白蛋白治疗肝硬化可改善总生存期 2017年4月22日

StephenW

Albumin treatment for cirrhosis improves overall survival
April 22, 2017

AMSTERDAM — Patients with cirrhosis who were treated with human albumin experienced improvement in a number of outcomes, including overall survival, compared to standard therapy, according to data presented at the International Liver Congress.


“Long-term albumin administration to patients with decompensated cirrhosis could be seen as a disease-modifying treatment,” Mauro Bernardi, MD, of the University of Bologna, in Italy, said in a press conference. “At the moment, the only curative approach is transplant. Treatment to influence the survival of these patients is most needed.”

In the current study, all participants received anti-mineralocorticoid at 200 mg per day plus furosemide at 25 mg per day. Those in the treatment group were given human albumin at 40 g twice a week for 2 weeks, then 40 g per week. Patients were followed monthly for 18 months unless they underwent transplantation or transjugular intrahepatic portosystemic shunt (TIPS).

The primary endpoint was OS. Parameters including cumulative number of paracentesis, ascites incidence, bacterial infections, renal dysfunction, HRS type 1, hepatic encephalopathy, portal hypertensive gastrointestinal bleeding, hospital admission and QOL comprised the secondary outcomes.

OS rates were 78% for the albumin group and 66% for the standard therapy group (HR = 0.62; 95% CI, 0.40-0.95). “Mortality was reduced by 38% in the human albumin group,” Bernardi said.

Paracentesis rates were 38% in the albumin arm and 66% in the standard therapy arm (IR = 3.50; 95% CI, 0.40-0.53), representing a reduction of 54% (P < .0001).

Other findings indicated that albumin reduced hospital stay duration by 19.4 days per year, representing a 45% reduction compared with standard therapy (P < .0001).

Regarding quality of life, patients in the albumin group improved at 3 months (P = .059) and 6 months (P = .004) before a slight drop-off at 12 months (P = .127).

Refractory ascites also improved in the albumin group (0.54, P < .0001), as did spontaneous bacterial peritonitis (SBP; IRR = 032; P < .0001), non-SBP bacterial infections (IRR = 0.70; P = .0045), episodes of renal dysfunction (IRR = 0.50; P < .0001), hepatorenal syndrome type 1 (IRR = 0.38; P = .0039), and grade 3 or 4 hepatic encephalopathy (IRR = 0.48; P < .0001), according to Bernardi.

Variceal bleeding rates did not differ between the two study arms.

Four patients developed adverse reactions to albumin. Two were mild allergic reactions, while there was one case of life-threatening severe sepsis and one case of life-threatening septic shock plus disseminated intravascular coagulation.

He concluded that this approach aids in managing ascites and improves both survival and QOL. “It reduces the incidence of severe complications of cirrhosis and reduces the number of hospitalizations,” he said. “It is generally well tolerated.” – by Rob Volansky

Reference: Caraceni P, et al. LBO-08. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.

Disclosure: Bernardi reports consulting for Baxter Healthcare SA and CSL Behring GmbH and delivering sponsored lectures for Abbvie Italia, Baxter Healthcare SA, CSL Behring GmbH, Gilead Sciences, Grifols SA, and PPTA Europe.

StephenW

白蛋白治疗肝硬化可改善总生存期
2017年4月22日

AMSTERDAM - 根据国际肝脏大会提供的数据，与人类白蛋白治疗的肝硬化患者相比，标准治疗相比，有许多结果改善，包括总体生存期。


意大利博洛尼亚大学的Mauro Bernardi博士在新闻发布会上说：“向代偿失代偿期肝硬化患者的长期白蛋白给药可以看作是一种改善疾病的治疗方法。 “目前，唯一的治疗方法是移植。影响这些患者生存的治疗方法是最需要的。“

在目前的研究中，所有参与者每天接受200mg的抗盐皮质激素加上每天25mg的呋塞米。治疗组中的那些给予人白蛋白40g，每周两次，持续2周，然后每周40g。患者按月进行18个月，除非进行移植或经颈静脉肝内门体分流术（TIPS）。

主要端点是OS。包括累积累积次数，腹水发病率，细菌感染，肾功能不全，HRS 1型，肝性脑病，门静脉高压胃肠道出血，入院和生活质量等参数包括次要结局。

白蛋白组的OS率为78％，标准治疗组的OS率为66％（HR = 0.62; 95％CI，0.40-0.95）。 “人类白蛋白组的死亡率降低了38％，”Bernardi说。

白蛋白臂的穿刺率为38％，标准治疗组的穿刺率为66％（IR = 3.50; 95％CI，0.40-0.53），减少54％（P <0.0001）。

其他研究结果表明，白蛋白每年降低住院时间19.4天，比标准治疗降低45％（P <0.0001）。

关于生活质量，在12个月轻微下降之前，白蛋白组患者在3个月时改善（P = 0.059）和6个月（P = .004）（P = .127）。

自发性细菌性腹膜炎（SBP; IRR = 032; P <0.0001），非SBP细菌感染（IRR = 0.70; P = .0045），白蛋白组（0.54，P <0.0001） ，肾功能障碍（IRR = 0.50; P <0.0001），1型肝肾综合征（IRR = 0.38; P = .0039），3级或4级肝性脑病（IRR = 0.48; P <0.0001）到伯纳迪。

两个研究组之间的静脉曲张出血率没有差异。

四名患者发生白蛋白不良反应。两个是轻度过敏反应，而有一例是危及生命的严重脓毒症，另有一例是危及生命的脓毒症休克加弥散性血管内凝血。

他认为这种方法有助于控制腹水，改善生存和生活质量。他说：“减少严重肝硬化并发症的发生率，减少住院次数。” “普遍耐受性很好” - 由Rob Volansky

参考文献：Caraceni P，et al。 LBO-08。主讲：国际肝会; 2017年4月19日至24日阿姆斯特丹

披露：Bernardi向Baxter Healthcare SA和CSL Behring GmbH报告咨询，并为Abbvie Italia，Baxter Healthcare SA，CSL Behring GmbH，Gilead Sciences，Grifols SA和PPTA Europe提供赞助演讲。

MP4

中国的植物源重组人血清白蛋白上月末刚批准临床试验

StephenW

31/5000
人白蛋白非常昂贵