摘要：

the purpose of the study was to evaluate the effect of lisofylline (lsf) on engraftment, regimen-related toxicities (rrt), and mortality in patients undergoing allogeneic bone marrow transplantation (bmt). we performed a multicenter, randomized placebo-controlled trial in 60 patients with hematologic malignancies receiving bmt from hla-identical sibling donors. patients were randomized to receive either placebo, 2mg/kg lsf or 3mg/kg lsf every 6h, beginning before conditioning and continuing to day 21 or hospital discharge. treatment groups were balanced with respect to conditioning regimen and disease stage. however, significantly more patients in the 2mg/kg lsf group were at high risk for rrt due to performance status1, age40 years, and prior exposure to cmv. nausea and vomiting were the only adverse events observed in a higher proportion of lsf-treated patients that led to study withdrawal in six of 42 patients (14%). the times to neutrophil recovery to500/μl and platelet recovery (>20000/μl) were not improved by LSF treatment. Nevertheless, no patient who received treatment with 3mg/kg LSF developed a documented infection between day 0 and 35 or had a serious or fatal infection between day 0 and 100 (=0.003placebo for both). The day-100 survival rate was also significantly improved in the 3mg/kg LSF group (89%), compared with either the 2mg/kg LSF (48%) or placebo (61%) groups (log-rank test, 3mg/kg LSFplacebo,=0.026). We conclude that treatment with LSF 3mg/kg reduced the incidence of infections and improved 100-day survival in patients receiving related-donor allogeneic bone marrow transplantation.(2000)283–291.

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