门冬胰岛素与常规人胰岛素治疗中国糖尿病患者的Meta分析

Meta-analysis of insulin aspart versus regular human insulin in diabetes treatment in China

目的比较门冬胰岛素(IAsp)与常规人胰岛素(RHI)用于基础-餐时胰岛素(BB)或胰岛素泵(CSII)治疗中国糖尿病患者的疗效及安全性。方法检索MEDLINE(via OVID))、The Cochrane Library、Embase、PubMed、CBM、中国知网(CNKI)、万方数据库,从建库至2015年11月,比较IAsp与RHI治疗糖尿病患者的随机对照试验(RCT)。采用RevMan 5.3软件分别对新诊断和已接受治疗的糖尿病人群进行Meta分析。结果纳入40项研究,累计新诊断患者1087例,已治疗患者2395例。两类人群中,IAsp组早、午、晚餐后2 hPG(新诊断人群MD=-1.22、-1.70、-1.44,95%CI:-1.79^-0.64、-2.77^-0.63、-2.12^-0.75;已治疗人群MD=-1.19、-1.14、-1.03,95%CI:-1.39^-0.98、-1.27^-1.02、-1.25^-0.81)和FPG(新诊断人群MD=-0.55,95%CI:-0.97^-0.12;已治疗人群MD=-0.24,95%CI:-0.44^-0.03)均低于RHI组;IAsp组达血糖控制目标时间更短(新诊断人群MD=-1.58,95%CI:-1.74^-1.42;已治疗人群MD=-1.73,95%CI:-2.10^-1.36),低血糖风险(新诊断人群RR=0.33,95%CI:0.19~0.56;已治疗人群RR=0.44,95%CI:0.32~0.61)更低(P<0.05)。CSII治疗时,IAsp组胰岛素日剂量更少。结论对于中国糖尿病患者,IAsp在控制2 hPG、缩短血糖达标时间、降低低血糖风险方面均较RHI更有优势。

Objective To compare the efficacy and safety of insulin aspart （IAsp） versus regular human insulin （RHI） used in basal bolus （BB） or continuous subcutaneous insulin infusion （CSII） regimen in patients with diabetes mellitus in Chinese population. Methods We searched MEDLINE （via OVID）, the Cochrane Library, Embase, PubMed, CBM, China National Knowledge Infrastructure （CNKI）, and Wanfang databases from the beginning of the databases to November, 2015. The randomized controlled trials comparing IAsp and RHI in DM were searched. The meta-analysis in newly diagnosed DM and treated DM was performed by RevMan 5.3. Results A total of 40 trials were included in this study, with 1087 newly diagnosed and 2395 treated DM patients. In both groups, IAsp was better in lowering 2 hours postprandial plasma glucose （2 hPG） after breakfast, lunch and dinner （For newly diagnosed population MD=-1. 22,-1. 70, -1. 44; 95%CI：-1. 79--0. 64, -2.77--0. 63, -2. 12--0. 75; for treated population MD=-1. 19, -1. 14, -1. 03% 95%CI：-1.39--0. 98,-1. 27--1. 02, -1.25 --0. 81） and fasting plasma glucose （For newly diagnosed population MD= -0. 55,95 % CI：- 0, 97- -0.12;for treated population MD：-0. 24,95%CI： -0. 44--0. 03） when compared with RHL IAsp could shorten the time to achieve blood glucose target（For newly diagnosed population MD=-1.58,95% CI： - 1.74% - 1.42 % for treated population MD= - 1.73,950% CI： - 2.10-- 1.36） and reduce the risk of hypoglycaemia compared with RHI （ For newly diagnosed population RR = 0. 33,95 % CI： 0.19 - 0. 56 ; for treated population RR=0. 44,95%CI： 0. 32-0.61） （P〈0.05）. Moreover, the total daily insulin dose was lower in IAsp therapy than in RHI therapy when using CSII regimen. Conclusion In Chinese DM patients, IAsp shows advantages in controlling 2 hPG, shortening the time to achieve blood glucose target and lowering the risk of hypoglycaemia when compared with RHI.