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1、伏格列波糖胶囊治疗2型糖尿病多中心、随机、双盲、平行对照临床试验摘要目的：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0.2mg,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1h血糖(毛细血管和静脉)、餐后2h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)o两组糖化血红蛋白下降值的差
2、值的95%可信区间为(-0.3574,0.2864)o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)o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)01-0018-04Multicenter,randomized,double-blind,parallel-controlledclinicalt
3、rialofvoglibosecapsulesforthetreatmentoftype2diabetesYELongbinl,MIAOHongl,NINGGuang2,LIUZhiwei3,LIUWei4,LIUChao5,WANGChangjiang6(1.CentralResearchInstitute,ShanghaiPharmaceuticalGroupCo.，Ltd,Shanghai201203,China；2.RuijinHospitalaffiliatedtoSchoolofMedicine,ShanghaiJiaoTongUniversity，S
4、hanghai200025,China；3.ShanghaiChangzhengHospital,Shanghai200003,China；4.RenjiHospitalaffiliatedtoSchoolofMedicine,ShanghaiJiaoTongUniversity,Shanghai200001,China；5.TheFirstHospitalaffiliatedtoNanjingMedicalUniversity,Nanjing210029,China；6.TheFirstHospitalaffiliatedtoAnhuiMedicalUniver
5、sity,Hefei230022,China)ABSTRACTObjective：Toevaluatetheefficacyandsafetyofvoglibosecapsulesinthetreatmentoftype2diabetesmellitus.Methods:Amulticenter,randomized,double-blind,parallel-controlledclinicaltrialwascarriedout.Atotalof239patientswithtype2diabetesmellituswereenrolledat5sites,w
6、hichwererandomlydividedintotwogroupsat1：1andtreatedatthricedailyfor12weekswith0.2mgofeithervoglibosecapsules(experimentalgroup)orvoglibosetablets(controlgroup)justbeforemeals・Results：Aftertreatment,thefastingbloodglucose(capillaryandvenous),1and2hour?spostprandialcapillary(orvenouspla
7、sma)bloodglucose,andHbAlclevelsweresignificantlydecreased(P0.05)・The95%confidenceinterval(CI)forthedifferenceinHbAlcdecreasebetweentwogroupswasfrom一0.3574to0.2864.Theincidenceofadversedrugreactionsinexperimentalgroup(8.47%)wassimilar(P>0.05)tothatineontrolgroup(5.88%)・Conclusion：Theef
8、ficac
