Objective: To evaluate the efficacy and safety of a domestic human plasma derived coagulation Factor Ⅸ concentrate (pd-FⅨ) in patients with hemophilia B. Methods: The study was a multicenter, open-label and single-arm study. The efficacy of pd-F Ⅸ was evaluated by objective performance criteria. The doses of pd-FⅨ were calculated according to the bleeding symptom and disease severity. The infusion efficiency of pd-FⅨ and improvement of bleeding symptoms were measured at 30 minutes and (24±4) h after the first infusion, respectively. Adverse events were recorded. Viral infection and FⅨ inhibitor were detected 90 d after the first infusion. Results: All 36 subjects with hemophilia B were enrolled in the study. The median age of these patients was 31 years old and the median injection doses were 4 (1-17) times. The hemostatic effect of 27/36 (75.00%) and 9/36 (25.00%) acute bleeding events were rated as "excellent" and "better" , respectively. The recovery rate was 111.92% (65.55%-194.28%) at 30 minutes after infusion of FⅨ. There was no adverse event related to FⅨ. No reactivation of HBV, HCV or HIV and FⅨ inhibitor was detected at 90-104 d after the first FⅨ infusion. Conclusion: This domestically made human plasma derived FⅨ concentrate is safe and effective in the treatment of acute bleeding in patients with hemophilia B. Clinical trial registration China food and Durg Administration, 2016L08027.

Objective:To explore the relationship between lower respiratory tract microflora and type of anti-tuberculosis immune response, clinical characteristics in patients with pulmonary tuberculosis (PT).Methods:The clinical data of 80 patients with PT and 80 patients with non-PT from January 2018 to March 2020 in the Second Hospital of Zhejiang Medical School of Changxing District were retrospectively analyzed. All patients were treated with bronchoalveolar lavage, the bronchoalveolar lavage fluid counts of Haemophilus, Neisser coccus, Streptococcus and Veillonella were detected by germiculture, and the bronchoalveolar lavage fluid expression levels of T-bet mRNA (Th1 immune response) and GATA-3 mRNA (Th2 immune response) was detected by real-time polymerase chain reaction. The clinical symptoms of PT were recorded. The correlation was analyzed by Pearson correlation analysis.Results:There were no statistical differences in bronchoalveolar lavage fluid Neisser coccus, Veillonella and Haemophilus between patients with PT and patients with non-PT ( P>0.05); the bronchoalveolar lavage fluid Streptococcus in patients with PT was significantly lower than that in patients with non-PT (630 ± 120 vs. 1 000 ± 330), and there was statistical difference ( P<0.05). There was no statistical difference in expression level of T-bet mRNA between patients with PT and patients with non-PT ( P>0.05); the expression level of GATA-3 mRNA in patients with PT was significantly lower that in patients with non-PT: (5.883 ± 1.864) ×10 4 vs. (3.997 ± 1.186) ×10 6, and there was statistical difference ( P<0.05). Pearson correlation analysis result showed that fever was positively correlated with bronchoalveolar lavage fluid Neisser coccus and Veillonella ( r = 0.402 and 0.566, P<0.01 or <0.05); proportion of tuberculosis foci to lung area was positively correlated with T-bet and GATA-3 mRNA ( r = 0.024 and 0.442, P<0.05), the body weight loss was positively correlated with T-bet mRNA ( r = 0.112, P<0.05); GATA-3 mRNA was positively correlated with bronchoalveolar lavage fluid Neisser coccus ( r =0.332, P<0.05), T-bet mRNA was positively correlated with bronchoalveolar lavage fluid Haemophilus ( r = 0.162, P<0.05). Conclusions:There is a significant correlation between the Th1/Th2 immune response type and the bronchoalveolar lavage fluid Haemophilus and Neisser coccus in patients with PT, and the fever symptoms is also significantly related to Neisser coccus and Veillonella. There is a certain correlation between weight loss and the quantitative results of proportion of tuberculosis foci to lung area and the type of immune response.