摘要
目的探讨每日3次门冬胰岛素(BIAsp)方案联合二甲双胍治疗2型糖尿病(T2DM)的有效性和安全性。方法 37例T2DM患者,随机分为2组。试验组20例,给予每日3次注射方案(BIAsp50-50-30方案)。对照组17例,给予每日2次注射方案(BIAsp30-30方案)。均联合应用二甲双胍治疗,共16 wk。观察2组患者糖化血红蛋白(HbA_(1c))、全日7个时点血糖、血脂、低血糖事件及其他不良反应。结果治疗16 wk后,试验组每日7个时点血糖、HbA_(1c)和低密度脂蛋白胆固醇(LDL-C)较治疗前均下降(P<0.05),对照组每日6个时点血糖、HbA_(1c)较治疗前下降(P<0.05),而午餐后2 h血糖和LDL-C治疗前后无明显变化(P>0.05)。2组各项指标治疗前后组间比较均无显著差异(P>0.05)。2组低血糖发生率无显著差异(P>0.05),均未见严重不良反应发生。结论当与二甲双胍联合治疗T2DM时,BIAsp50-50-30方案安全、有效,且控制午餐后血糖较BIAsp30-30方案满意,并有助降低LDL-C水平。
AIM To investigate the efficacy and safety of insulin aspart three times daily combined with oral metformin in type 2 diabetic mellitus (T2DM). METHODS Thirty-seven patients with T2DM were randomly divided into two groups, and were treated respectively with the insulin aspart three times daily (BIAsp50-50-30 program, n = 20) or the insulin aspart two times daily (BIAsp30-50 program, n = 17) both combined with oral metformin for 16 weeks. Blood glucose at 7 time points, glycosylated hemoglobin A1c (HbA1c) and lipid were tested, hypoglycemia and other adverse reactions were observed. RESULTS After 16 weeks treatment, HbA1c, low-density lipoprotein cholesterol (LDL-C) and 7 points blood glucose were significantly decreased (P 〈 0.05) in the group of BIAsp50-50-30, HbA1c and 6 points blood glucose were significantly decreased (P 〈 0.05) except 2 h post-lunch blood glucose and LDL-C (P 〉 0.05) in the group of BIAsp30-30. There were no significant differences before and after treatment between two groups (P 〉 0.05). No serious adverse reactions were observed in both groups. CONCLUSION Combined with metformin in the treatment of T2DM, the BIAsp50-50-30 program is effective and safe. Moreover, the BIAsp50-50-30 program controls blood glucose after lunch better than BIAsp30-30 and helps to reduce LDL-C level.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2010年第7期499-502,共4页
Chinese Journal of New Drugs and Clinical Remedies