机构地区:[1]昆明医科大学第一附属医院糖尿病科,650032
出 处:《中国糖尿病杂志》2016年第5期443-450,共8页Chinese Journal of Diabetes
摘 要:目的系统评价持续胰岛素皮下输注治疗中国T2DM患者的有效性和安全性。方法检索中文数据库,包括CBM、CNKI、万方数据库、维普数据库从建库至2015年9月已发表的持续胰岛素皮下输注和多次胰岛素皮下注射治疗T2DM的临床疗效对比的随机对照试验(RCT)。按Cochrane系统评价纳入文献质量并提取临床效应指标。采用RevMan 5.3统计学软件进行荟萃分析。I^2值检验各研究间的异质性,采用α=0.05作为检验水准。结果共纳入15个RCT。Meta分析结果显示,两组比较:(1)新诊断T2DM亚组FPG控制差异无统计学意义(MD=-0.07,95%CI:-0.48~0.34,P=0.74);不明确是否为新诊断T2DM亚组FPG控制差异有统计学意义(MD=-0.50,95%CI:-0.87^-0.14,P=0.007);总体FPG控制差异有统计学意义(MD=-0.31,95%CI:-0.59^-0.04,P=0.02),持续胰岛素皮下输注组FPG降低程度优于多次胰岛素皮下注射组。(2)新诊断T2DM亚组2 hPG控制差异无统计学意义(MD=-0.48,95%CI:-1.00~0.03,P=0.07);不明确是否为新诊断T2DM亚组2 hPG控制差异有统计学意义(MD=-0.85,95%CI:-1.34^-0.37,P=0.0006);总体2 hPG控制差异有统计学意义(MD=-0.68,95%CI:-1.03^-0.32,P=0.0002),表明持续胰岛素皮下输注组2 hPG下降程度大于多次胰岛素皮下注射组。(3)持续胰岛素皮下输注组HbA_1c降低程度大于多次胰岛素皮下注射组(MD=-0.27,95%CI:-0.46^-0.07,P=0.008)。持续胰岛素皮下输注组低血糖发生率低于多次胰岛素皮下注射组(OR=0.26,95%CI:0.17~0.40,P<0.00001)。(4)持续胰岛素皮下输注组生活质量优于多次胰岛素皮下注射组(MD=-17.88,95%CI:-20.71^-15.04,P<0.00001)。结论与多次胰岛素皮下注射治疗比较,持续胰岛素皮下输注治疗能更有效地控制T2DM患者血糖,且安全性好,患者生活质量更高。Objective To systematically review the efficacy and safety of continuous subcutaneous insulin infusion(CSII) in the treatment of patients with type 2 diabetes in China.Methods We searched Chinese database including CBM,CNKI,Wanfang and VIP data to collect published randomized controlled trials(RCTs) on the comparison of efficacy between CSII and multiple subcutaneous insulin infusion(MSII) in type 2 diabetes from inception until September,2015.Clinical characteristics were assessed and references' quality was evaluated by standard criteria of Cochrane systemic review.Meta-analysis was performed by RevMan 5.3 software.Results A total of 15 randomized controlled trials were included.The results of meta-analysis showed:(1) There was no statistical significance of FPG between CSII and MSII patients in subgroup of patients with newly diagnosed type 2 diabetes(MD=- 0.07,95%CI:-0.48~0.34,P=0.74).In the subgroup of unknown newly diagnosed type 2 diabetes,the FPG reduction was significantly better in CSII group than in MSII group(MD=- 0.50,95%CJ:-0.87~-0.14,P=0.007).In total group,the FPG reduction was significantly better in CSII group than in MSII group(MD=- 0.31,95%CI:- 0.59~-0.04,P = 0.02).(2) In the subgroup of newly diagnosed type 2 diabetes,there was no statistical significance of 2-hour postprandial blood glucose(2 hPG) between CSII and MSII treatment(MD=-0.48,95%C7:-1.00- 0.03,P=0.07).In the subgroup of unknown newly diagnosed type 2diabetes,the 2 hPG reduction was significantly better in CSII group than in MSII group(MD=-0.85,95%CI:-1.34-0.37,P=0.0006).In total group,the 2 hPG reduction was significantly better in CSII group than in MSII group(MD=-0.68,95%CI:-1.03~-0.32,P = 0.0002).(3) The reduction of HbA1 c was significantly better in CSII group than in MSII group(MD=- 0.27,95%CI:-0.46 ~-0.07,P=0.008).The incidence of hypoglycemia was lower in CSII group than in MSII group(OR = 0.26,95%CI.0.17~0.40,P〈0.00001).(4) Qu
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