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患者对预填充笔式注射器与预填充注射器皮下注射达贝泊汀α的认知:一项随机、交叉研究。

Patients' perceptions of subcutaneous delivery of darbepoetin alfa by autoinjector prefilled pen versus prefilled syringe: a randomized, crossover study.

机构信息

Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.

出版信息

Clin Ther. 2012 Sep;34(9):1948-53. doi: 10.1016/j.clinthera.2012.07.012. Epub 2012 Aug 15.

Abstract

BACKGROUND

Subcutaneous injection of erythropoiesis-stimulating agents for the correction of anemia associated with chronic kidney disease is well recognized. Different delivery devices are available, although their impact on patient-reported outcomes is limited.

OBJECTIVES

Subcutaneous delivery of darbepoetin alfa via an autoinjector prefilled pen (PFP) and prefilled syringe (PFS) were compared and assessed according to patient-rated preferences and perceptions.

METHODS

In this single-center, randomized, open-label, double-crossover study, patients continued using the PFS for 4 injections or were switched to the PFP for the same number of injections, after which they were switched to the alternative device. Following further 4 injections using the new device, patients were switched back to the initial device. Questionnaires were administered at the end of each series of injections for each device and at the start and end of the study.

RESULTS

For overall device preference, the majority (62%) of patients responded with PFP, whereas 32% preferred the PFS mode of delivery. This preference for PFP was driven by a perception of increased convenience and ease of use compared with PFS. No significant differences in pain scores were noted between the 2 devices. Most patients rated both devices as being "easy" or "extremely easy" to use and were either "satisfied" or "extremely satisfied."

CONCLUSION

When given the choice, most patients preferred the PFP mode of administration compared with PFS due to convenience and ease of use. ClinicalTrials.gov identifier: ACTRN12611000839909.

摘要

背景

皮下注射红细胞生成刺激剂纠正慢性肾脏病相关贫血已得到广泛认可。目前有多种不同的给药装置可供选择,但它们对患者报告结局的影响有限。

目的

比较并评估达贝泊汀α通过预填充笔(PFP)和预填充注射器(PFS)进行皮下给药的患者偏好和感受。

方法

在这项单中心、随机、开放标签、双交叉研究中,患者继续使用 PFS 进行 4 次注射,或更换为 PFP 进行相同次数的注射,之后再更换为另一种装置。在使用新装置进行了另外 4 次注射后,患者再换回初始装置。在每次装置注射结束时以及研究开始和结束时,都对患者进行问卷调查。

结果

对于整体装置偏好,大多数(62%)患者选择 PFP,而 32%的患者更喜欢 PFS 给药模式。与 PFS 相比,PFP 具有更高的便利性和易用性,这是选择 PFP 的主要原因。两种装置的疼痛评分无显著差异。大多数患者认为两种装置都“容易”或“非常容易”使用,且满意度均为“满意”或“非常满意”。

结论

当有选择时,大多数患者更喜欢使用 PFP 给药模式,而不是 PFS,因为 PFP 更方便且易用。临床试验注册号:ACTRN12611000839909。

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