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奥曲肽早期治疗对术后肠外瘘患者疗效的随机双盲安慰剂对照试验

Randomized double-blind placebo-controlled trial of early octreotide in patients with postoperative enterocutaneous fistula.

作者信息

Sancho J J, di Costanzo J, Nubiola P, Larrad A, Beguiristain A, Roqueta F, Franch G, Oliva A, Gubern J M, Sitges-Serra A

机构信息

Department of Surgery, Hospital Universitari del Mar, Universitat Autònoma de Barcelona, Spain.

出版信息

Br J Surg. 1995 May;82(5):638-41. doi: 10.1002/bjs.1800820521.

DOI:10.1002/bjs.1800820521
PMID:7613936
Abstract

Somatostatin and octreotide both enhance closure of gastrointestinal fistulas. The present trial was undertaken to test whether early combined treatment with parenteral nutrition and octreotide 100 micrograms every 8 h by subcutaneous injection had a beneficial effect compared with parenteral nutrition plus placebo. Thirty-one patients with post-operative gastrointestinal or pancreatic fistula were randomly assigned to receive parenteral nutrition plus octreotide (14 patients) or placebo (17) within 8 days of fistula onset. The percentage reduction in output and rate of spontaneous closure within 20 days were analysed. Mean(s.d.) reduction in output was similar after octreotide and placebo at 24 h (66(43) versus 68(47) per cent, P = 0.9), 48 h (60(46) versus 57(43) per cent, P = 0.8) and 72 h (62(50) versus 66(49) per cent, P = 0.9) after starting the combined treatment. Closure within 20 days was observed in eight of 14 fistulas in patients given octreotide and in six of 17 in those receiving placebo (P = 0.4). Administration of octreotide, within 8 days of fistula onset, associated with parenteral nutrition does not significantly increase the spontaneous fistula closure rate compared with parenteral nutrition plus placebo.

摘要

生长抑素和奥曲肽均可促进胃肠瘘闭合。本试验旨在检验在瘘管形成早期,与肠外营养加安慰剂相比,联合使用肠外营养和每8小时皮下注射100微克奥曲肽是否具有有益效果。31例术后胃肠或胰瘘患者在瘘管形成8天内被随机分配接受肠外营养加奥曲肽(14例患者)或安慰剂(17例)。分析了20天内瘘液排出量减少的百分比和自发闭合率。联合治疗开始后24小时、48小时和72小时,奥曲肽组和安慰剂组瘘液排出量的平均(标准差)减少相似(分别为66(43)%对68(47)%,P = 0.9;60(46)%对57(43)%,P = 0.8;62(50)%对66(49)%,P = 0.9)。接受奥曲肽治疗的患者中14例瘘管有8例在20天内闭合,接受安慰剂治疗的患者中17例瘘管有6例在20天内闭合(P = 0.4)。与肠外营养加安慰剂相比,瘘管形成8天内给予奥曲肽并联合肠外营养,并不会显著提高瘘管自发闭合率。

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