查看更多>>摘要：目的 系统评价胰岛素Icodec治疗2型糖尿病（T2DM）的疗效和安全性，为临床合理用药提供循证依据。 方法 计算机检索美国国立医学图书馆数据库（PubMed）、荷兰医学文摘数据库（Embase）、循证医学数据库（the Cochrane Library）、科学引文数据库（Web of Science）、中国生物医学文献数据库（Sinomed）、中国知网（CNKI）、万方数据库和维普数据库，收集比较胰岛素Icodec（试验组）和安慰剂或其他降糖药物（对照组）治疗2型糖尿病疗效与安全性的随机对照试验（RCT），检索时限均为从建库至2023年8月。疗效指标包括：糖化血红蛋白（HbA1c）水平、HbA1c达标（HbA1c<7%）率、空腹血浆血糖（FPG）水平、体重、葡萄糖在目标范围内时间（TIR）百分比；安全性指标包括：低血糖事件发生率、注射部位反应发生率、药物过敏反应事件发生率、严重不良反应事件发生率。由两位评价员独立筛选文献，并从文献中提取资料和评价被纳入研究的偏倚风险后，采用RevMan 5.4软件对数据进行Meta分析。 结果 共纳入7项研究，3 286例患者。Meta分析结果显示，疗效方面，与对照组相比，胰岛素Icodec在降低HbA1c（WMD=-0.16%，95%CI -0.26%~-0.07%，P<0.01）、提高HbA1c达标率（OR=1.50，95%CI 1.29~1.74，P<0.01）中更有优势，但在降低FPG水平方面两组差异无统计学意义（WMD=-0.05 mmol/L，95%CI -0.29~0.20 mmol/L，P=0.71），且会增加患者体重水平（WMD=0.52 kg，95%CI 0.22~0.82 kg，P<0.01），但是可以提高患者TIR百分比（WMD=5.86%，95%CI 2.02%~9.70%，P=0.003）；安全性方面，与对照组相比，胰岛素Icodec组的低血糖事件发生率增加（OR=1.37，95%CI 1.17~1.61，P<0.01），而过敏反应发生率（OR=0.91，95%CI 0.64~1.31，P=0.62）、注射部位反应发生率（OR=1.03，95%CI 0.63~1.66，P=0.92）以及严重不良反应事件发生率（OR=0.97，95%CI 0.75~1.24，P=0.79）差异无统计学意义。 结论 胰岛素Icodec能降低患者HbA1c水平，提高患者HbA1c达标率，且不增加注射部位反应事件、过敏事件以及严重不良反应事件的发生率。 Objective To systematically evaluate the efficacy and safety of insulin Icodec in the treatment of type 2 diabetes mellitus (T2DM) in order to provide evidence-based guidance for the rational clinical use of drug. Methods The databases of PubMed, Embase, Cochrane Library, Web of Science, Sinomed, CNKI, Wanfang and VIP were searched by computer to identify randomized controlled trials (RCT) comparing the efficacy and safety of insulin Icodec (trial group) versus placebo or other hypoglycemic agents (control group) in the treatment of T2DM were collected from the date of database inception to August 2023. The efficacy indexes included: glycated hemoglobin A1c (HbA1c) level, HbA1c compliance rate (HbA1c<7%), fasting plasma glucose (FPG) level, body weight level, time in range (TIR) percentage. Safety indicators included: incidence of hypoglycemia events, incidence of injection site reactions, incidence of drug allergic reactions, and incidence of serious adverse events. Two evaluators independently screened the literature, extracted data from the literature and assessed the risk of bias of the studies included, and performed a meta-analysis of the data using RevMan 5.4 software. Results Seven studies with a total of 3 286 patients were included. The results of meta-analysis showed that compared with the control group, insulin Icodec reduced HbA1c (WMD=-0.16%, 95%CI -0.26%--0.07%, P<0.01), increased the rate of HbA1c compliance (OR=1.50, 95%CI 1.29-1.74, and decreased HbA1c compliance (WMD=-0.16%, 95%CI -0.26%--0.07%, P<0.01). However, there was no statistically significant difference between the two groups in reducing FPG levels (WMD=-0.05 mmol/L, 95%CI -0.29-0.20 mmol/L,P=0.71), and it increased the body weight of patients (WMD=0.52 kg, 95%CI 0.22-0.82 kg, P<0.01), but increased the percentage of TIR in patients (WMD=5.86%, 95%CI 2.02%-9.70%,P=0.003). In terms of safety, although the incidence of hypoglycemic events (OR=1.37, 95%CI 1.17-1.61, P<0.01) was higher in the insulin Icodec group than in the control group, the incidence of anaphylaxis was higher in insulin Icodec group than in the control group (OR=0.91, 95%CI 0.64-1.31,P=0.62), injection site reaction (OR=1.03, 95%CI 0.63-1.66, P=0.92) and incidence of serious adverse events (OR=0.97, 95%CI 0.75-1.24, P=0.79), there was no significant difference between insulin Icodec and control groups. Conclusions Insulin Icodec can lower HbA1c levels in patients and increase the rate of HbA1c compliance without increasing the incidence of injection site reactions, allergic events and serious adverse events.
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