We evaluated SOFA scores for respiratory, cardiovascular, renal and hepatic organ systems between the two groups from day 0 through day 28. The patients in the rhTM group showed a tendency calcitriol?hormone toward a decrease in respiratory score (P = 0.075) and renal score (P = 0.069) compared to those in the control group by repeated measures ANOVA, but the differences between the two groups were not statistically significant. No significant differences in cardiovascular score (P = 0.190) and hepatic score (P = 0.586) were observed between the two groups.Effect of treatment on inflammation and coagulation dataThe serial changes in CRP levels in the two groups are shown in Figure Figure4.4. CRP level decreased more quickly in the rhTM group than in the control group, although the difference between the two groups was not statistically significant (P = 0.
144). There was no difference in the recovery of platelet counts between the two groups (P = 0.509). However, the interaction between the treatment and time was statistically significant (P = 0.040), suggesting that the recovery of platelet counts in the rhTM group might have been greater than that in the control group after day 5 as shown in Figure Figure55.Figure 4Serial changes from baseline in levels of CRP in the two groups. Data are expressed as group means �� standard error of the mean. CRP level decreased over time in both groups (P < 0.001). Although CRP level in the rhTM group tended to decrease ...Figure 5Serial changes from baseline in platelet counts in the two groups. Data are expressed as group means �� standard error of the mean.
Platelet counts increased over time in both groups (P < 0.001). Although the changes in platelet counts ...In terms of FDP analysis, we included only patients for whom baseline values and subsequent values were recorded; thus, FDP data for all patients in the rhTM group and for 23 of 45 patients in the control group were analyzed. The baseline characteristics of the 23 control group patients were not different from those of the other control group patients. There was a significant difference in the change of FDP level from baseline between the two groups (P = 0.017) as shown in Figure Figure66.Figure 6Serial changes from baseline in levels of FDP in the two groups. Data are expressed as group means �� standard error of the mean.
The degree of decrease in FDP level was significantly greater in the rhTM group than in the control group Drug_discovery (P = 0.017). …Adverse eventsDuring the study period, one serious adverse event related to bleeding occurred in the rhTM group (5.0%), and two adverse events occurred in the control group (4.4%); however, there was no significant difference in the incidence of this adverse event between groups. The bleeding event in the rhTM group was cerebral hemorrhage requiring craniotomy, from which the patient recovered. The cerebral hemorrhage occurred on day 10, five days after the end of rhTM administration.