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用于急性食管静脉曲张出血的生长抑素类似物。

Somatostatin analogues for acute bleeding oesophageal varices.

作者信息

Gøtzsche P C

机构信息

The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, Denmark, 2100.

出版信息

Cochrane Database Syst Rev. 2002(1):CD000193. doi: 10.1002/14651858.CD000193.

Abstract

BACKGROUND

Somatostatin and its derivatives are often used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver. The placebo controlled trials have shown varying results, however, and their power has been quite low. An updated systematic review of a previously published meta-analysis was therefore performed.

OBJECTIVES

To study whether somatostatin or analogues improve survival or reduce the number of blood transfusions in patients with suspected or verified acute or recently bleeding oesophageal varices.

SEARCH STRATEGY

MEDLINE and The Cochrane Library were searched in August 2001. Reference lists of articles and authors.

SELECTION CRITERIA

All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute bleeding from oesophageal varices.

DATA COLLECTION AND ANALYSIS

The effect variables extracted were: mortality, number of blood transfusions, number with balloon tamponade, number with initial haemostasis and number with rebleeding. Intention to treat analyses were conducted; a random effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10).

MAIN RESULTS

The meta-analysis comprised 12 trials and 1452 patients. The active drugs did not reduce mortality significantly (relative risk 0.93, 95% confidence interval (CI) 0.75 to 1.14). The number of transfusions was less with drugs, the difference between experimental and control therapy was 1.0 units of blood products (95% CI 0.6 to 1.5). Number of patients failing initial haemostasis was also reduced (relative risk 0.68, 95% CI 0.50 to 0.92). There were no significant differences in use of balloon tamponade (relative risk 0.68, 95% CI 0.37 to 1.24), or in number of patients with rebleeding (relative risk 0.61, 95% CI 0.35 to 1.09). It should be noted, however, that the trials were heterogeneous with respect to the secondary outcomes.

REVIEWER'S CONCLUSIONS: The effect corresponded to one unit of blood saved per patient. It can be discussed whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled studies of somatostatin analogues in acute bleeding from oesophageal varices. On the other hand, the confidence interval for the effect on mortality was wide. Hence, a large placebo controlled trial is needed if one wishes to rule out the possibility that a worthwhile effect on mortality may have been overlooked.

摘要

背景

生长抑素及其衍生物常用于肝硬化患者食管静脉曲张破裂出血的紧急治疗。然而,安慰剂对照试验结果各异,且检验效能较低。因此,对之前发表的一项荟萃分析进行了更新的系统评价。

目的

研究生长抑素或其类似物能否提高疑似或确诊的急性或近期食管静脉曲张破裂出血患者的生存率或减少输血次数。

检索策略

2001年8月检索了MEDLINE和Cochrane图书馆。还检索了文章和作者的参考文献列表。

入选标准

所有比较生长抑素或其类似物与安慰剂或不治疗对疑似食管静脉曲张急性出血患者疗效的随机试验。

数据收集与分析

提取的效应变量为:死亡率、输血次数、气囊压迫止血的患者数、首次止血的患者数和再出血的患者数。进行意向性分析;如果各试验之间存在显著异质性(P<0.10),则优先采用随机效应分析。

主要结果

该荟萃分析纳入了12项试验和1452例患者。活性药物并未显著降低死亡率(相对危险度0.93,95%可信区间(CI)0.75至1.14)。药物治疗组的输血次数较少,试验组与对照组治疗的差异为1.0单位血制品(95%CI 0.6至1.5)。首次止血失败的患者数也减少了(相对危险度0.68,95%CI 0.50至0.92)。气囊压迫止血的使用情况(相对危险度0.68,95%CI 0.37至1.24)或再出血患者数(相对危险度0.61,95%CI 0.35至1.09)无显著差异。然而,应注意的是,各试验在次要结局方面存在异质性。

评价者结论

该效应相当于每位患者节省一个单位的血液。这种效果是否值得探讨。研究结果并不表明有必要对生长抑素类似物治疗食管静脉曲张急性出血进行进一步的安慰剂对照研究。另一方面,对死亡率影响的可信区间较宽。因此,如果想排除可能忽略了对死亡率有价值影响的可能性,则需要进行一项大型安慰剂对照试验。

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