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一项针对神经内分泌肿瘤患者的随机交叉研究,以评估患者对由患者本人/伴侣或医护人员注射的兰瑞肽长效凝胶(®)的偏好。

Randomized crossover study in patients with neuroendocrine tumors to assess patient preference for lanreotide Autogel(®) given by either self/partner or a health care professional.

作者信息

Johanson Viktor, Wilson Benedicte, Abrahamsson Anna, Jianu Constantin, Calissendorff Jan, Wall Najme, Grønbæk Henning, Florholmen Jon, Ohberg Anders, Granberg Dan

机构信息

Department of Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.

出版信息

Patient Prefer Adherence. 2012;6:703-10. doi: 10.2147/PPA.S34337. Epub 2012 Oct 17.

Abstract

BACKGROUND

Lanreotide Autogel(®) is supplied in prefilled syringes. Therefore, it is possible for patients with neuroendocrine tumors to use self-/partner-administered injections. The primary objective of this study was to assess the proportion of patients preferring self/partner injections over injections administered by health care professionals, and to describe the impact of self/partner administration on efficacy, safety, and costs.

METHODS

Of 62 eligible patients, 26 (42%) patients with neuroendocrine tumors treated with a stable dose of lanreotide Autogel 90 mg or 120 mg every 4 weeks agreed to participate in this Phase IV, international, open-label, crossover study, conducted at hospitals in Sweden, Norway, and Denmark. Patients were randomized to two blocks, starting with administration of lanreotide Autogel by either self/partner or a health care professional. Preference for injections administered by self/partner or health care professionals was measured, as well as efficacy, safety, and health care resource utilization (both direct and indirect costs).

RESULTS

Of 25 evaluable patients, 22 (88%) preferred self/partner injections, mainly because they experienced increased independence. Based on all patients asked to participate (n = 62), 35% preferred self/partner injections on a regular basis. There was no difference in efficacy or safety between the two administration blocks.

CONCLUSION

Many patients with neuroendocrine tumors prefer self/partner injection of lanreotide Autogel, and are able to self/partner inject without any impact on efficacy or safety. This administration method seems to provide a good alternative for suitable patients to increase patient independence and reduce the number of clinic visits.

摘要

背景

兰瑞肽缓释凝胶(Lanreotide Autogel®)采用预填充注射器包装。因此,神经内分泌肿瘤患者有可能自行注射或由伴侣协助注射。本研究的主要目的是评估相较于由医护人员注射,更倾向于自行/由伴侣注射的患者比例,并描述自行/由伴侣注射对疗效、安全性和成本的影响。

方法

在瑞典、挪威和丹麦的医院进行了这项IV期国际开放标签交叉研究,62例符合条件的患者中,26例(42%)接受每4周一次稳定剂量90mg或120mg兰瑞肽缓释凝胶治疗的神经内分泌肿瘤患者同意参与。患者被随机分为两组,开始时分别由自行/伴侣或医护人员注射兰瑞肽缓释凝胶。测量了对自行/由伴侣或医护人员注射的偏好,以及疗效、安全性和医疗资源利用情况(包括直接和间接成本)。

结果

在25例可评估患者中,22例(88%)更喜欢自行/由伴侣注射,主要原因是他们感觉独立性增强。在所有被邀请参与的患者(n = 62)中,35%的患者通常更喜欢自行/由伴侣注射。两个注射组在疗效或安全性方面没有差异。

结论

许多神经内分泌肿瘤患者更喜欢自行/由伴侣注射兰瑞肽缓释凝胶,并且能够自行/由伴侣注射,而不会对疗效或安全性产生任何影响。这种注射方式似乎为合适的患者提供了一个很好的选择,可以增强患者的独立性并减少门诊就诊次数。

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