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奥曲肽治疗急性非静脉曲张性上消化道出血的疗效:一项随机、双盲、安慰剂对照试验

The Effect of Octreotide in Acute Nonvariceal Upper Gastrointestinal Bleeding: A Randomized, Double-Blind, Placebo-Controlled Trial.

作者信息

Abrishami Masoud, Peymani Payam, Zare Marziyeh, Lankarani Kamran B

机构信息

Health Policy Research Center, Institute of Heath, Shiraz University of Medical Sciences, Shiraz, Iran.

Department of Clinical Pharmacology and Toxicology, University Hospital Zurich-University of Zurich, Switzerland.

出版信息

J Res Pharm Pract. 2020 Jun 26;9(2):94-100. doi: 10.4103/jrpp.JRPP_19_57. eCollection 2020 Apr-Jun.

Abstract

OBJECTIVE

Nonvariceal upper gastrointestinal bleeding (NUGIB) is a common cause of hospitalization and is associated with considerable mortality and morbidity. Octreotide has been shown to be an effective treatment in the control of variceal UGIB. Theoretically, octreotide could be effective in the treatment of other types of bleeding ulcers.

METHODS

This randomized, double-blind, placebo-controlled trial was carried out on patients with NVUGIB who had been admitted to two referral centers in Shiraz, Iran. Patients were randomized to two groups: Group A ( = 58) received octreotide and Group B ( = 58) received a placebo. Patients in both groups received pantoprazole 40 mg as an initial dose, then 40 mg every 12 h intravenously. In addition to the pantoprazole, patients in Group A received 100 μg octreotide subcutaneously every 8 h for 72 h or until they were discharged. Patients in Group B received pantoprazole and a placebo at the same dose schedule.

FINDINGS

There were no statistically significant differences between Groups A and B in terms of mortality (0 vs. 5.17%; = 0.21,) rebleeding rate (5.17% vs. 1.72%; = 0.5), blood transfusion requirement (1.65 ± 0.47 units vs. 1.70 ± 0.45 units; = 0.45), length of hospital stay (1.96 ± 1.00 days vs. 1.65 ± 0.84 days; = 0.44), and need for surgery (1.72% vs. 1.72%; = 0.7).

CONCLUSION

The results showed that use of subcutaneous octreotide as an adjuvant treatment did not have a beneficial effect on the treatment of NVUGIB.

摘要

目的

非静脉曲张性上消化道出血(NUGIB)是住院的常见原因,且与相当高的死亡率和发病率相关。奥曲肽已被证明是控制静脉曲张性上消化道出血(UGIB)的有效治疗方法。从理论上讲,奥曲肽可能对其他类型的出血性溃疡有效。

方法

这项随机、双盲、安慰剂对照试验在伊朗设拉子的两个转诊中心收治的NUGIB患者中进行。患者被随机分为两组:A组(n = 58)接受奥曲肽治疗,B组(n = 58)接受安慰剂治疗。两组患者均以40毫克泮托拉唑作为初始剂量,然后每12小时静脉注射40毫克。除泮托拉唑外,A组患者每8小时皮下注射100微克奥曲肽,持续72小时或直至出院。B组患者按相同剂量方案接受泮托拉唑和安慰剂治疗。

结果

A组和B组在死亡率(0%对5.17%;P = 0.21)、再出血率(5.17%对1.72%;P = 0.5)、输血需求(1.65±0.47单位对1.70±0.45单位;P = 0.45)、住院时间(1.96±1.00天对1.65±0.84天;P = 0.44)以及手术需求(1.72%对1.72%;P = 0.7)方面均无统计学显著差异。

结论

结果表明,皮下注射奥曲肽作为辅助治疗对NUGIB的治疗没有有益效果。

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