利用真实世界数据评估基于肠促胰岛素的治疗与急性胰腺炎风险的关联:来自观察性研究的 1,324,515 例患者的荟萃分析。

Using real-world data to evaluate the association of incretin-based therapies with risk of acute pancreatitis: a meta-analysis of 1,324,515 patients from observational studies.

机构信息

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China; Department of Pharmacy, Peking University Third Hospital, Beijing, China.

出版信息

Diabetes Obes Metab. 2015 Jan;17(1):32-41. doi: 10.1111/dom.12386. Epub 2014 Oct 6.

Abstract

AIM

To investigate the real-world incidence of acute pancreatitis (AP) associated with incretin-based therapy (IBT).

METHODS

We carried out a systematic review and meta-analysis of observational studies using Medline, PubMed, Embase, the Cochrane Database, ClinicalTrials.gov and conference proceedings. We included: those studies in which AP was a pre-defined clinical outcome; longitudinal studies (case-control, cohort); studies that adjusted for confounders; studies that reported on a population exposed to IBT; studies in which non-IBT users or past users (who received IBTs >90 days before the index date) were used as the control group; studies that reported risk estimates [relative risks, odds ratios (ORs) or hazard ratios] with 95% confidence intervals (CIs) for AP event with IBT use, or that reported sufficient data to estimate these; and publications in the English language. Data were extracted by two independent investigators, and a consensus was reached with involvement of a third. Study-specific ORs from seven cohort studies and two case-control studies were meta-analysed using random-effects models. Associations were tested in subgroups representing different patient characteristics and study quality.

RESULTS

A total of nine studies that included 1,324,515 patients and 5195 cases of AP were included in our meta-analysis. The summary estimate of OR for an association between IBT and AP was 1.03 (95% CI 0.87-1.20).

CONCLUSIONS

The present meta-analysis of real-world data does not suggest that IBT is associated with AP. Although we should continue to remain vigilant, IBTs should be regarded as reasonable options to consider adding to the regimen of a patient with type 2 diabetes.

摘要

目的

调查基于肠促胰岛素治疗(IBT)的急性胰腺炎(AP)的真实世界发病率。

方法

我们使用 Medline、PubMed、Embase、Cochrane 数据库、ClinicalTrials.gov 和会议记录进行了系统评价和观察性研究的荟萃分析。我们纳入了:AP 是预先定义的临床结局的研究;纵向研究(病例对照、队列研究);调整混杂因素的研究;报告接受 IBT 治疗人群的研究;将非 IBT 使用者或过去使用者(在索引日期前 90 天以上接受 IBT 治疗)作为对照组的研究;报告 IBT 使用与 AP 事件相关的风险估计值[相对风险、比值比(OR)或风险比]及其 95%置信区间(CI)的研究,或报告了足以估计这些数据的研究;以及英文出版物。两名独立研究者提取数据,如有需要,第三名研究者参与达成共识。使用随机效应模型对来自 7 项队列研究和 2 项病例对照研究的研究特异性 OR 进行荟萃分析。根据不同的患者特征和研究质量,对亚组进行了关联测试。

结果

共纳入了 9 项研究,包括 1324515 名患者和 5195 例 AP 病例。IBT 与 AP 之间关联的汇总估计 OR 为 1.03(95%CI 0.87-1.20)。

结论

本真实世界数据的荟萃分析并未表明 IBT 与 AP 相关。尽管我们应继续保持警惕,但应将 IBT 视为考虑添加到 2 型糖尿病患者治疗方案中的合理选择。

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