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英夫利昔单抗加速输注:安全性、不良事件预测因素、患者满意度及成本分析。一项针对炎症性肠病患者的队列研究。

Accelerated Infliximab Infusion: Safety, Factors Predicting Adverse Events, Patients' Satisfaction and Cost Analysis. A Cohort Study in IBD Patients.

作者信息

Mazzuoli S, Tricarico D, Demma F, Furneri G, Guglielmi F W

机构信息

Gastroenterology & Artificial Nutrition Dept., "San Nicola Pellegrino" Hospital, Trani (BT), Italy.

Department of Pharmacology and Pharmaceutical Sciences, University of Bari "Aldo Moro", Bari, Italy.

出版信息

PLoS One. 2016 Nov 16;11(11):e0166443. doi: 10.1371/journal.pone.0166443. eCollection 2016.

Abstract

BACKGROUND

Standard Infliximab infusion consists of a 2-hour intravenous administration. Recently, Infliximab shortened infusion has been included in the Infliximab label as possible maintenance regimen for patients tolerating Infliximab induction therapy.

AIM

To verify if accelerated 1-hour Infliximab infusions are as safe as standard administrations, in patients with Inflammatory Bowel Disease.

METHODS

Seventy-four patients treated between September 2008 and November 2014 were evaluated. Patients were eligible for 1-hour infusion if they had no history of infusion reactions during the previous 2-hour infusions.

RESULTS

Twenty-three patients received 2-hour infusions, 16 patients received 1-hour infusions, 35 patients received 2-hour infusions followed by 1-hour infusions. A total of 1,123 Infliximab infusions were administered. The proportion of patients experiencing infusion reaction was: 4% over the 1-hour infusions and 9% over the 2-hour (P = 0.318). Adverse reaction/infusion rate was 0.55% over the 1-hour infusions and 0.66% over the 2-hour (P = 0.835). In the logistic model, accelerated infusion was the only statistically significant predictor of infusion reaction risk reduction (-90%; P = 0.024). Mean satisfaction was 8/10 (±0.84) with 1-hour regimen and 6/10 (±0.56) with 2-hour infusions (P = 0.000). The mean total cost was reduced by 47% with the 1-hour regimen (133.54€ and 250.86€ for 1-hour and 2-hour infusions, respectively).

CONCLUSIONS

Accelerated Infliximab infusion does not increase the acute infusion reaction incidence. In patients with inflammatory bowel disease, the 1-hour regimen should be preferred to 2-hour protocol also due to positive effects on indirect costs and patient's satisfaction.

摘要

背景

英夫利昔单抗标准输注为2小时静脉给药。最近,英夫利昔单抗缩短输注已被列入英夫利昔单抗标签,作为耐受英夫利昔单抗诱导治疗患者的可能维持方案。

目的

验证在炎症性肠病患者中,1小时加速输注英夫利昔单抗是否与标准给药一样安全。

方法

对2008年9月至2014年11月期间接受治疗的74例患者进行评估。如果患者在之前的2小时输注期间没有输注反应史,则有资格接受1小时输注。

结果

23例患者接受2小时输注,16例患者接受1小时输注,35例患者先接受2小时输注,然后接受1小时输注。共进行了1123次英夫利昔单抗输注。发生输注反应的患者比例为:1小时输注时为4%,2小时输注时为9%(P = 0.318)。不良反应/输注率在1小时输注时为0.55%,2小时输注时为0.66%(P = 0.835)。在逻辑模型中,加速输注是输注反应风险降低的唯一具有统计学意义的预测因素(-90%;P = 0.024)。1小时方案的平均满意度为8/10(±0.84),2小时输注的平均满意度为6/10(±0.56)(P = 0.000)。1小时方案的平均总成本降低了47%(1小时和2小时输注分别为133.54€和250.86€)。

结论

加速英夫利昔单抗输注不会增加急性输注反应发生率。在炎症性肠病患者中,由于对间接成本和患者满意度有积极影响,1小时方案应优于2小时方案。

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