1.Risk factors for knee injury complicated with adolescent tibial tubercle fractures
Qingshuang ZHANG ; Jinchen CHEN ; Linkun WU ; Yuancheng PAN ; Song CHEN ; Ran LIN ; Shunyou CHEN
Chinese Journal of Orthopaedic Trauma 2025;27(8):695-701
Objective:To systematically analyze the risk factors for knee injury complicated with adolescent tibial tubercle fractures (ATTF).Methods:A retrospective study was conducted to analyze the clinical data of the 90 adolescent patients (the observation group) who had been treated and fully followed up for knee injury complicated with ATTF at Department of Pediatric Orthopedics, The Second General Hospital of Fuzhou from September 2017 to April 2024. There were 86 males and 4 females, with a mean age of 14.0 (13.0, 14.0) years. The injury was on the left side in 51 cases, on the right side in 34 ones, and on the bilateral sides in 5 ones. All their injuries resulted from sports activities. In addition, another contemporary 90 patients with knee injury but no exercise-induced ATTF were enrolled as the control group, including 54 males and 36 females with a mean age of 14.0 (13.0, 14.3) years. Their injury was on the left side in 45 cases, on the right side in 41 ones, and on the bilateral sides in 4 ones. Univariate analysis was conducted to compare gender, age, injury side, height, weight, body mass index, history of Osgood-Schlatter disease (OSD), and injury mechanism between the 2 groups. Variables with P<0.1 were included in a multivariate logistic regression analysis to screen independent risk factors for ATTF. The receiver operating characteristic (ROC) curve was used to evaluate their predictive values. The optimal cutoff value was determined by Youden index. Results:The univariate analysis showed that gender, height, weight, body mass index, and OSD history were significantly correlated with the occurrence of ATTF ( P<0.05). The multivariate logistic regression analysis further confirmed that male ( P=0.017), height ( P=0.021), weight ( P=0.014), body mass index ( P=0.032) and history of OSD ( P=0.003) were independent risk factors for ATTF. The ROC curve analysis showed that weight had the largest area under the curve (AUC) in prediction of the ATTF risk, suggesting that its predictive value was the most significant. Conclusion:Male, height, weight, body mass index, and prior OSD are independent risk factors for ATTF, with the highest predictive value in weight.
2.Risk factors for knee injury complicated with adolescent tibial tubercle fractures
Qingshuang ZHANG ; Jinchen CHEN ; Linkun WU ; Yuancheng PAN ; Song CHEN ; Ran LIN ; Shunyou CHEN
Chinese Journal of Orthopaedic Trauma 2025;27(8):695-701
Objective:To systematically analyze the risk factors for knee injury complicated with adolescent tibial tubercle fractures (ATTF).Methods:A retrospective study was conducted to analyze the clinical data of the 90 adolescent patients (the observation group) who had been treated and fully followed up for knee injury complicated with ATTF at Department of Pediatric Orthopedics, The Second General Hospital of Fuzhou from September 2017 to April 2024. There were 86 males and 4 females, with a mean age of 14.0 (13.0, 14.0) years. The injury was on the left side in 51 cases, on the right side in 34 ones, and on the bilateral sides in 5 ones. All their injuries resulted from sports activities. In addition, another contemporary 90 patients with knee injury but no exercise-induced ATTF were enrolled as the control group, including 54 males and 36 females with a mean age of 14.0 (13.0, 14.3) years. Their injury was on the left side in 45 cases, on the right side in 41 ones, and on the bilateral sides in 4 ones. Univariate analysis was conducted to compare gender, age, injury side, height, weight, body mass index, history of Osgood-Schlatter disease (OSD), and injury mechanism between the 2 groups. Variables with P<0.1 were included in a multivariate logistic regression analysis to screen independent risk factors for ATTF. The receiver operating characteristic (ROC) curve was used to evaluate their predictive values. The optimal cutoff value was determined by Youden index. Results:The univariate analysis showed that gender, height, weight, body mass index, and OSD history were significantly correlated with the occurrence of ATTF ( P<0.05). The multivariate logistic regression analysis further confirmed that male ( P=0.017), height ( P=0.021), weight ( P=0.014), body mass index ( P=0.032) and history of OSD ( P=0.003) were independent risk factors for ATTF. The ROC curve analysis showed that weight had the largest area under the curve (AUC) in prediction of the ATTF risk, suggesting that its predictive value was the most significant. Conclusion:Male, height, weight, body mass index, and prior OSD are independent risk factors for ATTF, with the highest predictive value in weight.
3.Evaluation of the efficacy and safety of human coagulation factor Ⅷ in the treatment of hemophilia A patients
Ruyi CHEN ; Yan WU ; Yiyun LIU ; Mingxia HOU ; Qingshuang SONG ; Xuanlin ZHONG ; Xueyun WANG ; Wenjie XIE ; Caiping GUO ; Zhan ZHANG ; Yunjia ZHANG
Chinese Journal of Blood Transfusion 2022;35(12):1220-1225
【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.
4.A multicenter phase Ⅲ clinical study of human prothrombin complex concentrate in treatment of hemophilia B
Wei ZHANG ; Yirun LIU ; Yan WU ; Xuanlin ZHONG ; Qingshuang SONG ; Shitao CHEN ; Xueyun WANG ; Caiping GUO ; Zhan ZHANG ; Yunjia ZHANG
Chinese Journal of Blood Transfusion 2022;35(9):915-919
【Objective】 To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B. 【Methods】 The clinical data of 36 patients with hemophilia B treated with human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. from May 2018 to April 2019 were retrospectively analyzed, and its clinical efficacy and safety were analyzed. 【Results】 A total of 35 subjects entered the full analysis set (FAS)and safety set (SS), 33 subjects entered the per protocol Set (PPS). Thirty minutes after the first infusion of FAS subjects, the activity of coagulation factor Ⅸ increased from (3.93±0.975) IU/dL to (25.61±9.337) IU/dL, and the infusion efficiency was (96.43±22.007)%. The increased value of coagulation factor Ⅱ activity was (73.25±14.874) IU/dL. The activity of coagulation factor Ⅶ was (42.79±16.847) IU/dL. The increased value of coagulation factor Ⅹ activity was (65.29±17.042) IU/dL. The increased value of coagulation factor Ⅸ activity was (21.68±9.434%) IU/dL. Twenty-four hours after the first infusion of FAS subjects, the improvement of bleeding symptoms and signs was excellent in 21 cases (60%), improved in 14 cases (40.0%), and the effective rate was 100%. The incidence of adverse reactions was 2.9%(1/35), and there was no antibody to human coagulation factor Ⅸ and new virus infection. 【Conclusion】 Infusion of human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. in the treatment of hemophilia B has significant clinical efficacy and good safety.

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