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肝硬化患者复发性出血预防的提示:随机临床试验的荟萃分析

TIPS for prevention of recurrent bleeding in patients with cirrhosis: meta-analysis of randomized clinical trials.

作者信息

Luca A, D'Amico G, La Galla R, Midiri M, Morabito A, Pagliaro L

机构信息

Department of Radiology, University of Palermo, Italy.

出版信息

Radiology. 1999 Aug;212(2):411-21. doi: 10.1148/radiology.212.2.r99au46411.

Abstract

PURPOSE

To compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) creation with those of endoscopic treatment with or without propranolol administration (i.e, conventional treatment) on recurrent bleeding, encephalopathy, and mortality by using meta-analysis of 11 published randomized clinical trials.

MATERIALS AND METHODS

Data from 11 relevant studies were retrieved by means of computerized and manual search. The combinability of the studies was assessed in terms of clinical and statistical criteria. Data were extracted on the basis of the intention-to-treat principle, and treatment effects were measured as risk differences between TIPS creation and conventional treatment. Pooled estimates were computed according to a random-effects model.

RESULTS

A total of 750 patients were included in 11 trials. No significant heterogeneity was found for any of the outcomes. Pooled risk differences were recurrent bleeding, -31% (95% CI, -39%, -23%); encephalopathy, +16% (95% CI, +10%, +22%); death due to all causes, +2% (95% CI, -4%, +9%); and death due to bleeding, -5% (95% CI, -11%, +6%). Clinically important complications occurred in 22% of patients and were associated with both treatments. TIPS dysfunction occurred in 55% of patients.

CONCLUSION

TIPS creation markedly reduces risk of rebleeding but increases risk of encephalopathy without affecting survival. Therefore, TIPS creation may not be the best first-choice therapy for prevention of recurrent variceal bleeding. Criteria for selection of candidates for TIPS creation should be assessed in future prospective studies.

摘要

目的

通过对11项已发表的随机临床试验进行荟萃分析,比较经颈静脉肝内门体分流术(TIPS)与内镜治疗联合或不联合普萘洛尔给药(即传统治疗)对复发性出血、肝性脑病和死亡率的影响。

材料与方法

通过计算机检索和手工检索获取11项相关研究的数据。根据临床和统计标准评估研究的可合并性。基于意向性治疗原则提取数据,并将治疗效果测量为TIPS与传统治疗之间的风险差异。根据随机效应模型计算合并估计值。

结果

11项试验共纳入750例患者。任何结局均未发现显著异质性。合并风险差异为:复发性出血,-31%(95%CI,-39%,-23%);肝性脑病,+16%(95%CI,+10%,+22%);全因死亡,+2%(95%CI,-4%,+9%);出血性死亡,-5%(95%CI,-11%,+6%)。22%的患者发生了具有临床意义的并发症,且与两种治疗方法均相关。55%的患者出现TIPS功能障碍。

结论

TIPS显著降低再出血风险,但增加肝性脑病风险,且不影响生存率。因此,TIPS可能不是预防静脉曲张再出血的最佳首选治疗方法。未来的前瞻性研究应评估TIPS治疗候选人的选择标准。

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