重庆医学2018，Vol.47Issue(7)：915-918,4.DOI:10.3969/j.issn.1671-8348.2018.07.015
复方盐酸吡格列酮格列美脲片与格列美脲片治疗2型糖尿病的疗效与安全性对照研究
Comparative study of efficacy and safety of compound pioglitazone hydrochloride glimepiride tablet and glimepiride tablet in treating type 2 diabetes mellitus
摘要
Abstract
Objective To compare the efficacy and safety of compound pioglitazone hydrochloririe glimepiride tablet and glimepiride tablet in the treatment of type 2 diabetic mellitus(T2DM) for evaluating the effectiveness and safety of compound pioglitazone hydrochloride glimepiride tablet for treating T2DM.Methods The random,double-blind,double-dummy,positive drugs parallel control clinical study method was adopted.Thirty-three T2DM patients with poorly controlled blood glucose were randomly assigned to the test group(n=22) and control group(n=11) by the 2 ∶ 1 ratio.The test group was given compound pioglitazone hydrochloride glimepiride tablet,while the control group received glimepiride tablet.The treatment cycle was 12 weeks.The differences of FBG,HbA1c,FINS and HOMA-IR in the two groups were compared between before and after treatment.Moreover the changes of body mass,blood pressure and blood lipids as well as adverse events occurrence were compared between the two groups.Results Thirty-one cases finished the treatment follow up(21 cases in the test group and 10 cases in the control group);the decreased amplitudes of HbA1c levels after 12-week treatment in the test group and control group were (0.99 ± 1.87)％ and (-0.02 ± 0.90) ％ respectively,which of FPG were (0.94 ± 1.87) mmol/L and (0.37 ± 2.62) mmol/L respectively.The FPG and HbA1c levels after treatment in the test group were decreased compared with before treatment,the difference was statistically significant (P＜0.01).The change difference of FPG and HbA1c in the control group had no statistical difference(P＞0.05).FINS and HOMO-IR in the test group were significantly decreased before and after treatment,the difference was statistically significant (P＜0.01).The incidence rate of hypoglycemia had no statistically significant difference between the test group and control group.Conclusion The effectiveness of compound pioglitazone hydrochloride glimepiride tablet in treating T2 DM is superior to the single use of glimepiride,while the safety is equivalent to single use of glimepiride.关键词
2型糖尿病/有效性研究/复方盐酸吡格列酮格列美脲片/安全性Key words
type 2 diabetes mellitus/effectiveness study/compound pioglitazone hydrochloride glimepiride tablet/security分类
医药卫生引用本文复制引用
蒲丹岚,尹经霞,谢洁,杨刚毅,廖涌..复方盐酸吡格列酮格列美脲片与格列美脲片治疗2型糖尿病的疗效与安全性对照研究[J].重庆医学,2018,47(7):915-918,4.基金项目
重庆市卫计委2016医学科研计划项目(2016MSXM212) （2016MSXM212）
重庆市南岸区科技攻关计划项目(20111723). （20111723）
