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戈利木单抗用于溃疡性结肠炎临床实践的初步经验。

Initial experience with golimumab in clinical practice for ulcerative colitis.

作者信息

Castro-Laria Luisa, Argüelles-Arias Federico, García-Sánchez Valle, Benítez José Manuel, Fernández-Pérez Ramón, Trapero-Fernández Ana María, Gallardo-Sánchez Francisco, Pallarés-Manrique Héctor, Gómez-García María, Cabello-Tapia María José, Talavera-Fabuel Aurora, Bejarano-García Ana, Leo-Carnerero Eduardo, Hernández-Martínez Álvaro, Caunedo-Álvarez Ángel, Herrerías-Gutiérrez Juan Manuel

机构信息

Digestivo, H Universitario Virgen Macarena, España.

Digestivo, H. Universitario Virgen Macarena, España.

出版信息

Rev Esp Enferm Dig. 2016 Mar;108(3):129-32. doi: 10.17235/reed.2016.4068/2015.

DOI:10.17235/reed.2016.4068/2015
PMID:26786341
Abstract

BACKGROUND

Golimumab is a TNF-blocking agent indicated as a second-line therapy in ulcerative colitis.

PURPOSE

To research the effectiveness and safety of golimumab in patients with ulcerative colitis in clinical practice.

METHODS

Retrospective study of the effectiveness and safety of golimumab in patients with ulcerative colitis. All patients received golimumab 200 mg subcutaneously at week 0, and golimumab 100 mg subcutaneously at week 2. After the induction treatment, each patient received 50 mg sc. every 4 weeks in patients with body weight less than 80 kg, and 100 mg every 4 weeks in patients with body weight greater than or equal to 80 kg.

RESULTS

Study of a group of 23 ulcerative colitis patients, 7 of whom were naive to any anti-TNF therapy, and 16 patients who had previously been treated with an anti-TNF agent other than golimumab (non-naive patients). The average treatment time with golimumab was 14.3 weeks. Globally, withdrawal of corticosteroids was observed in 74% of cases. Clinical response was observed in 85.5% of patients who had not received biological treatment previously, and in patients who had previously received biological treatment the response rate was 75%.

CONCLUSIONS

In this short study, golimumab seems to be an alternative treatment in naive and non-naive anti-TNF ulcerative colitis patients. It is also a safe therapy, given that there were no adverse effects in the patients studied.

摘要

背景

戈利木单抗是一种肿瘤坏死因子阻断剂,被用作溃疡性结肠炎的二线治疗药物。

目的

研究戈利木单抗在临床实践中治疗溃疡性结肠炎患者的有效性和安全性。

方法

对戈利木单抗治疗溃疡性结肠炎患者的有效性和安全性进行回顾性研究。所有患者在第0周皮下注射200mg戈利木单抗,在第2周皮下注射100mg戈利木单抗。诱导治疗后,体重小于80kg的患者每4周皮下注射50mg,体重大于或等于80kg的患者每4周皮下注射100mg。

结果

研究了一组23例溃疡性结肠炎患者,其中7例未接受过任何抗TNF治疗,16例曾接受过除戈利木单抗以外的抗TNF药物治疗(非初治患者)。戈利木单抗的平均治疗时间为14.3周。总体而言,74%的病例观察到停用皮质类固醇。在未接受过生物治疗的患者中,85.5%观察到临床反应,在曾接受过生物治疗的患者中,反应率为75%。

结论

在这项短期研究中,戈利木单抗似乎是初治和非初治抗TNF溃疡性结肠炎患者的一种替代治疗方法。鉴于所研究的患者未出现不良反应,它也是一种安全的治疗方法。

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