1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
2.Expert Consensus of Multidisciplinary Diagnosis and Treatment for Paroxysmal Nocturnal Hemoglobinuria(2024)
Miao CHEN ; Chen YANG ; Ziwei LIU ; Wei CAO ; Bo ZHANG ; Xin LIU ; Jingnan LI ; Wei LIU ; Jie PAN ; Jian WANG ; Yuehong ZHENG ; Yuexin CHEN ; Fangda LI ; Shunda DU ; Cong NING ; Limeng CHEN ; Cai YUE ; Jun NI ; Min PENG ; Xiaoxiao GUO ; Tao WANG ; Hongjun LI ; Rongrong LI ; Tong WU ; Bing HAN ; Shuyang ZHANG ; MULTIDISCIPLINE COLLABORATION GROUP ON RARE DISEASE AT PEKING UNION MEDICAL COLLEGE HOSPITAL
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1011-1028
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal hematopoietic stem cell disease caused by abnormal expression of glycosylphosphatidylinositol (GPI) on the cell membrane due to mutations in the phosphatidylinositol glycan class A(PIGA) gene. It is commonly characterized by intravascular hemolysis, repeated thrombosis, and bone marrow failure, as well as multiple systemic involvement symptoms such as renal dysfunction, pulmonary hypertension, swallowing difficulties, chest pain, abdominal pain, and erectile dysfunction. Due to the rarity of PNH and its strong heterogeneity in clinical manifestations, multidisciplinary collaboration is often required for diagnosis and treatment. Peking Union Medical College Hospital, relying on the rare disease diagnosis and treatment platform, has invited multidisciplinary clinical experts to form a unified opinion on the diagnosis and treatment of PNH, and formulated the
3.Early gait analysis after total knee arthroplasty based on artificial intelligence dynamic image recognition
Ming ZHANG ; Ya-Nan SUI ; Cheng WANG ; Hao-Chong ZHANG ; Zhi-Wei CAI ; Quan-Lei ZHANG ; Yu ZHANG ; Tian-Tian XIA ; Xiao-Ran ZU ; Yi-Jian HUANG ; Cong-Shu HUANG ; Xiang LI
China Journal of Orthopaedics and Traumatology 2024;37(9):855-861
Objective To explore early postoperative gait characteristics and clinical outcomes after total knee arthroplasty(TKA).Methods From February 2023 to July 2023,26 patients with unilateral knee osteoarthritis(KOA)were treated with TKA,including 4 males and 22 females,aged from 57 to 85 years old with an average of(67.58±6.49)years old;body mass in-dex(BMI)ranged from 18.83 to 38.28 kg·m-2 with an average of(26.43±4.15)kg·m-2;14 patients on the left side,12 pa-tients on the right side;according to Kellgren-Lawrence(K-L)classification,6 patients with grade Ⅲ and 20 patients with grade Ⅳ;the courses of disease ranged from 1 to 14 years with an average of(5.54±3.29)years.Images and videos of standing up and walking,walking side shot,squatting and supine kneeling were taken with smart phones before operation and 6 weeks after operation.The human posture estimation framework OpenPose were used to analyze stride frequency,step length,step length,step speed,active knee knee bending angle,stride length,double support phase time,as well as maximum hip flexion angle and maximum knee bending angle on squatting position.Western Ontario and McMaster Universities(WOMAC)arthritis index and Knee Society Score(KSS)were used to evaluate clinical efficacy of knee joint.Results All patients were followed up for 5 to 7 weeks with an average of(6.00±0.57)weeks.The total score of WOMAC decreased from(64.85±11.54)before op-eration to(45.81±7.91)at 6 weeks after operation(P<0.001).The total KSS was increased from(101.19±9.58)before opera-tion to(125.50±10.32)at 6 weeks after operation(P<0.001).The gait speed,stride frequency and stride length of the affected side before operation were(0.32±0.10)m·s-1,(96.35±24.18)steps·min-1,(0.72±0.14)m,respectively;and increased to(0.48±0.11)m·s 1,(104.20±22.53)steps·min-1,(0.79±0.10)m at 6 weeks after operation(P<0.05).The lower limb support time and active knee bending angle decreased from(0.31±0.38)sand(125.21±11.64)° before operation to(0.11±0.04)s and(120.01±13.35)° at 6 weeks after operation(P<0.05).Eleven patients could able to complete squat before operation,13 patients could able to complete at 6 weeks after operation,and 9 patients could able to complete both before operation and 6 weeks after operation.In 9 patients,the maximum bending angle of crouching position was increased from 76.29° to 124.11° before operation to 91.35° to 134.12° at 6 weeks after operation,and the maximum bending angle of hip was increased from 103.70° to 147.25° before operation to 118.61° to 149.48° at 6 weeks after operation.Conclusion Gait analysis technology based on artificial intelligence image recognition is a safe and effective method to quantitatively identify the changes of pa-tients'gait.Knee pain of KOA was relieved and the function was improved,the supporting ability of the affected limb was im-proved after TKA,and the patient's stride frequency,stride length and stride speed were improved,and the overall movement rhythm of both lower limbs are more coordinated.
4.Randomized controlled study on treatment of intertrochanteric fracture of femur with proximal femoral nail antirotation assisted by robot navigation
Xi-Cong CHEN ; Jian CAI ; Hui-Liang ZENG ; Guo-Cai CHEN ; Guan-Ming ZHOU
Journal of Regional Anatomy and Operative Surgery 2024;33(9):768-772
Objective To investigate the therapeutic effects of proximal femoral nail antirotation(PFNA)assisted by robot navigation and PFNA guided by C-arm X-ray machine for the treatment of intertrochanteric fracture of femur(IFOF).Methods The 100 patients with unilateral IFOF in our hospital were selected as the study subjects.They were divided into the control group(50 cases)and the robot-assisted group(50 cases)according to random number table method.The control group was treated with PFNA internal fixation under C-arm X-ray machine fluoroscopy,and the robot-assisted group was treated with PFNA internal fixation assisted by robot navigation.Surgical indicators,fracture reduction and fracture healing,stress response indexes,hip joint function,quality of life score and incidence of surgery related complications were compared between the two groups.Results The operation time,total fluoroscopy time,nail placement time and fracture healing time of the robot-assisted group were shorter than those of the control group(P<0.05);and the intraoperative blood loss,guide needle adjustment frequency,and fluoroscopy frequency of the robot-assisted group were less than those of the control group(P<0.05).The fracture reduction and fracture healing in the robot-assisted group were better than those in the control group(P<0.05).Two days after operation,the levels of serum norepinephrine(NE),angiotensin Ⅱ(Ang Ⅱ)and superoxide dismutase(SOD)in the two groups were higher than those before operation(P<0.05),and the levels of serum NE,Ang Ⅱ and SOD in the robot-assisted group were lower than those in the control group(P<0.05).The Harris score and 36-item short-form(SF-36)score of patients 7 days and 3 months after surgery in the two groups were higher than those before surgery(P<0.05),and the above scores 3 months after surgery were higher than those 7 days after surgery(P<0.05).Harris score and SF-36 score 7 days and 3 months after operation in the robot-assisted group were higher than those in the control group(P<0.05).The incidence of complications in the robot-assisted group was lower than that in the control group(P<0.05).Conclusion Compared with the C-arm X-ray machine fluoroscopy,the treatment of IFOF with PFNA assisted by robot navigation can further shorten the operation time,reduce the surgical trauma and the incidence of complications,achieve better effect of fracture reduction and healing,reduce stress response of the body,and improve hip joint function and quality of life for patients.
5.Efficacy and Mechanism of Yishen Shengjing Prescription in Treatment of Oligoasthenospermia
Yu-jie HU ; Yan-tong XU ; Jian GAO ; Cong CHEN ; Jia-lin LI ; Cai ZHANG ; Quan-tao MA ; Xiao-yao LIU ; Wei-ling WANG ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(11):93-101
ObjectiveWe aimed to investigate the efficacy and mechanism of Yishen Shengjing Prescription (YSP) in the treatment of oligoasthenospermia in rats. MethodThe oligoasthenospermia rat model was established by injection with cyclophosphamide (35 mg·kg-1·d-1) for 5 consecutive days. Rats were randomly assigned into control group (without treating with cyclophosphamide), model group, low- (YSP-L), medium- (YSP-M), and high- (YSP-H) dose (2.91, 5.83, and 11.66 g·kg-1, respectively) groups, Wuzi Yanzongwan (WYW, 1.03 g·kg-1) group, and L-carnitine (0.17 g·kg-1) group, with 8 rats in each group. After 28 days of drug intervention, the body weight, testicular weight, and testicular index of rats were recorded. The sperm quality in epididymis was detected by computer-assisted sperm analysis (CASA) system. Hematoxylin-eosin (HE) staining was employed for observation of testicular tissue morphology. The levels of malondialdehyde (MDA) and superoxide dismutase (SOD) in testicular tissue were detected by colorimetry. The levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone (T) in serum were determined by enzyme-linked immunosorbent assay(ELISA). TdT-mediated dUTP nick-end labeling (TUNEL) was employed to detect the apoptosis of testicular cells. The protein levels of B cell lymphoma-2(Bcl-2), Bax, and cleaved Caspase-3 in testicular tissue were detected by Western blot. ResultCompared with the control group, the model group showed decreased body weight, testicular weight and index, sperm concentration and motility (P<0.01) and increased testicular pathological score (P<0.01). Compared with the model group, the YSP-M, YSP-H, WYW, and L-carnitine groups showed increased body weight, testicular weight, testicular index, sperm concentration and motility and decreased testicular pathological score. After modeling, the SOD level decreased (P<0.01) while the MDA content increased (P<0.01) in the testicular tissue. YSP-H, WYW, and L-carnitine reversed the SOD and MDA level changes caused by modeling. Compared with the control group, the model group exhibited declined T level (P<0.01) and increased FSH and LH levels (P<0.01). Compared with the model group, YSP, WYW, and L-carnitine increased the T level (P<0.01) and decreased the LH level (P<0.05, P<0.01). The apoptosis rate of spermatogenic cells in the model group was higher than that in the control group (P<0.01), whereas YSP-M, WYW, and L-carnitine reversed such changes (P<0.01). The model group rats showed decreased expression of Bcl-2(P<0.05) and increased expression of Bax and cleaved Caspase-3 (P<0.05, P<0.01). Compared the model group, YSP-M, YSP-H, WYW, and L-carnitine up-regulated the Bcl-2 expression and down-regulated the cleaved Caspase-3 expression (P<0.05, P<0.01). ConclusionYSP improved the sperm quality of oligoasthenospermia model rats by regulating the antioxidant system and sex hormone levels and inhibiting the apoptosis of spermatogenic cells.
6.Determination of paclitaxel prodrug in SD rat plasma by LC-MS/MS and its application in preclinical pharmacokinetic studies
Guo-cai WANG ; Xiang-yi WANG ; Cong-cong XIAO ; Jian-peng HUANG ; Meng YU ; Jiu-ming HE
Acta Pharmaceutica Sinica 2022;57(9):2798-2804
A fast and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of prodrug of paclitaxel (Pro-PTX) and paclitaxel (PTX) in rat plasma was developed. The plasma samples were subjected to protein precipitation with acetonitrile (0.1% formic acid), and then separated by LC with an Ultimate AQ-C18 column (50 mm × 3.0 mm, 3 μm) and acetonitrile-1 mmol·L-1 ammonium formate (containing 0.1% formic acid) as the mobile phase. Multiple reaction monitoring (MRM) scanning mode was used to detect the ion responses
7.Virtual reality-assisted management of communicated solitary fibrous tumor in skull base: a case report.
Wang Hu ZHENG ; Chao LI ; Yu Qiu ZHOU ; Yong Cong CAI ; Teng LI ; Jian JIANG ; Rong Hao SUN ; Chun Yan SHUI ; Xu WANG ; Tian Qi HE ; Yu Dong NING ; Gang QIN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2022;57(1):65-68
8.Resection of submandibular gland and tumor via transaxillary gasless endoscopy: a case report.
Xiao Lei CHEN ; Chao LI ; Yu Qiu ZHOU ; Yu Dong NING ; Yong Cong CAI ; Rong Hao SUN ; Chun Yan SHUI ; Xu WANG ; Tian Qi HE ; Wang Hu ZHENG ; Jian JIANG ; Chao Ran XU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2022;57(2):212-214
9.Study on the production efficiency of platelet components in 24 prefecture-level blood stations in China
Minyu HUA ; Wei NIU ; Jian YAO ; Shouguang XU ; Yuxia QIU ; Li LI ; Dongmei ZHAO ; JiaYu WAN ; Feng YAN ; Hongzhi JIA ; Hao LI ; Jiaqi QIIAN ; Peng WANG ; Zhenxing WANG ; Lin BAO ; Shan WEN ; Sheng YE ; Xuefang FENG ; Man ZHANG ; Xiaobo CAI ; Wei ZHANG ; Dexu CHU ; Youhua SHEN ; Peifang CONG ; Hui ZHANG ; Yan QIU
Chinese Journal of Blood Transfusion 2022;35(9):937-942
【Objective】 To learn the production efficient of platelet components among prefecture-level blood stations in China, to provide supporting data for those blood stations to optimize the production mode of platelet components and continuously improve production efficiency and supply capacity. 【Methods】 The data from 2017 to 2020 was obtained from 24 prefecture-level blood stations who were the members of the practice comparison network for blood institutes in China. The collection units of apheresis platelets, the number of dual-collections of apheresis platelets and plasma, the average apheresis units of one platelet apheresis procedure, the discarded rate of apheresis platelets, the amount of expired apheresis platelets and the amount of apheresis platelets issued were collected. For concentrated platelets, the prepared amount of platelet concentrates and the amount of expired platelet concentrates were collected; both the quantity of qualified and issued concentrated platelets were submitted for statistical analysis.The total output and efficiency of platelet components were calculated based on the collected data. 【Results】 The average annual growth rate of apheresis platelets collection in 24 prefecture-level blood stations was 12.23%, accounting for 99.80% of the total platelet output; the average collection unit of one platelets apheresis procedure was 1.75; from 2019 to 2020, only 5 blood stations performed dual-collection of platelet and plasma during one apheresis procedure; the discarded rate of apheresis platelets was 0.28%, of which 0.007% was due to expiration. A total of 1 621.2 therapeutic units of concentrated platelets were prepared, and 13.03% of them was discarded due to the expiration. The production efficiency of platelet components was 97.56%, of which the production efficiency of apheresis platelets was 97.61% and the production efficiency of concentrated platelets was 74.43%. 【Conclusion】 There are large regional differences in the supply capacity of platelet components in prefecture-level blood stations. Apheresis platelets are the main resource of platelet components product, and the collection capacity is increasing over the years with the characteristics of high production efficiency and low expiration scrapping rate. However, the preparation of concentrated platelets are still limited with relatively low production and high expiration discarded rate.
10.Repair of mandibular defects with free iliac musculocutaneous flap assisted by digital and 3D printing technology: a case report.
Xu WANG ; Chao LI ; Tian Qi HE ; Wang Hu ZHENG ; Wei LIU ; Yu Yao ZHANG ; Xiao Lei CHEN ; Yu Qiu ZHOU ; Chun Yan SHUI ; Yu Dong NING ; Yong Cong CAI ; Jian JIANG ; Rong Hao SUN ; Wei WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2021;56(1):89-92

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