Gøtzsche Peter C, Hróbjartsson Asbjørn
Nordic Cochrane Centre, Rigshospitalet, Dept. 3343, Blegdamsvej 9, Copenhagen Ø, Denmark, 2100.
Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD000193. doi: 10.1002/14651858.CD000193.pub3.
Somatostatin and its derivatives are sometimes used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver.
To study whether somatostatin or its analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices.
PubMed and The Cochrane Library were searched (November 2007). Reference lists of publications, contacts with authors.
All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices.
The outcome measures extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted if possible; a random-effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two groups: trials with a low risk of bias, which had concealed allocation of patients and were double-blind, and other trials.
We included 21 trials (2588 patients). The drugs did not reduce mortality significantly (relative risk 0.97, 95% confidence interval (CI) 0.75 to 1.25, for the trials with a low risk of bias, and 0.80, 95% CI 0.63 to 1.01, for the other trials). Units of blood transfused were 0.7 (0.2 to 1.1) less with drugs in the trials with a low risk of bias and 1.5 (0.9 to 2.0) less in the other trials. Number of patients failing initial haemostasis was reduced, relative risk 0.68 (0.54 to 0.87). Number of patients with rebleeding was not significantly reduced for the trials with a low risk of bias, relative risk 0.84 (0.52 to 1.37) while it was substantially reduced in the other trials, relative risk 0.36 (0.19 to 0.68). Use of balloon tamponade was rarely reported.
AUTHORS' CONCLUSIONS: The need for blood transfusions corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled trials of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality might have been overlooked.
生长抑素及其衍生物有时用于肝硬化患者食管静脉曲张破裂出血的紧急治疗。
研究生长抑素或其类似物是否能提高食管静脉曲张破裂出血患者的生存率或减少输血需求。
检索了PubMed和Cochrane图书馆(2007年11月)。查阅了出版物的参考文献列表,并与作者进行了联系。
所有比较生长抑素或其类似物与安慰剂或未治疗的随机试验,试验对象为疑似食管静脉曲张急性或近期出血的患者。
提取的结局指标为:死亡率、输血量、气囊压迫的使用、初始止血和再出血情况。尽可能对所有随机分组的患者进行意向性分析;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。试验分为两组:偏倚风险低的试验,即采用了患者分配隐藏且为双盲的试验,以及其他试验。
我们纳入了21项试验(2588例患者)。对于偏倚风险低的试验,药物并未显著降低死亡率(相对危险度0.97,95%置信区间(CI)为0.75至1.25);对于其他试验,相对危险度为0.80,95%CI为0.63至1.01。在偏倚风险低的试验中,使用药物后输血量减少了0.7单位(0.2至1.1);在其他试验中,减少了1.5单位(0.9至2.0)。初始止血失败的患者数量减少,相对危险度为0.68(0.54至0.87)。对于偏倚风险低的试验,再出血患者数量未显著减少,相对危险度为0.84(0.52至1.37);而在其他试验中,再出血患者数量大幅减少,相对危险度为0.36(0.19至0.68)。气囊压迫的使用情况很少有报告。
输血需求相当于每位患者节省了半单位血液。这种效果是否值得怀疑。研究结果并不表明需要进行本文所综述类型的进一步安慰剂对照试验。如果想排除可能忽略了对死亡率有价值的影响的可能性,则需要开展一项纳入数千名患者的大型安慰剂对照试验。