Dore Robin K, Feldman Robert G, Taylor Kathleen A, See Kyoungah, Dalsky Gail P, Warner Margaret R
Robin K Dore MD, Inc., 18102 Irvine Boulevard, Suite 104, Tustin, CA 92780-3423, USA.
Curr Med Res Opin. 2009 Oct;25(10):2413-22. doi: 10.1185/03007990903173074.
To determine functionality and acceptability of a new teriparatide (Forteo, Eli Lilly and Company, Indianapolis, IN, USA) delivery device by patients with osteoporosis.
This was an eight week, single-arm, multicenter, open-label clinical trial. Patients received teriparatide 20 microg/day by subcutaneous injection using a new delivery device. Men and postmenopausal women with osteoporosis at high risk for fracture were stratified to Current User (n = 92) or Not Current User (n = 107) groups. Current Users had used the original delivery device for > or =8 weeks, including uninterrupted use for four weeks before enrollment.
ClinicalTrials.gov, NCT00577863.
The primary objective was to detect common complaints (> or =3% for all patients) regarding the functionality and acceptability of the new device. Complaints were categorized as functional (e.g., malfunction), nonfunctional (e.g., size), or user manual. Secondary objectives included questionnaire assessment of preference of the new versus original device, features of the new delivery device, and analysis of adverse events.
A total of 31 patients (16%) reported 47 complaints (four functional, 27 nonfunctional, and 16 user manual). There were two common complaints: device size (4.0%) and lack of information on alcohol swabs (3.5%). Overall, patients agreed that the new device was easy to use (99.5%), easy to learn to use (99%), easy to attach a needle (97%), easy to hold while injecting (95%), and that it reduced their reluctance to take injections (90%). Most Current Users (92%) preferred the new delivery device over the original device. Adverse events reported by > or =2% of patients were upper respiratory infection (3.5%), urinary tract infection (2%), influenza (2%), and headache (2%). Limitations include the one-arm study design and the short (eight week) duration of the study.
Patients found the new teriparatide delivery device easy to use and Current Users preferred the new delivery device over the original device.
确定骨质疏松症患者对一种新型特立帕肽（福善美，美国礼来公司，印第安纳波利斯，印第安纳州）给药装置的功能及接受程度。
这是一项为期8周的单臂、多中心、开放标签的临床试验。患者使用一种新型给药装置皮下注射特立帕肽20微克/天。将有高骨折风险的骨质疏松症男性和绝经后女性分为当前使用者组（n = 92）和非当前使用者组（n = 107）。当前使用者使用原给药装置超过或等于8周，包括在入组前连续使用4周。
ClinicalTrials.gov，NCT00577863。
主要目的是检测关于新装置功能及接受程度的常见抱怨（所有患者中≥ 3%）。抱怨分为功能性（如故障）、非功能性（如尺寸）或用户手册类。次要目的包括通过问卷评估对新装置与原装置的偏好、新给药装置的特点以及不良事件分析。
共有31名患者（16%）报告了47项抱怨（4项功能性、27项非功能性和16项用户手册类）。有两项常见抱怨：装置尺寸（4.0%）和酒精擦拭布信息缺失（3.5%）。总体而言，患者认为新装置易于使用（99.5%）、易于学习使用（99%）、易于连接针头（97%）、注射时易于握持（95%），并且它降低了他们对注射的抵触情绪（90%）。大多数当前使用者（92%）更喜欢新给药装置而非原装置。≥ 2%的患者报告的不良事件有上呼吸道感染（3.5%）、尿路感染（2%）、流感（2%）和头痛（2%）。局限性包括单臂研究设计以及研究持续时间短（8周）。
患者发现新型特立帕肽给药装置易于使用，并且当前使用者更喜欢新给药装置而非原装置。
