School of Health Sciences, Division of Pharmacy and Optometry, University of Manchester , Manchester, UK.
Department of Reproductive Medicine, Saint Mary's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre , Manchester, UK.
Expert Opin Drug Deliv. 2020 Nov;17(11):1647-1654. doi: 10.1080/17425247.2020.1813106. Epub 2020 Oct 13.
Gonadotropin injections for fertility treatment regimens are usually self-injected, typically over 8-12 days during the assisted reproductive technology cycle. Parenteral gonadotropins are available in different formulations and administered through various systems. A user experience study and risk assessment were performed to evaluate different product types for risks to the patient when preparing and administering injections.
Nine women of child-bearing age each prepared and administered injections of six products representing single- and multidose vials of menotropin for reconstitution (Merional® and Menopur®), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon®), and without cartridges (Gonal-f®), and single-use FSH pre-filled pens (Bemfola®). Risk assessments based on user feedback were made with reference to EU regulations for implementing practices for safe use of injectable products.
Products requiring reconstitution with diluent in glass ampoules were associated with medium risk for sharps injury and a lower level of user confidence. Pen injectors were considered easy-to-use, with a low risk of sharps injury. Single-use pens were associated with the lowest risk of dosing errors.
The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice.
促性腺激素注射剂用于生育治疗方案，通常由患者自行注射，在辅助生殖技术周期中通常需要注射 8-12 天。生殖激素有不同的制剂，通过不同的系统给药。为了评估在准备和注射过程中不同产品类型对患者的风险，进行了一项用户体验研究和风险评估。
9 名育龄妇女分别准备和注射了 6 种产品，这些产品代表了用于复溶的单剂量和多剂量小瓶的人绒毛膜促性腺激素（Merional®和 Menopur®）、带有（Puregon®）和不带药筒的卵泡刺激素（FSH）可重复使用笔式注射器、以及单次使用的 FSH 预填充笔式注射器（Bemfola®）。根据用户反馈，参考欧盟关于实施安全使用注射产品的实施规范，对风险进行了评估。
需要用玻璃安瓿中的稀释剂复溶的产品与锐器伤害的中度风险以及较低的用户信心相关。笔式注射器被认为易于使用，锐器伤害的风险较低。一次性笔与最低的剂量错误风险相关。
该研究确定了 FSH 给药方案之间在锐器伤害和剂量错误风险方面的差异，临床医生在做出治疗选择时应考虑这些差异。
