Uchino Rie, Isayama Hiroyuki, Tsujino Takeshi, Sasahira Naoki, Ito Yukiko, Matsubara Saburo, Takahara Naminatsu, Arizumi Toshihiko, Toda Nobuo, Mohri Dai, Togawa Osamu, Yagioka Hiroshi, Yanagihara Yoshitsugu, Nakajima Katsuyoshi, Akiyama Dai, Hamada Tsuyoshi, Miyabayashi Koji, Mizuno Suguru, Kawakubo Kazumichi, Kogure Hirofumi, Sasaki Takashi, Yamamoto Natsuyo, Nakai Yousuke, Hirano Kenji, Tada Minoru, Koike Kazuhiko
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
Gastrointest Endosc. 2013 Dec;78(6):842-850. doi: 10.1016/j.gie.2013.06.028. Epub 2013 Jul 30.
Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone.
The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP.
A multicenter, randomized, placebo-controlled, double-blind clinical trial.
Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan.
Patients undergoing therapeutic or interventional-diagnostic ERCP.
The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP.
The primary endpoint was the incidence of PEP. Secondary endpoints were the incidence of hyperenzymemia and enzyme levels (amylase, pancreatic amylase, lipase). Risk factors for PEP were evaluated.
We initially enrolled 500 patients in the study (250 in the risperidone group and 250 in the placebo group), but 17 (11 in the risperidone and 6 in the placebo group) were excluded after randomization. PEP developed in 24 patients (10.0%) in the risperidone group and 21 patients (8.6%) in the placebo group (P = .587). Serum amylase levels at 3 hours after ERCP were lower in the risperidone group (P = .007 in a single test of hypothesis, significance removed by Bonferroni correction for multiple testing). In multivariate analysis, a small papilla of Vater, total procedure time ≥40 minutes, and stenosis of the intrahepatic duct were significantly associated with PEP.
Multiplicity of study centers and a relatively wide time range of drug administration time.
Risperidone did not show a benefit in prevention of PEP in this trial. (
NCT000004592.).
我们之前的研究表明，与单独使用乌司他丁相比，乌司他丁与利培酮联合使用可降低内镜逆行胰胆管造影术后胰腺炎（PEP）的发生率。
本研究旨在评估单独使用利培酮预防PEP的疗效。
一项多中心、随机、安慰剂对照、双盲临床试验。
日本东京和埼玉县的两家学术医院和五家转诊医院。
接受治疗性或介入诊断性内镜逆行胰胆管造影术的患者。
患者在ERCP前0.5至2小时随机接受2mg口服利培酮或口服安慰剂。
主要终点是PEP的发生率。次要终点是高酶血症的发生率和酶水平（淀粉酶、胰淀粉酶、脂肪酶）。评估PEP的危险因素。
我们最初招募了500名患者参与研究（利培酮组250名，安慰剂组250名），但随机分组后有17名患者（利培酮组11名，安慰剂组6名）被排除。利培酮组有24名患者（10.0%）发生PEP，安慰剂组有21名患者（8.6%）发生PEP（P = 0.587）。ERCP后3小时利培酮组血清淀粉酶水平较低（在单假设检验中P = 0.007，经Bonferroni多重检验校正后显著性消失）。多变量分析显示， Vater乳头较小、总操作时间≥40分钟和肝内胆管狭窄与PEP显著相关。
研究中心的多样性以及药物给药时间范围相对较宽。
在本试验中，利培酮在预防PEP方面未显示出益处。（临床试验注册号：NCT000004592。）
