scholarly journals Systematic Review of Controlled Clinical Trials on the Use of Ursodeoxycholic Acid for the Prevention of Hepatic Veno-occlusive Disease in Hematopoietic Stem Cell Transplantation

2007 ◽  
Vol 13 (2) ◽  
pp. 206-217 ◽  
Author(s):  
Jason Tay ◽  
Alan Tinmouth ◽  
Dean Fergusson ◽  
Lothar Huebsch ◽  
David S. Allan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Ursodeoxycholic Acid ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Controlled Clinical Trials ◽  
Hematopoietic Stem

A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation

2020 ◽  
Author(s):  
Benjamin W Teh ◽  
Vivian K Y Leung ◽  
Francesca L Mordant ◽  
Sheena G Sullivan ◽  
Trish Joyce ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Influenza Vaccination ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Influenza B ◽  
High Dose ◽  
Hematopoietic Stem

Abstract Background Seroprotection and seroconversion rates are not well understood for 2-dose inactivated influenza vaccination (IIV) schedules in autologous hematopoietic stem cell transplantation (autoHCT) patients. Methods A randomized, single-blind, controlled trial of IIV in autoHCT patients in their first year post-transplant was conducted. Patients were randomized 1:1 to high-dose (HD) IIV followed by standard dose (SD) vaccine (HD-SD arm) or 2 SD vaccines (SD-SD arm) 4 weeks apart. Hemagglutination inhibition (HI) assay for IIV strains was performed at baseline, 1, 2, and 6 months post–first dose. Evaluable primary outcomes were seroprotection (HI titer ≥40) and seroconversion (4-fold titer increase) rates and secondary outcomes were geometric mean titers (GMTs), GMT ratios (GMRs), adverse events, influenza-like illness (ILI), and laboratory-confirmed influenza (LCI) rates and factors associated with seroconversion. Results Sixty-eight patients were enrolled (34/arm) with median age of 61.5 years, majority male (68%) with myeloma (68%). Median time from autoHCT to vaccination was 2.3 months. For HD-SD and SD-SD arms, percentages of patients achieving seroprotection were 75.8% and 79.4% for H1N1, 84.9% and 88.2% for H3N2 (all P > .05), and 78.8% and 97.1% for influenza-B/Yamagata (P = .03), respectively. Seroconversion rates, GMTs and GMRs, and number of ILI or LCIs were not significantly different between arms. Adverse event rates were similar. Receipt of concurrent cancer therapy was independently associated with higher odds of seroconversion (OR, 4.3; 95% CI, 1.2–14.9; P = .02). Conclusions High seroprotection and seroconversion rates against all influenza strains can be achieved with vaccination as early as 2 months post-autoHCT with either 2-dose vaccine schedules. Clinical Trials Registration Australian New Zealand Clinical Trials Registry: ACTRN12619000617167.

Systematic Review of Controlled Clinical Trials on the Use of Ursodeoxycholic Acid for the Prevention of Hepatic Sinusoidal Obstruction Syndrome in Hematopoietic Stem Cell Transplantation.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2966-2966
Author(s):  
Jason Tay ◽  
Alan T. Tinmouth ◽  
Dean Fergusson ◽  
Lothar B. Huebsch ◽  
David S. Allan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Ursodeoxycholic Acid ◽  
Randomized Clinical Trials ◽  
Sinusoidal Obstruction Syndrome ◽  
Hematopoietic Stem ◽  
Hepatic Sinusoidal Obstruction Syndrome

Abstract Background: Hepatic sinusoidal obstruction syndrome (HSOS) is a serious life-threatening complication of hematopoietic stem cell transplantation (HSCT). Currently, there is no optimal therapeutic strategy and preventive measures are ill-defined. Ursodeoxycholic acid (UA) is well-tolerated, inexpensive oral medication that has been associated with possible benefit as a prophylactic agent. We sought to summarize and quantify the clinical effects of prophylactic ursodeoxycholic acid in the context of HSCT. We undertook a systematic review of studies addressing the use of UA as monotherapy or in combination with other agents in patients undergoing HSCT. Methods: The Search Strategy included MEDLINE (1966 to 4th week of March 2006), EMBASE (1980 to 4th week of March 2006), all EBM Reviews (4th quarter of 2005), Ovid Healthstar (1966 to 4th week of March 2006) and Google Scholar on March 20/2006. A random effects model was used to summarize outcome data. Results: Six studies representing 824 patients were included in the review; 4 randomized clinical trials and 2 historical controlled studies. Three randomized clinical trials comparing prophylactic UA to no treatment demonstrated reduced proportion of HSOS (Relative Risk (RR) 0.34; 95% CI 0.17–0.66). When limited to higher quality studies, the effects remain (RR 0.36; 95%CI 0.15–0.90). Transplant related mortality also appears to be reduced (RR 0.58; 95% CI 0.35–0.95. However, UA did not significantly improve the outcomes of acute graft versus host disease (RR 0.76; 95% CI 0.53–1.09), relapse (RR 0.77; 95% CI 0.46–1.31) or overall survival (RR 1.22; 95 % CI 0.96–1.54). Conclusion: UA is effective for HSOS prophylaxis in patients undergoing HSCT. HSCT centers should consider UA as standard therapy and controlled trials of novel treatments for HSOS should consider the use of UA as a comparator.

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