Verrips G H, Hirasing R A, Fekkes M, Vogels T, Verloove-Vanhorick S P, Delemarre-Van de Waal H A
TNO Prevention and Health, Leiden, The Netherlands.
Acta Paediatr. 1998 Feb;87(2):154-8. doi: 10.1080/08035259850157589.
The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi-Jector results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi-Jector is a needle-free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two-period cross-over trial. A questionnaire was used to assess psychological responses such as non-compliance, opinion on ease of preparation, affective responses to administration and local side-effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi-Jector less offputting (p < 0.01), less painful with respect to both frequency (p < 0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p < 0.01). No difference in compliance was detected. Most subjects preferred the Medi-Jector for future use (p < 0.05). The mean score on a 1-10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi-Jector and 6.8 (SD 2.3) for the multidose injection pen (p < 0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi-Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi-Jector (p < 0.06). It is concluded that use of the Medi-Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles.
使用Medi-Jector每日注射生长激素所引起的不良心理反应比使用多剂量注射笔进行皮下注射更少。Medi-Jector是一种无针注射装置，可通过喷射注射将生长激素输送到皮下。研究组由18名10岁及以上的儿童组成，他们参与了一项关于通过喷射注射或皮下注射生长激素的生物等效性和生物等效力的研究。此前，所有受试者均使用市售多剂量注射笔接受过生长激素治疗。该研究设计为前瞻性、随机、两阶段交叉试验。使用一份问卷来评估心理反应，如不依从性、对制剂简易程度的看法、对注射的情感反应和局部副作用，以及总体偏好。此外，受试者在研究期间记日记。受试者发现，与使用28G针头的多剂量注射笔相比，Medi-Jector更不让人讨厌（p<0.01），在注射频率（p<0.04）和强度（p<0.01）方面疼痛更少，且不那么令人不适（p<0.05）（p<0.01）。未检测到依从性方面的差异。大多数受试者更倾向于在未来使用Medi-Jector（p<0.05）。在1至10分的评分量表上（10分为优秀），Medi-Jector的平均得分为7.9（标准差1.4），多剂量注射笔的平均得分为6.8（标准差2.3）（p<0.08）。Medi-Jector每天出现可见瘀伤的发生率（2.5，标准差2.1）高于多剂量注射笔（0.7，标准差1.1）（p<0.01），但儿童对瘀伤表现出无差异的情感反应。18名受试者中有13人决定继续使用Medi-Jector进行治疗（p<0.06）。得出的结论是，在生长激素治疗中使用Medi-Jector比使用28G针头的多剂量注射笔往往会导致更少的不良心理反应。
