Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.
Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.
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DOI：
10.2147/ppa.s13132
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发表时间：
2010-10-05
影响因子：
2.2
通讯作者：
Laurent PE
中科院分区：
文献类型：
--
作者：
Berteau C;Schwarzenbach F;Donazzolo Y;Latreille M;Berube J;Abry H;Cotten J;Feger C;Laurent PE
开发了一种一次性自动注射器，用于慢性疾病患者的皮下（SC）自我注射。为了验证其性能并评价其可接受性，在健康志愿者中进行了一项临床研究，比较了受试者使用自动注射器进行的SC注射与护士使用注射器进行的SC注射。这是一项比较使用自动注射器进行SC自我注射与使用注射器进行SC护士给药注射的随机化、单中心、交叉研究。向健康志愿者注射两种体积（0.2 mL和1 mL）。研究目的包括评估注射系统注射量的准确性和一致性，以及与注射相关的皮肤反应和疼痛。通过超声评价SC组织层中的液体贮库。使用关于对注射技术的态度和情绪的问卷调查来评价受试者的接受程度，并通过寻求受试者对最终研究注射或未来治疗的首选系统来挑战。在40例受试者中共进行了960次注射（480次使用自动注射器，480次使用注射器）。两种系统之间的平均液体泄漏和注射体积无显著差异。使用自动注射器的注射相关疼痛显著低于使用注射器。注射部位的局部皮肤反应总体令人满意。所有受试者均适当进行了注射。研究结束时，所有40例受试者均首选自动注射装置进行最终研究注射和未来治疗。本研究表明，受试者使用的自动注射器在注射给药的性能和安全性方面与护士使用的注射器相似，在疼痛、总体接受度和偏好方面更好。
A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects’ preferred system for a final study injection or future treatment. A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.
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DOI：
10.1054/ijom.2002.0397
发表时间：
2003-10-01
影响因子：
2.4
作者：
Sieg, P;Hakim, SG;Hermes, D
通讯作者：
Hermes, D
影响因子：
2.3
作者：
Pannier, Anne;Jordan, Paul;Reigner, Bruno
通讯作者：
Reigner, Bruno
影响因子：
4.9
作者：
Gabriel SE;Michaud K
通讯作者：
Michaud K
影响因子：
4.6
作者：
SHRIGLEY, RL;KOBALLA, TR
通讯作者：
KOBALLA, TR
影响因子：
7.4
作者：
Collins, SL;Moore, RA;McQuay, HJ
通讯作者：
McQuay, HJ