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缩短英夫利昔单抗输注时间的疗效与安全性。

Efficacy and safety of reducing duration of infliximab infusion.

作者信息

Fukuyo Shunsuke, Saito Kazuyoshi, Yamaoka Kunihiro, Sawamukai Norifumi, Hirata Shintaro, Nawata Masao, Iwata Shigeru, Tanaka Yoshiya

机构信息

The First Department of Internal Medicine, University of Occupational and Environmental Health , Japan, Kitakyushu , Japan.

出版信息

Mod Rheumatol. 2014 Mar;24(2):275-80. doi: 10.3109/14397595.2013.843747. Epub 2013 Oct 11.

DOI:10.3109/14397595.2013.843747
PMID:24251990
Abstract

OBJECTIVE

To evaluate the safety and efficacy of reducing the duration of infliximab infusion for rheumatoid arthritis (RA) treatment.

METHODS

The first 6 infliximab infusions were each administered over a 2-h period. If no adverse reaction was observed, infusion times were shortened to 1 h starting with the seventh infusion with further shortening to 30 min starting with the thirteenth infusion. Subjects were divided into two groups: shortened infusion time group, in which infusion times were shortened as above; and constant infusion time group, in which infusion time was 2 h. Incidence of infusion reactions and improvement in disease activity score for 28 joints (DAS-28) erythrocyte sedimentation rate (ESR) for total infusions were compared for the seventh to twelfth and thirteenth to eighteenth infusions.

RESULTS

The incidences of infusion reactions after the seventh to twelfth and thirteenth to eighteenth infusions in the shortened infusion time group were 0.53% and 0.58%, respectively. In the constant infusion time group, these were 0.70% and 0.67%, respectively. Furthermore, shortening the infusion duration did not affect the DAS-28 (ESR) improvement rate.

CONCLUSIONS

We established that this stage-wise shortening of infusion duration, first to 1 h and then to 30 min, did not compromise the safety or efficacy of treatment.

摘要

目的

评估缩短英夫利昔单抗输注时间用于类风湿关节炎(RA)治疗的安全性和有效性。

方法

英夫利昔单抗的前6次输注每次持续2小时。若未观察到不良反应,则从第7次输注开始将输注时间缩短至1小时,从第13次输注开始进一步缩短至30分钟。受试者分为两组:缩短输注时间组,即按照上述方法缩短输注时间;以及固定输注时间组,其输注时间为2小时。比较第7至12次输注以及第13至18次输注时两组的输注反应发生率和28个关节疾病活动评分(DAS-28)、红细胞沉降率(ESR)的改善情况。

结果

缩短输注时间组第7至12次输注以及第13至18次输注后的输注反应发生率分别为0.53%和0.58%。固定输注时间组的相应发生率分别为0.70%和0.67%。此外,缩短输注持续时间并未影响DAS-28(ESR)的改善率。

结论

我们证实,这种分阶段将输注持续时间先缩短至1小时,然后再缩短至30分钟的方法,不会损害治疗的安全性或有效性。

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