持续皮下胰岛素输注治疗初诊2型糖尿病有效性和安全性的系统评价

Continuous subcutaneous insulin infusion versus oral drug therapy in patients with newly diagnosed type 2 diabetes mellitus:a systematic review

目的:系统评价持续皮下胰岛素输注(continuous subcutaneous insulin infusion,CSII)治疗初诊2型糖尿病(type 2 diabetes mellitus,T2DM)患者的有效性和安全性。方法:计算机检索PubMed、Medline、EMbase、Cochrane Library、IsI、CBM、CNKI、VIP、万方等数据库,检索时间从建库至2012年12月;手工检索相关杂志纸质版。纳入所有CSII与口服药物治疗初诊T2DM的随机对照试验(randomized controlled trials,RCTs)。根据Cochrane系统评价方法,由2名评价员按照纳入排除标准独立进行质量评价和资料提取,核对后采用RevMan 5.2软件进行Meta分析。结果:共纳入10个RCTs,802例新诊断T2DM患者。Meta分析结果显示,CSII治疗对初诊T2DM患者血糖疗效优于口服药物组[空腹血糖(fasting plasma glucose,FPG):MD=0.90,95%CI=0.52~1.27,P=0.000;2 h餐后血糖(2 hour plasma glucose,2hPG):MD=2.76,95%CI=1.66~3.68,P=0.000;糖化血红蛋白(hemoglobin A1c,HbA1c)3个月疗效:MD=0.96,95%CI=0.19~1.73,P=0.010;血糖达标时间:MD=-5.20,95%CI=-5.98^-4.43,P=0.000;1年血糖缓解率:OR=3.98,95%CI=2.48~6.38,P=0.000]。CSII治疗对胰岛素抵抗指数(homeostasis model assessment insulin resistance index,HOMA-IR)的效果较口服药物组好(MD=1.02,95%CI=0.37~1.67,P=0.002),对β细胞功能指数(homeostasis model assessment forβcell function,HOMA-β)的短期疗效与口服药物组相比尚无统计学差异(MD=-8.10,95%CI=-23.10~6.90,P=0.290)。CSII治疗组低血糖发生率高于口服药物治疗组(RR=1.63,95%CI=1.07~2.48,P=0.020)。结论:初诊T2DM患者CSII对血糖的疗效明显优于口服药物,有利于降低HOMA-IR和恢复胰岛β细胞的功能;CSII相对容易引发低血糖,需要注意预防。

Objective：To evaluate the efficacy and safety of continuous subcutaneous insulin infusion（CSII）treatment in newly diagnosed type 2 diabetes（T2DM）. Methods：Literature was retrieved online since December 2012 in PubMed,MEDLINE,EMbase,Cochrane Library,IsI,CBM,CNKI,VIP and Wan Fang databases. Documents retrieval was hand-searched in print edition of related journals. All randomized controlled trails（RCTs）of CSII and oral medication in the treatment of newly diagnosed T2DM were included in the study. According to the method of Cochrane systematic review,the selection of studies,extraction of data and assessment of methodological quality were performed independently by two reviewers. Meta analyses were performed using Review Manager5.2 software. Results：Ten RCTs involving 802 newly-diagnosed T2DM patients were included. Results of meta analyses showed that in the treatment of newly diagnosed T2DM,blood glucose efficacy of CSII was superior to that of oral drug（fasting plasma glucose（FPG）：MD=0.90,95%CI=0.52 to 1.27,P=0.000;2 hours plasma glucose（2hPG）：MD=2.76,95%CI=1.66 to 3.68,P=0.000;hemoglobin A1c（HbA1c）at 3 months：MD=0.96,95%CI=0.19 to 1.73,P=0.010;the time of blood glucose reaching the target range：MD=-5.20,95%CI=-5.98 to-4.43,P=0.000;1 year glycemic remission rate：OR=3.98,95%CI=2.48 to 6.38,P=0.000）. Homeostasis model assessment insulin resistance index（HOMA-IR）efficacy of CSII group was superior to that of oral drug group（MD=1.02,95%CI=0.37 to 1.67,P=0.002）. There was no statistical difference between two group in the short-term efficacy of the homeostasis model assessment for βcell function（HOMA-β）（MD=-8.10,95%CI=-23.10 to 6.90,P=0.290）. Incidence of hypoglycemia in CSII group was higher than that in oral drug group（RR=1.63,95%CI=1.07 to 2.48,P=0.020）. Conclusion：CSII therapy for newly diagnosed patients with T2DM is more effective than oral medication and can lower HOMA-IR and promote pancreatic β cell functional recovery. CSII is relatively easy to cause hypoglycemia and more attention should be paid to its prevention.