伏格列波糖胶囊治疗2型糖尿病的多中心、随机、双盲、平行对照临床试验(1)
摘 要 目的：评价伏格列波糖胶囊治疗2型糖尿病的有效性和安全性。方法：采用多中心、随机、双盲双模拟、平行对照的试验设计，在5个中心共入选239例2型糖尿病患者，随机分为试验组和对照组，分别在餐前即刻口服伏格列波糖胶囊和伏格列波糖片0.2 mg，每日3次，疗程12周。结果：试验组和对照组治疗后空腹血糖(毛细血管和静脉)、餐后1 h血糖(毛细血管和静脉)、餐后2 h血糖(毛细血管和静脉)和糖化血红蛋白与治疗前相比较均显著下降(P<0.001)，而两组间比较均没有统计学差异(P>0.05)。两组糖化血红蛋白下降值的差值的95%可信区间为(-0.3574， 0.2864)。试验组和对照组的不良反应发生率分别为8.47%和5.88%，两组不良反应发生率无统计学差异(P>0.05)。结论：伏格列波糖胶囊能够有效地降低2型糖尿病患者的空腹血糖、餐后高血糖和糖化血红蛋白水平，其疗效和安全性与伏格列波糖片相当。
关键词 伏格列波糖胶囊 伏格列波糖片 2型糖尿病
中图分类号：R969.4； R977.15 文献标识码：B 文章编号：1006-1533(2013)01-0018-04
, http://www.100md.com
Multicenter， randomized， double-blind， parallel-controlled
clinical trial of voglibose capsules for the treatment of type 2 diabetes
YE Longbin1， MIAO Hong1， NING Guang2， LIU Zhiwei3， LIU Wei4， LIU Chao5， WANG Changjiang6
(1. Central Research Institute， Shanghai Pharmaceutical Group Co.， Ltd，Shanghai 201203， China；2. Ruijin Hospital affiliated to School
of Medicine， Shanghai Jiao Tong University， Shanghai 200025， China；3. Shanghai Changzheng Hospital，Shanghai 200003， China；
, http://www.100md.com
4. Renji Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 200001， China；5. The First Hospital affiliated
to Nanjing Medical University， Nanjing 210029， China；6. The First Hospital affiliated to Anhui Medical University， Hefei 230022， China)
ABSTRACT Objective： To evaluate the efficacy and safety of voglibose capsules in the treatment of type 2 diabetes mellitus. Methods： A multicenter， randomized， double-blind， parallel-controlled clinical trial was carried out. A total of 239 patients with type 2 diabetes mellitus were enrolled at 5 sites， which were randomly divided into two groups at 1：1 and treated at thrice daily for 12 weeks with 0.2 mg of either voglibose capsules (experimental group) or voglibose tablets (control group) just before meals. Results： After treatment， the fasting blood glucose (capillary and venous)， 1 and 2 hour’s postprandial capillary (or venous plasma) blood glucose， and HbA1c levels were significantly decreased (P<0.001) in both groups compared with baseline (before treatment). There was no significant difference between the two groups regarding these changes (P>0.05). The 95% confidence interval (CI) for the difference in HbA1c decrease between two groups was from -0.3574 to 0.2864. The incidence of adverse drug reactions in experimental group (8.47%) was similar (P>0.05) to that in control group (5.88%). Conclusion： The efficacy and safety of voglibose capsules in the treatment of type 2 diabetes mellitus is comparable to those of voglibose tablets.
, http://www.100md.com(叶龙彬 苗红 宁光 刘志民 刘伟 刘超 王长江)
关键词 伏格列波糖胶囊 伏格列波糖片 2型糖尿病
中图分类号：R969.4； R977.15 文献标识码：B 文章编号：1006-1533(2013)01-0018-04
, http://www.100md.com
Multicenter， randomized， double-blind， parallel-controlled
clinical trial of voglibose capsules for the treatment of type 2 diabetes
YE Longbin1， MIAO Hong1， NING Guang2， LIU Zhiwei3， LIU Wei4， LIU Chao5， WANG Changjiang6
(1. Central Research Institute， Shanghai Pharmaceutical Group Co.， Ltd，Shanghai 201203， China；2. Ruijin Hospital affiliated to School
of Medicine， Shanghai Jiao Tong University， Shanghai 200025， China；3. Shanghai Changzheng Hospital，Shanghai 200003， China；
, http://www.100md.com
4. Renji Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 200001， China；5. The First Hospital affiliated
to Nanjing Medical University， Nanjing 210029， China；6. The First Hospital affiliated to Anhui Medical University， Hefei 230022， China)
ABSTRACT Objective： To evaluate the efficacy and safety of voglibose capsules in the treatment of type 2 diabetes mellitus. Methods： A multicenter， randomized， double-blind， parallel-controlled clinical trial was carried out. A total of 239 patients with type 2 diabetes mellitus were enrolled at 5 sites， which were randomly divided into two groups at 1：1 and treated at thrice daily for 12 weeks with 0.2 mg of either voglibose capsules (experimental group) or voglibose tablets (control group) just before meals. Results： After treatment， the fasting blood glucose (capillary and venous)， 1 and 2 hour’s postprandial capillary (or venous plasma) blood glucose， and HbA1c levels were significantly decreased (P<0.001) in both groups compared with baseline (before treatment). There was no significant difference between the two groups regarding these changes (P>0.05). The 95% confidence interval (CI) for the difference in HbA1c decrease between two groups was from -0.3574 to 0.2864. The incidence of adverse drug reactions in experimental group (8.47%) was similar (P>0.05) to that in control group (5.88%). Conclusion： The efficacy and safety of voglibose capsules in the treatment of type 2 diabetes mellitus is comparable to those of voglibose tablets.
, http://www.100md.com(叶龙彬 苗红 宁光 刘志民 刘伟 刘超 王长江)