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抗肿瘤坏死因子α诱导治疗开始后C反应蛋白降低率可预测克罗恩病患者的继发反应丧失。

C-Reactive protein reduction rate following initiation of anti-tumor necrosis factor α induction therapy predicts secondary loss of response in patients with Crohn's disease.

作者信息

Song Joo Hye, Hong Sung Noh, Lee Jung Eun, Kim Kyunga, Kim Tae Jun, Kim Eun Ran, Chang Dong Kyung, Kim Young-Ho

机构信息

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Korea.

Research Institute for Future Medicine, Samsung Medical Center, Biostatistics and Clinical Epidemiology Center , Seoul , Korea.

出版信息

Scand J Gastroenterol. 2019 Jul;54(7):876-885. doi: 10.1080/00365521.2019.1638962. Epub 2019 Jul 15.

Abstract

The objective of this study is to identify clinical predictors of primary non-response (PNR) and secondary loss of response (LOR), in Crohn's disease (CD) patients treated with anti-tumor necrosis factor α (anti-TNF) agents. This retrospective, longitudinal, and observational cohort study included 283 patients with CD who received anti-TNF treatments from November 2006 to July 2017 at Samsung Medical Center, Seoul, Korea. A total of 212 patients with CD were eligible and based on clinical responses, divided into three groups: PNR, LOR, and responder groups. PNR occurred in 13 patients (6.1%). C-Reactive protein (CRP) level at initiation of anti-TNF (baseline CRP) was a possible predictor of PNR compared to the non-PNR group (baseline CRP >1 mg/dl, OR = 4.34, 95% CI = 1.06-17.83,   .042). During maintenance therapy, incidence of LOR was 12.2% at 1-year, 23.6% at 2-years, 36.3% at 3-years, and 52.1% at 5-years. Combining baseline CRP level and CRP reduction rate [(CRP at 12-14 weeks-baseline CRP)/baseline CRP] was a possible predictor of 1-year LOR compared to the responder group (baseline CRP >1 mg/dl and CRP reduction rate > -70%, OR = 18.86, 95% CI = 3.40-104.55,   .001). In the Cox hazard proportional model, a combination of baseline CRP level and CRP reduction rate was possible predictors of long-term LOR during maintenance therapy (baseline CRP >1 mg/dl and CRP reduction rate > -70%, HR = 5.84, 95% CI = 2.75-12.41,   .001). Baseline CRP level and CRP reduction rate might be clinical predictors for PNR or LOR to anti-TNF in patients with CD, and could guide proper therapeutic interventions in patients with CD.

摘要

本研究的目的是确定接受抗肿瘤坏死因子α(抗TNF)药物治疗的克罗恩病(CD)患者原发性无反应(PNR)和继发性反应丧失(LOR)的临床预测因素。这项回顾性、纵向观察性队列研究纳入了2006年11月至2017年7月在韩国首尔三星医疗中心接受抗TNF治疗的283例CD患者。共有212例CD患者符合条件,并根据临床反应分为三组:PNR组、LOR组和反应者组。13例患者(6.1%)出现PNR。与非PNR组相比,抗TNF治疗开始时的C反应蛋白(CRP)水平(基线CRP)可能是PNR的预测因素(基线CRP>1mg/dl,OR=4.34,95%CI=1.06-17.83,P=0.042)。在维持治疗期间,LOR的发生率在1年时为12.2%,2年时为23.6%,3年时为36.3%,5年时为52.1%。与反应者组相比,将基线CRP水平和CRP降低率[(12-14周时的CRP-基线CRP)/基线CRP]相结合可能是1年LOR的预测因素(基线CRP>1mg/dl且CRP降低率>-70%,OR=18.86,95%CI=3.40-104.55,P=0.001)。在Cox风险比例模型中,基线CRP水平和CRP降低率的组合可能是维持治疗期间长期LOR的预测因素(基线CRP>1mg/dl且CRP降低率>-70%,HR=5.84,95%CI=2.75-12.41,P=0.001)。基线CRP水平和CRP降低率可能是CD患者抗TNF治疗PNR或LOR的临床预测因素,并可指导CD患者进行适当的治疗干预。

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