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易泵™电子生长激素自动注射器的治疗依从性和患者接受度:来自 824 名儿童及其家长的调查结果。

Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents.

机构信息

Paediatric Department, University of Pavia, IRCCS San Matteo Foundation, Pavia, Italy.

出版信息

BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.

Abstract

BACKGROUND

Accurately monitoring adherence to treatment with recombinant human growth hormone (r-hGH) enables appropriate intervention in cases of poor adherence. The electronic r-hGH auto-injector, easypod™, automatically records the patient's adherence to treatment. This study evaluated adherence to treatment of children who started using the auto-injector and assessed opinions about the device.

METHODS

A multicentre, multinational, observational 3-month survey in which children received r-hGH as part of their normal care. Physicians reviewed the recorded dose history and children (with or without parental assistance) completed a questionnaire-based survey. Children missing ≤2 injections per month (92% of injections given) were considered adherent to treatment. Adherence was compared between GH treatment-naïve and treatment-experienced children.

RESULTS

Of 834 recruited participants, 824 were evaluated. The median (range) age was 11 (1-18) years. From the recorded dose history, 87.5% of children were adherent to treatment over the 3-month period. Recorded adherence was higher in treatment-naïve (89.7%, n = 445/496) than in treatment-experienced children (81.7%, n = 152/186) [Fisher's exact test FI(X) = 7.577; p = 0.0062]. According to self-reported data, 90.2% (607/673) of children were adherent over 3 months; 51.5% (421/817) missed ≥1 injection over this period (mainly due to forgetfulness). Concordance between reported and recorded adherence was 84.3%, with a trend towards self-reported adherence being higher than recorded adherence. Most children liked the auto-injector: over 80% gave the top two responses from five options for ease of use (720/779), speed (684/805) and comfort (716/804). Although 38.5% (300/780) of children reported pain on injection, over half of children (210/363) considered the pain to be less or much less than expected. Given the choice, 91.8% (732/797) of children/parents would continue using the device.

CONCLUSIONS

easypod™ provides an accurate method of monitoring adherence to treatment with r-hGH. In children who received treatment with r-hGH using easypod™, short-term adherence is good, and significantly higher in treatment-naïve children compared with experienced children. Children/parents rate the device highly. The high level of acceptability of the device is reflected by a desire to continue using it by over 90% of the children in the survey.

摘要

背景

准确监测重组人生长激素(r-hGH)治疗的依从性,可在依从性差的情况下进行适当干预。电子 r-hGH 自动注射器 easypod™可自动记录患者的治疗依从性。本研究评估了开始使用自动注射器的儿童的治疗依从性,并评估了他们对该设备的看法。

方法

这是一项多中心、多国、观察性的 3 个月调查,在此期间,儿童接受 r-hGH 作为常规护理的一部分。医生查看了记录的剂量史,儿童(有无家长协助)完成了基于问卷的调查。每月错过≤2 次注射(给予 92%的注射)的儿童被认为治疗依从性良好。比较了 GH 治疗初治和治疗经验丰富的儿童的依从性。

结果

在招募的 834 名参与者中,824 名接受了评估。中位(范围)年龄为 11 岁(1-18 岁)。根据记录的剂量史,87.5%的儿童在 3 个月期间治疗依从性良好。治疗初治组(89.7%,n=445/496)的记录依从性高于治疗经验丰富组(81.7%,n=152/186)[Fisher 确切检验 FI(X)=7.577;p=0.0062]。根据自我报告的数据,90.2%(607/673)的儿童在 3 个月内依从性良好;51.5%(421/817)在此期间错过≥1 次注射(主要是因为健忘)。报告的和记录的依从性之间的一致性为 84.3%,报告的依从性呈上升趋势高于记录的依从性。大多数儿童喜欢自动注射器:超过 80%的儿童从五个选项中选择了易于使用(720/779)、速度(684/805)和舒适度(716/804)这两个最佳选项。尽管 38.5%(300/780)的儿童在注射时感到疼痛,但超过一半的儿童(210/363)认为疼痛比预期的要轻或轻得多。如果有选择,91.8%(732/797)的儿童/家长将继续使用该设备。

结论

easypod™提供了一种监测 r-hGH 治疗依从性的准确方法。在接受 r-hGH 治疗的儿童中,使用 easypod™的短期依从性良好,在初治儿童中显著高于经验丰富的儿童。儿童/家长对该设备评价很高。超过 90%的调查儿童希望继续使用该设备,这反映了该设备高度的可接受性。

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