Bohannon N J, Ohannesian J P, Burdan A L, Holcombe J H, Zagar A
Eli Lilly and Company, Indianapolis, Indiana, USA.
Clin Ther. 2000 Sep;22(9):1049-67. doi: 10.1016/s0149-2918(00)80084-3.
This study assessed acceptability of a new 3.0-mL prefilled insulin pen device, the Humulin/Humalog Pen, as a method of delivering human insulin. Secondary objectives were to determine whether the pen device might facilitate initiation of insulin therapy in patients currently receiving oral antihyperglycemic agents and to monitor the safety of this pen device in clinical practice.
For both the patient and health care provider, significant negative perceptions of the use of insulin therapy persist, including patient inconvenience, social stigma from insulin injections, and insufficient time for the provider to train the patient.
This 6-week, open-label, noncomparative study was conducted at 33 centers in the United States. Patients with type 1 or type 2 diabetes treated with insulin therapy or oral antihyperglycemic agents were enrolled in the study. Before the study, 62% (194 patients) had used a syringe and vial for insulin injection, 28% (87 patients) had used an insulin pen device, and 10% (30 patients) were insulin-naive. Prior therapy was unknown in 1% (4 patients). Patients used the Humulin/Humalog Pen for > or = 1 injection of insulin daily for 6 weeks. At the beginning and end of the study, patients completed a questionnaire designed to elicit their perceptions of the Humulin/Humalog Pen; physicians completed a questionnaire at the end of the study. Frequencies and percentages of all categoric responses were calculated and summarized.
A total of 315 patients (136 type 1, 179 type 2 diabetes) were enrolled. Of the 299 patients who completed questionnaires at the end of the study, 76% (226 patients) were somewhat or extremely satisfied with the pen, 78% (234 patients) probably or definitely would continue to use the pen, and 80% (239 patients) probably or definitely would recommend the pen to others. Of the 33 physicians who completed questionnaires at the end of the study, 97% (32) thought that the pen was better overall compared with a vial and syringe, 88% (29) thought that it took less time to teach patients to use the pen, and 73% (24) thought that it took less time to initiate insulin therapy with the pen.
The Humulin/Humalog Pen had an acceptable safety profile and was well accepted by patients and physicians.
本研究评估了一种新型3.0毫升预填充胰岛素笔装置(优泌林/优泌乐笔)作为注射人胰岛素方法的可接受性。次要目的是确定该笔式装置是否有助于目前正在接受口服降糖药治疗的患者开始胰岛素治疗,并监测该笔式装置在临床实践中的安全性。
对于患者和医护人员而言,对胰岛素治疗的使用仍存在明显的负面看法,包括患者不便、胰岛素注射带来的社会污名,以及医护人员没有足够时间培训患者。
这项为期6周的开放标签、非对照研究在美国的33个中心进行。纳入接受胰岛素治疗或口服降糖药治疗的1型或2型糖尿病患者。研究前,62%(194例患者)使用注射器和小瓶注射胰岛素,28%(87例患者)使用胰岛素笔装置,10%(30例患者)未使用过胰岛素。1%(4例患者)既往治疗情况不明。患者每天使用优泌林/优泌乐笔注射胰岛素≥1次,共6周。在研究开始和结束时,患者完成一份旨在了解他们对优泌林/优泌乐笔看法的问卷;医生在研究结束时完成一份问卷。计算并总结所有分类回答的频率和百分比。
共纳入315例患者(136例1型糖尿病,179例2型糖尿病)。在研究结束时完成问卷的299例患者中,76%(226例患者)对该笔式装置有些满意或非常满意,78%(234例患者)可能或肯定会继续使用该笔式装置,80%(239例患者)可能或肯定会向他人推荐该笔式装置。在研究结束时完成问卷的33名医生中,97%(32名)认为该笔式装置总体上比小瓶和注射器更好,88%(29名)认为教患者使用该笔式装置花费的时间更少,73%(24名)认为使用该笔式装置开始胰岛素治疗花费的时间更少。
优泌林/优泌乐笔具有可接受的安全性,并且受到患者和医生的广泛接受。