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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.
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Objective@#To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m2, 10 mg/m2 or 12 mg/m2 as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) .@*Methods@#A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m2) as induction chemotherapy in newly diagnosed patients of adult AML.@*Results@#Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m2 group, IDA 10 mg/m2 group and IDA 12 mg/m2 group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively (P<0.001) . After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95% CI) of IDA 10 mg/m2 group and IDA 12 mg/m2 group were 0.49 (0.34-0.70) and 0.36 (0.18-0.71) , as compared with the IDA 8 mg/m2 group (P<0.001, P=0.003) . In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA (P=0.007) . Interestingly, IA regimen with IDA 10 mg/m2 was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[OR=0.47 (95% CI 0.31-0.71) , P<0.001]. CR rates in adverse group was 50.0% (18/36) , 60.6% (43/71) and 81.8% (18/22) respectively (P=0.089) . However, the odds ratios (95% CI) of IDA 12 mg/m2 when compared with the IDA 8 mg/m2 was 0.22 (0.06-0.80) , after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×109/L in IDA 8 mg/m2 group, IDA 10 mg/m2 group and IDA 12 mg/m2 group were 14 (11-18) , 15 (11-20) and 18 (14-22) , respectively (P=0.012) and of platelet count lower than 20×109/L were 14 (7-17) , 15 (11-20) and 17 (15-21) , respectively (P=0.001) . The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively (P<0.001) .@*Conclusions@#For young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m2 is clinically superior to IDA 8 mg/m2 and IDA 12 mg/m2 in favorable intermediate AML subgroup. However, idarubicin 12 mg/m2 is more suitable to adverse AML subgroup.
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Objective To construct mouse model of acute myeloid leukemia and detect the expression of ANGPT 1 ,ANGPT2 and VEGF gene on the cells its as well as the clinical significance .Methods The HL‐60 cells were transfected to NOD/SCID mouse through abdominal injection to construct mouse model of acute myeloid leukemia .Then identify mouse model by histopathology and Flow Cytometry .The expression of ANGPT2 ,ANGPT1 and VEGF mRNA in the tumor tissues of mouse model was detected by real‐time fluorescence quantitative PCR .The expression of ANGPT2 will be analyzed on the survival time of mouse model by Spearman′s correlation method .Results Mouse model has been successfully identified by histopathology and Flow Cytometry .The expression of ANGPT2 and VEGF in mouse mode was significantly detected ,which was that of higher than normal group (P0 .05) .The higher expression of ANGPT2 in mouse model had a short survival time in mouse with acute myeloid leukemia .Conclusion This study showed that ANGPT2 mRNA was over‐expressed in acute myeloid leukemia .The increasing expression of ANGPT2 mRNA may lead to poor prognosis in mouse with acute myeloid leukemia .
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Objective To investigate the effects of clinical pathway-based teaching methods in clinical teaching of hematology. Methods Interns, which studied in department of hematology, were classified non-randomized into two groups. The interns in experimental group received idiopathic thrombocytopenic purpura (ITP) clinical pathway-based teaching. And the interns in the control group received the seventh edition textbook of medicine-based traditional teaching. All interns were oral tested when they finished two weeks period clinical studied of hematology. Meanwhile, a questionnaire designed for clinical pathway-based teaching was included in this test only for the experimental group. Results There were 32 interns recruited in the group of clinical pathway-based teaching and 38 interns in the control group of traditional teaching. There were statistically significant differences between the two groups in the fields of the key points about history of diseases ( = 0.0017), assessment of diagnostic criteria and differential diagnosis ( =0.0074), selection of laboratory examination items ( <0.0001) for ITP. The group of clinical pathway-based teaching achieved higher scores than the control group. However, there was no statistically significant difference between the two groups in the field of selection of first-line treatment measure of ITP ( = 0.1155) . Moreover, the control group achieved higher scores than the group of clinical pathway-based teaching in the field of how to treat ITP patients with first-line treatment failure ( =0.0003) . In addition,there were 93.8%interns in the experimental group accepted the new clinical pathway-based teaching tool in the survey. The open-ended question survey showed the clinical pathway teaching method was more simple, intuitive and standardizing than the traditional one. Conclusion The ITP clinical pathway, as an interns teaching tool of hematology, is helpful for understanding more clearly the diagnosis and treatment of ITP. However, an in-depth explanation is necessary combination with textbook of medicine study in the clinical teaching of ITP.