门冬胰岛素30与预混人胰岛素治疗中国2型糖尿病患者的Meta分析  

Meta-analysis comparing treatment with biphasic insulin aspart 30 to premix human insulin in Chinese type 2 diabetes patients

作　　者：张雪莲[1] 崔玲 罗斌 杨文英[1] ZHANG Xuelian;CUI Ling;LUG Bin(Department of Endocrinology,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]中日友好医院内分泌科,100029 [2]诺和诺德(中国)制药有限公司

出　　处：《中国糖尿病杂志》2018年第9期723-732,共10页Chinese Journal of Diabetes

摘　　要：目的比较门冬胰岛素30(BIAsp 30)与预混人胰岛素治疗中国T2DM患者的疗效及安全性。方法检索MEDLINE、The Cochrane Library、Embase、PubMed、CBM、中国知网、维普及万方数据库从建库至2017年3月的文献,纳入BIAsp 30与预混人胰岛素治疗中国T2DM患者,治疗时长至少12周的随机对照试验(RCT)并进行Meta分析。结果纳入169项RCTs共13682例中国T2DM患者。BIAsp 30与预混人胰岛素治疗后HbA_1c较基线下降幅度更大(10RCTs,n=596,MD-0.73,95%CI-1.01^-0.45,I^2=79%),随访结束时HbA_1c水平更低(153RCTs,n=12178,MD-0.44,95%CI-0.51^-0.38,I^2=92%),HbA_1c达标率更高(7RCTs,n=917,RR1.09,95%CI 1.02~1.18,I^2=13%)。BIAsp 30组治疗后FPG及2hPG均低于预混人胰岛素组。BIAsp 30较预混人胰岛素具有更低的低血糖发生风险(总体低血糖:94RCTs,n=7317,RR0.37,95%CI0.33~0.42,I^2=0%;严重低血糖:14RCTs,n=1498,RR0.24,95%CI 0.14~0.42,I^2=0%;夜间低血糖:17RCTs,n=1253,RR0.20,95%CI0.11~0.36,I^2=0%),胰岛素日剂量(按天计算)较预混人胰岛素组更少。两组治疗后体重变化差异无统计学意义(P>0.05)。对于Meta分析中的一些终点,观察到一定程度的异质性。结论对于中国T2DM患者,与预混人胰岛素相比,BIAsp 30可更好地改善血糖控制,且低血糖发生风险更低。Objective To assess the efficacy and safety of biphasie insulin aspart 30 （BIAsp 30） versus premix human insulin for the treatment in Chinese subjects with type 2 diabetes mellitus （T2DM）. Methods The following databases were searched to identify the randomised controlled trials （RCTs）from database inception to March 2017 ： MEDLINE,The Cochrane Library, Embase, PubMed, CBM, CNKI, VIP and Wanfang. RCTs comparing BIAsp 30 with premix human insulin for the treatment of T2DM in Chinese population with a treatment period ≥ 12 weeks were included, and meta-analysis was performed. Results A total of 169 RCTs with 13682 patients were included. Compared with premix human insulin, patients receiving BIAsp 30 showed greater reduction in HbA1 c from baseline （10 RCTs, n= 596,MD - 0. 73, 95%CI --1.01 ^- 0. 45, I2 = 79%）, lower HbA1c levels （153 RCTs, n = 12178, MD -0. 44, 95 % CI -0.51^-0. 38,I2=92%） at the end of the trial, and higher proportion of subjects achieving HbAlc〈 7% （7 RCTs,n=917,RR 1.09,95%CI 1.02~1.18,I2 =13%）. FPG and 2 hPG at the end of the trial were significantly lower in BIAsp 30 group than premix human insulin group. BIAsp 30 showed significantly lower risk of hypoglycaemia （overall： 94 RCTs, n = 7317,RR 0. 37, 95% CI O. 33 ~ 0. 42,I2 = 0% severe： 14 RCTs ,n=1498,RR 0. 24,95%CI O. 14~0. 42,I2=O%;noctumal：17 RCTs ,n=1253,RR 0.20,95% CI 0. 11~0. 36,I2=0%） compared with premix human insulin. The total daily insulin dose （units/day）was significantly lower in BIAsp 30 group than premix human insulin group. The difference between BIAsp 30 and premix human insulin in the change of body weight from baseline was not statistically significant. Substantial level of heterogeneity was observed for some of the endpoints. Conclusion For the Chinese T2DM patients,BIAsp 30 showed better glycaemic control and lower hypoglycaemia risk compared with premix human insulin.

关 键 词：双时相门冬胰岛素30 预混人胰岛素 糖尿病 2型 META分析 

分 类 号：R587.1[医药卫生—内分泌]