Kershenobich D, Vargas F, Garcia-Tsao G, Perez Tamayo R, Gent M, Rojkind M
Department of Gastroenterology, Instituto Nacional de la Nutricion Salvador Zubiran, Mexico City, D.F., Mexico.
N Engl J Med. 1988 Jun 30;318(26):1709-13. doi: 10.1056/NEJM198806303182602.
There is preliminary evidence that colchicine, an inhibitor of collagen synthesis, may be beneficial in the treatment of cirrhosis of the liver. To evaluate the use of colchicine (1 mg per day, five days per week) in the treatment of hepatic cirrhosis, we performed a randomized, double-blind, placebo-controlled trial in which 100 patients were followed for up to 14 years. Forty-five patients had alcoholic cirrhosis, 41 had posthepatitic cirrhosis, and the remaining 14 had cirrhosis with various other causes. Histologic studies were available for 92 percent of patients. Seventy-three patients were in Child-Turcotte class A, 26 were in class B, and one was in class C. Fifty-four patients received colchicine, and 46 received placebo. The overall survival in the colchicine group was markedly better than in the placebo group (median survival, 11 and 3.5 years, respectively; P less than 0.001). The cumulative 5-year survival rates were 75 percent in the colchicine group and 34 percent in the placebo group; the corresponding 10-year survival rates were 56 percent and 20 percent. Among the 30 patients treated with colchicine who underwent repeated liver biopsies, histologic improvement was seen in 9; the liver appeared normal in 2, and 7 had minimal portal fibrosis. No histologic improvement was observed in the 14 members of the placebo group who had two or more biopsies. Few side effects were observed in either group.
有初步证据表明,秋水仙碱作为一种胶原蛋白合成抑制剂,可能对肝硬化治疗有益。为评估秋水仙碱(每日1毫克,每周服用5天)治疗肝硬化的效果,我们进行了一项随机、双盲、安慰剂对照试验,对100例患者进行了长达14年的随访。45例为酒精性肝硬化,41例为肝炎后肝硬化,其余14例为其他各种原因导致的肝硬化。92%的患者有组织学研究资料。73例患者为Child-Turcotte A级,26例为B级,1例为C级。54例患者接受秋水仙碱治疗,46例接受安慰剂治疗。秋水仙碱组的总体生存率明显高于安慰剂组(中位生存期分别为11年和3.5年;P<0.001)。秋水仙碱组的累积5年生存率为75%,安慰剂组为34%;相应的10年生存率分别为56%和20%。在接受秋水仙碱治疗的30例接受重复肝活检的患者中,9例有组织学改善;2例肝脏外观正常,7例有轻微门静脉纤维化。在接受两次或更多次活检的安慰剂组的14名患者中未观察到组织学改善。两组均观察到很少的副作用。