肌肉注射双氯芬酸预防内镜逆行胰胆管造影术后胰腺炎：一项随机试验。
Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial.
作者信息
Park Se Woo, Chung Moon Jae, Oh Tak Geun, Park Jeong Youp, Bang Seungmin, Park Seung Woo, Song Si Young
机构信息
Department of Internal Medicine, Institute of Gastroenterology, Hallym University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
出版信息
Endoscopy. 2015 Jan;47(1):33-9. doi: 10.1055/s-0034-1390743. Epub 2014 Nov 19.
BACKGROUND AND STUDY AIMS
Rectal nonsteroidal anti-inflammatory drugs have been shown to reduce the incidence of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of this study was to determine whether intramuscular diclofenac reduces the risk of PEP.
PATIENTS AND METHODS
Patients who underwent ERCP were randomized to receive either 90 mg of diclofenac or placebo by intramuscular injection immediately after the procedure. PEP was defined as elevated serum amylase levels (at least three times the upper limit of normal 24 hours after the procedure) associated with new or worsened upper abdominal, epigastric, or back pain.
RESULTS
In total, 380 patients were randomized, and 343 were eligible for analysis. The two groups were similar regarding clinical and demographic factors, as well as patient- and procedure-related risk factors for PEP. PEP developed in 20/170 patients (11.8 %) in the placebo group and in 22/173 patients (12.7 %) in the diclofenac group (P = 0.87). Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP (odds ratio 0.79; 95 % confidence interval 0.39 - 1.25; P = 0.51).
CONCLUSION
Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.Clinicaltrials.gov NCT01717599.
背景与研究目的
直肠非甾体抗炎药已被证明可降低内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的发生率。本研究的目的是确定肌肉注射双氯芬酸是否能降低PEP的风险。
患者与方法
接受ERCP的患者在术后立即被随机分为两组，分别接受90毫克双氯芬酸肌肉注射或安慰剂注射。PEP的定义为血清淀粉酶水平升高（术后24小时至少为正常上限的三倍），并伴有新发或加重的上腹部、上腹部或背部疼痛。
结果
总共380例患者被随机分组，343例符合分析条件。两组在临床和人口统计学因素以及PEP的患者和手术相关风险因素方面相似。安慰剂组170例患者中有20例（11.8%）发生PEP，双氯芬酸组173例患者中有22例（12.7%）发生PEP（P = 0.87）。多因素回归分析未能表明肌肉注射双氯芬酸可预防PEP（优势比0.79；95%置信区间0.39 - 1.25；P = 0.51）。
结论
预防性肌肉注射双氯芬酸对PEP没有有益的预防作用。Clinicaltrials.gov NCT01717599。
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