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无针注射对 2 型糖尿病患者心理性胰岛素抵抗及胰岛素剂量的影响。

Effect of needle-free injection on psychological insulin resistance and insulin dosage in patients with type 2 diabetes.

机构信息

Department of Endocrinology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.

Dalian Key Laboratory of Prevention and Treatment of Metabolic Diseases and the Vascular Complications, The First Affiliated Hospital of Dalian Medical University, Dalian, China.

出版信息

Front Endocrinol (Lausanne). 2024 May 8;15:1379830. doi: 10.3389/fendo.2024.1379830. eCollection 2024.

Abstract

BACKGROUND AND OBJECTIVE

Psychological insulin resistance (PIR), which refers to the reluctance of diabetic patients to use insulin, is a frequently encountered clinical issue. Needle-free injection (NFI) offers advantages in terms of expediting insulin absorption and mitigating adverse reactions related to injection. To evaluate the effects of subcutaneous injection of insulin aspart 30 with NFI on PIR and insulin dosage in patients with type 2 diabetes mellitus (T2DM).

METHODS

Sixty-four patients with T2DM participated in this randomized, prospective, open, crossover study. Insulin aspart 30 was administered subcutaneously to each subject via QS-P NFI and Novo Pen 5 (NP) successively. The effects of NFI on PIR were analyzed. Differences in insulin dosage, glycemic variability, and injection safety were compared at similar levels of glycemic control.

RESULTS

After the administration of NFI, the insulin treatment attitude scale score decreased (53.7 ± 7.3 vs. 58.9 ± 10.7, p<0.001), the insulin treatment adherence questionnaire score increased (46.3 ± 4.9 vs. 43.8 ± 7.1, p<0.001), and the insulin treatment satisfaction questionnaire score increased (66.6 ± 10.5 vs. 62.4 ± 16.5, p<0.001). At the same blood glucose level, NFI required a smaller dosage of insulin aspart 30 compared with that of NP (30.42 ± 8.70 vs. 33.66 ± 9.13 U/d, p<0.001). There were no differences in glycemic variability indices (standard deviation, mean amplitude of glycemic excursion or coefficient of variation) between the two injection methods. Compared with NP, NFI did not increase the incidence of hypoglycemia (17.2% vs. 14.1%, p=0.774), and it decreased the incidence of induration (4.7% vs. 23.4%, p=0.002) and leakage (6.3% vs. 20.3%, p=0.022) while decreasing the pain visual analog scale score (2.30 ± 1.58 vs. 3.11 ± 1.40, p<0.001).

CONCLUSION

NFI can improve PIR in patients with T2DM and be used with a smaller dose of insulin aspart 30 while maintaining the same hypoglycemic effect.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/, identifier ChiCTR2400083658.

摘要

背景与目的

心理性胰岛素抵抗(PIR)是指糖尿病患者不愿意使用胰岛素,这是临床上常见的问题。无针注射(NFI)在加速胰岛素吸收和减轻与注射相关的不良反应方面具有优势。评估速效门冬胰岛素 30 经 NFI 皮下注射对 2 型糖尿病(T2DM)患者 PIR 和胰岛素剂量的影响。

方法

64 例 T2DM 患者参与了这项随机、前瞻性、开放、交叉研究。通过 QS-P NFI 和 NovoPen 5(NP)先后对每位患者进行速效门冬胰岛素 30 皮下注射。分析 NFI 对 PIR 的影响。比较不同血糖控制水平下,胰岛素剂量、血糖变异性和注射安全性的差异。

结果

NFI 给药后,胰岛素治疗态度量表评分降低(53.7±7.3 分比 58.9±10.7 分,p<0.001),胰岛素治疗依从性问卷评分升高(46.3±4.9 分比 43.8±7.1 分,p<0.001),胰岛素治疗满意度问卷评分升高(66.6±10.5 分比 62.4±16.5 分,p<0.001)。在相同血糖水平下,NFI 所需的速效门冬胰岛素 30 剂量低于 NP(30.42±8.70 比 33.66±9.13 U/d,p<0.001)。两种注射方法的血糖变异性指标(标准差、血糖波动幅度或变异系数)无差异。与 NP 相比,NFI 并未增加低血糖发生率(17.2%比 14.1%,p=0.774),降低了硬结发生率(4.7%比 23.4%,p=0.002)和漏液发生率(6.3%比 20.3%,p=0.022),同时降低了疼痛视觉模拟量表评分(2.30±1.58 比 3.11±1.40,p<0.001)。

结论

NFI 可改善 T2DM 患者的 PIR,使用速效门冬胰岛素 30 时剂量更小,同时保持相同的降糖效果。

临床试验注册

https://www.chictr.org.cn/,注册号 ChiCTR2400083658。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/651c/11129580/b5be13c79a99/fendo-15-1379830-g001.jpg

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