CAJ | 학술논문

目的评价匹伐他汀对高胆固醇血症患者血糖的效应及其治疗糖尿病高胆固醇血症的疗效.方法以多中心、非盲、不设平行对照的方式开展为期12周的Ⅳ期临床试验.结果用药期间,与基线比较治疗4周和12周,空腹血糖(FPG)、糖化血红蛋白(HbA1c)异常率在安全集非糖尿病受试对象(FPG:14.2％比14.1％和11.0％；HbAlc:14.3％比15.1％和16.1％)、未服用降糖药物的糖尿病受试对象(FPG:7/7比4/7和5/7;HbA1c:5/5比4/4和5/5)差异均无统计学意义(P值均＞0.05).与基线相比,治疗4周和12周时符合方案集55例糖尿病高胆固醇血症患者的血清TC[(6.51±0.94) mmol/L比(5.12±0.93) mmol/L和(4.54±1.00) mmol/L]、LDL-C[ (4.11±0.79)mmol/L比(3.02±0.81) mmol/L和(2.51±0.70) mmol/L]、TG [2.10(1.53,2.54) mmol/L比1.62(1.26,2.00) mmol/L和1.35(1.10,1.86) mmol/L]水平明显下降(P值均＜0.05)；33.3％高危患者和10.0％极高危患者的TC值达到治疗目标值；55.6％高危患者和40.0％极高危患者的LDL-C值达标.结论匹伐他汀对患者血糖无明显影响,可用于我国糖尿病高胆固醇血症患者的长期治疗.
목적 평개필벌타정대고담고순혈증환자혈당적효응급기치료당뇨병고담고순혈증적료효.방법 이다중심、비맹、불설평행대조적방식개전위기12주적Ⅳ기림상시험.결과 용약기간,여기선비교치료4주화12주,공복혈당(FPG)、당화혈홍단백(HbA1c)이상솔재안전집비당뇨병수시대상(FPG:14.2％비14.1％화11.0％；HbAlc:14.3％비15.1％화16.1％)、미복용강당약물적당뇨병수시대상(FPG:7/7비4/7화5/7;HbA1c:5/5비4/4화5/5)차이균무통계학의의(P치균＞0.05).여기선상비,치료4주화12주시부합방안집55례당뇨병고담고순혈증환자적혈청TC[(6.51±0.94) mmol/L비(5.12±0.93) mmol/L화(4.54±1.00) mmol/L]、LDL-C[ (4.11±0.79)mmol/L비(3.02±0.81) mmol/L화(2.51±0.70) mmol/L]、TG [2.10(1.53,2.54) mmol/L비1.62(1.26,2.00) mmol/L화1.35(1.10,1.86) mmol/L]수평명현하강(P치균＜0.05)；33.3％고위환자화10.0％겁고위환자적TC치체도치료목표치；55.6％고위환자화40.0％겁고위환자적LDL-C치체표.결론 필벌타정대환자혈당무명현영향,가용우아국당뇨병고담고순혈증환자적장기치료.
Objective To evaluate the effect of pitavastatin on blood glucose in patients with hypercholesterolemia,and to investigate the efficacy of pitavastatin in diabetic patients combined with hypercholesterolemia.Method This study was a 12-week,multi-center,open-label,without parallel-group comparison,phase Ⅳ clinical trail.Results Contrasting to baseline,the prevalences at week 4 and 12 post-treatment of abnormal fasting plasma glucose (FPG) and glycosylated hemoglobin Alc (HbA1c)( FPG:14.2％ vs 14.1％ and 11.0％ ; HbA1c:14.3％ vs 15.1％ and 16.1％ ) in the safety set subjects without diabetes mellitus (DM),as well as in those with DM but not taking glucose-lowering drugs (FPG:7/7 vs 4/7 and 5/7; HbAlc:5/5 vs 4/4 and 5/5) had no significant changes (all P vaules ＞0.05).Contrasting to baseline,the levels of TC [ (6.51±0.94) mmol/L vs (5.12 ±0.93) mmol/L and (4.54 ±1.00) mmol/L],LDL-C [(4.11 ±0.79)mmol/L vs (3.02 ±0.81) mmol/L and (2.51 ±0.70)mmol/L] and TG [2.10(1.53,2.54) mmol/L vs 1.62(1.26,2.00) mmol/L and 1.35(1.10,1.86)mmol/L]at week 4 and 12 post-treatment in the per protocol set 55 subjects with DM were significantly reduced (all P values ＜ 0.05 ) ; 33.3％ of subjects at high risk and 10.0％ of subjects at very high risk had achieved a TC target value; 55.6％ of subjects at high risk and 40.0％ of subjects at very high risk had achieved a LDL-C target value.Conclusion Pitavastatin has a safe effect on blood glucose and it could be used to treat diabetic patients combined with hypercholesterolemia in China.