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The Japanese multicenter open randomized trial of ursodeoxycholic acid prophylaxis for hepatic veno‐occlusive disease after stem cell transplantation
Author(s) -
Ohashi Kazuteru,
Tanabe Juichi,
Watanabe Reiko,
Tanaka Takeshi,
Sakamaki Hisashi,
Maruta Atsuo,
Okamoto Shinichiro,
Aotsuka Nobuyuki,
Saito Kenji,
Nishimura Miki,
Oh Hakumei,
Matsuzaki Michio,
Takahashi Satoshi,
Yonekura Shuji
Publication year - 2000
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/(sici)1096-8652(200005)64:1<32::aid-ajh6>3.0.co;2-n
Subject(s) - medicine , ursodeoxycholic acid , hepatic veno occlusive disease , transplantation , gastroenterology , randomized controlled trial , incidence (geometry) , regimen , clinical trial , adverse effect , surgery , stem cell , prospective cohort study , complication , hematopoietic stem cell transplantation , physics , biology , optics , genetics
Hepatic veno‐occlusive disease (VOD) is a common transplant‐related complication of stem cell transplantation. There is no safe and proven therapy for established VOD, and attempts have focused on its prevention. Limited studies have suggested that prophylactic use of ursodeoxycholic acid (UDCA) reduced the incidence of VOD. To confirm the preventive effect of UDCA on VOD, we conducted a prospective, unblinded randomized, multicenter study of UDCA involving 132 patients who underwent stem cell transplantation for a variety of disorders. Sixty‐seven patients were assigned to the UDCA‐treated group, and 65 patients were assigned to the control group. The clinical characteristics of the two groups were similar with respect to primary diagnosis, age, sex, and baseline organ function. The preparative regimen and GVHD prophylaxis did not differ significantly between the two groups. UDCA was highly effective in preventing VOD, which occurred in only 3.0% in the UDCA‐treated group, as opposed to 18.5% in the control group ( P = 0.0043). There were no adverse effects attributable to UDCA. The initial promising report of a prophylactic effect of UDCA on VOD after stem cell transplantation was confirmed in this prospective study. Am. J. Hematol. 64:32–38, 2000. © 2000 Wiley‐Liss, Inc.