他汀类药物的长期使用与 ERCP 术后急性胰腺炎的风险（STARK）：一项国际多中心前瞻性队列研究的研究方案。

Chronic use of statins and risk of post-ERCP acute pancreatitis (STARK): Study protocol for an international multicenter prospective cohort study.

机构信息

Abdominal Center and University of Helsinki, Department of Surgery, Helsinki University Hospital, Helsinki, Finland.

Gastroenterology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL-FISABIO Foundation), Alicante, Spain.

出版信息

Dig Liver Dis. 2018 Dec;50(12):1362-1365. doi: 10.1016/j.dld.2018.07.042. Epub 2018 Aug 20.

DOI:10.1016/j.dld.2018.07.042

PMID:30224317

Abstract

BACKGROUND

Acute pancreatitis (AP) is the most common complication after endoscopic retrograde cholangiopancreatography (ERCP). Statins have been traditionally associated to an increased risk of AP, however, recent evidence suggests that statins may have a protective role against this disease.

AIMS

Our primary aim is to investigate whether the use of statins has a protective effect against post-ERCP pancreatitis (PEP). Secondary outcomes are: to evaluate the effect of other drugs on the incidence of PEP; to ascertain the relationship between the use of statins and the severity of PEP; and to evaluate the effect of other risk and protective factors on the incidence of PEP.

METHODS

STARK is an international multicenter prospective cohort study. Centers from Spain, Italy, Croatia, Finland and Sweden joined this study. The total sample size will include about 1016 patients, which was based on assuming a 5% incidence of PEP among non-statin (NSt) users, a 1-3 ratio of statin (St) and NSt consumers respectively, a 70% decrease in PEP among St consumers, an alpha-error of 0.05 and beta-error of 0.20. All patients aged ≥18 years scheduled for ERCP will be offered to enter the study.

DISCUSSION

STARK study will ascertain whether statins, a safe, widely used and inexpensive drug, can modify the incidence of PEP.

摘要

背景

急性胰腺炎（AP）是内镜逆行胰胆管造影术（ERCP）后最常见的并发症。他汀类药物传统上与 AP 风险增加相关，但最近的证据表明他汀类药物可能对这种疾病具有保护作用。

目的

我们的主要目的是研究他汀类药物的使用是否对 ERCP 后胰腺炎（PEP）有保护作用。次要结果是：评估其他药物对 PEP 发生率的影响；确定他汀类药物的使用与 PEP 严重程度之间的关系；评估其他风险和保护因素对 PEP 发生率的影响。

方法

STARK 是一项国际多中心前瞻性队列研究。来自西班牙、意大利、克罗地亚、芬兰和瑞典的中心加入了这项研究。总样本量将包括约 1016 名患者，这是基于假设非他汀类药物（NSt）使用者中 PEP 的发生率为 5%，他汀类药物（St）和 NSt 使用者的比例分别为 1-3，St 使用者中 PEP 的发生率降低 70%，α错误为 0.05，β错误为 0.20。所有年龄≥18 岁的计划接受 ERCP 的患者都将被邀请参加该研究。