A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities.
A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities.
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DOI：
10.1016/j.pan.2020.09.023
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Enders FT
中科院分区：
文献类型：
--
作者：
Vege SS;Horibe M;Chari ST;Clemens MA;Loftus CG;Enders FT
尽管与急性胰腺炎(AP)相关的发病率和死亡率很高，但在过去的几十年里，美国只有一项小型随机对照药物试验(RCT)可用。因此，我们在AP中进行了单中心、双盲、安慰剂对照的己酮可可碱随机对照试验。共服用9剂己酮可可碱400 mg或安慰剂片剂，每天三次，在诊断后72小时内按药房随机分组给予。主要结果是包括以下任何一项的综合结果：死亡、胰周和/或胰腺坏死、感染性胰腺坏死、持续性器官衰竭、持续性全身性炎症反应综合征、住院时间超过4天、需要重症监护和需要对坏死进行干预。在2015年7月7日至2017年4月4日期间，我们确定了685名AP患者，233人符合资格标准，176人接受了研究。其中91人(51.7%)下降，最后比较己酮可可碱组的45人和安慰剂组的38人(总计83人)。两组患者的主要结局无显著差异(27例[60.0%]vs15例[39.5%]；P=0.06)。己酮可可碱组没有任何益处，但有更长的住院时间(42%比21%；P=0.04)和更高的再住院率(16%比3%；P=0.047)，我们不能证明己酮可可碱比安慰剂优越。较小的样本量和纳入所有类型的严重程度可能是缺乏疗效的原因。本研究中观察到的挑战表明，为了在AP中成功地进行药物试验，多中心合作是必不可少的。
Despite substantial morbidity and mortality associated with acute pancreatitis (AP), only one small randomized controlled drug trial (RCT) is available in the past few decades from the United States. Hence, we conducted a single-center, double-blind, placebo-controlled RCT of pentoxifylline in AP. A total of 9 doses of oral pentoxifylline 400 mg or placebo tablet, three times daily, was administered within 72 hours of diagnosis, using randomization blocks by pharmacy. Primary outcome was a composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis. Between July 7, 2015, and April 4, 2017, we identified 685 patients with AP, 233 met eligibility criteria and 176 were approached for the study. Of these, 91 (51.7%) declined and finally 45 in pentoxifylline group and 38 in placebo group (83 total) were compared. There were no significant differences in primary outcome (27[60.0%] vs 15[39.5%]; P=.06). Pentoxifylline group was not associated with any benefit, but withlonger stay (42 % vs. 21%; P=.04) and higher readmission rates (16 %vs 3%; P=.047) We could not demonstrate superiority of pentoxifylline over placebo. Smaller sample size and inclusion of all types of severity might be the reasons for lack of efficacy. The challenges observed in the present study indicate that, in order to conduct a successful drug trial in AP, a multi center collaboration is essential.
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影响因子：
2.9
作者：
Abu-El-Haija M;Gukovskaya AS;Andersen DK;Gardner TB;Hegyi P;Pandol SJ;Papachristou GI;Saluja AK;Singh VK;Uc A;Wu BU
通讯作者：
Wu BU
影响因子：
3
作者：
GREWAL, HP;ELDIN, AM;GABER, AO
通讯作者：
GABER, AO
DOI：
10.1038/s41395-018-0048-1
发表时间：
2018-05
期刊：
The American journal of gastroenterology
影响因子：
--
作者：
Buxbaum J;Quezada M;Chong B;Gupta N;Yu CY;Lane C;Da B;Leung K;Shulman I;Pandol S;Wu B
通讯作者：
Wu B
影响因子：
29.4
作者：
Akriviadis, E;Botla, R;Shakil, O
通讯作者：
Shakil, O
影响因子：
3.8
作者：
Norman, JG;Fink, GW;Franz, MG
通讯作者：
Franz, MG