Effects of insulin regimens for type 2 diabetes mellitus: a systematic review and network meta-analysis.

However, the comparative effectiveness and safety of different insulin regimens remain uncertain.

然而，不同胰岛素方案的相对有效性和安全性仍不确定。

We aimed to compare the effects of basal, basal-bolus, biphasic and prandial insulin regimens on glycaemic management, weight, severe hypoglycaemia, insulin dose and quality of life in adults with type 2 diabetes.

我们旨在比较基础、基础-餐后、双相和餐后胰岛素方案对2型糖尿病成人血糖管理、体重、严重低血糖、胰岛素剂量和生活质量的影响。

Methods

We conducted a systematic reviewand network meta-analysisof RCTs.

我们进行了随机对照试验的系统评价和网络荟萃分析。

PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov were searched through to September 2025.

检索了PubMed、EMBASE、Cochrane图书馆和ClinicalTrials.gov，直至2025年9月。

The inclusion criteria for studies were RCTs enrolling adults with type 2 diabetes that compared at least two of the specified insulin regimens over ≥12 weeks.

研究的纳入标准是随机对照试验，招募了患有2型糖尿病的成人，比较了至少两种指定的胰岛素方案，持续时间≥12周。

Pairs of reviewers independently screened studies, extracted data and assessed risk of bias using the Cochrane RoB-2 tool.

成对的审查员独立筛选研究，提取数据并使用Cochrane RoB-2工具评估偏倚风险。

Network meta-analyses were performed using a frequentist random-effects model, with basal insulin as the reference.

使用频率随机效应模型进行网络荟萃分析，以基础胰岛素作为参考。

Results

Fifty-eight RCTs involving 19,122 participants were included.

纳入了涉及19,122名参与者的58项随机对照试验(RCTs)。

Compared with basal insulin, HbA1c reduction was -3.4 mmol/mol (95% CI -4.9, -1.9 mmol/mol) (-0.31% [95% CI -0.45%, -0.17%]) with a basal-bolus insulin regimen, -2.7 mmol/mol (95% CI -3.7, -1.6 mmol/mol) (-0.24% [95% CI -0.34%, -0.15%]) with biphasic insulin and -4.1 mmol/mol (95% CI -6.2, -2.1 mmol/mol) (-0.38% [95% CI -0.57%, -0.19%]) with prandial insulin.

与基础胰岛素相比，基础-餐后胰岛素治疗方案的HbA1c降低为-3.4 mmol/mol（95%置信区间-4.9, -1.9 mmol/mol）（-0.31% [95%置信区间-0.45%, -0.17%]），双相胰岛素为-2.7 mmol/mol（95%置信区间-3.7, -1.6 mmol/mol）（-0.24% [95%置信区间-0.34%, -0.15%]），餐后胰岛素为-4.1 mmol/mol（95%置信区间-6.2, -2.1 mmol/mol）（-0.38% [95%置信区间-0.57%, -0.19%]）。

These results were classified as being of moderate confidence due to incoherence.

由于不一致性，这些结果被归类为中等可信度。

All regimens were associated with approximately 30% increased probability of achieving HbA1c target, 1 kg greater weight gain, and a borderline increase in the risk of severe hypoglycaemia.

所有方案与实现HbA1c目标的概率增加约30%、体重增加1公斤以及严重低血糖风险的边缘性增加相关。

Insulin doses were slightly higher with basal-bolus and biphasic regimens.

基础-餐后和双相胰岛素治疗方案的胰岛素剂量略高。

Quality-of-life data were limited.

生活质量的数据有限。

Subgroup analyses for insulin initiation and intensification yielded consistent results.

胰岛素启动和加强的亚组分析结果一致。

conclusions/interpretation

Complex insulin regimens provide modest glycaemic benefits over basal insulin but are associated with greater weight gain and a suggested higher risk of hypoglycaemia.

复杂的胰岛素治疗方案在血糖控制上仅提供轻微的优势，相较于基础胰岛素治疗，但与更大的体重增加和可能更高的低血糖风险相关。

These results are based on evidence of moderate confidence.

这些结果基于中等信心水平的证据。

These trade-offs support the need for individualised regimen selection, informed by clinical context, patient preferences and treatment goals.

这些权衡支持了根据临床背景、患者偏好和治疗目标进行个体化方案选择的需要。

trial_registration

PROSPERO registration no.

PROSPERO 注册号

CRD42020181473.

CRD42020181473

funding

This research was supported by the Committee for the Development of Higher Education Personnel (CAPES) and the Hospital de Clínicas de Porto Alegre - FIPE HCPA.

本研究得到了高等教育人员发展委员会（CAPES）和波尔图阿雷格里临床医院 - FIPE HCPA的支持。