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对不孕不育症女性和生育护士目前可使用的重组人促卵泡激素笔式注射器的使用和操作失误进行评估。

An evaluation of the use and handling errors of currently available recombinant human follicle-stimulating hormone pen injectors by women with infertility and fertility nurses.

机构信息

Global Clinical Development, Merck Serono S.p.A , Rome , Italy.

Global Strategic Insights, Merck KGaA , Darmstadt , Germany.

出版信息

Expert Opin Drug Deliv. 2019 Sep;16(9):1003-1014. doi: 10.1080/17425247.2019.1651290. Epub 2019 Aug 14.

Abstract

: This study compared preference ratings of women with infertility and nurses before and after simulated injection, and handling errors, with the GONAL-f®, Bemfola®, Ovaleap® and Rekovelle® pen injectors. : Injector-naïve women and injector-experienced fertility nurses tested injectors with masked labels in a randomized testing order. Injections were made into a foam pad and injectors were rated before and after use. Handling errors were recorded during the study. Ratings and errors were compared between pen injectors using ordinal or Poisson linear mixed models adjusted for testing order. : 120 women and 60 nurses participated. All participants tested GONAL-f and Bemfola injectors. Because of their similarity, participants tested either Rekovelle (71 women; 30 nurses) or Ovaleap (49 women; 30 nurses) injectors. The ratings from women were higher for GONAL-f vs other injectors after simulated use (p < 0.001 for all comparisons). Fertility nurses rated GONAL-f injector higher than other injectors both before and after use (p < 0.01 for all comparisons). Adjusted rates of total handling errors were lower with the GONAL-f vs other injectors (p < 0.001 for all comparisons) for both groups. : GONAL-f injector was rated significantly higher than other injectors, which may be related to less handling errors observed with the GONAL-f injector.

摘要

这项研究比较了不孕妇女和护士在模拟注射和处理错误前后对 GONAL-f®、Bemfola®、Ovaleap®和 Rekovelle®笔式注射器的偏好评分。

无经验的注射者和有经验的生育护士用带有遮蔽标签的注射器以随机测试顺序进行测试。将注射器注入泡沫垫中,并在使用前后对其进行评分。在研究过程中记录处理错误。使用有序或泊松线性混合模型调整测试顺序对笔式注射器进行评分和错误比较。

共有 120 名女性和 60 名护士参加了这项研究。所有参与者都测试了 GONAL-f 和 Bemfola 注射器。由于它们的相似性,参与者测试了 Rekovelle(71 名女性;30 名护士)或 Ovaleap(49 名女性;30 名护士)注射器。模拟使用后,女性对 GONAL-f 的评分高于其他注射器(所有比较均 p < 0.001)。使用前后,生育护士对 GONAL-f 注射器的评分均高于其他注射器(所有比较均 p < 0.01)。两组的总处理错误率均低于 GONAL-f 与其他注射器(所有比较均 p < 0.001)。

GONAL-f 注射器的评分明显高于其他注射器,这可能与 GONAL-f 注射器观察到的处理错误较少有关。

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