中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2011年
10期
826-830
,共5页
吕朝晖%潘长玉%高妍%郭立新%宁光%刘志民%陆菊明%贾培红%王晓霞%孙首悦%郑矫阳
呂朝暉%潘長玉%高妍%郭立新%寧光%劉誌民%陸菊明%賈培紅%王曉霞%孫首悅%鄭矯暘
려조휘%반장옥%고연%곽립신%저광%류지민%륙국명%가배홍%왕효하%손수열%정교양
糖尿病,2型%磺酰脲化合物%吡格列酮
糖尿病,2型%磺酰脲化閤物%吡格列酮
당뇨병,2형%광선뇨화합물%필격렬동
Diabetes mellitus,type 2%Sulphonyurea compounds%Pioglitazone
目的 评价盐酸吡格列酮30 mg与磺酰脲类药物并用治疗2型糖尿病的有效性和安全性。方法 采用多中心、随机、双盲和安慰剂平行对照的研究方法。236例使用稳定剂量磺酰脲类药物治疗至少30 d而血糖控制不佳(空腹血糖7.5～ 13.0 mmol/L，糖化血红蛋白7.0％～12.0％)的2型糖尿病患者随机分入吡格列酮30 mg组与安慰剂组，磺酰脲类药物种类和剂量不变，治疗随访共16周。结果 16周时，吡格列酮组空腹血糖下降(1.48±2.08) mmol/L，安慰剂组则上升(0.17±1.92) mmol/L(P ＜0.05)；吡格列酮组和安慰剂糖化血红蛋白分别下降(0.92±0.10)％和(0.28±0.11)％，空腹胰岛素下降(0.24±0.04) mU/L和(0.09±0.04) mU/L，稳态模型评价法计算的胰岛素抵抗指数下降1.42±2.90和0.46 ±3.52，TG平均下降0.36 mmol/L和0.14 mmol/L，HDL-C则平均上升0.17 mmol/L和0.05 mmol/L，两组间差异均有统计学意义(值均P＜0.05)。结论 为期16周的临床研究显示，2型糖尿病患者在单纯应用磺酰脲类血糖控制欠佳时加用吡格列酮30 mg/d，不仅可进一步改善血糖控制、增强胰岛素敏感性，还可降低TG、升高HDL-C水平，安全性和耐受性好。
目的 評價鹽痠吡格列酮30 mg與磺酰脲類藥物併用治療2型糖尿病的有效性和安全性。方法 採用多中心、隨機、雙盲和安慰劑平行對照的研究方法。236例使用穩定劑量磺酰脲類藥物治療至少30 d而血糖控製不佳(空腹血糖7.5～ 13.0 mmol/L，糖化血紅蛋白7.0％～12.0％)的2型糖尿病患者隨機分入吡格列酮30 mg組與安慰劑組，磺酰脲類藥物種類和劑量不變，治療隨訪共16週。結果 16週時，吡格列酮組空腹血糖下降(1.48±2.08) mmol/L，安慰劑組則上升(0.17±1.92) mmol/L(P ＜0.05)；吡格列酮組和安慰劑糖化血紅蛋白分彆下降(0.92±0.10)％和(0.28±0.11)％，空腹胰島素下降(0.24±0.04) mU/L和(0.09±0.04) mU/L，穩態模型評價法計算的胰島素牴抗指數下降1.42±2.90和0.46 ±3.52，TG平均下降0.36 mmol/L和0.14 mmol/L，HDL-C則平均上升0.17 mmol/L和0.05 mmol/L，兩組間差異均有統計學意義(值均P＜0.05)。結論 為期16週的臨床研究顯示，2型糖尿病患者在單純應用磺酰脲類血糖控製欠佳時加用吡格列酮30 mg/d，不僅可進一步改善血糖控製、增彊胰島素敏感性，還可降低TG、升高HDL-C水平，安全性和耐受性好。
목적 평개염산필격렬동30 mg여광선뇨류약물병용치료2형당뇨병적유효성화안전성。방법 채용다중심、수궤、쌍맹화안위제평행대조적연구방법。236례사용은정제량광선뇨류약물치료지소30 d이혈당공제불가(공복혈당7.5～ 13.0 mmol/L，당화혈홍단백7.0％～12.0％)적2형당뇨병환자수궤분입필격렬동30 mg조여안위제조，광선뇨류약물충류화제량불변，치료수방공16주。결과 16주시，필격렬동조공복혈당하강(1.48±2.08) mmol/L，안위제조칙상승(0.17±1.92) mmol/L(P ＜0.05)；필격렬동조화안위제당화혈홍단백분별하강(0.92±0.10)％화(0.28±0.11)％，공복이도소하강(0.24±0.04) mU/L화(0.09±0.04) mU/L，은태모형평개법계산적이도소저항지수하강1.42±2.90화0.46 ±3.52，TG평균하강0.36 mmol/L화0.14 mmol/L，HDL-C칙평균상승0.17 mmol/L화0.05 mmol/L，량조간차이균유통계학의의(치균P＜0.05)。결론 위기16주적림상연구현시，2형당뇨병환자재단순응용광선뇨류혈당공제흠가시가용필격렬동30 mg/d，불부가진일보개선혈당공제、증강이도소민감성，환가강저TG、승고HDL-C수평，안전성화내수성호。
Objective To evaluate the safety and efficacy of 30 mg pioglitazone hydrochloride combined with sulphonyurea in the treatment of type 2 diabetic patients.Methods A randomized, double blind, placebo-controlled, parallel group, multicenter study was performed.A total of 236 patients, who had fasting plasma glucose(FPG) 7.5-13.0 mmol/L and glycosylated hemoglobin A1c(HbA1 c) 7.0％ -12.0％,treated with stable dosage of a sulphonyurea for at least 30 days previously, were randomized to receive placebo or pioglitazone 30 mg once daily for 16 weeks.The sulphonyurea and dosage remained unchanged.Results The patients who had been treated with pioglitazone 30 mg showed significant decrease than that in the placebo group on the average from baseline in FPG [(1.48 ±2.08) mmol/L vs (-0.17 ± 1.92)mmol/L, P＜0.05], and in HbAlc [(0.92 ±0.10)％ vs (0.28 ±0.11)％, P＜0.05].Since fasting plasma insulin (Flns) levels decreased (0.24 ±0.04) mU/L and (0.09 ±0.04) mU/L in the two groups.The homeostatic model assessment insulin resistant (HOMA-IR) decreased 1.42 ± 2.90 and 0.46 ± 3.53 in two groups.The triglyceride level was decreased 0.36 mmol/L and 0.14 mmol/L, and the HDL-C level increased 0.17 mmol/L and 0.05 mmol/L in two groups.There were significant differences in two groups (all P ＜ 0.05).Conclusions The 16-week clinical study demonstrated that pioglitazone hydrochloride with a dosage of 30mg daily, could significantly improve the blood glucose control and enhance the insulin sensitivity, lower triglyceride and raise HDL-C level as an additional therapy to a stable-dose sulphonyurea in Chinese type 2 diabetic patients previously poorly controlled by single sulphonyurea therapy, and furthermore had good safety and compliance.
