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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) and conventional human insulin (RHI) in the treatment of diabetes in Chinese patients with basic-meal insulin (BB) or insulin pump (CSII). Methods A randomized controlled trial comparing IAsp with RHI in the treatment of diabetes mellitus was performed from the database to MEDLINE (via OVID), The Cochrane Library, Embase, PubMed, CBM, CNKI and Wanfang database. (RCT). RevMan 5.3 software was used for meta-analysis of newly diagnosed and treated diabetic subjects. Results included 40 studies, a total of 1087 newly diagnosed patients, 2395 patients have been treated. Two groups of patients, IAsp group morning, afternoon and dinner after 2 hPG (new diagnosis of MD = -1.22, -1.70, -1.44, 95% CI: -1.79 ~ -0.64, -2.77 ~ -0.63, -2.12 ~ 0.75; treated people MD = -1.19, -1.14, -1.03, 95% CI: -1.39-0.98, -1.27-1.02, -1.25-0.81) and FPG (new diagnosis MD = -0.55, 95 % CI: -0.97 ~ -0.12; treated group MD = -0.24,95% CI: -0.44 ~ -0.03) were lower than the RHI group; IAsp group shorter glycemic control target time (new diagnosis of MD = -1.58 , 95% CI: -1.74 to -1.42; treated population MD = -1.73, 95% CI: -2.10 to -1.36), hypoglycemic risk (RR = 0.33, 95% CI: 0.19 to 0.56 for newly diagnosed population; Treatment group RR = 0.44, 95% CI: 0.32 to 0.61) were lower (P <0.05). In the CSII group, the daily dose of insulin was less in the IAsp group. Conclusion For Chinese patients with diabetes, IAsp has more advantages than RHI in controlling 2-hPG, shortening blood glucose compliance time and reducing the risk of hypoglycemia.