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英夫利昔单抗治疗炎症性肠病:关注不良事件。

Infliximab in inflammatory bowel disease: attention to adverse events.

作者信息

Uyanikoglu A, Ermis F, Akyuz F, Pinarbasi B, Baran B, Aydogan T, Demir K, Besisik F, Kaymakoglu S

机构信息

Department of Gastroenterology, Harran University, Medical Faculty, Sanliurfa, Turkey.

出版信息

Eur Rev Med Pharmacol Sci. 2014 Aug;18(16):2337-42.

Abstract

OBJECTIVE

To assess the efficacy and adverse effects of infliximab in patients with Crohn's disease and ulcerative colitis who are resistant to conventional therapy or having fistulising type Crohn's disease.

PATIENTS AND METHODS

The patients with a diagnosis of inflammatory bowel disease received infliximab between 2007 and 2009 were followed-up prospectively. Infliximab 5 mg/kg was given at week 0, 2, 6, and every 8 weeks thereafter. Early and late adverse events occurring during the treatment were recorded for each patient.

RESULTS

There were 36 patients [mean age 35±12, 17 male] included in the study. Thirty-two (88%) patients were receiving concomitant long-term immunosuppressive therapy. Complete or partial response was obtained in 75% of all patients. At least one adverse event was observed in 10 (28%) patients. Anaphylaxis was seen in 2 (6%) patients, mild acute infusion reaction in 2 (6%) patients, hypotension in 2 (6%) patients, respiratory distress in 2 (6%) patients, skin rash and eruptions in 2 (6%) patients, one hypertension (3%) and one (3%) tightness in the chest. Treatment was continued in all except patients with anaphylaxis. No infection, tumour or cases of death were observed.

CONCLUSIONS

Several adverse events might be observed in patients who receive infliximab. Care should be given to patients whom treatment was restarted after a break in regard to anaphylaxis. No serious adverse event was observed during infliximab treatment except allergic events.

摘要

目的

评估英夫利昔单抗对常规治疗无效或患有瘘管型克罗恩病的克罗恩病和溃疡性结肠炎患者的疗效及不良反应。

患者与方法

对2007年至2009年间接受英夫利昔单抗治疗的炎性肠病患者进行前瞻性随访。在第0、2、6周给予英夫利昔单抗5mg/kg,此后每8周给药一次。记录每位患者治疗期间发生的早期和晚期不良事件。

结果

本研究纳入36例患者[平均年龄35±12岁,男性17例]。32例(88%)患者同时接受长期免疫抑制治疗。75%的患者获得完全或部分缓解。10例(28%)患者观察到至少一种不良事件。2例(6%)患者出现过敏反应,2例(6%)患者出现轻度急性输注反应,2例(6%)患者出现低血压,2例(6%)患者出现呼吸窘迫,2例(6%)患者出现皮疹和皮肤疹,1例(3%)患者出现高血压,1例(3%)患者出现胸部紧绷感。除过敏反应患者外,所有患者均继续治疗。未观察到感染、肿瘤或死亡病例。

结论

接受英夫利昔单抗治疗的患者可能会出现多种不良事件。对于中断治疗后重新开始治疗的患者,应注意过敏反应。除过敏事件外,英夫利昔单抗治疗期间未观察到严重不良事件。

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