Greenwald Bruce D, Caldwell Stephen H, Hespenheide Elizabeth E, Patrie James T, Williams Jeffrey, Binmoeller Kenneth F, Woodall Lysa, Haluszka Oleh
Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Am J Gastroenterol. 2003 Sep;98(9):1982-8. doi: 10.1111/j.1572-0241.2003.07637.x.
N-butyl-2-cyanoacrylate has been reported to be effective for bleeding varices but is not available in the United States. We report the initial US experience with cyanoacrylate in this prospective trial and evaluate its safety, efficacy, and relative costs.
Patients with active or recent gastric variceal bleeding were eligible. Cyanoacrylate therapy was performed until variceal occlusion was achieved. Rebleeding was assessed at 72 h (acute phase), 6 wk (subacute phase), and 1 yr (chronic phase). Survival was assessed at 3 months and 1 yr. Cost analysis was performed comparing the first 17 patients to historical control patients not treated with cyanoacrylate.
A total of 44 patients were enrolled, 37 with cirrhosis and seven with noncirrhotic portal hypertension (NCPH). In cirrhotic patients, rebleeding was seen in two of 37 (5%) at 72 h, one of 30 (3%) at 6 wk, and five of 28 (18%) at 1 yr. Survival without shunt at 3 months was 30 of 34 (88%) and at 1 yr was 24 of 31 (77%). In NCPH patients, rebleeding was seen in two of seven (29%) at 72 h. These patients received definitive therapy for NCPH after diagnosis. Mortality and costs were substantially higher in the non-cyanoacrylate group. The odds of death were greater by 7-fold in the non-cyanoacrylate group than within the cyanoacrylate group (95% CI = 1.18-41.36, p = 0.0318). At 3 months, there was a 3.18-fold difference (95% CI = 1.05-9.64, p = 0.0411) in accrued costs; at 1 yr, the difference was 2.55-fold (95% CI = 0.96-6.94, p = 0.0585). The cost-effective ratio was estimated as 108,237 US dollars/death averted, reflecting marked cost reduction with improved survival in the cyanoacrylate-treated group. This is believed to result largely from avoidance of shunt interventions.
Cyanoacrylate treatment of gastric varices is safe, clinically effective, and cost effective.
据报道，氰基丙烯酸正丁酯对静脉曲张出血有效，但在美国无法获得。我们在这项前瞻性试验中报告了美国使用氰基丙烯酸酯的初步经验，并评估其安全性、有效性和相对成本。
符合条件的患者为活动性或近期胃静脉曲张出血患者。进行氰基丙烯酸酯治疗直至静脉曲张闭塞。在72小时（急性期）、6周（亚急性期）和1年（慢性期）评估再出血情况。在3个月和1年时评估生存率。进行成本分析，将前17例患者与未接受氰基丙烯酸酯治疗的历史对照患者进行比较。
共纳入44例患者，其中37例为肝硬化患者，7例为非肝硬化门静脉高压（NCPH）患者。在肝硬化患者中，72小时时37例中有2例（5%）再次出血，6周时30例中有1例（3%）再次出血，1年时28例中有5例（18%）再次出血。3个月时无分流生存的患者为34例中的30例（88%），1年时为31例中的24例（77%）。在NCPH患者中，72小时时7例中有2例（29%）再次出血。这些患者在诊断后接受了NCPH的确定性治疗。非氰基丙烯酸酯组的死亡率和成本显著更高。非氰基丙烯酸酯组的死亡几率比氰基丙烯酸酯组高7倍（95%CI = 1.18 - 41.36，p = 0.0318）。在3个月时，累计成本有3.18倍的差异（95%CI = 1.05 - 9.64，p = 0.0411）；在1年时，差异为2.55倍（95%CI = 0.96 - 6.94，p = 0.0585）。成本效益比估计为108,237美元/避免死亡，这反映了氰基丙烯酸酯治疗组在提高生存率的同时成本显著降低。这被认为主要是由于避免了分流干预。
氰基丙烯酸酯治疗胃静脉曲张安全、临床有效且具有成本效益。
