德谷胰岛素对比其他长效基础胰岛素类似物治疗1型糖尿病的有效性和安全性分析  

Efficacy and safety of insulin degludec vs other long-acting basal insulin analogues in the treatment of type 1 diabetes

作　　者：张帅 耿岳[1] 万里燕 纪立伟 ZHANG Shuai;GENG Yue;WAN Liyan;JI Liwei(Department of Pharmacy,the First Hospital of Tsinghua University,Beijing 100016,China;Department of Pharmaceutical Science,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]清华大学第一附属医院药学部,北京100016 [2]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究所,北京100730

出　　处：《中国药物警戒》2022年第12期1358-1361,1367,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2020YFC2008305)。

摘　　要：目的对比德谷胰岛素与其他长效基础胰岛素类似物在治疗1型糖尿病(T1DM)中的疗效与安全性,为临床提供证据参考。方法检索PubMed、Cochrane图书馆、Clinical Trails.gov、中国知网、万方数据、中文科技期刊数据库、药物临床试验登记与信息公示平台等建库至2021年3月31日,关于德谷胰岛素治疗T1DM的随机对照试验(RCT),对符合纳入标准的研究用Rev Man 5.4.1软件进行Meta分析。结果Meta分析共纳入5项RCT,合计2256例患者。Meta分析结果显示,对于成人T1DM患者,与其他长效基础胰岛素类似物相比,德谷胰岛素在降低糖化血红蛋白(HbA1c)方面无明显统计学差异[MD=0.01,95%CI(-0.05,0.08),P=0.69],降低空腹血糖(FPG)方面更优[MD=-0.85,95%CI(-1.15,-0.56),P<0.00001],使用德谷胰岛素比使用地特胰岛素体重增加更多[MD=1.07,95%CI(0.47,1.67),P<0.00001];总低血糖[RR=0.95,95%CI(0.92,0.97),P=0.0003]、严重低血糖发生率[RR=0.78,95%CI(0.66,0.93),P=0.005]、夜间低血糖发生率[RR=0.70,95%CI(0.61,0.80),P<0.00001]更低。文献综述显示德谷胰岛素也适用于T1DM的儿童和青少年;降低血糖波动及低血糖发生率的特点可能使其具有更好的成本效益。结论对于成年T1DM患者,与其他长效基础胰岛素类似物相比,德谷胰岛素降低HbA1c的效果及安全性相当,在减少FPG、减少低血糖发生率,尤其是夜间低血糖发生率方面更具有优势,这些优势可能带来更优的成本效益。德谷胰岛素可以作为FPG相对较高或具有低血糖高风险的T1DM患者治疗的一种选择。Objective To evaluate the efficacy and safety of insulin degludec(IDeg)vs other long-acting basal insulin analogues in the treatment of type 1 diabetes(T1DM),and provide evidence-based reference for clinical treatment.Methods PubMed,Cochrane Library,Clinical Trails.gov,CNKI,Wangfang Database,VIP and Chinadrugtrials.org.cn from the inception to March 31,2021 were searched for articles related to randomized controlled trials about IDeg in the treatment of T1DM.Studies that met the inclusion criteria were analyzed using Rev Man 5.4.1.Results Totally,5 RCTs were enrolled in meta-analysis,involving 2256 patients.Results of Meta-analysis showed that for adult T1DM patients,there was no significant difference between IDeg and other long-acting basal insulin analogues in the ability to lower HbA1c[MD=0.01,95%CI(-0.05,0.08),P=0.69],and the former was more effective in reducing FPG[MD=-0.85,95%CI(-1.15,-0.56),P<0.00001].Weight gain was greater with IDeg than with insulin detemir[MD=1.07,95%CI(0.47,1.67),P<0.00001].The overall confirmed hypoglycemia rates[RR=0.95,95%CI(0.92,0.97),P=0.0003],severe hypoglycemia rates[RR=0.78,95%CI(0.66,0.93),P=0.005]and nocturnal hypoglycemia rates[RR=0.70,95%CI(0.61,0.80),P<0.00001]were lower with IDeg.Literature review found that insulin IDeg was also suitable for children and teenagers with type 1diabetes.The reduced blood glucose fluctuations and hypoglycemia made it more cost effective.Conclusion For adult T1DM patients,IDeg is not only as effective and safe as other long-acting basal insulin analogues,but also has advantages in reducing FPG and the incidence of hypoglycemia,especially nocturnal hypoglycemia.IDeg may be an option for T1DM patients with relatively high fasting glucose or at high risk of hypoglycemia.

关 键 词：德谷胰岛素 1型糖尿病 长效基础胰岛素 META分析 有效性 安全性 

分 类 号：R977.15[医药卫生—药品]