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在中国糖尿病患者中,从生物类似药(巴沙林)转换为原研药(来得时)甘精胰岛素是有效的:一项回顾性病历审查。

Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review.

作者信息

Hu Xia, Zhang Lei, Dong Yanhu, Dong Chao, Jiang Jikang, Gao Weiguo

机构信息

Qingdao Endocrine and Diabetes Hospital, Qingdao, 266071, China.

出版信息

F1000Res. 2018 Apr 18;7:477. doi: 10.12688/f1000research.13923.1. eCollection 2018.

DOI:10.12688/f1000research.13923.1
PMID:29862021
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5941245/
Abstract

This study investigated the effectiveness and safety of switching from Basalin® to Lantus® in Chinese patients with diabetes mellitus (DM).  A retrospective chart review conducted using the electronic medical records of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. All patients were diagnosed with DM and underwent switching of insulin from Basalin to Lantus during hospitalization. Data collected included fasting (FBG), pre- and post-prandial whole blood glucose, insulin dose, reasons for insulin switching and hypoglycemia. Four study time points were defined as: hospital admission, Basalin initiation, insulin switching (date of final dose of Basalin), and hospital discharge. Blood glucose measurements were imputed as the values recorded closest to the dates of these four time points for each patient. Data from 73 patients (70 patients with type 2 diabetes, 2 with type 1, and 1 undisclosed) were analyzed. At admission, mean glycated hemoglobin (HbA1c) and FBG were 8.9% (SD=1.75) and 9.98 (3.22) mmol/L, respectively. Between Basalin initiation and insulin switch, mean FBG decreased from 9.68 mmol/L to 8.03 mmol/L (p<0.0001), over a mean 10.8 (SD=6.85) days of Basalin treatment, and reduced further to 7.30 mmol/L at discharge (p=0.0116) following a mean 6.6 (7.36) days of Lantus. The final doses of Basalin and Lantus were similar (0.23 vs. 0.24 IU/kg/day; p=0.2409). Furthermore, reductions in pre- and post-prandial blood glucose were also observed between Basalin initiation, insulin switch and hospital discharge. The incidence of confirmed hypoglycemia was low during Basalin (2 [2.4%]) and Lantus (1 [1.2%]) treatment, with no cases of severe hypoglycemia. In this study population, switching from Basalin to Lantus was associated with further reductions in blood glucose, although the dose of insulin glargine did not increase. Further studies are required to verify these findings and determine the reason for this phenomenon.

摘要

本研究调查了中国糖尿病患者从甘舒霖®转换为来得时®的有效性和安全性。使用青岛内分泌与糖尿病医院2005年至2016年住院患者的电子病历进行回顾性图表审查。所有患者均被诊断为糖尿病,并在住院期间接受了从甘舒霖到来得时的胰岛素转换。收集的数据包括空腹血糖(FBG)、餐前和餐后全血血糖、胰岛素剂量、胰岛素转换原因和低血糖情况。定义了四个研究时间点:入院、开始使用甘舒霖、胰岛素转换(甘舒霖最后一剂的日期)和出院。血糖测量值采用每个患者最接近这四个时间点日期记录的值。分析了73例患者的数据(70例2型糖尿病患者、2例1型糖尿病患者和1例未披露类型者)。入院时,平均糖化血红蛋白(HbA1c)和FBG分别为8.9%(标准差=1.75)和9.98(3.22)mmol/L。在开始使用甘舒霖和胰岛素转换之间,平均FBG从9.68 mmol/L降至8.03 mmol/L(p<0.0001),甘舒霖治疗平均10.8(标准差=6.85)天,在来得时平均治疗6.6(7.36)天后出院时进一步降至7.30 mmol/L(p=0.0116)。甘舒霖和来得时的最终剂量相似(0.23 vs. 0.24 IU/kg/天;p=0.2409)。此外,在开始使用甘舒霖、胰岛素转换和出院之间,还观察到餐前和餐后血糖的降低。在甘舒霖(2例[2.4%])和来得时(1例[1.2%])治疗期间,确诊低血糖的发生率较低,无严重低血糖病例。在该研究人群中,从甘舒霖转换为来得时与血糖进一步降低相关,尽管甘精胰岛素的剂量未增加。需要进一步研究以验证这些发现并确定这一现象的原因。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5120/5941245/57fcf644222d/f1000research-7-15136-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5120/5941245/6b0017354f77/f1000research-7-15136-g0000.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5120/5941245/57fcf644222d/f1000research-7-15136-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5120/5941245/6b0017354f77/f1000research-7-15136-g0000.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5120/5941245/57fcf644222d/f1000research-7-15136-g0001.jpg

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