达格列净治疗急性心肌梗死合并2型糖尿病患者的临床研究OA北大核心CSTPCD
Clinical trial of daglizin in the treatment of patients with acute myocardial infarction complicated with type 2 diabetes
目的 探究达格列净片对急性心肌梗死(AMI)合并2型糖尿病(T2DM)患者介入术后心肌酶谱、二尖瓣血流和主要不良心血管事件(MACE)的影响.方法 将AMI合并T2DM患者按队列法分为对照组和试验组.对照组在介入治疗前,口服阿司匹林片300 mg和替格瑞洛片180mg,qd,连续服用至介入治疗当日;介入治疗后,给予阿司匹林片100 mg,qd,口服替格瑞洛片,每次90 mg,早晚各1次.在对照组治疗的基础上,试验组在患者入院后每天晨间给予达格列净片5~10 mg,qd,连续治疗3个月.比较2组患者临床疗效、血糖控制效果[空腹血糖(FPG)、餐后2 h血糖(2 h PG)]、心肌酶谱指标[肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)]、心室重构指标[左心室射血分数(LVEF)、左心室收缩末期内径(LVESD)]、药物不良反应以及MACE发生情况.结果 对照组入组55例,试验组入组59例.治疗后,试验组和对照组总有效率分别为88.14%(52例/59例)和72.73%(40例/55例),在统计学上差异有统计学意义(P<0.05).治疗后,试验组和对照组的FPG分别为(7.29±0.71)和(7.81±0.75)mmol·L-1,2 h PG 分别为(8.66±1.33)和(9.59±1.38)mmol·L-1,CK 分别为(145.68±29.82)和(163.68±42.16)U·L-1,CK-MB 分别为(8.21±2.37)和(10.33±3.08)U·L-1,LVEF 分别为(57.63±8.74)%和(51.41±6.49)%,LVESD分别为(33.26±5.33)和(39.51±5.38)mm.试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).治疗期间,试验组的药物不良反应主要包括恶心呕吐、腹泻、便秘;对照组药物不良反应主要包括低血糖、腹泻、头痛.试验组和对照组总药物不良反应发生率分别为6.68%(4例/59例)和9.09%(5例/55例),在统计学上差异无统计学意义(P>0.05).随访3个月,试验组与对照组MACE总发生率分别为5.08%和18.18%,在统计学上差异有统计学意义(P<0.05).结论 达格列净片治疗AMI合并T2DM患者疗效显著,可提高血糖控制效果,降低心肌损伤,抑制心室重构,并减少MACE风险,安全性较高.
Objective To observe the influence of dapagliflozin tablets on myocardial enzymes,mitral valve blood flow and major adverse cardiovascular events(MACE)in patients with acute myocardial infarction(AMI)complicated with type 2 diabetes mellitus(T2DM)after interventional therapy.Methods AMI patients with T2DM were divided into control group and treatment group by cohort method.The control group was given aspirin tablets 300 mg and ticagrelor 180 mg orally,qd,until the day of interventional treatment.After interventional therapy,aspirin tablets 100 mg,qd,oral ticagrelor tablets 90 mg each time,once in the morning and once in the evening.On the basis of the treatment in the control group,the patients in the treatment group were given dapagliflozin tablets 5-10 mg,qd,every morning after admission.After 3 months of continuous treatment,the clinical efficacy,blood glucose control effect[fasting plasma glucose(FPG),2 hour postprandial blood glucose(2 h PG)],myocardial enzymes indicators[creatine kinase(CK),creatine kinase isoenzyme-MB(CK-MB)],ventricular remodeling indicators[left ventricular ejection fraction(LVEF),left ventricular end systolic diameter(LVESD)],adverse drug reactions and MACE were compared between the two groups.Results There were 55 cases in the control group and 59 cases in the treatment group.After treatment,the total effective rates of the treatment group and the control group were 88.14%(52 cases/59 cases)and 72.73%(40 cases/55 cases),respectively,the difference was statistically significant(P<0.05).After treatment,the FPG of the treatment group and the control group were(7.29±0.71)and(7.81±0.75)mmol·L-1,respectively;the 2 h PG were(8.66±1.33)and(9.59±1.38)mmol·L-1,respectively;the CK were(145.68±29.82)and(163.68±42.16)U·L-1,respectively;the CK-MB were(8.21±2.37)and(10.33±3.08)U·L-1,respectively;the LVEF were(57.63±8.74)%and(51.41±6.49)%,respectively;LVESD were(33.26±5.33)and(39.51±5.38)mm,respectively.The above indexes in the treatment group were significantly different from those in the control group(all P<0.05).During the treatment,the adverse drug reactions in the treatment group mainly included nausea and vomiting,diarrhea,constipation.The adverse drug reactions in the control group mainly included hypoglycemia,diarrhea,headache.The total incidence of adverse drug reactions in the treatment group and the control group was 6.68%(4 cases/59 cases)and 9.09%(5 cases/55 cases),respectively,and the difference was not statistically significant(P>0.05).After 3 months of follow-up,the total incidence of MACE in the treatment group and the control group was 5.08%and 18.18%,respectively,the difference was statistically significant(P<0.05).Conclusion Dapagliflozin has a significant efficacy in the treatment of AMI patients with T2DM,and it can enhance the effect of blood glucose control,reduce the myocardial injury,inhibit the ventricular remodeling,and reduce the risk of MACE,with high safety.
林伟;熊尚全;詹萍;赵利;李翠云;林超;林飞宁;王婷
福建中医药大学附属人民医院心血管科,福建 福州 350004
药学
达格列净片急性心肌梗死2型糖尿病心肌酶谱二尖瓣血流主要不良心血管事件
dapagliflozin tabletacute myocardial infarctiontype 2 diabetes mellitusmyocardial enzymesmitral valve blood flowmajor adverse cardiovascular event
《中国临床药理学杂志》 2024 (020)
2924-2928 / 5
福建省教育厅中青年教师教育科研基金资助项目(JAT200195)
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