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依卡替班疗效调查中遗传性血管性水肿发作的治疗:依卡替班自我给药与医护人员给药的分析

Treatment of HAE Attacks in the Icatibant Outcome Survey: An Analysis of Icatibant Self-Administration versus Administration by Health Care Professionals.

作者信息

Hernández Fernandez de Rojas Dolores, Ibañez Ethel, Longhurst Hilary, Maurer Marcus, Fabien Vincent, Aberer Werner, Bouillet Laurence, Zanichelli Andrea, Caballero Teresa

机构信息

Department of Allergy, IIS Hospital La Fe, Valencia, Spain.

出版信息

Int Arch Allergy Immunol. 2015;167(1):21-8. doi: 10.1159/000430864. Epub 2015 Jun 25.

DOI:10.1159/000430864
PMID:26112099
Abstract

BACKGROUND

Icatibant, a selective bradykinin B2 receptor antagonist for the treatment of acute hereditary angio-oedema (HAE) attacks in adults, can be administered by health care professionals (HCPs) or self-administered. This analysis compared characteristics and outcomes of acute HAE attacks treated with self-administered and HCP-administered icatibant in a real-world setting.

METHODS

The Icatibant Outcome Survey (Shire, Zug, Switzerland; NCT01034969) is an international observational study monitoring the safety and effectiveness of icatibant treatment. Descriptive retrospective analyses were performed (February 2008 to December 2012).

RESULTS

Icatibant was used in 652 attacks in 170 patients with HAE type I/II. Most icatibant injections were self-administered (431/652, 68.5%). The proportion of self-treated attacks increased over time (40.3% in 2009 vs. 89.7% in 2012). The median time to administration was significantly shorter in self- versus HCP-treated attacks (1.5 vs. 2.4 h; p = 0.016). Earlier treatment (<2 h after onset) was significantly associated with a shorter median time to resolution (2.5 vs. 5.0 h; p = 0.032) and attack duration (3.0 vs. 14.0 h; p < 0.0001), regardless of administration method. Patients self-administered icatibant for attacks of all severities; overall, 34.7% of severe and 30.2% of very severe attacks were HCP treated. Logistic regression analysis did not find use of long-term prophylaxis, attack location or gender to be predictive for self-administration.

CONCLUSIONS

The proportion of HAE attacks treated with self-administered icatibant increased over time. Patients successfully self-administered icatibant for a wide variety of HAE attacks, demonstrating that icatibant is generally well tolerated and effective for self-administration. Self-administration of icatibant provides a complementary option to HCP administration, enabling optimization of patient care.

摘要

背景

依卡替班是一种用于治疗成人急性遗传性血管性水肿(HAE)发作的选择性缓激肽B2受体拮抗剂,可由医护人员给药或患者自行给药。本分析比较了在实际临床环境中,由患者自行给药和由医护人员给药的依卡替班治疗急性HAE发作的特征和结果。

方法

依卡替班疗效调查(瑞士楚格希雷公司;NCT01034969)是一项监测依卡替班治疗安全性和有效性的国际观察性研究。进行了描述性回顾性分析(2008年2月至2012年12月)。

结果

170例I/II型HAE患者共发生652次发作并使用了依卡替班。大多数依卡替班注射是由患者自行给药(431/652,68.5%)。自行给药发作的比例随时间增加(2009年为40.3%,2012年为89.7%)。自行给药发作与医护人员给药发作相比,给药的中位时间显著更短(1.5小时对2.4小时;p = 0.016)。无论给药方式如何,早期治疗(发作后<2小时)与较短的中位缓解时间(2.5小时对5.0小时;p = 0.032)和发作持续时间(3.0小时对14.0小时;p < 0.0001)显著相关。患者自行使用依卡替班治疗所有严重程度的发作;总体而言,34.7%的重度发作和30.2%的极重度发作由医护人员治疗。逻辑回归分析未发现长期预防用药、发作部位或性别可预测自行给药情况。

结论

随着时间的推移,自行给药依卡替班治疗的HAE发作比例增加。患者成功地自行使用依卡替班治疗各种HAE发作,表明依卡替班通常耐受性良好且自行给药有效。依卡替班自行给药为医护人员给药提供了一种补充选择,有助于优化患者护理。

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