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无针注射器在中国 2 型糖尿病患者基础胰岛素治疗中的疗效和安全性:一项多中心、前瞻性、随机、交叉研究。

Efficacy and safety of a needle-free injector in Chinese patients with type 2 diabetes mellitus treated with basal insulin: a multicentre, prospective, randomised, crossover study.

机构信息

Department of Endocrinology, Xijing Hospital, Fourth Military Medical University , Xi'an , Shaanxi , China.

Department of Endocrinology, The first People's Hospital , YinChuan , China.

出版信息

Expert Opin Drug Deliv. 2019 Sep;16(9):995-1002. doi: 10.1080/17425247.2019.1649251. Epub 2019 Aug 5.

Abstract

: To evaluate the efficacy and safety of a needle-free injector in Chinese patients with type 2 diabetes mellitus treated with basal insulin. : 62 patients with type 2 diabetes were enrolled in a multicenter, randomised, prospective, open-label, crossover study. All patients received subcutaneous insulin glargine administered by a needle-free injector or a glargine pen for 7 ~ 14 days, and were then crossed over after wash out. : Patients in the insulin needle-free injector (NFI) and glargine pen (GP) groups achieved similar fasting blood glucose control . However, the dosage of insulin required to achieve the target FBG level in the NFI group was lower than in the GP group (16.14 ± 5.13 U/day vs 19.25 ± 6.20 U/day, respectively; = 0.0046). This difference was more significant in patients who received higher insulin dosages compared with those receiving lower dosages. Use of the needle-free injector was also associated with significantly less pain ( < 0.001) and less fear of injection ( < 0.001) than glargine pens. : The use of a needle-free injector can significantly lower the dosage of insulin required to achieve good glycemic control and reduce topical adverse reactions and the fear of injections as well, which help to improve patient compliance. Clinical Trial Registration Number KY20172077-1; NCT03420040.

摘要

: 评估无针注射器在接受基础胰岛素治疗的中国 2 型糖尿病患者中的疗效和安全性。: 62 例 2 型糖尿病患者参与了一项多中心、随机、前瞻性、开放标签、交叉研究。所有患者均接受无针注射器或甘精胰岛素笔皮下注射胰岛素 glargine,持续 7~14 天,然后洗脱后交叉。: 无针注射器(NFI)组和甘精胰岛素笔(GP)组患者的空腹血糖控制相似。然而,NFI 组达到目标 FBG 水平所需的胰岛素剂量低于 GP 组(分别为 16.14±5.13 U/天和 19.25±6.20 U/天;=0.0046)。与接受较低剂量胰岛素的患者相比,接受较高剂量胰岛素的患者差异更显著。与甘精胰岛素笔相比,无针注射器的使用还与明显较低的疼痛( < 0.001)和注射恐惧( < 0.001)相关。: 使用无针注射器可显著降低达到良好血糖控制所需的胰岛素剂量,并减少局部不良反应和注射恐惧,从而提高患者的依从性。临床试验注册号 KY20172077-1;NCT03420040。

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