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指刺式毛细血管采血量和疼痛感知:所有安全采血针都一样吗?

Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal?

机构信息

Regulatory Affairs Department, HTL-Strefa S.A , Ozorków, Poland.

出版信息

Postgrad Med. 2020 Apr;132(3):288-295. doi: 10.1080/00325481.2020.1717160. Epub 2020 Feb 6.

Abstract

OBJECTIVES

This study aimed to assess various types of safety lancets in terms of blood volume and pain perception during capillary blood sampling, a routine finger-puncture procedure for obtaining a small amount of human blood for running various screening and diagnostic tests.

METHODS

Data were collected from 100 adult healthy volunteers following finger-puncture procedure. Four different types of safety lancets were tested (Acti-Lance, Prolance, Medlance Plus, and MediSafe Solo). Each type has its own versions, giving 16 different safety lancets in total.

RESULTS

A significant difference in the mean capillary blood volume was found between blade and needle equipped safety lancets. MediSafe Solo type lancet had no blade version, and hence its use was associated with the lowest mean collected capillary blood volume (42.4 μL). Acti-Lance and Medlance Plus type lancets had one blade version and the mean collected capillary blood volume was 82.2 and 99.0 μL, respectively. Prolance type lancet had two blade versions, and its use was associated with the highest mean capillary blood volume (118.3 μL). The level of pain intensity was evaluated as low by the majority of patients for all lancets. Medlance Plus was the least painful and Acti-Lance was the most painful type of safety lancet. On a 0-to-10 scale of pain, 75% of punctures were assessed by the participants at a level not exceeding 3 points.

CONCLUSIONS

This study suggests that although all investigated safety lancets achieve adequate performance regarding the necessary capillary blood volume to run a diagnostic of test, lancets equipped with blades differ significantly from those equipped with needles in terms of the mean obtained capillary blood volume. Further, although all devices produced relatively low levels of pain, the amount of pain caused by blade versions of safety lancets has been found to be higher than that of needle versions.

CLINICALTRIALS.GOV ID: NCT04001348. (https://clinicaltrials.gov/ct2/show/NCT04001348?term=NCT04001348&draw=2&rank=1).

摘要

目的

本研究旨在评估在毛细血管采血过程中,各种类型的安全采血针对血量和疼痛感知的影响,这是一种常规的手指穿刺程序,用于获取少量人类血液以进行各种筛查和诊断测试。

方法

在手指穿刺程序后,从 100 名成年健康志愿者中收集数据。测试了四种不同类型的安全采血针(Acti-Lance、Prolance、Medlance Plus 和 MediSafe Solo)。每种类型都有自己的版本,总共 16 种不同的安全采血针。

结果

在配备刀片和针的安全采血针之间,发现平均毛细血管血量存在显著差异。MediSafe Solo 型采血针没有刀片版本,因此其使用与采集的平均毛细血管血量最低(42.4μL)相关。Acti-Lance 和 Medlance Plus 型采血针有一个刀片版本,采集的平均毛细血管血量分别为 82.2μL 和 99.0μL。Prolance 型采血针有两个刀片版本,其使用与最高平均毛细血管血量(118.3μL)相关。大多数患者对所有采血针的疼痛强度评估均为低水平。Medlance Plus 是最不痛的,而 Acti-Lance 是最痛的安全采血针。在 0 到 10 的疼痛量表上,75%的穿刺由参与者评估为不超过 3 分的水平。

结论

本研究表明,虽然所有研究的安全采血针在进行诊断测试所需的必要毛细血管血量方面都表现出色,但在获得的平均毛细血管血量方面,配备刀片的采血针与配备针的采血针存在显著差异。此外,尽管所有设备产生的疼痛程度相对较低,但安全采血针的刀片版本引起的疼痛量被发现高于针版本。

临床试验注册号

NCT04001348(https://clinicaltrials.gov/ct2/show/NCT04001348?term=NCT04001348&draw=2&rank=1)。

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