中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2015年
4期
307-312
,共6页
陈频%陈晨%邵珠林%徐向进%黄勤
陳頻%陳晨%邵珠林%徐嚮進%黃勤
진빈%진신%소주림%서향진%황근
糖尿病,2型%利拉鲁肽
糖尿病,2型%利拉魯肽
당뇨병,2형%리랍로태
Diabetes mellitus,type 2%Liraglutide
目的 观察对新诊断的糖化血红蛋白(HbA1c) ＞9％的2型糖尿病患者采用利拉鲁肽治疗的有效性及安全性.方法 采用开放、随机、平行、对照方法,纳入新诊断HBA1c＞9％的2型糖尿病患者随机接受利拉鲁肽治疗组(LIRA组,25例)和甘精胰岛素治疗组(IGla组,24例),联用二甲双胍和瑞格列奈片治疗18个月后评价有效性及安全性.结果 (1)与基线比较,治疗结束时LIRA组体重、BMI、腰围均明显下降(P＜0.01),而IGla组体重、BMI、腰围均增加(P＜0.01).(2)LIRA组和IGla组空腹血糖(FPG)、糖负荷后2h血糖(2hPG)、HbA1c均呈显著下降(P＜ 0.01);LIRA组2hPG显著低于IGla组(P＜0.01),而且24 h平均血糖水平(MBG)、24h最大血糖波动幅度(LAGE)、24 h平均血糖漂移幅度(MAGE)均明显下降(P＜0.05或P＜0.01).(3)与基线比较,LIRA组△I30/△G30[△I30为口服葡萄糖耐量试验(OGTT)中30min胰岛素(I30)与空腹胰岛素的差值,△G30为30 min血糖(G30)与FPG的差值]、3hOGTT中180 min内C肽AUC(AUCcP180)、胰岛素敏感指数(Matsuda指数)明显增高(分别为4.88±1.55比7.60±1.91,9.23±2.66比13.18±2.72,39.28±20.35比54.64±23.34,P值均＜0.01),稳态模型法评估的胰岛素抵抗指数(HOMA-IR)降低(4.41±1.58比3.52±1.44,P＜0.05);IGla组仅HOMA-IR降低(4.92±1.84比4.57±1.80,P＜0.05);LIRA组△I30/△G30、AUCCP180 Matsuda指数均高于IGla组(分别为7.60±1.91比4.18±1.00,13.18±2.72比10.53±2.68,54.64±23.34比41.65±17.84,P值均＜0.05),HOMA-IR低于IGla组(3.52±1.44比4.57±1.80,P＜0.05).(4) LIRA组HbA1c≤6.5％的达标率及联用口服降糖药用量明显优于IGla组.(5)两组低血糖事件和不良反应发生率差异无统计学意义.结论 对新诊断HbA1c＞9％的2型糖尿病采用利拉鲁肽在平稳改善糖代谢、恢复胰岛分泌功能及胰岛素敏感性的作用优于甘精胰岛素.
目的 觀察對新診斷的糖化血紅蛋白(HbA1c) ＞9％的2型糖尿病患者採用利拉魯肽治療的有效性及安全性.方法 採用開放、隨機、平行、對照方法,納入新診斷HBA1c＞9％的2型糖尿病患者隨機接受利拉魯肽治療組(LIRA組,25例)和甘精胰島素治療組(IGla組,24例),聯用二甲雙胍和瑞格列奈片治療18箇月後評價有效性及安全性.結果 (1)與基線比較,治療結束時LIRA組體重、BMI、腰圍均明顯下降(P＜0.01),而IGla組體重、BMI、腰圍均增加(P＜0.01).(2)LIRA組和IGla組空腹血糖(FPG)、糖負荷後2h血糖(2hPG)、HbA1c均呈顯著下降(P＜ 0.01);LIRA組2hPG顯著低于IGla組(P＜0.01),而且24 h平均血糖水平(MBG)、24h最大血糖波動幅度(LAGE)、24 h平均血糖漂移幅度(MAGE)均明顯下降(P＜0.05或P＜0.01).(3)與基線比較,LIRA組△I30/△G30[△I30為口服葡萄糖耐量試驗(OGTT)中30min胰島素(I30)與空腹胰島素的差值,△G30為30 min血糖(G30)與FPG的差值]、3hOGTT中180 min內C肽AUC(AUCcP180)、胰島素敏感指數(Matsuda指數)明顯增高(分彆為4.88±1.55比7.60±1.91,9.23±2.66比13.18±2.72,39.28±20.35比54.64±23.34,P值均＜0.01),穩態模型法評估的胰島素牴抗指數(HOMA-IR)降低(4.41±1.58比3.52±1.44,P＜0.05);IGla組僅HOMA-IR降低(4.92±1.84比4.57±1.80,P＜0.05);LIRA組△I30/△G30、AUCCP180 Matsuda指數均高于IGla組(分彆為7.60±1.91比4.18±1.00,13.18±2.72比10.53±2.68,54.64±23.34比41.65±17.84,P值均＜0.05),HOMA-IR低于IGla組(3.52±1.44比4.57±1.80,P＜0.05).(4) LIRA組HbA1c≤6.5％的達標率及聯用口服降糖藥用量明顯優于IGla組.(5)兩組低血糖事件和不良反應髮生率差異無統計學意義.結論 對新診斷HbA1c＞9％的2型糖尿病採用利拉魯肽在平穩改善糖代謝、恢複胰島分泌功能及胰島素敏感性的作用優于甘精胰島素.
목적 관찰대신진단적당화혈홍단백(HbA1c) ＞9％적2형당뇨병환자채용리랍로태치료적유효성급안전성.방법 채용개방、수궤、평행、대조방법,납입신진단HBA1c＞9％적2형당뇨병환자수궤접수리랍로태치료조(LIRA조,25례)화감정이도소치료조(IGla조,24례),련용이갑쌍고화서격렬내편치료18개월후평개유효성급안전성.결과 (1)여기선비교,치료결속시LIRA조체중、BMI、요위균명현하강(P＜0.01),이IGla조체중、BMI、요위균증가(P＜0.01).(2)LIRA조화IGla조공복혈당(FPG)、당부하후2h혈당(2hPG)、HbA1c균정현저하강(P＜ 0.01);LIRA조2hPG현저저우IGla조(P＜0.01),이차24 h평균혈당수평(MBG)、24h최대혈당파동폭도(LAGE)、24 h평균혈당표이폭도(MAGE)균명현하강(P＜0.05혹P＜0.01).(3)여기선비교,LIRA조△I30/△G30[△I30위구복포도당내량시험(OGTT)중30min이도소(I30)여공복이도소적차치,△G30위30 min혈당(G30)여FPG적차치]、3hOGTT중180 min내C태AUC(AUCcP180)、이도소민감지수(Matsuda지수)명현증고(분별위4.88±1.55비7.60±1.91,9.23±2.66비13.18±2.72,39.28±20.35비54.64±23.34,P치균＜0.01),은태모형법평고적이도소저항지수(HOMA-IR)강저(4.41±1.58비3.52±1.44,P＜0.05);IGla조부HOMA-IR강저(4.92±1.84비4.57±1.80,P＜0.05);LIRA조△I30/△G30、AUCCP180 Matsuda지수균고우IGla조(분별위7.60±1.91비4.18±1.00,13.18±2.72비10.53±2.68,54.64±23.34비41.65±17.84,P치균＜0.05),HOMA-IR저우IGla조(3.52±1.44비4.57±1.80,P＜0.05).(4) LIRA조HbA1c≤6.5％적체표솔급련용구복강당약용량명현우우IGla조.(5)량조저혈당사건화불량반응발생솔차이무통계학의의.결론 대신진단HbA1c＞9％적2형당뇨병채용리랍로태재평은개선당대사、회복이도분비공능급이도소민감성적작용우우감정이도소.
Objective To evaluate the efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin A1c (HbA1c) ＞ 9％.Methods This was an open-labelled,randomized,parallel-group,treat-to-target trial.Newly diagnosed T2DM patients with HbA1c ＞ 9％ were enrolled.These patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide (LIRA,n =25) or the insulin glargine (IGla,n =24) at bedtime.Efficacy and safety were assessed and compared after 18-month treatment.Results (1) Compared with the baseline,patients with LIRA had significantly reduced mean body weight,BMI and waist circumference (P ＜ 0.01),whereas,the above indexes were increased (P ＜ 0.01) in patients treated with IGla.(2) After 18 months of treatment,fasting plasma glucose (FPG),2-hour plasma glucose after a 75g oral glucose load(2hPG) and HbA1c were significantly improved in all patients (P ＜ 0.01),with 2hPG,mean blood glucose (MBG),the largest amplitude of glycemic excursions (LAGE),mean amplitude of glycemic excursions (MAGE) were significantly lower in LIRA group than in IGla group (all P ＜ 0.05).(3) HOMA-IR decreased in both groups (P ＜ 0.05).However,△I30/△G30,AUCCP180 and Matsuda index were only significantly increased in patients treated with LIRA (respectively,4.88 ± 1.55 vs 7.60 ± 1.91,9.23 ± 2.66 vs 13.18 ± 2.72,39.28 ± 20.35 vs 54.64 ± 23.34,all P ＜ 0.01),while HOMA-IR reduced(4.41 ± 1.58 vs 3.52 ± 1.44,P ＜0.05).But in IGla group only HOMAIR was reduced (4.92 ± 1.84 vs 4.57 ± 1.80,P ＜0.05).The index of △I30/△G30,AUCCP180 and Matsuda index in LIRA group are higher than those of indexes in IGla group(respectively,7.60 ± 1.91 vs 4.18 ± 1.00,13.18 ± 2.72 vs 10.53 ± 2.68,54.64 ± 23.34 vs 41.65 ± 17.84,all P ＜ 0.05),while HOMA-IR is lower (3.52 ± 1.44 vs 4.57 ± 1.80,P ＜ 0.05).(4) The rate of HbA1 c ≤ 6.5 ％ and the dosages of oral anti-diabetic drugs in LIRA group were significantly better than that in IGla group.(5) No significant differences were observed in hypoglycemic episodes and adverse events between two groups.Conclusion It seems that liraglutide is superior to insulin glargine in newly diagnosed T2DM patients with HbA1c ＞ 9％ in improving beta-cell function,insulin sensitivity and glucose homeostasis.
