1.Construction and application evaluation of a core competency framework-based training program for cardiovascular nurse specialists
Haiyan YU ; Yuting LAI ; Bi LIN ; Hong CAI ; Sailan LI ; Junqin ZHANG ; Huabing LEI ; Yuan CHEN
Chinese Journal of Medical Education Research 2025;24(10):1408-1414
Objective:To construct and evaluate a training program for cardiovascular nurse specialists based on a core competency framework.Methods:Among 61 trainees participating in the first training class for cardiovascular nurse specialists organized by a provincial nursing society, a training program focusing on the nine core competencies for cardiovascular nurse specialists was implemented, which consisted of 4-week theoretical and 4-week practical training. The effectiveness of the training program was evaluated using the Kirkpatrick model. Data analyses were performed by using SPSS 26.0. Categorical data were presented as the number of cases; continuous variables in normal distribution were expressed as mean±standard deviation; and continuous variables in non-normal distribution were presented as median (interquartile range) and compared using non-parametric tests.Results:At the reaction level, the satisfaction rates of trainees with the theoretical and practical sections of the training program were 98.36% (60/61) and 95.08% (58/61), respectively. At the learning level, the comprehensive assessment score of the trainees was (83.01±3.39) points, and all of them successfully obtained their completion certificates, with a pass rate of 100.00% (61/61). At the behavior level, the core competencies for cardiovascular nurse specialists were significantly improved after training [the total score increased from 291.00 (254.00, 334.25) to 410.50 (354.50, 433.00), P<0.001]. At the results level, at six months after training, there were significant increases in the number of participants engaging in cardiovascular care practices, clinical nursing education and guidance, leadership roles, and research projects within their units as well as the number of individuals achieving career advancement (all P<0.05). Conclusions:The trainees are highly satisfied with the core competency-focused cardiovascular nurse training program, which can improve core competencies and cardiovascular nursing capabilities, expand the scope of cardiovascular nursing services, and foster the sustained advancement of the participants.
2.Research on the anti-hepatocellular carcinoma activity and mechanisms of glycyrrhetinic acid derivatives
Xu-xin CUI ; Wen-ping CUI ; Yan-xing BI ; Fan CHENG ; Yu-ning LI ; Bao-lai ZHANG ; Quan-yi ZHAO ; Xiao-lai YANG
Chinese Pharmacological Bulletin 2025;41(11):2150-2157
Aim To design and synthesize a series of glycyrrhetinic acid derivatives by using glycyrrhetinic acid as the parent nucleus,screen their antitumor activ-ities,and investigate the in vitro and in vivo antitumor effects and mechanisms of the most active compound.Methods MTT assay was used to screen for the com-pound with the most potent antitumor activity.MTT as-say,wound healing assay,colony formation assay and Transwell migration assay were used to evaluate the effects of the compound on tumor cell viability and mi-gration.Flow cytometry was employed to assess the im-pact of the compound on tumor cell cycle progression and apoptosis.Western blot was conducted to verify the effects on the expression of pro-apoptotic proteins Bax,caspase-3 and cleaved caspase-3.A mouse model of hepatocellular carcinoma ascites tumor was estab-lished to examine the antitumor effects of the compound in vivo.Results Compound C22 was identified as having the most significant inhibitory effect on hepato-cellular carcinoma cells.C22 inhibited the viability and migration of hepatocellular carcinoma cells in a time and concentration-dependent manner.C22 upreg-ulated the expression of pro-apoptotic proteins Bax,caspase-3 and cleaved caspase-3 in hepatocellular car-cinoma cells,induced apoptosis,and arrested the cell cycle in the G0/G1 and S phases.C22 significantly re-duced the growth of mouse hepatocellular carcinoma as-cites tumors and prolonged survival.Conclusion Glycyrrhetinic acid derivative C22 significantly inhibits the viability and migration of hepatocellular carcinoma cells in vitro and in vivo,and induces cell cycle arrest and apoptosis.
3.Research on the anti-hepatocellular carcinoma activity and mechanisms of glycyrrhetinic acid derivatives
Xu-xin CUI ; Wen-ping CUI ; Yan-xing BI ; Fan CHENG ; Yu-ning LI ; Bao-lai ZHANG ; Quan-yi ZHAO ; Xiao-lai YANG
Chinese Pharmacological Bulletin 2025;41(11):2150-2157
Aim To design and synthesize a series of glycyrrhetinic acid derivatives by using glycyrrhetinic acid as the parent nucleus,screen their antitumor activ-ities,and investigate the in vitro and in vivo antitumor effects and mechanisms of the most active compound.Methods MTT assay was used to screen for the com-pound with the most potent antitumor activity.MTT as-say,wound healing assay,colony formation assay and Transwell migration assay were used to evaluate the effects of the compound on tumor cell viability and mi-gration.Flow cytometry was employed to assess the im-pact of the compound on tumor cell cycle progression and apoptosis.Western blot was conducted to verify the effects on the expression of pro-apoptotic proteins Bax,caspase-3 and cleaved caspase-3.A mouse model of hepatocellular carcinoma ascites tumor was estab-lished to examine the antitumor effects of the compound in vivo.Results Compound C22 was identified as having the most significant inhibitory effect on hepato-cellular carcinoma cells.C22 inhibited the viability and migration of hepatocellular carcinoma cells in a time and concentration-dependent manner.C22 upreg-ulated the expression of pro-apoptotic proteins Bax,caspase-3 and cleaved caspase-3 in hepatocellular car-cinoma cells,induced apoptosis,and arrested the cell cycle in the G0/G1 and S phases.C22 significantly re-duced the growth of mouse hepatocellular carcinoma as-cites tumors and prolonged survival.Conclusion Glycyrrhetinic acid derivative C22 significantly inhibits the viability and migration of hepatocellular carcinoma cells in vitro and in vivo,and induces cell cycle arrest and apoptosis.
4.Construction and application evaluation of a core competency framework-based training program for cardiovascular nurse specialists
Haiyan YU ; Yuting LAI ; Bi LIN ; Hong CAI ; Sailan LI ; Junqin ZHANG ; Huabing LEI ; Yuan CHEN
Chinese Journal of Medical Education Research 2025;24(10):1408-1414
Objective:To construct and evaluate a training program for cardiovascular nurse specialists based on a core competency framework.Methods:Among 61 trainees participating in the first training class for cardiovascular nurse specialists organized by a provincial nursing society, a training program focusing on the nine core competencies for cardiovascular nurse specialists was implemented, which consisted of 4-week theoretical and 4-week practical training. The effectiveness of the training program was evaluated using the Kirkpatrick model. Data analyses were performed by using SPSS 26.0. Categorical data were presented as the number of cases; continuous variables in normal distribution were expressed as mean±standard deviation; and continuous variables in non-normal distribution were presented as median (interquartile range) and compared using non-parametric tests.Results:At the reaction level, the satisfaction rates of trainees with the theoretical and practical sections of the training program were 98.36% (60/61) and 95.08% (58/61), respectively. At the learning level, the comprehensive assessment score of the trainees was (83.01±3.39) points, and all of them successfully obtained their completion certificates, with a pass rate of 100.00% (61/61). At the behavior level, the core competencies for cardiovascular nurse specialists were significantly improved after training [the total score increased from 291.00 (254.00, 334.25) to 410.50 (354.50, 433.00), P<0.001]. At the results level, at six months after training, there were significant increases in the number of participants engaging in cardiovascular care practices, clinical nursing education and guidance, leadership roles, and research projects within their units as well as the number of individuals achieving career advancement (all P<0.05). Conclusions:The trainees are highly satisfied with the core competency-focused cardiovascular nurse training program, which can improve core competencies and cardiovascular nursing capabilities, expand the scope of cardiovascular nursing services, and foster the sustained advancement of the participants.
5.Comparison of 7 methods for sample size determination based on confidence interval estimation for a single proportion.
Mi Lai YU ; Xiao Tong SHI ; Bi Qing ZOU ; Sheng Li AN
Journal of Southern Medical University 2023;43(1):105-110
OBJECTIVE:
To compare different methods for calculating sample size based on confidence interval estimation for a single proportion with different event incidences and precisions.
METHODS:
We compared 7 methods, namely Wald, AgrestiCoull add z2, Agresti-Coull add 4, Wilson Score, Clopper-Pearson, Mid-p, and Jefferys, for confidence interval estimation for a single proportion. The sample size was calculated using the search method with different parameter settings (proportion of specified events and half width of the confidence interval [ω=0.05, 0.1]). With Monte Carlo simulation, the estimated sample size was used to simulate and compare the width of the confidence interval, the coverage of the confidence interval and the ratio of the noncoverage probability.
RESULTS:
For a high accuracy requirement (ω =0.05), the Mid-p method and Clopper Pearson method performed better when the incidence of events was low (P < 0.15). In other settings, the performance of the 7 methods did not differ significantly except for a poor symmetry of the Wald method. In the setting of ω=0.1 with a very low p (0.01-0.05), failure of iteration occurred with nearly all the methods except for the Clopper-Pearson method.
CONCLUSION
Different sample size determination methods based on confidence interval estimation should be selected for single proportions with different parameter settings.
Confidence Intervals
;
Sample Size
;
Computer Simulation
;
Monte Carlo Method
;
Probability
6.Effects of placenta previa on surgical and pregnancy outcomes in patients with total/subtotal or segmental hysterectomy attributed to placenta accreta spectrum disorders
Miao HU ; Lili DU ; Yuliang ZHANG ; Shifeng GU ; Zhongjia GU ; Siying LAI ; Jingying LIANG ; Yu LIU ; Shilei BI ; Lizi ZHANG ; Dunjin CHEN
Chinese Journal of Perinatal Medicine 2023;26(8):635-643
Objective:To investigate the effects of placenta previa on the surgical and pregnancy outcomes in patients with total/subtotal or segmental hysterectomy attributed to placenta accreta spectrum disorders (PAS).Methods:This study retrospectively enrolled 510 patients who gave birth and underwent total/subtotal hysterectomy or segmental hysterectomy (local implantation site) due to PAS at the third Affiliated Hospital of Guangzhou Medical University from January 1, 2017, to December 31, 2022. These subjects were divided into the placenta previa group (427 cases) and non-placenta previa group (83 cases). According to the type of hysterectomy, they were further divided into the total/subtotal hysterectomy and placenta previa subgroup (221 cases), total/subtotal hysterectomy and non-placenta previa subgroup (23 cases), segmental hysterectomy and placenta previa subgroup (206 cases), and segmental hysterectomy and non-placenta previa subgroup (60 cases). Nonparametric test or Chi-square test were used to compare the differences in the clinical features, surgical and pregnancy outcomes between different groups. Binary logistic regression was used to analyze the effects of placenta previa on the risk of additional surgical procedures and adverse maternal outcomes. Results:(1) Compared with the non-placenta previa group, the hemorrhage volume within 24 h postpartum [1 541 ml (1 036-2 368 ml) vs 1 111 ml (695-2 000 ml), Z=-3.91] and the proportion of women requiring additional surgical procedures [84.8% (362/427) vs 69.9% (58/83), χ2=10.61], with total/subtotal hysterectomy [51.8% (221/427) vs 27.7% (23/83), χ2=16.10], cystoscopy and/or ureteral stenting [60.7% (259/427) vs 31.3% (26/83), χ2=24.25], total adverse pregnancy outcomes [86.9% (371/427) vs 65.1% (54/83), χ2=17.75], hemorrhage volume>1 500 ml within 24 h postpartum [54.1% (231/427) vs 33.7% (28/83), χ2=29.94], transfusion of blood products [75.9% (324/427) vs 47.0% (39/83), χ2=28.27] were all higher in the placenta previa group (all P<0.05). Binary logistic regression analysis found that for PAS patients with hysterectomy, regardless of the hysterectomy type (total/subtotal/segmental), placenta previa was risk factor for requiring additional surgical procedures ( aOR=3.26, 95% CI: 1.85-5.72) and adverse pregnancy outcomes ( aOR=5.59, 95% CI: 2.01-6.42), even if adjusting for the confounding factors such as maternal age, number of previous cesarean sections, parity, gestational weight gain, twin pregnancy, and the use of assisted reproductive technology. (2) In patients with total/subtotal hysterectomy, the proportion of women requiring additional surgical procedures was higher in those with placenta previa [82.8% (183/221) vs 56.5% (13/23), χ2=9.11] than those without placenta previa, especially the proportion of cystoscopy and/or ureteral stenting [67.9% (150/221) vs 34.8% (8/23), χ2=9.99] (both P<0.05). However, no significant difference was found in adverse pregnancy outcomes [89.6% (198/221) vs 87.0% (20/23), χ2<0.01, P=0.972] between the two groups. In patients with segmental hysterectomy, higher proportions of women requiring additional surgery [86.9% (179/206) vs 75.0% (45/60), χ2=4.94], with adverse pregnancy outcomes [84.0% (173/206) vs 56.7% (34/60), χ2=25.31], cystoscopy and/or ureteral stenting [52.9% (109/206) vs 30.0% (18/60), χ2=9.78], vascular occlusion [94.2% (194/206) vs 71.7% (43/60), χ2=24.23], hemorrhage volume>1 500 ml within 24 h postpartum [46.6% (96/206) vs 23.3% (14/60), χ2=10.37], and transfusion of blood products [68.9% (142/206) vs 33.3% (20/60), χ2=24.73] were found in the placenta previa group (all P<0.05). Furthermore, patients with placenta previa had more hemorrhage volume within 24 h postpartum [1 368 ml (970-2 026 ml) vs 995 ml (654-1 352 ml), Z=-3.66, P<0.001] in the segmental hysterectomy subgroup. After adjusting for the confounding factors such as age, number of previous cesarean sections, parity, gestational weight gain, twin pregnancy, and the use of assisted reproductive technology, binary logistic regression analysis found that placenta previa did not increase the risk of additional surgical operations ( aOR=2.71, 95% CI: 0.99-7.42) and adverse pregnancy outcomes ( aOR=2.14, 95% CI: 0.54-8.42) in patients with total/subtotal hysterectomy but were risk factors of the two outcomes for those with segmental hysterectomy ( aOR=4.67, 95% CI: 2.15-10.10; aOR=3.80, 95% CI: 1.86-7.77). Conclusions:Placenta previa increases the risk of additional surgical procedures and adverse pregnancy outcomes in patients with total/subtotal or segmental hysterectomy caused by PAS. Appropriate preparation is required after the clinical diagnosis of PAS with placenta previa.
7.Risk factors for infections after arthroscopic rotator cuff repair.
Jin-Jun LAI ; Xiao-Hong YU ; Yun-Gen HU ; Da-Wei BI ; Lei HAN
China Journal of Orthopaedics and Traumatology 2023;36(4):348-351
OBJECTIVE:
To explore risk factors for infections after arthroscopic rotator cuff repair, and improve the under standing for reducing infection.
METHODS:
Clinical data of 2 591 patients who underwent arthroscopic rotator cuff repair from January 2019 to January 2022 were retrospectively analyzed, including 1 265 males and 1 326 females, aged from 25 to 82 years old with an average age of (51.5±15.6) years old. They were divided into infection group(n=18) and uninfected group(n=2 573) according to whether or not patients had postoperative infection. Gender, age, smoking, diabetes, body mass index, local closure within 1 month before operation, operation time, preventive use of antibiotics, and internal fixation implantation between two groups were recorded. Univariate Logistic regression analysis screened factors associated with infections after arthroscopic rotator cuff repair. Theresultswere entered into the multivariate logistic regression analysis, screening the high risk factors for infections after arthroscopic rotator cuff repair.
RESULTS:
In 2 591 patients, 18 patients were infected after operation, infection rate was 0.69%. Univariate Logistic regression analysis showed that gender, age, operation time, antibiotic prophylaxis, internal fixation implantation were risk factors for infections after arthroscopic rotator cuff repair. Multivariate Logistic regression analysis showed male(OR=14.227), age≥65 years(OR=34.313), operation time≥2 h (OR=15.616), without antibiotic prophylaxis(OR=4.891), and internal fixation implantation(OR=5.103) were major risk factors for infection after arthroscopic rotator cuff repair(P<0.05).
CONCLUSION
Male, age≥65 years, operation time≥2 h, without antibiotic prophylaxis and internal fixation implantation were independent risk factors for infection after arthroscopic rotator cuff repair. Early diagnosis and timely treatment should be carried out to reduce the incidence of infection.
Female
;
Humans
;
Male
;
Adult
;
Middle Aged
;
Aged
;
Aged, 80 and over
;
Rotator Cuff
;
Rotator Cuff Injuries/surgery*
;
Retrospective Studies
;
Arthroscopy/adverse effects*
;
Risk Factors
;
Treatment Outcome
8.The impact of cesarean section frequency on the outcome of patients with placental implantation disease undergoing hysterectomy
Miao HU ; Yuliang ZHANG ; Shifeng GU ; Zhongjia GU ; Siying LAI ; Jingying LIANG ; Yu LIU ; Shilei BI ; Lili DU ; Lizi ZHANG ; Dunjin CHEN
Journal of Chinese Physician 2023;25(9):1290-1293
Objective:To investigate whether the number of previous cesarean sections affects the outcomes of patients with placental implantation disease undergoing hysterectomy.Methods:Using a retrospective cohort study design, the study samples were from the obstetric clinical database of the Third Affiliated Hospital of Guangzhou Medical University, and the study subjects were patients with placental implantation disease who underwent hysterectomy. Patients were grouped according to different previous cesarean section frequencies, and their clinical characteristics, surgical outcomes, and adverse maternal outcomes were compared in each group; The impact of previous cesarean sections on adverse outcomes in pregnant women was analyzed using multivariate logistic regression.Results:Among the 244 enrolled patients, 26 had no previous history of cesarean section (11%), 132 had a previous cesarean section once (54%), and 86 had a previous cesarean section ≥2 times (35%). There was no statistically significant difference in the usage rates of uterine artery embolization, suture hemostasis, and internal iliac artery embolization among the three groups of patients (all P>0.05). Among the adverse outcomes of pregnant and postpartum women, there was no statistically significant difference in the rates of shock, bladder injury, postpartum hemorrhage, postpartum hemorrhage >1 500 ml, admission to the intensive care unit (ICU), and transfusion of blood products among the three groups (all P>0.05). Univariate logistic regression analysis showed that the number of previous cesarean sections did not increase the risk of adverse outcomes, such as shock, postpartum hemorrhage, postpartum hemorrhage ≥1 500 ml, entry into the ICU, and transfusion of blood products. Multivariate logistic regression analysis found that the number of previous cesarean sections did not increase the risk of adverse outcomes in pregnant women. Conclusions:For patients with placental implantation disease undergoing hysterectomy, the number of previous cesarean sections may not be the main factor determining maternal outcomes. It is necessary to consider other possible influencing factors more comprehensively, including previous uterine surgery history, basic health status of pregnant women, comorbidities, and availability of medical resources.
9.Effect of acupuncture and moxibustion on intestinal flora in the rats with diarrhea-predominant irritable bowel syndrome based on 16S rDNA technique.
Bi-Yu LAI ; Meng-Ying HONG ; Yong-Jia HE ; Xing LI ; Shuang-Shuang WANG ; Yao CHEN ; Xin-Wu LI ; Jing NIE ; Dan LIU ; Chang SHE
Chinese Acupuncture & Moxibustion 2023;43(12):1411-1421
OBJECTIVES:
To explore the effect of acupuncture and moxibustion on intestinal flora in the rats with diarrhea-predominant irritable bowel syndrome (IBS-D) based on 16S rDNA technique.
METHODS:
Ten rats were randomized from 58 SPF-grade male SD rats to be the blank group. The remained 48 rats were prepared to be IBS-D models by the modified method of acetic acid enema combined with binding tail-clip stress. Forty successfully-modeled rats were randomly divided into a model group, an acupuncture group, a moxibustion group and a western medication group, with 10 rats in each one. In the acupuncture group, the needle was inserted at bilateral "Zusanli" (ST 36) and remained for 15 min in each rat. In the moxibustion group, the suspending moxibustion was delivered at bilateral "Zusanli" (ST 36) for 15 min. The rats in the western medication group were given pinaverium bromide suspension (10 mL/kg) by intragastric administration. The above interventions were performed once daily for consecutive 14 days. The body mass and the score of fecal trait were compared before and after modeling, as well as after intervention in each group. Fecal water content, diarrhea index and colon transit time (CTT) were measured after modeling and intervention in the rats of each group separately. After intervention, the colonic morphology of rats in each group was observed, and using 16S rDNA technique, the intestinal flora was detected.
RESULTS:
After modeling, compared with the blank group, the body mass and CTT were reduced (P<0.01); fecal trait scores, fecal water contents and diarrhea index increased (P<0.01) in the other 4 groups. After intervention, the body mass and CTT of the rats decreased (P<0.01), and fecal trait score, fecal water content and diarrhea index increased (P<0.01) in the model group compared with those in the blank group. In the acupuncture group, the moxibustion group and the western medication group, when compared with the model group, the body mass and CTT were elevated (P<0.01), while fecal trait scores, fecal water contents and diarrhea index declined (P<0.01). Compared with the western medication group, fecal water content decreased in the acupuncture group and the moxibustion group (P<0.05), while CTT increased in the acupuncture group (P<0.01), the body mass increased and fecal trait score was dropped in the moxibustion group (P<0.05). The colonic mucosa structure was clear and complete, and there was no obvious inflammatory cell infiltration in the blank group. The mild interstitial edema of intestinal mucosa was presented with the infiltration of few inflammatory cells in the model group. There was the infiltration of few inflammatory cells in the mucosa of the acupuncture group, the moxibustion group and the western medication group. Compared with the blank group, the indexes of Richness, Chao1, ACE and Shannon decreased in the model group (P<0.05). Indexes of Richness, Chao1 and ACE increased in the acupuncture group and the moxibustion group (P<0.05), and the Richness index in the western medication group increased (P<0.05) when compared with those in the model group. The relative abundance of Bacteroidetes, Proteobacteria and Prevotella increased (P<0.05), and that of Firmicutes and Muribaculaceae decreased (P<0.05) in the model group compared with those in the blank group. When compared with the model group, the relative abundance of Bacteroidetes, Proteobacteria and Prevotella was reduced (P<0.05), while that of Firmicutes and Muribaculaceae increased (P<0.05) in the acupuncture group, the moxibustion group and the western medication group; and that of Actinobacteria and Bifidobacterium increased in the acupuncture group and the moxibustion group (P<0.05). Compared with the blank group, the relative abundance of lipopolysaccharide (LPS) biosynthesis was elevated (P<0.05), and that of folate biosynthesis, lipoic acid metabolism, zeatin biosynthesis, ubiquinone and other terpenoid quinone biosynthesis decreased (P<0.05) in the model group. The relative abundance of LPS biosynthesis was dropped (P<0.05), and that of folate biosynthesis, lipoic acid metabolism, zeatin biosynthesis, ubiquinone and other terpenoid quinone biosynthesis increased (P<0.05) in the acupuncture group, the moxibustion group and the western medication group compared with those of the model group.
CONCLUSIONS
Either acupuncture or moxibustion can relieve the symptoms of IBS-D and protect intestinal mucosa, which may be associated with regulating the structure of intestinal flora and promoting nutrient metabolism and biosynthesis.
Rats
;
Male
;
Animals
;
Irritable Bowel Syndrome/therapy*
;
Moxibustion/methods*
;
Rats, Sprague-Dawley
;
Gastrointestinal Microbiome
;
Lipopolysaccharides
;
Thioctic Acid
;
Ubiquinone
;
Zeatin
;
Acupuncture Therapy
;
Diarrhea/therapy*
;
Terpenes
;
Water
;
Folic Acid
;
Acupuncture Points
10.A phase Ⅲ multi-center clinical trial on safety and efficacy of a domestic plasma derived factor Ⅸ for the treatment of patients with hemophilia B.
Wei LIU ; Rong Feng FU ; Ya Wei ZHOU ; Yun CHEN ; Jie YIN ; Zi Qiang YU ; Lin Hua YANG ; Mei Fang WANG ; Hui BI ; Ze Ping ZHOU ; Xin Sheng ZHANG ; Jie Lai XIA ; Ren Chi YANG
Chinese Journal of Hematology 2018;39(5):404-407
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.
Adult
;
China
;
Factor IX
;
Hemophilia A
;
Hemophilia B/therapy*
;
Hemorrhage
;
Humans
;
Plasma

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