地特胰岛素联合瑞格列奈治疗2型糖尿病的临床对照研究  

Clinical study of insulin detemir combined with repaglinide in the treatment of type 2 diabetes

作　　者：刘开平[1] 沈国清[1] 周晓芳[1] 蔡海刚[1] 朱荔[1] 丘红梅[1] 李薇 姚纪瑜[1] 陈纯娴[2] 杨绪兰[3] 

机构地区：[1]玉溪市人民医院内分泌科,云南玉溪653100 [2]福建医科大学附属第一医院内分泌科,福州350004 [3]成都军区昆明总医院营养科,昆明650032

出　　处：《中国临床药理学杂志》2015年第5期330-332,共3页The Chinese Journal of Clinical Pharmacology

基　　金：卫生厅青年基金项目(2008-2-16)

摘　　要：目的探讨地特胰岛素联合瑞格列奈治疗2型糖尿病的临床疗效及安全性。方法选取2013年1月2014年2月玉溪市人民医院收治的口服2种以上降糖药物血糖控制不佳的2型糖尿病患者85例,随机分为试验组（n=41）和对照组（n=44）。试验组给予地特胰岛素初始剂量0.1 U·kg-1,每晚22∶00皮下注射,瑞格列奈0.5~1.0 mg,三餐前15 min口服;对照组在早、晚餐前10 min皮下注射门冬胰岛素30,0.5~1.0 U·kg-1;2组患者治疗周期为3个月。观察患者治疗期间空腹血糖（FPG）、餐后2 h血糖（2 h PG）和糖化血红蛋白（Hb A1C）等指标变化情况。结果治疗后2组患者FPG、2 h PG及Hb A1C与治疗前比较均显著降低（P〈0.05）,但试验组患者治疗期间血糖波动较小。治疗后2组患者空腹C肽及餐后2 h C肽均明显下降（P〈0.05）,且试验组下降水平更为显著（P〈0.05）。治疗期间,试验组发生低血糖1例,对照组8例,对照组显著高于试验组（P〈0.05）。结论地特胰岛素联合瑞格列奈治疗2型糖尿病可平稳降低血糖水平,降低低血糖的发生率。Abstract： Objective To evaluate the efficacy and safety of insulin det- emir combined with repaglinide on the treatment of type 2 diabetes. Methods Eighty five cases with type 2 diabetes and not responsive to more than two abtidiabetic drugs were recruited in this study, and then were randomized divided into the experiment group （ n = 41 ） and control group （n = 44）. Patients in the experiment group were given treatment of insulin detemir 0. 1 U ~ kg-I through hypodermic injection at 22：00 com- bined with repaglinide 0. 5 - 1.0 mg 15 minutes before three meals, and those in the control group were treated with insulin aspart 30, 0. 5 - 1.0 U ~ kg t through hypodermic injection 10 minutes before breakfast and dinner. The treatment lasted for three months. The data of fasting plasma - glucose （ FPG ）, 2 - hour postprandial plasma glucose （ 2 h PG ）, hemoglobin A1C （HbA1C） and so on were recorded and compared between the two groups. Results The serum level of FPG, 2 h PG and HbA1C were significantly decreased in the two groups after treatment （ P 〈 0.05 ）, and glucose level in the experiment group was stabler than the control group. Levels of fasting blood - glucose C peptide and 2 - hour postprandial blood - glucose C peptide were statistically decreased in the both groups （ P 〈 0. 05 ）, with a more significant decrease found in experiment group （ P 〈 0. 05 ）. The risk to devel- op glucopenia was much higher in the control group than that in the experiment group （P 〈 0.05 ）. Conclusion Insu- lin detemir combined with repaglinide can significantly decrease the serum level of glucose in patients with type 2 diabe- tes with low risk to develop glucopenia.

关 键 词：2型糖尿病 地特胰岛素 瑞格列奈 门冬胰岛素30 临床试验对照研究 

分 类 号：R977.15[医药卫生—药品] R587.1[医药卫生—药学]