中华糖尿病杂志
中華糖尿病雜誌
중화당뇨병잡지
CHINES JOURNAL OF DLABETES MELLITUS
2012年
2期
90-94
,共5页
卜石%杨文英%陆菊明%洪天配%李强%李红%余叶蓉%翁建平%周智广%姬秋和%朱大龙%邹大进%陈定宇
蔔石%楊文英%陸菊明%洪天配%李彊%李紅%餘葉蓉%翁建平%週智廣%姬鞦和%硃大龍%鄒大進%陳定宇
복석%양문영%륙국명%홍천배%리강%리홍%여협용%옹건평%주지엄%희추화%주대룡%추대진%진정우
糖尿病,2型%胰岛素%降血糖药
糖尿病,2型%胰島素%降血糖藥
당뇨병,2형%이도소%강혈당약
Diabetes mellitus,type 2%Insulin%Hypoglycemic agents
目的 比较一种口服降糖药治疗后血糖控制不佳的2型糖尿病患者加用甘精胰岛素或第二种口服降糖药的疗效和安全性.方法 2006年6月至2007年12月从全国12个研究中心入选387例接受一种口服降糖药(双胍类或磺脲类药物)治疗但血糖控制不佳的2型糖尿病患者(糖化血红蛋白7.5％ ～11.0％,空腹血糖＞7.5 mmol/L),平均年龄54岁.采用随机表法(1∶1)将其分为加用甘精胰岛素组(n=193,起始剂量为10 U/d)和加用另一种口服降糖药组(n=194,加用磺脲类或双胍类药物,按产品说明书用药),治疗24周.调整2组用药剂量,使空腹血糖达到并维持在≤5.6 mmol/L.测定0及24周时糖化血红蛋白、标准餐试验空腹及餐后2h血糖、C肽水平.采用t检验或卡方检验进行数据统计.结果 共有375例患者(男184例,女191例)纳入最终分析,其中加用甘精胰岛素组186例,加用另一种口服降糖药组189例.治疗24周后,2组糖化血红蛋白较基线时显著下降,但2组糖化血红蛋白下降值的差异无统计学意义[分别为(1.5±1.3)％和(1.3±1.3)％,Z=-1.3914,P=0.1641].进一步亚组分析结果显示,加用甘精胰岛素组中胰岛素剂量＞0.2U·kg-1 ·d-1的亚组(n=114)24周时糖化血红蛋白较基线的下降幅度大于加用另一种口服降糖药组[分别为(1.6±1.2)％和(1.3±1.3)％,Z=-1.9962,P=0.0459].加用甘精胰岛素组空腹血糖及餐后2h血糖降低幅度均优于加用另一种口服降糖药组(Z=- 5.5516、- 3.9158,均P＜0.01).空腹及餐后2hC肽水平变化2组间差异有统计学意义(Z=- 5.3894、- 2.7775,均P＜0.01).2组低血糖事件发生率无明显差异.结论 在一种口服降糖药治疗后血糖控制不佳的2型糖尿病患者中加用甘精胰岛素治疗或增加第二种口服降糖药均能有效控制血糖,但前者充分调整剂量后降糖效果优于后者.
目的 比較一種口服降糖藥治療後血糖控製不佳的2型糖尿病患者加用甘精胰島素或第二種口服降糖藥的療效和安全性.方法 2006年6月至2007年12月從全國12箇研究中心入選387例接受一種口服降糖藥(雙胍類或磺脲類藥物)治療但血糖控製不佳的2型糖尿病患者(糖化血紅蛋白7.5％ ～11.0％,空腹血糖＞7.5 mmol/L),平均年齡54歲.採用隨機錶法(1∶1)將其分為加用甘精胰島素組(n=193,起始劑量為10 U/d)和加用另一種口服降糖藥組(n=194,加用磺脲類或雙胍類藥物,按產品說明書用藥),治療24週.調整2組用藥劑量,使空腹血糖達到併維持在≤5.6 mmol/L.測定0及24週時糖化血紅蛋白、標準餐試驗空腹及餐後2h血糖、C肽水平.採用t檢驗或卡方檢驗進行數據統計.結果 共有375例患者(男184例,女191例)納入最終分析,其中加用甘精胰島素組186例,加用另一種口服降糖藥組189例.治療24週後,2組糖化血紅蛋白較基線時顯著下降,但2組糖化血紅蛋白下降值的差異無統計學意義[分彆為(1.5±1.3)％和(1.3±1.3)％,Z=-1.3914,P=0.1641].進一步亞組分析結果顯示,加用甘精胰島素組中胰島素劑量＞0.2U·kg-1 ·d-1的亞組(n=114)24週時糖化血紅蛋白較基線的下降幅度大于加用另一種口服降糖藥組[分彆為(1.6±1.2)％和(1.3±1.3)％,Z=-1.9962,P=0.0459].加用甘精胰島素組空腹血糖及餐後2h血糖降低幅度均優于加用另一種口服降糖藥組(Z=- 5.5516、- 3.9158,均P＜0.01).空腹及餐後2hC肽水平變化2組間差異有統計學意義(Z=- 5.3894、- 2.7775,均P＜0.01).2組低血糖事件髮生率無明顯差異.結論 在一種口服降糖藥治療後血糖控製不佳的2型糖尿病患者中加用甘精胰島素治療或增加第二種口服降糖藥均能有效控製血糖,但前者充分調整劑量後降糖效果優于後者.
목적 비교일충구복강당약치료후혈당공제불가적2형당뇨병환자가용감정이도소혹제이충구복강당약적료효화안전성.방법 2006년6월지2007년12월종전국12개연구중심입선387례접수일충구복강당약(쌍고류혹광뇨류약물)치료단혈당공제불가적2형당뇨병환자(당화혈홍단백7.5％ ～11.0％,공복혈당＞7.5 mmol/L),평균년령54세.채용수궤표법(1∶1)장기분위가용감정이도소조(n=193,기시제량위10 U/d)화가용령일충구복강당약조(n=194,가용광뇨류혹쌍고류약물,안산품설명서용약),치료24주.조정2조용약제량,사공복혈당체도병유지재≤5.6 mmol/L.측정0급24주시당화혈홍단백、표준찬시험공복급찬후2h혈당、C태수평.채용t검험혹잡방검험진행수거통계.결과 공유375례환자(남184례,녀191례)납입최종분석,기중가용감정이도소조186례,가용령일충구복강당약조189례.치료24주후,2조당화혈홍단백교기선시현저하강,단2조당화혈홍단백하강치적차이무통계학의의[분별위(1.5±1.3)％화(1.3±1.3)％,Z=-1.3914,P=0.1641].진일보아조분석결과현시,가용감정이도소조중이도소제량＞0.2U·kg-1 ·d-1적아조(n=114)24주시당화혈홍단백교기선적하강폭도대우가용령일충구복강당약조[분별위(1.6±1.2)％화(1.3±1.3)％,Z=-1.9962,P=0.0459].가용감정이도소조공복혈당급찬후2h혈당강저폭도균우우가용령일충구복강당약조(Z=- 5.5516、- 3.9158,균P＜0.01).공복급찬후2hC태수평변화2조간차이유통계학의의(Z=- 5.3894、- 2.7775,균P＜0.01).2조저혈당사건발생솔무명현차이.결론 재일충구복강당약치료후혈당공제불가적2형당뇨병환자중가용감정이도소치료혹증가제이충구복강당약균능유효공제혈당,단전자충분조정제량후강당효과우우후자.
Objective To compare the efficacy and safety of insulin glargine vs additional oral antidiabetic drug (OAD) combined with one basic OAD in patients with poorly controlled type 2 diabetes mellitus (T2DM). Methods A total of 387 patients (mean age 54 years ) with T2DM who were inadequately controlled with one kind of sulfonylureas (SU) or metformin for at least 3 months were eligible for enrollment from 12 centres of China from June 2006 to December 2007.All the patients were randomized to receive insulin glargine (Group A,n =193 ) or an additional OAD (Group B,n =194) for 24 weeks.The changes in glycated haemoglobin (HbA1c) level,blood glucose parameters,and C-peptide level and incidence of hypoglycemia were assessed and compared between the two groups at 24 weeks.Student' s t test was used for data analysis. Results A total of 375 patients were included in the final analysis ( 186 in Group A and 189 in Group B).After 24-week treatment,the reduction of HbA1c from baseline was 1.5％ in Group A and 1.3％ in Group B (t =-7802.0,-6983.5,both P＜0.01),and the reduction was comparable between the two groups (Z =- 1.3914,P =0.1641 ).The reduction of HbAlc from baseline to 24 weeks in the subgroup of insulin glargine ≥0.2 U · kg 1 · d-1 (n =114) was significantly larger than that of Group B ( ( 1.6 ± 1.2) ％ vs ( 1.3 ± 1.3) ％,Z =- 1.9962,P =0.0459).The reduction of fasting plasma glucose (FPG) and 2-h plasma glucose ( 2-h PG) from baseline to 24 weeks in Group A was significantly larger than that in Group B (Z =- 5.5516,- 3.9158,both P ＜ 0.01 ).The changes of 0 or 2-h C-peptide level from baseline to 24 weeks were significantly different between the two groups( Z =-5.3894,-2.7775,both P ＜ 0.01 ). The incidence of hypoglycemia was comparable between the two groups.Conclusion These findings show that additional treatment with insulin glargine or another OAD could contribute to effective control of blood glucose,and insulin glargine may boast stronger effectiveness when the dosage is titrated sufficiently.
