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英夫利昔单抗谷浓度对炎症性肠病患者维持治疗 5 年持续临床缓解的预测价值。

Predictive value of infliximab trough levels in maintenance therapy for 5-year sustained clinical remission in patients with inflammatory bowel disease.

出版信息

Bratisl Lek Listy. 2023;124(7):485-492. doi: 10.4149/BLL_2023_074.

Abstract

BACKGROUND

Despite long-term use of infliximab (IFX) in IBD treatment, its optimized use is unclear due to its complicated pharmacokinetics/dynamics. Hence, the predictive value of IFX trough levels (TL) is important in treatment management.

METHODS

We performed a prospective, cross-sectional, observational study with 74 IBD patients treated with IFX (mean 9.1 years, SD ± 3). TL was measured during maintenance therapy, in which maintenance of remission was followed for 5 years.

RESULTS

TL > 3 µg/ml during maintenance therapy was a significant predictor of clinical remission in 5 years in UC patients (82 % vs 62 %, p 3 µg/ml during maintenance therapy in a cohort of IBD patients (p = 0.05). Deviations in percentage of remission and fraction of relapses in TL categories were insignificant in a cohort of CD patients (85 % vs 74 %, p > 0.05).

CONCLUSIONS

TL > 3 µg/ml during maintenance therapy is a strong predictor of sustained clinical remission for 5 years in UC patients. The use of combination therapy with AZA, due to its significant association with high TL, may have a practical benefit in achieving better clinical outcomes in UC patients (Tab. 2, Fig. 10, Ref. 20).

摘要

背景

尽管英夫利昔单抗(IFX)在 IBD 治疗中的应用已有很长时间,但由于其复杂的药代动力学/药效动力学,其最佳使用方法仍不明确。因此,IFX 谷浓度(TL)的预测价值在治疗管理中很重要。

方法

我们进行了一项前瞻性、横断面、观察性研究,纳入 74 例接受 IFX 治疗的 IBD 患者(平均 9.1 年,SD ± 3)。在维持治疗期间测量 TL,维持缓解期为 5 年。

结果

在 UC 患者中,维持治疗期间 TL > 3 µg/ml 是 5 年内临床缓解的显著预测因素(82% vs 62%,p = 0.003)。在 IBD 患者队列中,维持治疗期间 TL > 3 µg/ml 与缓解率和复发率的百分比差异无统计学意义(85% vs 74%,p > 0.05)。

结论

在 UC 患者中,维持治疗期间 TL > 3 µg/ml 是 5 年内持续临床缓解的有力预测因素。联合使用 AZA 的治疗方案可能具有实用价值,因为它与较高的 TL 显著相关,可改善 UC 患者的临床结局(表 2,图 10,参考文献 20)。

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