Ursodeoxycholic acid for the prevention of hepatic complications in allogeneic stem cell transplantation
Ursodeoxycholic acid for the prevention of hepatic complications in allogeneic stem cell transplantation
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DOI：
10.1182/blood-2001-12-0159
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发表时间：
2002-09-15
期刊：
影响因子：
20.3
通讯作者：
Ringdén, O
中科院分区：
文献类型：
--
作者：
Ruutu, T;Eriksson, B;Ringdén, O
在一项前瞻性、随机、开放标签、多中心试验中研究了熊去氧胆酸（UDCA）在预防异基因干细胞移植后肝脏并发症中的作用。从预处理前一天至移植后90天，共242例患者被分配接受（n = 123）或不接受（n = 119）UDCA，剂量为12 mg/kg/d。在UDCA治疗组中，血清胆红素水平超过50 μ M的患者比例明显较小（123例中的118例对119例中的31例，P = 0.04），同样，丙氨酸氨基转移酶水平超过100 U/L的患者比例也较小。肝静脉闭塞性疾病的发生率无差异。与对照组相比，UDCA治疗组中急性移植物抗宿主病（GVHD）的总体发生率较低，III至IV级急性GVHD（5/123 vs. 17/119，P = .01）、II至IV期肝脏和肠道GVHD以及III至IV期皮肤GVHD的发生率显著较低。慢性GVHD的发生率或复发率没有差异。在接受UDCA治疗的患者中，1年生存率明显高于对照组，分别为71%和55%（P = 0.02），非复发死亡率低于对照组，分别为19%和34%（P = 0.01）。在对照组中，GVHD的死亡人数明显更多。总之，UDCA给药可减少肝脏问题和严重急性GVHD，并提高生存率。这些结果表明，UDCA在预防同种异体移植中的移植相关并发症方面具有作用。
The role of ursodeoxycholic acid (UDCA) in the prevention of hepatic complications after allogeneic stem cell transplantation was studied in a prospective randomized open-label multicenter trial. A total of 242 patients were allocated to receive (n = 123) or not to receive (n = 119) UDCA in the dose of 12 mg/kg/d orally from the day preceding the conditioning until day 90 after transplantation. In the UDCA-treated group a significantly smaller proportion of patients developed a serum bilirubin level exceeding 50 muM (118 of 123 versus 31 of 119, P = .04), and similarly a smaller proportion of patients exceeded the alanine aminotransferase level of 100 U/L. There was no difference in the incidence of veno-occlusive disease of the liver. Compared to the control group, in the UDCA-treated group there was a nonsignificant trend toward a lower overall incidence of acute graft-versus-host disease (GVHD) and a significantly lower incidence of grade III to IV acute GVHD (5 of 123 versus 17 of 119, P = .01), stage II to IV liver and intestinal GVHD, and stage III to IV skin GVHD. There was no difference in the incidence of chronic GVHD or in the relapse rate. Among the patients given UDCA, the survival at 1 year was significantly better, 71% versus 55% (P = .02), and the nonrelapse mortality rate was lower, 19% versus 34% (P = .01), than in the control group. There were significantly more deaths in GVHD in the control group. In conclusion, UDCA administration reduced hepatic problems and severe acute GVHD and improved survival. These results suggest a role for UDCA in the prevention of transplant-related complications in allogeneic transplantation.