In recent years, new orthopaedic implantable devices continue to emerge, which require higher requirements for technical evaluation. Animal study is an important part of the research and development process for the new orthopedic implantable devices, which provides relevant evidence for product design and stereotyping. By introducing the purpose of animal study, and the application of 3R principle (replacement, reduction, refinement) in this field, we summarize the concern on the animal study, in order to provide reference for the development and research of new orthopedic implantable devices and biomaterials. At the same time, the application of evidence-based research methods such as systematic review in the field is introduced, which provides new tools and approaches for the technical review and regulatory science.
Animals ; Orthopedics ; Biocompatible Materials ; Prostheses and Implants ; Research Design

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.
Ossicular Prosthesis ; Ossicular Replacement ; Sound ; Prosthesis Design ; Treatment Outcome

Objective: To analyze the clinical characteristics of children with Burkitt lymphoma (BL) and to summarize the mid-term efficacy of China Net Childhood Lymphoma-mature B-cell lymphoma 2017 (CNCL-B-NHL-2017) regimen. Methods: Clinical features of 436 BL patients who were ≤18 years old and treated with the CNCL-B-NHL-2017 regimen from May 2017 to April 2021 were analyzed retrospectively. Clinical characteristics of patients at disease onset were analyzed and the therapeutic effects of patients with different clinical stages and risk groups were compared. Survival analysis was performed by Kaplan-Meier method, and Cox regression was used to identify the prognostic factors. Results: Among 436 patients, there were 368 (84.4%) males and 68 (15.6%) females, the age of disease onset was 6.0 (4.0, 9.0) years old. According to the St. Jude staging system, there were 4 patients (0.9%) with stage Ⅰ, 30 patients (6.9%) with stage Ⅱ, 217 patients (49.8%) with stage Ⅲ, and 185 patients (42.4%) with stage Ⅳ. All patients were stratified into following risk groups: group A (n=1, 0.2%), group B1 (n=46, 10.6%), group B2 (n=19, 4.4%), group C1 (n=285, 65.4%), group C2 (n=85, 19.5%). Sixty-three patients (14.4%) were treated with chemotherapy only and 373 patients (85.6%) were treated with chemotherapy combined with rituximab. Twenty-one patients (4.8%) suffered from progressive disease, 3 patients (0.7%) relapsed, and 13 patients (3.0%) died of treatment-related complications. The follow-up time of all patients was 24.0 (13.0, 35.0) months, the 2-year event free survival (EFS) rate of all patients was (90.9±1.4) %. The 2-year EFS rates of group A, B1, B2, C1 and C2 were 100.0%, 100.0%, (94.7±5.1) %, (90.7±1.7) % and (85.9±4.0) %, respectively. The 2-year EFS rates was higher in group A, B1, and B2 than those in group C1 (χ²=4.16, P=0.041) and group C2 (χ²=7.21, P=0.007). The 2-year EFS rates of the patients treated with chemotherapy alone and those treated with chemotherapy combined with rituximab were (79.3±5.1)% and (92.9±1.4)% (χ²=14.23, P<0.001) respectively. Multivariate analysis showed that stage Ⅳ (including leukemia stage), serum lactate dehydrogenase (LDH)>4-fold normal value, and with residual tumor in the mid-term evaluation were risk factors for poor prognosis (HR=1.38,1.23,8.52,95%CI 1.05-1.82,1.05-1.43,3.96-18.30). Conclusions: The CNCL-B-NHL-2017 regimen show significant effect in the treatment of pediatric BL. The combination of rituximab improve the efficacy further.
Adolescent ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Burkitt Lymphoma/drug therapy* ; Child ; Disease-Free Survival ; Female ; Humans ; Lactate Dehydrogenases ; Lymphoma, B-Cell/drug therapy* ; Male ; Prognosis ; Retrospective Studies ; Rituximab/therapeutic use* ; Treatment Outcome

Child ; Humans ; COVID-19 ; SARS-CoV-2 ; Hospitals, Pediatric

Objective: To investigate the diagnostic value of rapid antigen test based on colloidal gold immunochromatographic assay for the detection of SARS-CoV-2 infection in symptomatic patients. Methods: From May 20 to June 5 2022, 76 hospitalized children and their 55 accompanying family members with confirmed SARS-CoV-2 infection in the COVID-19 isolation unit of the Children's Hospital of Fudan University (designated referral hospital for SARS-CoV-2 infection in Shanghai) enrolled. Their nasopharyngeal swab specimens were consecutively collected. The samples were tested for SARS-CoV-2 nucleic acid by real-time quantitative. SARS-CoV-2 antigen was tested by immunochromatography. The correlation between the antigen detection results and the change of the cycle threshold (Ct) values were evaluated, as well as the sensitivity and specificity of SARS-CoV-2 antigen detection at different periods after the onset of the disease. Kappa consistency test was conducted to investigate the consistency between the 2 diagnostic methods. Results: Of the enrolled SARS-CoV-2 symptomatic infections, 76 were children, including 41 males and 35 females, with an age of 5 (2, 9) years; 55 were accompanying families, including 8 males and 47 females, with an age of 38 (32, 41) years. All 478 samples were simultaneously tested for SARS-CoV-2 antigen and nucleic acid. In any period from disease onset to negative conversion of viral nucleic acid, the overall sensitivity of the rapid antigen test was 48.2% (119/247), the specificity was 98.3% (227/231), and antigen test and nucleic acid test showed moderate consistency (κ=0.46, P<0.05). The sensitivity of antigen test was 100% (82/82) when the Ct value was ≤25. And the sensitivity of antigen test was 8/10, 4/15 and 8.3% (3/36) when the Ct value was 26, 30 and 35, respectively. All antigen tests were negative when Ct value was >35. During the period of 1-2 days, 3-5 days, 6-7 days, 8-10 days and >10 days after onset, the sensitivity and specificity of SARS-CoV-2 antigen test were 5/8 and 5/5, 90.2% (37/41) and 5/5, 88.9% (24/27) and 2/5, 45.0% (36/80) and 94.1% (32/34), 18.7% (17/91) and 98.9% (183/185) respectively. The Ct values of nasopharyngeal swabs were<26 during 2 to 7 days after onset, 28.7±5.0 on day 8, 34.5±2.9 on day 13 and > 35 after 14 days, respectively . Conclusion: SARS-CoV-2 antigen test in the patients with SARS-CoV-2 infection shows acceptable sensitivity and specificity within 7 days after onset of disease, and the sensitivity was positively correlated with viral load and negatively correlated with onset time.
Male ; Child ; Female ; Humans ; COVID-19 ; SARS-CoV-2 ; China ; COVID-19 Testing ; Nucleic Acids

Objective:To investigate the clinical application of noninvasive high frequency oscillatory ventilation(nHFOV)and heated humidified high flow nasal cannula(HHHFNC)in sequential ventilator evacuation of preterm infants with very low birth weight with respiratory distress syndrome(RDS).Methods:A total of 88 preterm infants of very low birth weight with RDS were enrolled in the study, who had received endotracheal intubation invasive ventilation and were ready to be replaced by non-invasive ventilation at neonatal intensive care unit(NICU)of Xuzhou Central Hospital from May 2017 to January 2020.All premature infants were routinely treated with caffeine citrate.They were divided into two groups through random number table: nHFOV/HHHFNC group(45 cases)and continuous positive airway pressure(nCPAP)/oxygen hood group(43 cases). nHFOV was given after invasive ventilator removal and HHHFNC transition was followed after nHFOV withdrawal in the nHFOV/HHHFNC group, while nCPAP was given after invasive ventilator removal and oxygen hood was followed after nCPAP withdrawal in the nCPAP/oxygen hood group.The main observation consequences were compared with arterial blood gas indexes after invasive ventilator evacuation, weaning effect and the incidence of related complications.Results:(1)There were no statistically differences between the two groups in terms of gender, gestational age, birth weight, Apgar score at 1 min and 5 min after birth, the number of glucocorticoid usage in 24 h before delivery, the number of pulmonary surfactant usage, invasive ventilation time and RDS grading( P>0.05). (2)The PaO 2, PaCO 2and oxygenation index(OI=100×MAP×FiO 2/PaO 2)of the nHFOV/HHHFNC group at 1 h and 24 h after invasive ventilator removal showed significant difference compared with the nCPAP/oxygen hood group( P<0.05). The differences as the following listed were statistically significant( P<0.05)between the two groups, including the failure rate of invasive ventilation weaning during 72 h [9%(4/45)vs.26%(11/43)], the incidence of frequent apnea [7%(3/45)vs.23%(10/43)], the failure rate of nHFOV and nCPAP noninvasive ventilation weaning [4%(2/45)vs.21%(9/43)], the oxygen-used time [12.02(9.08~12.31)d vs.14.44(11.32~13.26)d] and the incidence of nasal injury [4%(2/45)vs.26%(11/43)]. (3)The time of the first noninvasive ventilation of nHFOV and nCPAP, the incidences of lung air leakage, neonatal necrotizing enterocolitis, grade Ⅲ to Ⅳ intraventricular hemorrhage, above stageⅡretinopathy, bronchopulmonary dysplasia and the mortality rate between the two groups showed no statistical significance( P>0.05). Conclusion:nHFOV and HHHFNC used in the sequential ventilator evacuation of RDS in preterm infants with very low birth weight could improve oxygenation, reduce CO 2retention, improve the success rate of machine weaning and reduce the occurrence of apnea and nasal injury.

Aim To investigate whether adiponectin is involved in the protective effect of sevoflurane preconditioning on myocardial ischemia/reperfusion (MI/R) injury. Methods C57 mice were randomly divided into four groups; the Sham Control (sham group), the MI/R-Control (model group), the MI/R-Sevopre (pretreatment group) and the APN-KO-MI/R-Sevopre (knockout pretreatment group). The plasma adiponectin level was detected 24 h after MI/R modeling. Meanwhile, the left ventricular end-systolic diameter, end-diastolic diameter and ejection fraction were measured at 24 h. In addition, TUNEL staining was used to detect the left ventricular end-systolic diameter, end-diastolic diameter and ejection fraction and the morphology and apoptosis of myocardial cells in each group were observed. What' s more, the infarct area was observed by Evans blue TTC staining. Results Compared with sham group, model group had impaired heart function, decreased ejection fraction and increased end-diastolic and end-systolic diameters. Meanwhile, the myocardial infarction area and apoptotic cells significantly increased in model group, and the plasma adiponectin level decreased. However, compared with model group, mice in sevoflurane pretreatment group had improved heart function, decreased myocardial infarction area, decreased apoptotic cells and increased plasma adiponectin levels. And then, compared with pretreatment group, sevoflurane pretreatment in knockout pretreatment group reduced Ml/R injury. Conclusion The sevoflurane pretreatment protects MI/R injury by increasing plasma adiponectin levels.

Objective To develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method for the determination of oleandrin in blood and liver tissues, which could be applied to the cases of death caused by oleander poisoning.Methods Blood or liver tissues underwent a liquidliquid extraction (LLE) using ethyl acetate, and the extract was separated on an Agilent ZORBAX SB-C18column and eluted with a gradient of acetonitrile and 20 mmol/L ammonium acetate (containing0.1％formic acid).Oleandrin was detected using electrospray positive ionization (ESI+) with multiplereaction monitoring (MRM) mode.Results Oleandrin showed excellent linearity in both blood and liver samples in the corresponding linear range (r＞0.995 0), with detection limits 1 ng/mL and 2 ng/g, respectively, extraction recovery rates greater than 70.50％, both intra-and inter-day precisions less than10.71％, accuracies 98.42％-111.63％, and matrix effects 91.52％-106.39％.The method was successfully applied to a case of suspected oleander poisoning.Oleandrin was detected in the blood, urine, liver tissues, bile, stomach wall tissues and stomach contents of the cadaver, with the content ranging from65.5 to 29 600.0 ng/mL (ng/g).Conclusion The method developed in this study is simple and convenient to operate with good selectivity, and is suitable for the analysis of oleandrin in biological samples such as blood and liver tissues, which can provide technical support for forensic identification and clinical diagnosis and treatment of oleander poisoning.

OBJECTIVES: To detect the genotype of ABO blood group by SNaPshot technology. METHODS: DNA were extracted from the peripheral blood samples with known blood groups （obtained by serology） of 107 unrelated individuals in Yunnan. Six SNP loci of the 261th, 297th, 681th, 703th, 802th, and 803th nucleotide positions were detected by SNaPshot Multiplex kit, and relevant genetics parameters were calculated. RESULTS: In 107 blood samples, the allele frequencies of types A, B, O^A, and O^G were 0.355 1, 0.168 2, 0.230 0 and 0.247 6, respectively, while that of types A^G and cis AB were not detected. The genotyping results of ABO blood group were consistent with that of serologic testing. CONCLUSIONS SNaPshot technology can be adapted for genotyping of ABO blood group.
ABO Blood-Group System/genetics* ; Alleles ; Asian People/genetics* ; China ; DNA ; Ethnicity ; Gene Frequency ; Genotype ; Humans ; Polymerase Chain Reaction/methods* ; Polymorphism, Restriction Fragment Length

Objective: To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis. METHODS: This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients. RESULTS: Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P < 0.05) but showed no statistically significant difference from that at 4 weeks after drug withdrawal (19.03 ± 3.86) (P>0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05). CONCLUSIONS BDG is safe and effective for the treatment of type Ⅲ prostatitis.
Capsules ; Chronic Disease ; Delayed-Action Preparations ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Male ; Prostatitis ; drug therapy ; pathology ; Sulfonamides ; adverse effects ; therapeutic use ; Tamsulosin ; Treatment Outcome ; Urological Agents ; adverse effects ; therapeutic use