Abstract
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 stern 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 stern cell transplantation was confirmed in this prospective study. (C) 2000 Wiley-Liss, Inc.
| Original language | English |
|---|---|
| Pages (from-to) | 32-38 |
| Number of pages | 7 |
| Journal | American Journal of Hematology |
| Volume | 64 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2000 |
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Keywords
- Hepatic VOD
- Prophylaxis
- Stem cell transplantation
- Ursodeoxycholic acid (UDCA)
ASJC Scopus subject areas
- Hematology
Cite this
The japanese multicenter open randomized trial of ursodeoxycholic acid prophylaxis for hepatic veno-occlusive disease after stem cell transplantation. / 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.
In: American Journal of Hematology, Vol. 64, No. 1, 2000, p. 32-38.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The japanese multicenter open randomized trial of ursodeoxycholic acid prophylaxis for hepatic veno-occlusive disease after stem cell transplantation
AU - Ohashi, Kazuteru
AU - Tanabe, Juichi
AU - Watanabe, Reiko
AU - Tanaka, Takeshi
AU - Sakamaki, Hisashi
AU - Maruta, Atsuo
AU - Okamoto, Shinichiro
AU - Aotsuka, Nobuyuki
AU - Saito, Kenji
AU - Nishimura, Miki
AU - Oh, Hakumei
AU - Matsuzaki, Michio
AU - Takahashi, Satoshi
AU - Yonekura, Shuji
PY - 2000
Y1 - 2000
N2 - 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 stern 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 stern cell transplantation was confirmed in this prospective study. (C) 2000 Wiley-Liss, Inc.
AB - 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 stern 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 stern cell transplantation was confirmed in this prospective study. (C) 2000 Wiley-Liss, Inc.
KW - Hepatic VOD
KW - Prophylaxis
KW - Stem cell transplantation
KW - Ursodeoxycholic acid (UDCA)
UR - http://www.scopus.com/inward/record.url?scp=0034093330&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034093330&partnerID=8YFLogxK
U2 - 10.1002/(SICI)1096-8652(200005)64:1<32::AID-AJH6>3.0.CO;2-N
DO - 10.1002/(SICI)1096-8652(200005)64:1<32::AID-AJH6>3.0.CO;2-N
M3 - Article
C2 - 10815785
AN - SCOPUS:0034093330
VL - 64
SP - 32
EP - 38
JO - American Journal of Hematology
JF - American Journal of Hematology
SN - 0361-8609
IS - 1
ER -