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Double-blind, placebo-controlled, randomized trial of octreotide in malignant bowel obstruction.

Abstract：

CONTEXT:Does octreotide reduce vomiting in cancer-associated bowel obstruction? OBJECTIVES:To evaluate the net effect of adding octreotide or placebo to standardized therapies on the number of days free of vomiting for populations presenting with vomiting and inoperable bowel obstruction secondary to cancer or its treatment. METHODS:Twelve services enrolled people with advanced cancer presenting with vomiting secondary to bowel obstruction where surgery or anti-cancer therapies were not indicated immediately. In a double-blind study, participants were randomized to placebo or octreotide (600 μg/24 hours by infusion). Both arms received standardized supportive therapy (infusion of ranitidine [200 mg/24 hours], dexamethasone [8 mg/24 hours], and parenteral hydration [10-20 mL/kg/24 hours]). The primary outcome was patient-reported days free of vomiting at 72 hours. RESULTS:In a study that recruited to the numbers identified in its power calculation, 87 participants provided data at 72 hours (45, octreotide arm). Seventeen people (octreotide) and 14 (placebo) were free of vomiting for 72 hours (P = 0.67). Mean days free of vomiting were 1.87 (SD 1.10; octreotide) and 1.69 (SD 1.15; placebo; P = 0.47). An adjusted multivariate regression of the incidence of vomiting over the study showed a reduced number of episodes of vomiting in the octreotide group (incidence rate ratio = 0.40; 95% CI: 0.19-0.86; P = 0.019); however, people in the octreotide arm were 2.02 times more likely to be administered hyoscine butylbromide (P = 0.004), potentially reflecting increased colicky pain. CONCLUSION:Although there was no reduction in the number of days free of vomiting, the multivariate analysis suggests that further study of somatostatin analogues in this setting is warranted.

journal_name

J Pain Symptom Manage

journal_title

Journal of pain and symptom management

authors

Currow DC,Quinn S,Agar M,Fazekas B,Hardy J,McCaffrey N,Eckermann S,Abernethy AP,Clark K

doi

10.1016/j.jpainsymman.2014.09.013

subject

Has Abstract

pub_date

2015-05-01 00:00:00

pages

814-21

issue

eissn

0885-3924

issn

1873-6513

pii

S0885-3924(14)00559-4

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Double-blind, placebo-controlled, randomized trial of octreotide in malignant bowel obstruction.