Efficacy of XXXX for acute exacerbation of @entity2416 and @entity401 : a nonrandomized prospective study.

@entity1 @entity16058 @entity2416 @entity5642 @entity9820 @entity401
PURPOSE: Acute exacerbation (AE) is an important outcome of @entity2416 ( @entity2416 ) and @entity401 ( @entity401 ). Recombinant @entity1 soluble @entity9820 (rhTM) is a new drug for the treatment of disseminated @entity5642 in Japan. The objective of this study was to evaluate the efficacy of rhTM for AE of @entity2416 / @entity401 . METHODS: Twenty-two @entity1 with @entity16058 (16 @entity1 with @entity2416 and six @entity1 with @entity401 ) were enrolled in our study. Among them, eleven @entity1 were treated with rhTM (rhTM group), and eleven @entity1 were treated without rhTM (non-rhTM group). @entity1 admitted to our hospital prior to December 2013 were treated with rhTM, while those admitted after January 2014 were treated without rhTM. The primary endpoint was mortality at 90 days after AE treatment. The secondary endpoint was the safety of rhTM for AE- @entity2416 /AE- @entity401 . In addition, we examined prognostic factors of AE- @entity2416 /AE- @entity401 . RESULTS: The mortality rate was significantly lower in the rhTM group than in the non-rhTM group (mortality rate at 90 days: 36% vs 90%, P=0.023; median survival time: not reached vs 15.0 days, P=0.019). A univariate analysis revealed the respiratory rate (hazard ratio [HR] 1.09, 95% confidence interval [CI] 1.00-1.18, P=0.039) and rhTM administration (HR 0.21, 95% CI 0.06-0.77, P=0.013) as predictors of mortality at 90 days, and a multivariate analysis identified rhTM administration (HR 0.025, 95% CI 0.0006-0.94, P=0.046) as an independent predictor of mortality at 90 days. No serious adverse events were observed. CONCLUSION: The administration of rhTM is associated with reductions in mortality in @entity1 with AE- @entity2416 / @entity401 , without causing adverse events.
