新型口服抗糖尿病药物-瑞格列奈在中国2型糖尿病患者中的疗效及安全性分析

目的　对新型口服抗糖尿病药物瑞格列奈（Ｒｅｐａｇｌｉｎｉｄｅ，诺和龙） 的疗效及安全性进行评价。方法　从３ 个临床中心征集符合ＷＨＯ（１９８５ 年） 诊断标准的中国２ 型糖尿病患者共１５０ 例，按１：１ 分为瑞格列奈（７５ 例） 或者格列吡嗪（７５ 例） 进行治疗和比较。结果　经２ 周清洗、８ 周剂量调整、４ 周剂量维持后的结果显示： 与基础状态相比较，瑞格列奈及格列吡嗪治疗患者糖化血红蛋白（ＨｂＡ１ｃ） 水平及空腹血糖（ＦＢＧ） 均有显著下降， 瑞格列奈治疗组ＨｂＡ１ｃ 下降０ ．４３％ ， ＦＢＧ 下降０．９８ ｍ ｍｏｌ／Ｌ（Ｐ＜０ ．０５）；格列吡嗪治疗组ＨｂＡ１ｃ下降０．４５％ ，ＦＢＧ 下降１ ．０４ ｍ ｍｏｌ／Ｌ（ Ｐ＜０ ．０５） ，组间比较无显著差别（Ｐ＞ ０．０５） 。格列吡嗪治疗组１１ ％ 患者发生不同程度不良反应。瑞格列奈低血糖发生率仅为格列吡嗪治疗组的５０ ％ 。结论　在为期３ 个月的治疗中，瑞格列奈治疗对中国２ 型糖尿病患者的代谢控制与格列吡嗪效果相同，但治疗不良反应及低血糖发生率以瑞格列奈治疗组为低。瑞格列奈是治疗２ 型糖尿病的有效降糖药物，并可改善２ 型糖尿病患者对治疗的顺应性。

Efficacy and safetyofa novelanti diabeticagent Repaglinidein Chinesepatients withtype2 diabetes melli tus

Objective To evalute the efficacy and safety of a novelanti diabetic agent, Repaglinide(NovoNorm) ,intype2 diabeticpatients. Methods 150 Chinesetype 2 diabetic patients meeting the 1985WHOdiagnosiscriteria were recruited from 3 clinicalcenters. The patients were assigned to Repaglinide or glipizidetreatmentgroupin 1 :1 ratio. Results Thetrialconsisted ofa 2 week wash outfollowed by an 8 week dosageregulationanda4 week dose maintenanceperiods.After3 monthsoftreatment,inthe Repaglin ide groupthe meanreduction of HbA1candfasting blood glucose (FBG) was0 .43% and 0 .98 m mol/Lre spectively ( P< 0.05) ;intheglipizidegroup,the meanreduction of HbA1cand FBGwas0 .45 % and 1.04 mmol/Lrespectively ( P< 0 .05) .Thedifferenceinreductionof HbA1cand FBGbetweenthe2 groups was notstatisticallysignificant.Furthermore,11 % of glipizidetreated patientssufferedfrom moderate and se vereside effects while none of Repaglinide treated patients had severe side effects. Frequency of hypo glycemiainthe Repaglinidegroup wasfound to be halfofthatofthe glipizide group.Conclusion In com parisontoglipizide,Repaglinideprovidesequalefficacyin metaboliccontroland afforded asignificantlysuperi orsafety profilesuchthatpatientstreated with Repaglinide had highertreatmentcompliance.