Caldwell S H, Hespenheide E E, Greenwald B D, Northup P G, Patrie J T
GI/Hepatology Division, Digestive Health Center of Excellence, University of Virginia Medical Center, Charlottesville, VA 22908-0708, USA.
Aliment Pharmacol Ther. 2007 Jul 1;26(1):49-59. doi: 10.1111/j.1365-2036.2007.03351.x.
We assessed N-2-butyl-cyanoacrylate (enbucrilate) in 92 patients with gastric variceal bleeding under an FDA-approved investigation. These results extend our prior report of the first 44 patients.
Injection was performed with enbucrilate and ethiodol (1:1). Eighty patients had portal hypertension and 12 had splenic vein thrombosis.
In the portal hypertensive group, re-bleeding from gastric varices was seen in 4 of 80 (5%) from 0 to 72 h, 5 of 76 (6.5%) from > 72 h to 3 months and 9 of 51 (17%) from > 3 months to 1 year. Re-bleeding and survival were significantly related to the Child-Pugh class. In the splenic vein thrombosis group (n = 12), there was early rebleeding in 2 (17%) patients from 0 to 72 h, 1 (8%) from > 72 h to 3 months and none in the chronic phase (> 3 months to 1 year) although 1-year survival in this group was only 6 (50%) due to the underlying malignancy in most. Serious embolization was suspected in 2 patients (2%).
Enbucrilate offers an important intervention in gastric variceal bleeding which should be further studied in the US. A randomized trial is warranted to compare this intervention to radiological therapy.
在一项美国食品药品监督管理局(FDA)批准的调查中,我们对92例胃静脉曲张出血患者使用了N - 2 - 丁基 - 氰基丙烯酸酯(恩布酯)进行评估。这些结果扩展了我们之前对前44例患者的报告。
使用恩布酯和乙碘油(1:1)进行注射。80例患者患有门静脉高压,12例患有脾静脉血栓形成。
在门静脉高压组中,80例患者中有4例(5%)在0至72小时内胃静脉曲张再出血,76例中有5例(6.5%)在72小时以上至3个月时再出血,51例中有9例(17%)在3个月以上至1年时再出血。再出血和生存率与Child - Pugh分级显著相关。在脾静脉血栓形成组(n = 12)中,2例(17%)患者在0至72小时内早期再出血,1例(8%)在72小时以上至3个月时再出血,在慢性期(3个月以上至1年)无再出血,尽管由于大多数患者存在潜在恶性肿瘤,该组1年生存率仅为6例(50%)。怀疑2例患者(2%)发生严重栓塞。
恩布酯为胃静脉曲张出血提供了一种重要的干预措施,在美国应进一步研究。有必要进行一项随机试验,将这种干预措施与放射治疗进行比较。