CAJ | 학술논문

目的评价甘精胰岛素(来得时~(R))与格列美脲(亚莫利~(R))联合应用治疗口服降糖药控制不佳的2型糖尿病的有效性和安全性.方法采用随机、开放、低精蛋白锌胰岛素注射液(诺和灵N)平行对照和多中心临床研究方法.122例口服降糖药控制不佳的2型糖尿病患者随机分为睡前注射一次甘精胰岛素(n=62)或低精蛋白胰岛素(n=60),清晨口服3mg格列美脲两组,进行为期24周的观察.结果 (1)基线时除甘精胰岛素组口服降糖药物使用的时间显著长于低精蛋白胰岛素组之外,两组其他指标相似;(2)24周时,甘精胰岛素组与低精蛋白胰岛素组的平均HbA_(1C)分别下降了1.38%和1.41%,平均空腹血糖分别从12.30和11.90 mmol/L降至6.05和6.19 mmol/L,日平均血糖降幅分别为5.28和4.56 mmol/L;(3)试验结束时,甘精胰岛素组和低精蛋白胰岛素组分别有46.8%和71.1%的患者发生症状性低血糖(156次和293次),其中严重低血糖事件分别为3.2%和15.0%(2次和21次),夜间低血糖分别为37.1%和61.7%(87次和229次),两组间差异均具有显著统计学意义(P<0.05或P<0.01);(4)甘精胰岛素组与低精蛋向胰岛素组的日平均胰岛素剂量分别从9.7 IU和9.8 IU增至32.5 IU和29.5 IU.结论与低精蛋白胰岛素比较,睡前注射一次甘精胰岛素和清晨口服3 mg格列美脲联合应用可使口服降糖药控制不佳的2型糖尿病患者得到良好控制,且严重低血糖和夜间低血糖的发生率降低;作为基础胰岛素治疗,甘精胰岛素优于低精蛋白胰岛素.
목적 평개감정이도소(래득시~(R))여격렬미뇨(아막리~(R))연합응용치료구복강당약공제불가적2형당뇨병적유효성화안전성.방법 채용수궤、개방、저정단백자이도소주사액(낙화령N)평행대조화다중심림상연구방법.122례구복강당약공제불가적2형당뇨병환자수궤분위수전주사일차감정이도소(n=62)혹저정단백이도소(n=60),청신구복3mg격렬미뇨량조,진행위기24주적관찰.결과 (1)기선시제감정이도소조구복강당약물사용적시간현저장우저정단백이도소조지외,량조기타지표상사;(2)24주시,감정이도소조여저정단백이도소조적평균HbA_(1C)분별하강료1.38%화1.41%,평균공복혈당분별종12.30화11.90 mmol/L강지6.05화6.19 mmol/L,일평균혈당강폭분별위5.28화4.56 mmol/L;(3)시험결속시,감정이도소조화저정단백이도소조분별유46.8%화71.1%적환자발생증상성저혈당(156차화293차),기중엄중저혈당사건분별위3.2%화15.0%(2차화21차),야간저혈당분별위37.1%화61.7%(87차화229차),량조간차이균구유현저통계학의의(P<0.05혹P<0.01);(4)감정이도소조여저정단향이도소조적일평균이도소제량분별종9.7 IU화9.8 IU증지32.5 IU화29.5 IU.결론 여저정단백이도소비교,수전주사일차감정이도소화청신구복3 mg격렬미뇨연합응용가사구복강당약공제불가적2형당뇨병환자득도량호공제,차엄중저혈당화야간저혈당적발생솔강저;작위기출이도소치료,감정이도소우우저정단백이도소.
Objective To investigate the efficacy and safety of insulin glarsine(Lantus~(R))combined with glimepiride(Amaryl~(R))in type 2 diabetic patients whose blood glucose levels were inadequately controlled by oral antidiabetic drugs(OAD).Methods In this open-labeled,randomized,parallel,muhicenter,and non-inferiority study,122 patients were given either once.daily insulin glarsine(n=62)or NPH insulin(n=60)at bedtime,plus glimepiride for 24 weeks.Results Baseline characteristics were similar between the two groups.HbA_(1C) levels were decreased in the insulin glargine and NPH groups over the study period in the per-protocol population (1.38% vs 1.41%).Fasting blood glucose(12.30 to 6.05 mmoL/L and 11.90 to 6.19 mmol/L,respectively)and the mean daily blood glucose(6.28 vs 5.72 mmol/L)decreased similarly in beth groups during the study.Moreover.the number of hypoglycemic episodes was significantly lower in patients with insulin glarsine than those with NPH insulin(46.8% vs 71.1%,P<0.05),being particularly severe(3.2% vs 15.0%,P<0.05)and expressing nocturnal hypoglycemia(37.1% vs 61.7%,P<0.01).Daily insulin dose was increased from 9.7 to 32.5 IU in the insulin glarine group and from 9.8 to 29.5 IU in the NPH insulin group.Conclusion These results confirm earlier reports that insulin glargine provides similar glyeemic control with less hypoglycemia compared with NPH insulin. Insulin glargine yields better results in lowering the incidence of severe and nocturnal hypoglycemia.