risk ratio [RR]: 1.14; 95% confidence interval [CI] 0.88-1.47). PICO 2 Proactive vs no TDM: five studies pooled showed 19.5% [75/384] failed to maintain remission in the proactive TDM group vs 33.4% [248/742] in the no TDM group [RR: 0.60; 95% CI 0.35-1.04]. PICO 3 Proactive vs Reactive TDM: two retrospective studies pooled showed 14.2% [26/183] failure to maintain remission in the proactive TDM group and 64.7% [119/184] in the reactive TDM group [RR: 0.22; 95% CI 0.15-0.32]. PICO 4 TDM [proactive/reactive] vs No TDM: we pooled 10 studies showing 39.7% [332/837] failed to achieve remission in the TDM [proactive/reactive] cohort vs 40.3% [428/1063] in the no TDM cohort [RR: 0.94; 95% CI 0.77-1.14]. Overall, the quality of evidence in each PICO was very low when using GRADE.
This meta-analysis shows that data supporting use of TDM in adults are limited and of very low quality. Further well-designed randomized controlled trials are needed to determine the place of TDM in clinical practice.
在炎症性肠病（IBD）成人患者中使用治疗药物监测（TDM）仍然存在争议。我们进行了系统评价和荟萃分析，以回答四个临床 PICO（人群、干预、对照、结局）问题。
我们从成立到 2019 年 6 月 30 日，在 MEDLINE、Embase、Web of Science 和 Cochrane Central 中进行了检索。缓解通过手稿中临床缓解的定义来定义。使用 RevMan 5.3 分析数据。使用 GRADE 方法评估证据质量。
我们确定并筛选了 3365 篇摘要和 11 篇文章。PICO1 反应性与非 TDM：六项研究的荟萃分析显示，在反应性 TDM 后未能达到缓解的患者中，57.1%（257/450）与非 TDM 组的 44.7%（268/600）相比（风险比[RR]：1.14；95%置信区间[CI]：0.88-1.47）。PICO2 主动与非 TDM：五项研究的荟萃分析显示，在主动 TDM 组中，19.5%（75/384）未能维持缓解，而非 TDM 组中，33.4%（248/742）[RR：0.60；95%CI：0.35-1.04]。PICO3 主动与反应性 TDM：两项回顾性研究的荟萃分析显示，在主动 TDM 组中，14.2%（26/183）未能维持缓解，而在反应性 TDM 组中，64.7%（119/184）[RR：0.22；95%CI：0.15-0.32]。PICO4 TDM（主动/反应性）与非 TDM：我们对 10 项研究进行了荟萃分析，结果显示，在 TDM（主动/反应性）队列中，39.7%（332/837）未能达到缓解，而非 TDM 队列中，40.3%（428/1063）[RR：0.94；95%CI：0.77-1.14]。总体而言，每个 PICO 使用 GRADE 时，证据质量均非常低。
这项荟萃分析表明，支持在成人中使用 TDM 的数据有限且质量非常低。需要进一步进行设计良好的随机对照试验，以确定 TDM 在临床实践中的地位。
