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TIPS适应症:腹水

时间:2021-09-09 22:16来源:www.ynjr.net 作者:杨宁介入医学网
Ascites is the most common complication of PH in cirrhosis, with approximately 60% of compensated cirrhosis patients developing the condition within ten years of diagnosis[74]. 腹水是肝硬化中PH最常见的并发症,约60%的代偿性肝硬化患者在诊断
Ascites is the most common complication of PH in cirrhosis, with approximately 60% of compensated cirrhosis patients developing the condition within ten years of diagnosis[74].
腹水是肝硬化中PH最常见的并发症,约60%的代偿性肝硬化患者在诊断为[74]后10年内出现这种情况。
 
The 5-year survival is approximately 30% in patients with decompensated cirrhosis and ascites[75].
失代偿性肝硬化和腹水[75]患者的5年生存率约为30%。
 
Moreover, ascites is a direct cause of further complications, such as spontaneous bacterial peritonitis, hyponatremia, and HRS.
此外,腹水是导致进一步并发症的直接原因,如自发性细菌性腹膜炎、低钠血症和HRS。
 
For patients developing grade 3 ascites, large-volume paracentesis (LVP) with intravenous albumin (8 g for every L of fluid removed above 5 L) supplementation is the treatment of choice[76].
对于出现3级腹水的患者,静脉注射白蛋白(LVP)(5L以上液体8g)是[76]的治疗选择。
 
However, despite optimal medical therapy, 5%-10% of these patients develop RA, which is associated with an extremely poor prognosis and median survival of 6 mo[74,76,77].
然而,尽管进行了最佳的药物治疗,其中5%-10%的患者发展为RA,这与预后极差,中位生存期为6个月的[74,76,77]相关。
 
Liver transplantation, the only definitive treatment of RA, is limited by donor resources and high costs in developing countries.
肝移植是RA的唯一最终治疗方法,受到发展中国家供者资源和高成本的限制。
 
 Repeated LVP with albumin infusion is currently recommended as the first-line therapy for RA[76].
目前推荐重复LVP输注白蛋白作为RA[76]的一线治疗方法。
 
 Current guidelines recommend consideration of TIPS placement if more than three sessions of LVP have to be performed per month for symptomatic relief or procedure intolerance[78].
目前的指南建议,如果每月因症状缓解或腹水引流不耐受[78]而必须进行超过三次疗程的LVP,则考虑TIPS放置。


Although the efficacy of TIPS in controlling ascites has been well validated by several RCT's (between 1996-2004) and subsequent meta-analysis (2005-2006), the increased incidence of HE and controversial results on survival benefit resulted in LVP to be continually recommended as the first-line therapy for RA, ahead of TIPS[79-86].
尽管TIPS控制腹水的有效性已被一些随机对照试验(1996-2004年)和随后的荟萃分析(2005-2006年)很好地验证,但HE发病率的增加和有争议的生存获益结果导致LVP不断被推荐为RA的一线治疗方法,领先于TIPS[79-86]。
 
However, these RCTs were primarily evaluating the efficacy of ascites control rather than survival.
然而,这些随机对照试验主要是评估腹水控制的疗效,而不是生存。
 
Moreover, the early meta-analysis did not analyze survival as a time-dependent variable, and the confounding effect of liver transplantation on survival in patients with advanced cirrhosis was not considered[84-86].
此外,早期的meta分析并没有将生存率作为时间因变量进行分析,也不考虑肝移植对晚期肝硬化患者生存率的混杂影响[84-86]。
 
A meta-analysis conducted later using individual patient data of these RCTs confirmed that TIPS significantly improved TFS and reduced the recurrence of tense ascites[87].
随后使用这些RCT的个体患者数据进行的meta分析证实,TIPS显著改善了TFS,减少了紧张性腹水[87]的复发。
 
 Another RCT conducted later employed even stricter inclusion criteria (Child-Pugh score of < 11, serum bilirubin < 3 mg/dL, and creatinine < 1.9 mg/dL) and found that TIPS was significantly superior to paracentesis in the control of ascites in cirrhotic patients with RA with response rates of up to 60% at one year[88].
另一项随机对照试验后来采用了更严格的纳入标准(Chill-Pugh评分<11,血清胆红素<3mg/dL和肌酐<1.9mg/dL),发现TIPS在肝硬化RA患者腹水控制方面明显优于穿刺,1年[88]的应答率高达60%。
 
 More importantly, survival was significantly higher in the TIPS group attesting to the fact that careful patient selection is a pre-requisite for better outcomes after TIPS in patients with RA.
更重要的是,TIPS组的生存率显著更高,这证明了这样一个事实,即仔细选择患者是RA患者TIPS后更好预后的先决条件。
 
This finding was confirmed in a recent updated meta-analysis[89].
这一发现在最近更新的荟萃分析[89]中得到了证实。
 
However, the probability of post-treatment HE was increased by TIPS in all the studies with a significantly higher average number of episodes per patient.
然而,在所有的研究中,TIPS都增加了治疗后HE的概率,每个患者的平均发作次数明显更高。
 
Nevertheless, all these RCTs have used bare-metal stents for TIPS, and there was a high incidence of shunt dysfunction requiring stent revision.
然而,所有这些随机对照试验都使用裸金属支架进行TIPS,并且需要支架修正的分流功能障碍的发生率很高。
 
Thus, the conclusions drawn cannot be applied to the current clinical scenario where covered stents for TIPS are the norm.
因此,得出的结论不能用于目前的临床场景,其中覆盖支架是规范。

Multiple retrospective studies since then have reported survival benefit after covered TIPS in this clinical setting[90,91].
自那以后,多项回顾性研究报道了在[90,91]临床环境中覆盖TIPS后的生存获益。
 
Interestingly, the most recent RCT comparing TIPS (using covered stents) with LVP in patients with ascites found that covered TIPS improved survival and did not increase the risk of HE[92].
有趣的是,最近比较TIPS(使用覆盖支架)和LVP的RCT发现,覆盖TIPS提高了生存率,并没有增加HE[92]的风险。
 
Another retrospective study conducted later, which included patients with RA similarly showed that the risk of de-novo HE was not increased in the TIPS group[93].
随后进行的另一项回顾性研究,包括RA患者,同样表明,TIPS[93]组发生新生HE的风险没有增加。
 
Notably, this study employed smaller 8 mm diameter TIPS stents and found that while ascites control was similarly effective between TIPS responders and non-responders (as defined by a decrease in portal pressure to < 12 mmHg after TIPS implantation), HE occurred more often in patients with hemodynamic TIPS response, implying that a less aggressive PSPG reduction might be sufficiently effective for ascites control, while concomitantly decreasing the risk of post-TIPS HE.
值得注意的是,本研究采用了直径8mm的TIPS支架,发现虽然腹水控制在TIPS应答者和无反应者之间同样有效(定义为TIPS植入后门脉压降低至12mmmg),但在血流动力学TIPS反应患者中更常见,这意味着较低的PSPG降低可能对腹水控制足够有效,同时降低TIPS后HE的风险。
 
However, a randomized study comparing 8 mm vs 10 mm covered TIPS for RA had to be stopped midway after early results revealed worse ascites control with 8 mm stents[94].
然而,一项比较8mm和10mm覆盖的TIPS的随机研究不得不中途停止,因为早期结果显示8mm支架[94]的腹水控制更差。
 
Another recent retrospective study reported higher post-TIPS PSPG and greater need for LVP with 8 mm stents, with similar rates of encephalopathy[95].
最近的另一项回顾性研究报告了tips后PSPG需求更高,8mm支架下的LVP需求更高,脑病[95]发生率相似。
 
Therefore, the optimal diameter of covered TIPS stents for this indication remains unclear.
因此,针对这一适应症的覆膜TIPS支架的最佳直径尚不清楚。
 
Some studies have suggested that TIPS should not be undertaken in patients with a high (≥ 18) MELD score[96,97].
一些研究表明,对于MELD高(≥18)评分[96,97]的患者,不应进行TIPS。
 
 However, the role of MELD in patient selection remains unclear.
然而,MELD在患者选择中的作用尚不清楚。
 
 In the meta-analysis by Salerno et al[87], it was shown that compared with paracentesis, the benefit of TIPS on TFS could be seen across all MELD scores.
在Salerno等人[87]的荟萃分析中显示,与穿刺术相比,TIPS对TFS的好处可以在所有MELD评分中看到。
 
 More recently, two retrospective studies found no evidence that TIPS creation confers worse survival in patients with higher MELD scores compared with serial LVP[98,99].
最近,两项回顾性研究发现,没有证据表明,与连续LVP[98,99]相比,MELD评分较高的患者的生存率更差。
 
 A higher MELD score predicted poor survival, but survival was equally poor among patients whose RA was treated with serial LVP compared to TIPS.
较高的MELD评分可预测出较差的生存率,但与TIPS相比,接受连续LVP治疗的RA患者的生存率同样较差。
 
 Another retrospective review showed that early death after elective TIPS was highest in patients with MELD greater than 24[100].
另一项回顾性研究显示,MELD大于24[100]的患者在选择性TIPS后的早期死亡最高。


Gaba et al[101] compared various scores, including MELD and CTP score in the prediction of outcome after TIPS, and found that CTP score had the best overall capability at predicting mortality when TIPS is used for ascites.
Gaba等[101]比较了各种评分,包括MELD和CTP评分来预测TIPS后的结果,发现当使用TIPS治疗腹水时,CTP评分在预测死亡率方面的总体能力最好。
 
Bureau et al[102] have proposed the use of simple laboratory parameters (bilirubin < 50 μmol/L and platelets > 75 × 109/L) to predict 1-year survival following TIPS for RA, which form the basis of European Association for the Study of Liver Disease guidelines.
Bureau等人[102]建议使用简单的实验室参数(胆红素μmol/L和血小板75×109/L)来预测RATIPS后1年生存率,这构成了欧洲肝病研究协会指南的基础。

There has been a renewed interest in the role of TIPS in patients with recurrent ascites (three recurrences of symptomatic ascites within a year).
人们对TIPS在复发性腹水患者(一年内三次出现症状性腹水复发)中的作用再次产生了兴趣。
 
Studies, including the initial RCT's comparing TIPS with LVP, have grouped patients having recurrent ascites with those having RA.
研究,包括最初的RCT比较TIPS和LVP的研究,将复发性腹水患者和RA患者进行了分组。
 
 However, subgroup analyses performed on the pooled data of these RCTs showed that TIPS significantly improved TFS regardless of whether recurrent ascites patients were included or not in the trials[89].
然而,对这些随机对照试验的汇总数据进行的亚组分析显示,无论试验[89]中是否包括复发性腹水患者,TIPS都显著改善了TFS。
 
 A recent single-center retrospective study of 128 patients showed that placement of TIPS in patients with lower LVP frequency and creatinine levels is associated with superior ascites control[103].
最近一项对128例患者进行的单中心回顾性研究显示,在LVP频率和肌酐水平较低的患者中放置TIPS与优越的腹水控制[103]相关。
 
 Similar findings were reported by a prospective RCT comparing TIPS to LVP in patients with recurrent ascites and a limited LVP frequency, which demonstrated benefits in ascites control and survival in TIPS-treated patients but no difference in HE between the two groups[92].
一项前瞻性RCT对复发性腹水和LVP频率有限的患者的LVP进行了类似的结果,表明TIPS治疗的患者的腹水控制和生存有益处,但两组[92]之间的HE没有差异。

 
This was reiterated in the recent study on very early TIPS performed in patients with cirrhosis and first symptomatic ascites development[30].
这在最近关于肝硬化和首次症状腹水发展[30]患者早期TIPS的研究中得到了这一点。
 
 Thus, currently available data (Table ​(Table2)2) suggest that TIPS should be considered early in patients with difficult-to-treat ascites (not necessarily fulfilling the criteria of RA) having a stable underlying liver disease with relatively preserved renal function.
因此,目前可用的数据(表​(表2)2)表明,对于难以治疗的腹水(不一定符合RA的标准)的患者,在早期应考虑TIPS。
 
 However, a recent observational study on outcomes and mortality of patients with cirrhosis with recurrent ascites found that mortality does not differ significantly between patients with recurrent ascites and patients with ascites responsive to medical treatment and that recurrent ascites is not necessarily a sign of worsening of the liver disease, implying that these patients should not be prioritized for TIPS or liver transplant[104].
然而,最近一项关于肝硬化复发性腹水患者的结局和死亡率的观察性研究发现,复发性腹水患者和腹水患者之间的死亡率没有显著差异,复发性腹水不一定是肝病恶化的迹象,这意味着这些患者不应该优先考虑TIPS或肝移植[104]。
 
 Further large multicentre prospective RCTs are needed to assess the role of “early TIPS” in ascites.
需要进一步的大型多中心前瞻性随机对照试验来评估“早期TIPS”在腹水中的作用。
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