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首页> 外文期刊>Endoscopy International Open >Intravenous injection of low-dose flurbiprofen axetil for preventing post-ERCP pancreatitis in high-risk patients: An interim analysis of the trial
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Intravenous injection of low-dose flurbiprofen axetil for preventing post-ERCP pancreatitis in high-risk patients: An interim analysis of the trial

机译：静脉注射低剂量氟氯芬Axetil，用于预防高危患者的ERCP后胰腺炎：试验的临时分析

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Background and study aims: Several meta-analyses and randomized control trials have demonstrated the efficacy of rectal nonsteroidal anti-inflammatory drugs for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Diclofenac or indomethacin was administered at a dose of 100?mg in those studies, which may be too high for Asian population. In addition, rectal administration can be considered complicated. Patients and methods: This study was a prospective, randomized, placebo-controlled trial. Patients with a PEP risk score ≥?1 were randomly assigned to receive intravenous injection of 50?mg flurbiprofen axetil (flurbiprofen group) or saline only (placebo group). The primary outcome was reduced PEP. The secondary outcome was amylase level after 2 hours of ERCP as a predictor of PEP. (Clinical Trials.gov, ID UMIN000011322) Results: In total, 144 patients were enrolled from August 2013 to March 2015. We performed an interim analysis of the first 100 patients: 47 received flurbiprofen axetil and 53 received placebo. PEP occurred in 11 patients (11?%): 2 of 47 (4.3?%) in the flurbiprofen group and 9 of 53 (17?%) in the placebo group (P?=?0.042). Relative risk reduction was 62.4?%. Hyperamylasemia did not differ significantly (17.0?% vs. 26.4?%, P?=?0.109). This analysis resulted in early termination of the study for ethical reasons. Conclusions: Intravenous injection of low-dose flurbiprofen axetil after ERCP can reduce the incidence of PEP in high-risk patients
机译：背景和研究旨在：几种荟萃分析和随机对照试验表明了直肠非甾体抗炎药，用于预防内窥镜后逆行胆管炎（ERCP）胰腺炎（PEP）的疗效。在这些研究中以100μmg的剂量给药双氯芬酸或吲哚美辛，这对于亚洲人口可能过高。此外，直肠给药可以被认为是复杂的。患者和方法：本研究是一项前瞻性，随机，安慰剂对照试验。 PEP风险评分≥1的患者被随机分配给接受静脉注射50〜Mg Flurbrofen Axetil（Flbiprofen组）或仅（安慰剂组）。主要结果减少了PEP。次级结果是2小时的ERCP作为PEP的预测因子后的淀粉酶水平。 （临床试验.GOV，ID UMIN0011322）结果：总共有144名患者于2013年8月至2015年3月招募。我们对前100名患者进行了临时分析：47次接受的Flbiprofen Axetil和53次接受的安慰剂。 PEP发生在11名患者（11？％）：氟氯芬组中的47个（4.3〜％），安慰剂组中的9个（4.3？％），共53例（17℃）（p？= 0.042）。相对风险降低为62.4％。高亚亚血症并没有显着差异（17.0？％与26.4？％，p？= 0.109）。这种分析导致了研究的早期终止，因为道德原因。结论：ERCP后，静脉注射低剂量氟氯芬Axetil可以降低高风险患者PEP的发病率

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