摘要
目的探究非诺贝特联用辛伐他汀治疗2型糖尿病(T2DM)合并血脂异常患者的疗效和安全性。方法纳入如皋市人民医院2022年1月至2024年1月收治的100例T2DM合并血脂异常患者,按照信封法将患者随机分为辛伐他汀组(n=50,二甲双胍每次0.5 g、每日2次,辛伐他汀每次10 mg、每日1次,持续服用3个月)与联合非诺贝特组(n=50,在辛伐他汀组基础上加用非诺贝特,每次0.1 g,每日1次,持续服用3个月)。对比两组临床疗效、血糖指标[空腹血糖(FPG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)]、血脂指标[甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、载脂蛋白B(ApoB)]、体质量[体脂百分比(BF%)、BMI]、内皮功能指标[一氧化氮(NO)、内皮素1(ET-1)]以及药品不良反应。结果联合非诺贝特组的临床疗效高于辛伐他汀组(χ^(2)=4.000,P=0.046);治疗后,两组FPG、2 h PG、HbA1c均下降,联合非诺贝特组各指标低于辛伐他汀组(t=3.093、2.204、2.825,P=0.003、0.030、0.006);治疗后,两组TG、TC、LDL-C、ApoB均下降,HDL-C上升,联合非诺贝特组TG、TC、LDL-C、ApoB低于辛伐他汀组(t=2.580、4.060、5.112、5.369,P=0.011、<0.001、<0.001、<0.001),HDL-C高于辛伐他汀组(t=4.849,P<0.001);联合非诺贝特组血脂达标率高于辛伐他汀组(χ^(2)=4.332,P=0.037);治疗后,两组BF%、BMI均下降,联合非诺贝特组各指标低于辛伐他汀组(t=5.323、6.539,均P<0.001);治疗后,两组NO均上升,ET-1下降,联合非诺贝特组NO高于辛伐他汀组(t=4.976,P<0.001),联合非诺贝特组ET-1低于辛伐他汀组(t=4.688,P<0.001),差异均有统计学意义。联合非诺贝特组不良反应发生率(8.00%)与辛伐他汀组(4.00%)比较,差异无统计学意义(χ^(2)=0.709,P=0.400)。结论非诺贝特联用辛伐他汀可有效治疗T2DM合并血脂异常,控制患者血糖血脂,降低体质量,改善血管内皮指标,药物安全有效。
Objective To explore the efficacy and safety of fenofibrate combined with simvastatin in the treatment of type 2 diabetes(T2DM)patients with dyslipidemia.Methods A total of 100 patients with T2DM and dyslipidemia admitted to The People’s Hospital of Rugao from January 2022 to January 2024 were included in this study.According to the random allocation using envelope method,the patients were divided into the simvastatin group(n=50,metformin(0.5 g/time,twice a day)+simvastatin(10 mg/time,once a day),continuous administration for 3 months)and the combined fenofibrate group(n=50,fenofibrate(0.1 g/time,once a day),continuous administration for 3 months based on the regimen in the simvastatin group).The clinical efficacy,blood glucose changes(fasting plasma glucose(FPG),2 h postprandial blood glucose(2 h PG),glycosylated hemoglobin(HbA1c)),blood lipids indicators(triglyceride(TG),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),apolipoprotein B(ApoB)),body mass(body fat percentage(BF%),body mass index),endothelial function indicators(nitric oxide(NO),endothelin-1(ET-1))and adverse drug reactions were compared between the two groups.Results The clinical efficacy in the combined fenofibrate group was significantly higher than that in the simvastatin group(χ^(2)=4.000,P=0.046).After treatment,the levels of FPG,2 h PG and HbA1c in both groups were significantly decreased,and they were significantly lower in the combined group than in the control group(t=3.093,2.204,2.825,P=0.003,0.030,0.006).The levels of TG,TC,LDL-C and ApoB in both groups after treatment were significantly reduced while the HDL-C level was significantly enhanced,and the levels of TG,TC,LDL-C and ApoB were significantly lower(t=2.580,4.060,5.1125.369,P=0.011,<0.001,<0.001,<0.001),while the HDL-C level was significantly higher in the combined fenofibrate group than in the simvastatin group(t=4.849,P<0.001).The blood lipid compliance rate of the combined fenofibrate group was significantly higher than that of the simvastatin group(χ^(2)=4.332,P=0.037).The BF%and BMI were significantly decreased in both groups,and these indicators in the combined fenofibrate group were significantly lower than those in the simvastatin group(t=5.323,6.539,both P<0.001).The level of NO in both groups was significantly increased,while that of ET-1 was significantly decreased.The level of NO in the combined fenofibrate group was significantly higher than that in the simvastatin group(t=4.976,P<0.001),while that of ET-1 was significantly lower(t=4.688,P<0.001).There was no statistical significance in the incidence of adverse reactions between the combined fenofibrate group(8.00%)and the simvastatin group(4.00%)(χ^(2)=0.709,P=0.400).Conclusion Fenofibrate combined with simvastatin can effectively treat T2DM patients with dyslipidemia since it can control blood glucose and blood lipids,reduce body mass and improve vascular endothelial indicators.Meanwhile,it is safe and effective.
作者
马佳
汤金燕
柳文
陆媛
孔然
陆培培
周昌盛
Ma Jia;Tang Jinyan;Liu Wen;Lu Yuan;Kong Ran;Lu Peipei;Zhou Changsheng(Department of Pharmacy,The People’s Hospital of Rugao,Nantong 226500,China)
出处
《中国药物应用与监测》
2025年第5期834-838,共5页
Chinese Journal of Drug Application and Monitoring
基金
南通市药物政策与药学服务研究课题(2023NTPA18)。
关键词
非诺贝特
辛伐他汀
二甲双胍
2型糖尿病
血脂异常
血管内皮功能
Fenofibrate
Simvastatin
Metformin
Type 2 diabetes mellitus
Dyslipidemia
Vascular endothelial function
