Warren W D, Henderson J M, Millikan W J, Galambos J T, Brooks W S, Riepe S P, Salam A A, Kutner M H
Ann Surg. 1986 May;203(5):454-62. doi: 10.1097/00000658-198605000-00002.
This paper reports the preliminary results of a prospective randomized trial comparing endoscopic variceal sclerosis and distal splenorenal shunt (DSRS) in the management of patients with cirrhosis and variceal bleeding. Seventy-one patients have been entered; 36 have received sclerosis and 35 DSRS. Randomization of the study population was stratified on Child's A/B (56%) and Child's C (44%). Sixty-one per cent had alcoholic and 39% non-alcoholic cirrhosis. No patients have been lost to follow-up, which currently stands at a median of 26 months. Rebleeding occurred significantly (p less than 0.05) more frequently in patients in the sclerosis group (19 of 36: 53%) compared to DSRS (1 of 35: 3%), but only 11 of 36 (31%) were not controlled by further sclerosis and failed that therapy. Patients in whom sclerosis failed underwent surgery. Survival was significantly (p less than 0.01) improved in the sclerosis group (+ surgery in 31%), with an 84% 2-year survival compared to a 59% 2-year survival in the DSRS group. Portal perfusion was significantly (p less than 0.05) better maintained in the sclerosis (95%) compared to the DSRS (53%) group. Galactose elimination capacity improved significantly (p less than 0.05) in 21 patients successfully managed by sclerosis at 1 year and was significantly (p less than 0.01) better maintained in the sclerosis compared to DSRS group. The authors conclude that endoscopic sclerosis: has a higher rebleeding rate than DSRS, with one third of patients failing therapy from rebleeding; allows significant improvement in liver function when successful; and gives significantly improved survival in the management of variceal bleeding when backed up by surgical therapy for patients with uncontrolled rebleeding.
本文报告了一项前瞻性随机试验的初步结果,该试验比较了内镜下静脉曲张硬化术与远端脾肾分流术(DSRS)在肝硬化合并静脉曲张出血患者治疗中的效果。71例患者入组;36例接受了硬化术,35例接受了DSRS。研究人群按Child's A/B级(56%)和Child's C级(44%)进行分层随机分组。61%为酒精性肝硬化,39%为非酒精性肝硬化。没有患者失访,目前随访时间中位数为26个月。硬化术组患者再出血发生率(36例中的19例:53%)显著高于DSRS组(35例中的1例:3%)(p<0.05),但36例中只有11例(31%)经进一步硬化术治疗后出血未得到控制且治疗失败。硬化术治疗失败的患者接受了手术。硬化术组(31%接受手术)的生存率显著提高(p<0.01),2年生存率为84%,而DSRS组为59%。与DSRS组(53%)相比,硬化术组(95%)门静脉灌注得到显著更好的维持(p<0.05)。21例经硬化术成功治疗的患者在1年时半乳糖清除能力显著改善(p<0.05),与DSRS组相比,硬化术组该指标得到显著更好的维持(p<0.01)。作者得出结论:内镜下硬化术:再出血率高于DSRS,三分之一的患者因再出血治疗失败;成功时可显著改善肝功能;对于再出血无法控制的患者,辅以手术治疗时,在静脉曲张出血的治疗中可显著提高生存率。