西格列他钠联合重组人胰岛素对2型糖尿病患者的治疗效果

doi:10.3760/cma.j.cn441417-20240702-03026

摘要/Abstract

摘要：

目的　探讨2型糖尿病（T2DM）患者应用西格列他钠联合重组人胰岛素的治疗效果。方法　采用前瞻性研究，选取2022年2月至2024年2月在铜川市人民医院接受治疗的90例T2DM患者作为研究对象，按随机数字表法分为两组，各45例。对照组：男26例，女19例，年龄（65.46±3.53）岁，病程（7.78±1.24）年；给予重组人胰岛素治疗（重组人胰岛素注射液0.4～0.6 U/kg，2次/d，于早、晚餐前30 min腹部皮下注射）。观察组：男27例，女18例，年龄（66.13±3.42）岁，病程（8.14±1.37）年；在对照组的基础上联合西格列他钠治疗（西格列他钠片口服，2片/次，1次/d）。两组均治疗3个月。观察两组治疗前后血糖水平、空腹胰岛素、血脂指标、炎症因子、不良反应及临床疗效。采用t检验、χ²检验进行统计分析。结果　治疗后，观察组空腹血糖（FPG）、餐后2 h血糖（2 hPG）、糖化血红蛋白（HbA1c）、空腹胰岛素、总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）水平均低于对照组［（6.63±1.28）mmol/L比（7.95±1.56）mmol/L、（8.24±1.23）mmol/L比（10.16±1.65）mmol/L、（6.49±0.54）%比（7.36±0.87）%、（10.69±1.72）mU/L比（16.33±1.43）mU/L、（4.12±0.18）mmol/L比（4.95±0.63）mmol/L、（1.23±0.24）mmol/L比（1.76±0.38）mmol/L、（3.04±0.23）mmol/L比（3.86±0.75）mmol/L］，高密度脂蛋白胆固醇（HDL-C）水平高于对照组［（1.68±0.16）mmol/L比（1.23±0.19）mmol/L］，差异均有统计学意义（t=4.388、6.258、5.699、16.914、8.497、7.910、7.011、12.152，均P<0.05）。观察组C反应蛋白（CRP）、肿瘤坏死因子-α（TNF-α）、白细胞介素-6（IL-6）水平均低于对照组，差异均有统计学意义（t=6.489、4.124、14.999，均P<0.05）。观察组临床总有效率高于对照组［95.55%（43/45）比77.77%（35/45）］，差异有统计学意义（χ²=6.153，均P<0.05）。结论　T2DM患者应用西格列他钠联合重组人胰岛素治疗，可降低血糖水平，改善血脂水平，减轻炎症反应，提高临床疗效。

关键词:

2型糖尿病, 西格列他钠, 重组人胰岛素, 血糖, 疗效

Abstract:

Objective　To investigate the efficacy of chiglitazar sodium combined with recombinant human insulin in the treatment of type 2 diabetes mellitus (T2DM). Methods　A prospective study was carried out on 90 patients with T2DM who were treated in Tongchuan People's Hospital from February 2022 to February 2024. The patients were divided into two groups according to the random number table method. In the control group, there were 26 males and 19 females, aged (65.46±3.53) years, and the course of disease was (7.78±1.24) years. In the observation group, there were 27 males and 18 females, aged (66.13±3.42) years, and the course of disease was (8.14±1.37) years. The control group was treated with recombinant human insulin (recombinant human insulin injection 0.4-0.6 U/kg, subcutaneous injection into the abdomen 30 min before breakfast and dinner, twice a day). The observation group was combined with chiglitazar sodium on the basis of the control group (oral chiglitazar sodium tablets, 2 tablets/time, once a day). Both groups were treated for 3 months. The levels of blood glucose, fasting insulin, blood lipid indexes, and inflammatory factors before and after treatment, adverse reactions, and clinical efficacy of both groups were observed. t test and χ² test were used for statistical analysis. Results　After treatment, the levels of fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG), glycated hemoglobin (HbA1c), fasting insulin, total cholesterol (TC), triglyceride (TG), and low density lipoprotein cholesterol (LDL-C) in the observation group were lower than those in the control group [(6.63±1.28) mmol/L vs. (7.95±1.56) mmol/L, (8.24±1.23) mmol/L vs. (10.16±1.65) mmol/L, (6.49±0.54) % vs. (7.36±0.87) %, (10.69±1.72) mU/L vs. (16.33±1.43) mU/L, (4.12±0.18) mmol/L vs. (4.95±0.63) mmol/L, (1.23±0.24) mmol/L vs. (1.76±0.38) mmol/L, (3.04±0.23) mmol/L vs. (3.86±0.75) mmol/L], while the level of high density lipoprotein cholesterol (HDL-C) was higher than that in the control group [(1.68±0.16) mmol/L vs. (1.23±0.19) mmol/L], with statistically significant differences (t=4.388, 6.258, 5.699, 16.914, 8.497, 7.910, 7.011, and 12.152, all P<0.05). The levels of C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) in the observation group were lower than those in the control group, with statistically significant differences (t=6.489, 4.124, and 14.999, all P<0.05). The total effective rate of the observation group was higher than that of the control group [95.55% (43/45) vs. 77.77% (35/45)], the difference was statistically significant (χ²=6.153, P<0.05). Conclusion　In T2DM patients, chiglitazar sodium combined with recombinant human insulin can reduce the blood glucose level, improve the level of blood lipids, reduce the inflammatory reaction, and improve the clinical efficacy.

Key words:

Type 2 diabetes mellitus, Chiglitazar sodium, Recombinant human insulin, Blood glucose, Efficacy

关微焦建虎陈娟李秋云魏当.

西格列他钠联合重组人胰岛素对2型糖尿病患者的治疗效果 [J]. 国际医药卫生导报, 2025, 31(3): 478-482.

Guan Wei, Jiao Jianhu, Chen Juan, Li Qiuyun, Wei Dang.

Efficacy of chiglitazar sodium and recombinant human insulin in patients with type 2 diabetes mellitus [J]. International Medicine and Health Guidance News, 2025, 31(3): 478-482.

参考文献

[1] 王璐,魏安华,曾露,等. 恩格列净治疗2型糖尿病有效性安全性和经济性的快速卫生技术评估[J]. 医药导报,2023,42(12):1841-1849. DOI:10.3870/j.issn.1004-0781.2023. 12.017.
[2] Valaiyapathi B, Gower B, Ashraf AP. Pathophysiology of type 2 diabetes in children and adolescents[J]. Curr Diabetes Rev, 2020,16(3):220-229.DOI: 10.2174/1573399814666180608074510.
[3] 邵琛,耿丽娟,于菁菁.胰岛素分泌曲线与血糖谱在2型糖尿病合理选择胰岛素促泌剂中的应用[J].国际医药卫生导报,2024,30(5):771-775. DOI:10.3760/cma.j.issn.1007-1245. 2024.05.014.
[4] 车婷婷,王曦,刘圆圆,等. 重组人胰岛素注射液治疗糖尿病的多中心、随机、对照临床研究[J]. 中华内科杂志,2011,50(1):23-26. DOI:10.3760/cma.j.issn.0578-1426.2011. 01.008.
[5] 郭宁子,刘丽,岳瑞齐,等. 激光衍射法测定西格列他钠粒径分布[J]. 中国药物警戒,2024,21(2):147-151. DOI:10.19803/j.1672-8629.20230434.
[6] «中国糖尿病防治指南»编写组.中国糖尿病防治指南[M].北京.北京大学医学出版社,2004:17.
[7] Targher G, Corey KE, Byrne CD, et al. The complex link between NAFLD and type 2 diabetes mellitus - mechanisms and treatments[J]. Nat Rev Gastroenterol Hepatol, 2021,18(9):599-612. DOI: 10.1038/s41575-021-00448-y.
[8] Rein M, Ben-Yacov O, Godneva A,et al. Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial[J]. BMC Med, 2022,20(1):56.DOI: 10.1186/s12916-022- 02254-y.
[9] 张建,范文文. DPP-4抑制剂联合阿卡波糖治疗初诊老年T2DM患者的疗效分析[J]. 国际医药卫生导报,2022,28(23):3388-3391. DOI:10.3760/cma.j.issn.1007-1245. 2022.23.032.
[10] Li S, Lin G, Chen J,et al. The effect of periodic ketogenic diet on newly diagnosed overweight or obese patients with type 2 diabetes[J]. BMC Endocr Disord, 2022,22(1):34.DOI: 10.1186/s12902-022-00947-2.
[11] 朱晓艳,顾嘉燕,陈颖盈,等. 二甲双胍与精蛋白锌重组人胰岛素混合注射液治疗2型糖尿病临床观察[J]. 山西医药杂志,2023,52(15):1147-1151. DOI:10.3969/j.issn.0253- 9926.2023.15.007.
[12] Jia W, Ma J, Miao H,et al. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing)[J]. 2021,66(15):1581-1590.DOI: 10.1016/j.scib.2021.02.027.
[13] 瞿色华,单连强,陈爽,等. 重组人胰岛素样生长因子1对新生大鼠高氧诱导的支气管肺发育不良的保护作用及机制研究[J]. 中国临床药理学杂志,2022,38(12):1359-1362. DOI:10.13699/j.cnki.1001-6821.2022.12.014.
[14] 闫坤,原丽敏,张培育,等. PPARα激动剂联合GLP-1 RAs对2型糖尿病患者Omentin-1、Asprosin水平的影响[J]. 广东医学,2022,43(1):90-93. DOI:10.13820/j.cnki.gdyx. 20210643.
[15] 胡瑞萍,尚利峰,王和静,等. 基于PPARγ对糖转运及代谢的影响探讨罗格列酮对糖尿病小鼠胰腺癌模型的作用机制[J]. 中国药理学通报,2024,40(7):1325-1334. DOI:10.12360/CPB202401066.
[16] 吴彩斌,李明明. 过氧化物酶体增殖物激活受体激动剂对2型糖尿病患者动脉内皮功能的影响[J]. 山西医药杂志,2020,49(22):3112-3114. DOI:10.3969/j.issn.0253-9926. 2020.22.028.
[17] 罗娟,邝楠珍,李浪波,等. 胰岛素强化治疗后转换为西格列他钠联合司美格鲁肽治疗新诊断2型糖尿病合并非酒精性脂肪性肝病1例[J]. 中华糖尿病杂志,2023,15(Z2):130-134. DOI:10.3760/cma.j.cn115791-20230630- 00341.
[18] 姚林,罗腾,杨磊,等. PPARγ受体激动剂通过HIF-1α/BNIP3信号通路减轻脑出血模型大鼠继发性损伤的机制研究[J]. 实用心脑肺血管病杂志,2024,32(5):66-71. DOI:10.12114/j.issn.1008-5971.2024.00.096.
[19] 黄志龙,都渝,赵君. GLP-1激动剂联合替格瑞洛对2型糖尿病合并冠心病患者血清YKL-40及PPARγ的影响[J]. 中南医学科学杂志,2021,49(5):559-563. DOI:10.15972/j.cnki.43-1509/r.2021.05.015.
[20] 管纯一,马旭,夏红飞. 过氧化物酶体增殖物激活受体α对人绒毛滋养层细胞功能的影响[J]. 动物学杂志,2020,55(2):213-221. DOI:10.13859/j.cjz.202002010.
[21] 钱宇池,万璐,卢宇欣,等. 恩格列净通过上调Epac1表达抑制炎症反应减轻2型糖尿病大鼠肾损伤[J]. 细胞与分子免疫学杂志,2024,40(2):129-134. DOI:10.13423/j.cnki.cjcmi.009712.
[22] 张琳萍,姚筱,朱燕亭,等. 基于TLR4/NF-κB信号通路沉默miR-21对糖尿病肾病大鼠的干预效果[J]. 河北医药,2023,45(19):2891-2894,2900. DOI:10.3969/j.issn.1002-7386. 2023.19.002.
[23] 苏燕娜,林倍思,陈亚兰,等. PPARδ调控自噬在GLP-1受体激动剂艾塞那肽改善胰岛β细胞功能中的作用[J]. 中国病理生理杂志,2022,38(10):1737-1746. DOI:10.3969/j.issn.1000-4718.2022.10.002.
[24] 仇金玮,屈小伶,李媛媛. 胰岛素注射远程服务在2型糖尿病患者居家管理中的应用[J]. 中华现代护理杂志,2024,30(1):101-105. DOI:10.3760/cma.j.cn115682-20230626- 02524.
[25] Gawrieh S, Noureddin M, Loo N,et al. Saroglitazar, a PPAR-α/γ agonist, for treatment of NAFLD: a randomized controlled double-blind phase 2 trial[J]. Hepatology, 2021,74(4):1809-1824. DOI: 10.1002/hep.31843.