证据证据1:Garcia-Pagan JC, Caca K,Bureau C,et al. Early use of TIPS in patients with cirrhosis and variceal bleeding[J].N Engl J Med2010, 362(25):2370-2379.DOI:10.1056/NEJMoa0910102Child-PughC级或B级肝硬化在内镜下持续出血风险的很高患者,面临内镜治疗失败和预后不良,即使(后期)他们已经接受了经颈静脉肝内门体分流术(TIPS)的抢救性治疗。 本研究评价了TIPS在此类患者中的早期应用。 欧洲9个中心参与了这项随机对照研究 分组方案
296 Were excluded 排除病例
18 拒绝参加
(Declined to participate)
72 Child-Pugh A级
( Were in Child-Pugh Class A)
40 Child-PughB级,但在内镜下没有活动性出血
(Were in Child-Pugh Class B, but did not have active bleeding at endoscopy )
18 Child-Pugh评分>13分
(Had Child-Pugh score >13 points )
22 有孤立性胃静脉曲张
(Had isolated gastric variceal [værɪ'si:əl] bleeding )
18 有以前的TIPS或药物EBL
(Had previous TIPS or drugs+EBL) 17 超过75岁 (Were older than 75 yr)
34 有肝癌
(Had hepatocellular carcinoma)
20 有门静脉血栓
(Had portalvein thrombosis)
9 有肾衰
(Had renal failure)
6 有肝前门静脉高压
(Had prehepatic portal hypertension) 22 其他原因 (Had other reasons)
急性静脉曲张出血高危患者,出血后72h 内行覆膜支架TIPS,与采用药物联合内镜治疗相比,再出血率显著减低,近期或远期生存率明显提高,肝性脑病发生率没有增加。 治疗失败/在出血:During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy–EBL group as compared with 1 patient in the early-TIPS group (P=0.001) 一年出血控制:The 1-year actuarial [ˌæktʃʊ'eərɪəl] probability(精算概率) of remaining free of this composite end point was 50% in the pharmacotherapy–EBL group versus 97% in the early-TIPS group (P<0.001). 死亡病例 Sixteen patients died (12 in the pharmacotherapy–EBL group and 4 in the early-TIPS group, P=0.01) 一年生存率 The 1-year actuarial survival was 61% in the pharmacotherapy–EBL group versus 86% in the early-TIPS group (P<0.001) 挽救性TIPS结果 Seven patients in the pharmacotherapy–EBL group received TIPS as rescue therapy, but four died ICU住院天数:The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy–EBL group than in the early-TIPS group 副作用比较:No significant differences were observed between the two treatment groups with respect to serious adverse events. 证据2:Garcia-Pagan JC,Di Pascoli M, Caca K,et al. Use ofearly-TIPS for high-risk variceal bleeding: results of a post-RCT surveillance study[J]. JHepatol,2013,58(1):45-50.DOI:10.1016J.jhep.2012.08.020.
2013年即发表首个earlyTIPS研究3年后,GarciaPagan JC 在J Hepatol发表的一个回顾性的对照试验,提示对于early-TIPS的回顾性对照研究和3年前的RCT研究观察的结果一致;
文章回顾性研究因急性静脉曲张出血和治疗失败高风险(儿童Child C<14 或 Child B合并活动性出血)、早期TIPS(n=45)或药物内镜治疗(ET)(n=30)而入院的患者。 早期TIPS治疗的患者不能控制出血或再出血的发生率远低于接受内镜+药物治疗的患者 (3 vs. 15; p <0.001)。 在这一综合终点保持不变的1年精算概率为93% vs 53%(p <0.001)。 死亡率也是如此 ( 1年精算生存率分别为 86% 和 70%;p=0.056)。 不能控制出血再出血和存活的精算曲线在RCT中观察到的置信区间内。
FLG2。 急性静脉曲张出血高危患者,出血后72h 内行覆膜支架TIPS,与采用药物联合内镜治疗相比,再出血率显著减低,近期或远期生存率明显提高,肝性脑病发生率没有增加
|
Early TIPS (<72小时) | Late TIPS (3-28天) | |
Re-bleeding rate | 7.7% | 64。2% |
median survival (month) | 70.5 | 13.8 |