格列奇特控释片与格列奇特片治疗2型糖尿病临床疗效与安全性比较  

Efficacy and Safety in Type 2 Diabetes Treated by Controlled-release-gliclazide in Comparison with Gliclazide

作　　者：余丹菁[1] 姚君厘[1] 殳雪怡[1] 吴丹[1] 姜林娣[2] 高鑫[1] 

机构地区：[1]复旦大学附属中山医院内分泌科,上海200032 [2]复旦大学附属中山医院 循证医学中心,上海200032

出　　处：《中国临床医学》2005年第5期930-931,共2页Chinese Journal of Clinical Medicine

摘　　要：目的：对Ⅱ期随机对照临床试验中应用格列奇特控释片和格列奇特普通片治疗2型糖尿病患者的临床疗效和安全性进行比较。 方法：48例符合入组标准的2型糖尿病患者按1∶1随机分入格列奇特控释片组(A)和格列奇特普通片组(B)，两组各24例，分别服用 格列奇特控释片 30mg^+早餐前2片+安慰剂晚餐前2片和格列奇特普通片80mg+安慰剂，每日2次。所有患者均随访血糖、C 肽、 HbAlc，记录不良事件。结果：两组患者的空腹及餐后2h 静脉血糖和 HbAlc 均较治疗前有显著降低(P＜0． 0001) ，C 肽水平有明显 升高(P＜0． 01) ；降糖治疗的有效率分别为100%和95． 83%，所有临床参数的组间比较均无显著差异。所有不良事件均为轻度，无患 者因不良事件退出研究。结论：格列奇特控释片治疗2型糖尿病的临床疗效和格列奇特普通片相似，安全性良好。Objective：To assess clinical efficacy and safety in type 2 diabetes patients with controlled-release-gliclazide therapy,camparing with gliclazide. Methods： 48 patients with type 2 diabetes had been randomly allocated into controlled-release-gliclazide group（A） or gliclazide group（B） . Patients in group A received controlled-release-gliclazide 30 mg and placebo two times a day. Patients in group B received gliclazide 80 mg and placebo two times a day. All the patients had been treated for 12 weeks. Blood plasma glucose,HbAlc and C peptide were measured. Results.. The efficacy rates were 100% and 95. 83 % , respectively. No significant difference was found between the two groups. Both groups bad similar improvement in blood plasma glucose, HbAlc and C peptide. Conclusion： Controlled-release-gliclazide has similar efficacy and safety to gliclazide in treatment of type 2 diabetes.

关 键 词：2型糖尿病 格列奇特控释片 随机对照临床研究 

分 类 号：R587.1[医药卫生—内分泌]