持续皮下胰岛素注射治疗老年2型糖尿病效果的Meta分析与试验序贯分析  

Effectiveness of Continuous Subcutaneous Insulin Injection in Type 2 Diabetes in Older Adults:a Meta-analysis and Trial Sequential Analysis

作　　者：杨蓓 韩琳 王茵[1] 程康耀 YANG Bei;HAN Lin;WANG Yin;CHENG Kangyao(School of Nursing,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学护理学院,上海市201203

出　　处：《中国全科医学》2023年第15期1892-1901,共10页Chinese General Practice

基　　金：上海市教育委员会预算内教育教学项目(2021JX78)。

摘　　要：背景胰岛素在糖尿病患者的治疗中起着重要作用,可以进行每日多次皮下注射胰岛素(MDI),也可以通过胰岛素泵实现持续皮下胰岛素注射(CSII),目前对两种注射方法在老年2型糖尿病(T2DM)人群中的治疗效果仍存在争议。目的应用Meta分析方法评价CSII对老年T2DM患者的治疗效果,并用试验序贯分析(TSA)检验Meta分析结果的有效性。方法计算机检索Cochrane Library、Pub Med、Embase、Medline、Scopus、Web of Science、中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、维普期刊资源整合服务平台(CQVIP)和中国生物医学文献数据库(Sino Med)从建库至2021年12月公开发表的关于CSII治疗老年T2DM的随机对照试验(RCT)。试验组通过胰岛素泵实施CSII治疗,对照组采取MDI治疗。主要结局指标:空腹血糖(FPG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA_(1c))、低血糖发生率;次要结局指标:平均血糖波动幅度(MAGE)、胰岛素日用量、血糖达标时间。两名研究者独立筛选文献、评价文献质量并提取资料。采用Review Manager 5.3软件对符合质量标准的文献进行Meta分析,使用哥本哈根临床试验中心研发的TSA v0.9完成试验序贯分析。结果共纳入16篇RCT。Meta分析结果显示,试验组改善老年T2DM患者的FPG[MD=-0.82,95%CI(-1.09,-0.54),P<0.05]、2 h PG[MD=-0.76,95%CI(-1.39,-0.14),P<0.05]、HbA_(1c)[SMD=-1.23,95%CI(-2.23,-0.23),P<0.05]、严重低血糖发生率[RD=-0.10,95%CI(-0.17,-0.03),P<0.05]、胰岛素日用量[MD=-9.63,95%CI(-12.35,-6.92),P<0.05]、MAGE[MD=-1.19,95%CI(-1.40,-0.97),P<0.05]效果优于对照组。对主要结局指标进行试验序贯分析发现,CSII治疗能降低老年T2DM患者的FPG、2 h PG、HbA_(1c)水平和严重低血糖发生率。结论相对于MDI,CSII能进一步改善老年T2DM患者的血糖控制水平、降低低血糖发生率和平均血糖波动幅度。Background As an important part of diabetes treatment,insulin can be administered either by multiple daily injections(MDI)or continuous subcutaneous insulin infusion(CSII)via an insulin pump,but there are still controversies around the effectiveness of insulin administered by both methods in type 2 diabetes mellitus(T2DM)among older adults.Objective To evaluate the effectiveness of CSII in T2DM in older adults using meta-analysis,and to test the validity of the analysis results using trial sequential analysis(TSA).Methods Cochrane Library,Pub Med,Embase,Medline,Scopus,Web of Science,CNKI,Wanfang Data,CQVIP and Sino Med were retrieved for randomised controlled trials(RCTs)from inception to December 2021 regarding the effectiveness of CSII via an external insulin pump compared with that of MDI of insulin for older adults with T2DM.The primary outcomes included fasting plasma glucose(FPG),2-hour postprandial plasma glucose(2 h PG),HbA_(1c)and incidence of hypoglycaemia.The secondary outcomes included the mean amplitude of glycemic excursions(MAGE),total daily dose of insulin,and the time to achieve glycemic target.Two researchers independently carried out literature enrolment,quality evaluation and data extraction.Rev Man 5.3 was adopted for meta-analysis.TSA v0.9(Copenhagen Trial Unit)was adopted for TSA.Results Sixteen RCTs were included in total.Meta-analysis demonstrated that CSII via an external insulin pump outperformed MDI of insulin in improving FPG[MD=-0.82,95%CI(-1.09,-0.54),P<0.05],2 h PG[MD=-0.76,95%CI(-1.39,-0.14),P<0.05],HbA_(1c)[SMD=-1.23,95%CI(-2.23,-0.23),P<0.05],incidence of severe hypoglycaemia[RD=-0.10,95%CI(-0.17,-0.03),P<0.05],total daily dose of insulin[MD=-9.63,95%CI(-12.35,-6.92),P<0.05],and MAGE[MD=-1.19,95%CI(-1.40,-0.97),P<0.05].Better improved primary outcomes by CSII via an external insulin pump were also found by a TSA,namely more significantly reduced FPG,2 h PG,and HbA_(1c).Conclusion CSII via an external insulin pump has been shown to be more effective in improving glycaemic control

关 键 词：糖尿病 2型 胰岛素 注射 皮下 老年人 血糖 Meta分析 治疗结果 

分 类 号：R587.1[医药卫生—内分泌]