沙格列汀联合门冬胰岛素30治疗老年Ⅱ型糖尿病患者的系统评价

    Saxagliptin Combined with Insulin Aspart 30 in Treatment of Elderly with TypeⅡDiabetes: A Meta-Analysis

    • 摘要: 目的 系统评价沙格列汀联合门冬胰岛素30治疗老年(年龄≥60周岁)Ⅱ型糖尿病患者的有效性和安全性。 方法 从PubMed、EMBASE、ClinicalTrials.gov、Cochrane 图书馆、CNKI、CBM、Wanfang、VIP数据库中检索沙格列汀联合门冬胰岛素30对比门冬胰岛素30治疗老年Ⅱ型糖尿病患者的文献,检索时间截止至2018年10月。根据Cochrane 5.1 手册要求,进行数据提取和质量评价后,采用RevMan 5.3软件进行Meta分析。 结果 纳入10项研究,合计1 068例患者。Meta分析结果显示: 与门冬胰岛素30(对照组)相比,沙格列汀联合门冬胰岛素30(试验组)能显著提高总有效率(相对危险度1.30,95%可信区间 1.18~1.43, P=0.000 01)、降低空腹血糖(均数差-1.64,95%可信区间-1.70~-1.57,P<0.000 01)、餐后2小时血糖(均数差 -1.15,95%可信区间 -1.22~-1.08,P<0.000 01)、体质量指数(均数差 -1.85,95%可信区间-2.62~-1.08,P<0.000 01))、低血糖事件发生率(相对危险度 0.21,95%可信区间0.11~0.40,P<0.000 01),但对糖化血红蛋白的降低无显著性影响(均数差 -0.37,95%可信区间-0.84~0.1,P=0.12)。亚组分析显示: 疗程为3周时,沙格列汀联合门冬胰岛素30降低糖化血红蛋白不及门冬胰岛素30(均数差 0.65,95%可信区间0.57~0.72,P<0.000 01);疗程为12周时,沙格列汀联合门冬胰岛素30降低糖化血红蛋白优于门冬胰岛素30(均数差 -1.16,95%可信区间-1.90~-0.43,P=0.002)。 结论 沙格列汀联合门冬胰岛素30治疗老年2型糖尿病患者安全有效,但研究间存在一定的异质性,故需更多高质量、大样本、多中心的随机对照试验予以验证。

       

      Abstract: Objective To systematically review the efficacy and safety of Saxagliptin combined with Insulin aspart 30 in the treatment of elderly (≥60) with type Ⅱdiabetes. Methods The databases including PubMed, EMBASE, ClinicalTrials.gov, Cochrane library, CNKI, CBM, Wanfang and VIP Data were searched from the inception to October 2018. The quality of included randomized controlled trials were assessed according to the Cochrane Handbook 5.1, And meta-analysis was performed by RevMan 5.3 software. Results Ten trials were included, involving 1 068 patients. Meta-analysis results showed, the total effective rate(RR=1.30,95%CI 1.18~1.43, P=0.000 01)was significantly improved in experimental group(Saxagliptin combined with Insulin Aspart 30) than those in control group(Insulin Aspart 30 only). Compared with control group, experimental group could significantly reduce fasting blood glucose(MD=-1.64,95%CI -1.70~-1.57,P<0.000 01)、2-hour postprandial blood glucose(MD=-1.15,95%CI -1.22~-1.08,P<0.000 01)、body mass index(MD=-1.85,95%CI -2.62~-1.08,P<0.000 01)and the incidence of hypoglycemia(RR=0.21,95%CI 0.11~0.40,P<0.000 01)except for glycosylated hemoglobin A1(HbA1c)(MD=-0.37,95%CI -0.84~0.1,P=0.12). Subgroup analysis showed that treatment lasted for 12 weeks, experimental group performed better in reducing HbA1c(MD=-1.16,95%CI -1.90~-0.43,P=0.002) than control group, by contrast, control group could significantly reduce HbA1c(MD=0.65,95%CI 0.57~0.72,P<0.000 01)with treatment lasted for 3 weeks. Conclusions Based on the current clinical evidence, Saxagliptin combined with Insulin Aspart 30 is an efficacious and safe choice for elderly type Ⅱ diabetic patient, but there is certain heterogeneity between the studies, therefore it is necessary for more high quality, large scale, multicenter, randomized controlled trial to be verified.

       

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