OBJECTIVE: To investigate the diagnostic efficacy of ^99mTc-MDP three-phase bone scintigraphy (TPBS) combined with C-reactive protein (CRP) for periprosthetic joint infection (PJI). METHODS: The clinical data of 198 patients who underwent revision surgery of artificial joint between January 2017 and January 2024 and received TPBS examination before surgery were retrospectively analyzed. There were 77 males and 121 females with an average age of 63.74 years ranging from 24 to 92 years. There were 90 cases of hip arthroplasty and 108 cases of knee arthroplasty. PJI was diagnosed according to the 2013 American Musculoskeletal Infection Society (MSIS) standard diagnostic criteria. The sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predict value (PPV) were calculated. The receiver operating characteristic (ROC) curve was used to compare the diagnostic performance of the three methods, and the area under curve (AUC) was used to evaluate the diagnostic performance. RESULTS: According to the 2013 MSIS criteria, 116 cases were diagnosed as PJI, and the remaining 82 cases were aseptic loosening. The cases of PJI diagnosed by TPBS, CRP, and TPBS-CRP were 125, 109, and 137 respectively, and the cases of aseptic loosening were 73, 89, and 61 respectively. The sensitivity, accuracy, NPV, and PPV of TPBS-CRP combination in the diagnosis of PJI were higher than those of TPBS and CRP, but the specificity was lower than that of TPBS and CRP. ROC curve analysis further showed that the AUC value of TPBS-CRP combination was better than that of TPBS and CRP. The severity of bone defect and the duration of symptoms in patients with false positive TPBS diagnosis were worse than those in patients with true negative TPBS diagnosis (P<0.05), but there was no significant difference in the survival time of prosthesis between the two groups (P>0.05). Among the patients diagnosed with PJI by TPBS, CRP, and TPBS-CRP, 49, 35, and 54 patients had received antibiotic treatment 2 weeks before diagnosis, respectively. There was no significant difference in the diagnostic accuracy of TPBS and TPBS-CRP before diagnosis between patients treated with and without antibiotics and those not treated (P>0.05). The diagnostic accuracy of antibiotic therapy before CRP diagnosis was significantly lower than that of untreated patients (P<0.05). CONCLUSION TPBS and CRP have limited specificity in differentiating PJI from aseptic loosening. The TPBS-CRP combination diagnostic method can synergize the local bone metabolic characteristics and systemic inflammatory response to achieve higher diagnostic accuracy, but caution should be exercised in patients with severe bone defects and longer symptom duration.
Humans ; Prosthesis-Related Infections/blood* ; Middle Aged ; Male ; Female ; Aged ; C-Reactive Protein/metabolism* ; Retrospective Studies ; Adult ; Radionuclide Imaging/methods* ; Arthroplasty, Replacement, Knee/adverse effects* ; Aged, 80 and over ; Technetium Tc 99m Medronate ; Arthroplasty, Replacement, Hip/adverse effects* ; Sensitivity and Specificity ; Knee Prosthesis/adverse effects* ; ROC Curve ; Reoperation ; Radiopharmaceuticals ; Young Adult

Objective: To verify the feasibility and accuracy of the transanal multipoint full-layer puncture biopsy (TMFP) technique in determining the residual status of cancer foci after neoadjuvant therapy (nCRT) in rectal cancer. Methods: Between April 2020 and November 2022, a total of 78 patients from the Beijing Chaoyang Hospital of Capital Medical University, the Beijing Friendship Hospital of Capital Medical University, the Qilu Hospital of Shandong University, the Zhongnan Hospital of Wuhan University with advanced rectal cancer received TMFP after nCRT participated in this prospective multicenter trial. There were 53 males and 25 females, aged (M(IQR)) 61 (13) years (range: 35 to 77 years). The tumor distance from the anal verge was 5 (3) cm (range: 2 to 10 cm). The waiting time between nCRT and TMFP was 73 (26) days (range: 33 to 330 days). 13-point transanal puncture was performed with a 16 G tissue biopsy needle with the residual lesion as the center. The specimens were submitted for independent examination and the complications of the puncture were recorded. The consistency of TMFP and radical operation specimen was compared. The consistency of TMPF with clinical remission rates for the diagnosis of complete pathological remission was compared by sensitivity, specificity, negative predictive value, positive predictive value and accuracy. Statistical analysis between groups was performed using the χ² analysis, and a paired χ² test was used to compare diagnostic validity. Results: Before TMFP, clinical complete response (cCR) was evaluated in 27 cases. Thirty-six cases received in vivo puncture, the number of punctures in each patient was 13 (8) (range: 4 to 20), 24 cases of tumor residue were found in the puncture specimens. The sensitivity to judgment (100% vs. 60%, χ²=17.500, P<0.01) and accuracy (88.5% vs. 74.4%, χ²=5.125, P=0.024) of TMFP for the pathologic complete response (pCR) were significantly higher than those of cCR. Implement TMFP based on cCR judgment, the accuracy increased from 74.4% to 92.6% (χ²=4.026, P=0.045). The accuracy of the in vivo puncture was 94.4%, which was 83.3% of the in vitro puncture (χ²=1.382, P=0.240). Overall, the accuracy of TMFP improved gradually with an increasing number of cases (χ²=7.112, P=0.029). Conclusion: TMFP is safe and feasible, which improves the sensitivity and accuracy of rectal cancer pCR determination after nCRT, provides a pathological basis for cCR determination, and contributes to the safe development of the watch and wait policy.

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

OBJECTIVES: To establish a simple and rapid qualitative and quantitative detection method of dexmedetomidine in blood. METHODS: Blood was separated on the Allure PFP Propyl liquid chromatography column with isocratic elution after it was precipitated by acetonitrile and filtered. Qualitative and quantitative analysis of dexmedetomidine was performed using positive ion scan mode and multi-reaction monitoring mode. RESULTS: The limit of detection of dexmedetomidine in blood was 0.2 ng/mL and the limit of quantification was 0.5 ng/mL. The linearity of the method was good in the range of 0.5-1 000 ng/mL, and the correlation coefficient was greater than 0.99. The accuracy of the method was 90.34%-112.67% and the extraction recovery was 50.05%-91.08%, with no significant matrix effect. CONCLUSIONS This method is simple, selective and suitable for the qualitative and quantitative analysis of dexmedetomidine in blood, which can provide a reference for drug-facilitated cases involving dexmedetomidine.
Tandem Mass Spectrometry/methods* ; Chromatography, High Pressure Liquid/methods* ; Dexmedetomidine/analysis* ; Reproducibility of Results ; Chromatography, Liquid/methods*

Objective:To asscentain the 131I activity concentration in 131I treatment workplaces and to explore the method of estimating the internal dose to workers by air sampling and to analyze its influencing factors. Methods:Air sampling method was used to collect aerosols containing radioactivity in 10 randomly selected workplaces in Zhengzhou where 131I therapy was performed. Aactivity concentration of 131I in treatment workplace was measured for gamma emitters by gamma-ray spectrometry. The internal dose due to 131I inhalation was estimated based on measurement result and field investigation result. Results:The activity concentration of 131I in air samples from 19 subpacking rooms ranged from 0.087 to 570 Bq/m 3, with an average of (51.04 ± 128.58) Bq/m 3. Those from 11 wards ranged from 0.162 to 54.6 Bq/m 3, with an average of (7.97 ± 15.89) Bq/m 3. In terms of the work hours recommended by the national standard GBZ 129-2016 Specifications for individual monitoring of occupational internal exposure, the estimated annual effective dose to radiation workers due to the inhalation of 131I ranges from 0.002 to 10 mSv, with an average of (0.61 ± 1.80) mSv, below the dose limit specified in the national standards. Conclusions:The samples with high 131I activity concentration in nuclear medicine workplaces of 10 medical institutions selected in Zhengzhou are mostly distributed in tertiary class hospitals operating large amount of radionuclide with large numbers of thyroid cancer patients adimitted. The result ing internal dose to radiation workers cannot be ignored. Estimating the internal dose based on the measurement result of air samples has a large uncertainty.However, air sampling method can promptly detect radioactive contamination in case of abnormal events or accidents, providing early warning for workers to carry out dose measurement from external exposure and internal exposure assessment.

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 ; COVID-19 Testing

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