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A randomised, double blind, multicentre trial of octreotide in moderate to severe acute pancreatitis

机译:奥曲肽对中度至重度急性胰腺炎的随机,双盲,多中心试验

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摘要

BACKGROUND—The pharmacological inhibition of exocrine pancreatic secretion with the somatostatin analogue octreotide has been advocated as a specific treatment of acute pancreatitis.
AIM—To investigate the efficacy of octreotide in acute pancreatitis in a randomised, placebo controlled trial.
METHODS—302 patients from 32 hospitals, fulfilling the criteria for moderate to severe acute pancreatitis within 96 hours of the onset of symptoms, were randomly assigned to one of three treatment groups: group P (n=103) received placebo, while groups O1 (n=98) and O2 (n=101) received 100 and 200 µg of octreotide, respectively, by subcutaneous injection three times daily for seven days. The primary outcome variable was a score composed of mortality and 15 typical complications of acute pancreatitis.
RESULTS—The three groups were well matched with respect to pretreatment characteristics. An intent to treat analysis of all 302 patients revealed no significant differences among treatment groups with respect to mortality (P: 16%; O1: 15%; O2: 12%), the rate of newly developed complications, the duration of pain, surgical interventions, or the length of the hospital stay. A valid for efficacy analysis (251 patients) also revealed no significant differences.
CONCLUSIONS—This trial shows no benefit of octreotide in the treatment of acute pancreatitis.


Keywords: acute pancreatitis; somatostatin; octreotide; randomised controlled multicentre trial
机译:背景—生长激素抑制素类似物奥曲肽抑制外分泌胰腺分泌的药理作用已被认为是急性胰腺炎的一种特殊治疗方法。目的—在一项随机,安慰剂对照试验中研究奥曲肽在急性胰腺炎中的疗效。方法—来自32所医院的302名在症状发作后96小时内符合中度至重度急性胰腺炎标准的患者被随机分配到三个治疗组之一:P组(n = 103)接受安慰剂,而O1组( n = 98)和O2(n = 101)每天皮下注射7次,分别接受100和200μg的奥曲肽。主要结果变量是由死亡率和急性胰腺炎的15种典型并发症组成的评分。结果:这三组在预处理特征方面非常匹配。对全部302名患者进行治疗的意图分析显示,各治疗组之间在死亡率,新发并发症的发生率,疼痛持续时间,手术方面无显着差异(P:16%; O1:15%; O2:12%)干预措施或住院时间。功效分析的有效对象(251位患者)也没有发现显着差异。结论—该试验显示奥曲肽在治疗急性胰腺炎中无益处。关键词:急性胰腺炎;生长抑素奥曲肽随机对照多中心试验

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