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医师主导与患者主导的甘精胰岛素滴定治疗在印度 2 型糖尿病患者中的疗效和安全性:亚洲甘精胰岛素治疗达标研究(ATLAS)的亚组分析。

Effectiveness and Safety of Physician-Led Versus Patient-Led Titration of Insulin Glargine in Indian Patients with Type 2 Diabetes Mellitus: A Subanalysis of the Asian Treat to Target Lantus Study (ATLAS).

机构信息

Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.

All India Institute of Diabetes and Research, Swasthya Diabetes Care, Jay Mangal Society, Ahmedabad, India.

出版信息

Diabetes Technol Ther. 2019 Nov;21(11):656-664. doi: 10.1089/dia.2019.0037. Epub 2019 Aug 9.

Abstract

Titration of basal insulin led by either the physician or the patient is not well understood in India. This analysis of Indian subset of Asian Treat to Target Lantus Study (ATLAS) compared effectiveness of patient-led with physician-led titration of once-daily insulin glargine 100 U/mL (Glargine-U-100) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetes drug (OAD). In this open-label parallel group study, randomized patients (either physician-led or patient-led [self-titration] group) followed the same dose titration algorithm (fasting blood glucose [FBG] target 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led group versus the physician-led group. Patients (40-75 years) were randomized to either the physician-led group ( = 39) or the patient-led group ( = 36). At week 24, self-titration led to a greater decline in HbA1c than physician-led titration (-1.3% vs. -1.1%). Mean decrease in FBG was more in the patient-led group than in the physician-led group (-53.7 mg/dL vs. -35.5 mg/dL). Mean daily dose of Glargine-U-100 at week 24 was higher in the patient-led group than in the physician-led group (30.0 U vs. 23.8 U). At any time during the study, 30.6% and 7.7% of patients in the patient-led and physician-led groups, respectively, showed target HbA1c level of <7.0% without severe hypoglycemia. Treatment satisfaction and quality of life improved in both groups. Overall, treatment was safe and well tolerated, and none of the events led to treatment discontinuation. Patient-led adjustment of Glargine-U-100 in outpatient setting can be a safe and effective method for glycemic control in Indian patients with T2DM uncontrolled on OADs.

摘要

在印度,医生或患者主导的基础胰岛素滴定方案并不被广泛了解。这项亚洲治疗达标-来得时研究(ATLAS)的印度亚组分析比较了患者主导与医生主导的每日一次胰岛素甘精 100U/mL(甘精 U-100)滴定方案对口服抗糖尿病药物(OAD)控制不佳的 2 型糖尿病(T2DM)患者的疗效。在这项开放标签的平行组研究中,随机分组的患者(医生主导或患者主导[自我滴定]组)遵循相同的剂量滴定算法(空腹血糖[FBG]目标 110mg/dL[6.1mmol/L])。主要终点是患者主导组与医生主导组在第 24 周时平均糖化血红蛋白(HbA1c)的变化。患者(40-75 岁)随机分为医生主导组(n=39)或患者主导组(n=36)。在第 24 周时,自我滴定导致 HbA1c 下降幅度大于医生滴定(-1.3% vs. -1.1%)。患者主导组的 FBG 平均下降幅度大于医生主导组(-53.7mg/dL vs. -35.5mg/dL)。第 24 周时,患者主导组的甘精 U-100 日平均剂量高于医生主导组(30.0U vs. 23.8U)。在研究期间的任何时候,患者主导组和医生主导组分别有 30.6%和 7.7%的患者达到了无严重低血糖的 HbA1c 目标水平<7.0%。两组的治疗满意度和生活质量均有所改善。总的来说,治疗是安全且耐受良好的,没有任何事件导致治疗中断。在门诊环境中,患者主导的甘精 U-100 调整可以是一种安全有效的方法,用于控制 OAD 控制不佳的印度 T2DM 患者的血糖。

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