Park Chang-Hwan, Paik Woo Hyun, Park Eun Taek, Shim Chan Sup, Lee Tae Yoon, Kang Changdon, Noh Myung Hwan, Yi Sun Youn, Lee Jong Kyun, Hyun Jong Jin, Lee Jun Kyu
Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea.
Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13.
BACKGROUND AND STUDY AIMS : The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.
In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer's solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP).
395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % - 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % - 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % - 17.2 %; 15 /129; = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 - 0.76; = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 - 1.27; = 0.17).
Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.
背景与研究目的：本研究旨在确定最适合降低内镜逆行胰胆管造影术（ERCP）后胰腺炎发生率的静脉补液类型。
在一项前瞻性随机多中心试验中，将首次接受ERCP的中高风险患者随机分为三组（1:1:1），分别接受：用乳酸林格氏液（LRS）或生理盐水（NSS）进行积极静脉补液（ERCP期间3 mL/kg/h，ERCP后推注20 mL/kg并以3 mL/kg/h持续8小时），或用LRS进行标准静脉补液（ERCP期间及之后8小时均为1.5 mL/kg/h）。主要终点为ERCP后胰腺炎（PEP）。
共纳入395例患者，385例完成方案。三组在人口统计学特征上无显著差异。积极LRS组（3.0%，95%置信区间[CI] 0.1% - 5.9%；4/132）、积极NSS组（6.7%，95%CI 2.5% - 10.9%；9/134）和标准LRS组（11.6%，95%CI 6.1% - 17.2%；[15/129]；P = 0.03）的意向性分析（ITT）PEP发生率存在显著差异。在两组比较中，积极LRS组的ITT PEP发生率显著低于标准LRS组（相对风险[RR] 0.26，95%CI 0.08 - 0.76；P = 0.008）。积极NSS组与标准LRS组的ITT PEP发生率无显著差异（RR 0.57，95%CI 0.26 - 1.27；P = [0.17]）。
对于中高风险患者，用LRS进行积极补液是预防PEP的最佳静脉补液方法。
