This paper provides a systematic review of the policies, regulations, and management requirements in the development and use of in vitro diagnostic reagents by healthcare institutions, along with their current implementation status both domestically and internationally, and includes a case analysis of the pilot program at Peking Union Medical College Hospital (PUMCH). The Medical Affairs Department of PUMCH, serving as the leading and operational management unit, established a multi-department collaborative governance structure and developed a full-lifecycle management model encompassing project selection, manufacturing approach determination, regulatory submission and approval, batch production, and clinical implementation. Under this management model, the hospital successfully completed five projects within just one year, achieving the highest number of project filings nationwide. Economic benefit evaluation of the first approved reagent, which is urgently required by clinical practice and named allergen-specific immunoglobulin E detection assay for Fraxinus pennsylvanica pollen, demonstrates that the project realized controllable risk and predictable commercial value, and proves that proactive implementation of systematic management model and project systematic construction is the key to successfully advancing laboratory-developed test programs. The experiences provide both theoretical insights and practical guidance for peer medical institutions seeking to develop and implement self-developed in vitro diagnostic reagents.

Objective:To evaluate the effectiveness of a novel endoscopic oronasal shields in reducing aerosol transmission during upper gastrointestinal endoscopy.Methods:Patients undergoing sedated upper gastrointestinal endoscopy at Lhasa People's Hospital (December 2023-February 2024) were randomized 1∶1 via SAS 9.4 to shield or control groups. A six-channel particle counter (0.3, 0.5, 1.0, 2.5, 5.0, 10.0 μm) measured aerosol particles. The primary outcome was pre-/post-procedure aerosol variation at the endoscopist's facial position. The secondary outcome was device safety.Results:The study enrolled 100 patients (50 per group) with comparable baseline characteristics. Procedure duration showed no significant difference (7.8±3.9 min VS 8.1±4.2 min, t=0.500, P=0.615). The oronasal shield group demonstrated significantly reduced aerosol increases at 0.3 μm [(57.87±19.26)×10?/L VS (203.32±18.33)×10?/L, t=4.295, P<0.001], 0.5 μm [(19.36±3.60)×10?/L VS (64.61±12.67)×10?/L, t=4.949, P<0.001], 1.0 μm [(15.31±4.42)×10?/L VS (54.11±9.12)×10?/L, t=4.507, P<0.001], and 2.5 μm [(7.38±2.90)×10?/L VS (23.33±5.17)×10?/L, t=3.723, P<0.001]. Adverse event rates (cough, hiccups, hypoxemia, etc.) showed no significant differences ( P>0.05). Conclusion:Endoscopic oronasal shields safely reduce aerosol generation without prolonging procedure time, potentially mitigating exposure risks in endoscopy centers.

Objective:To evaluate the effectiveness of a novel endoscopic oronasal shields in reducing aerosol transmission during upper gastrointestinal endoscopy.Methods:Patients undergoing sedated upper gastrointestinal endoscopy at Lhasa People's Hospital (December 2023-February 2024) were randomized 1∶1 via SAS 9.4 to shield or control groups. A six-channel particle counter (0.3, 0.5, 1.0, 2.5, 5.0, 10.0 μm) measured aerosol particles. The primary outcome was pre-/post-procedure aerosol variation at the endoscopist's facial position. The secondary outcome was device safety.Results:The study enrolled 100 patients (50 per group) with comparable baseline characteristics. Procedure duration showed no significant difference (7.8±3.9 min VS 8.1±4.2 min, t=0.500, P=0.615). The oronasal shield group demonstrated significantly reduced aerosol increases at 0.3 μm [(57.87±19.26)×10?/L VS (203.32±18.33)×10?/L, t=4.295, P<0.001], 0.5 μm [(19.36±3.60)×10?/L VS (64.61±12.67)×10?/L, t=4.949, P<0.001], 1.0 μm [(15.31±4.42)×10?/L VS (54.11±9.12)×10?/L, t=4.507, P<0.001], and 2.5 μm [(7.38±2.90)×10?/L VS (23.33±5.17)×10?/L, t=3.723, P<0.001]. Adverse event rates (cough, hiccups, hypoxemia, etc.) showed no significant differences ( P>0.05). Conclusion:Endoscopic oronasal shields safely reduce aerosol generation without prolonging procedure time, potentially mitigating exposure risks in endoscopy centers.

To explore the clinical application value of rapid on-site evaluation (ROSE) in endoscopic ultra sound-guided fine needle aspiration (EUS-FNA) for the diagnosis of digestive system space-occupying lesions, a retrospective analysis was conducted on 14 patients who underwent EUS-FNA at the Digestive Endoscopy Center of Lhasa People's Hospital from August 2022 to August 2023 due to abdominal or digestive tract space-occupying lesions. Seven cases underwent EUS-FNA combined with ROSE, and 7 cases underwent EUS-FNA only. Puncture and diagnosis of the two methods and the occurrence of complications were compared. All patients received procedures smoothly, and no adverse events or complications related to endoscopic procedure occurred during or after the operation. Patients who performed EUS-FNA combined with ROSE were punctured with 1.5±0.5 needles, and those who performed EUS-FNA alone were punctured with 2.6±0.4 needles. EUS-FNA combined with ROSE puncture was successful in 7 cases and EUS-FNA alone was successful in 6 cases. Among the patients who underwent EUS-FNA combined with ROSE, the diagnostic results were consistent with the final diagnosis in 6 cases, and in 5 cases who underwent EUS-FNA alone. ROSE is simple and convenient to operate, can reduce the number of EUS-FNA puncture, and improve the adequacy rate of EUS-FNA puncture samples and diagnostic accuracy, which is worth of further promotion and research.

Hypothyroidism alone can lead to myocardial fibrosis and result in heart failure, but traditional hormone replacement therapy does not improve the fibrotic situation. Hydrogen sulfide (H 2 S), a new gas signaling molecule, possesses antiinflammatory, antioxidant, and anti-fibrotic capabilities. Whether H 2 S could improve hypothyroidism-induced myocardial fibrosis are not yet studied. In our study, H 2 S could decrease collagen deposition in the myocardial tissue of rats caused by hypothyroidism. Furthermore, in hypothyroidism-induced rats, we found that H 2 S could enhance cystathionine-gamma-lyase (CSE), not cystathionine β-synthase (CBS), protein expressions. Finally, we noticed that H 2 S could elevate autophagy levels and inhibit the transforming growth factor-β1 (TGF-β1) signal transduction pathway. In conclusion, our experiments not only suggest that H 2 S could alleviate hypothyroidism-induced myocardial fibrosis by activating autophagy and suppressing TGF-β1/ SMAD family member 2 (Smad 2) signal transduction pathway, but also show that it can be used as a complementary treatment to conventional hormone therapy.

This article introduces a high-throughput molecular screening chip： peptide arrays. As a kind of biochip， the peptide arrays are easy to synthesis， stable in probe chemistry， high-throughput in screening and highly specific compared with other biochips. To analyze the new high-throughput data， researchers have recently proposed a series of deep learning and bioinformatics methods to study the binding characteristics of peptide probes and target molecules. Those algorithms could be used to predict the binding affinity of protein targets against peptides. Moreover， peptide arrays could also play important roles in analyzing protein-protein interactions，screening novel drug peptides， disease diagnosis and general health assessment based on recent reports. The application of this new technology could provide novel insights into public health research.

Objective:To observe the effects of acupuncture and moxibustion on phosphatase and PTEN-induced putative kinase 1(PINK1)/Parkin signaling pathway in the midbrain substantia nigra of Thy1-α synuclein(αSyn)transgenic model mice with Parkinson disease(PD). Methods:Twenty-four Thy1-αSyn transgenic mice were randomly divided into a model group,an acupuncture group,an acupuncture + moxibustion group,and a Western medicine group.Six wild-type mice in the same litter were used as the wild-type group.In the acupuncture group,Baihui(GV20)and Yanglingquan(GB34)were selected for acupuncture.In the acupuncture + moxibustion group,Guanyuan(CV4)was added on the basis of the acupuncture group.The Western medicine group was given rapamycin intraperitoneal injection at a dose of 10 mg/(kg·bw).The wild-type group and the model group were fixed without intervention.The overall rod performance(ORP)score of mice was observed in each group.The immunohistochemical method was used to detect the tyrosine hydroxylase(TH)positive neurons in the substantia nigra of mice in each group.The αSyn was detected by the immunofluorescence chemical method.The expression levels of αSyn,microtubule-associated protein 1 light chain 3(LC3)-Ⅱ/LC3-Ⅰ,autophagy protein sequestosome-1/protein 62(SQSTM-1/p62),PINK1,Parkin,and ubiquitin-specific protease 30(USP30)proteins were detected by Western blotting assay.The expression levels of LC3B,p62,PINK1,Parkin,and USP30 mRNAs were detected by fluorescence quantitative polymerase chain reaction. Results:Compared with the wild-type group,the ORP score,the p62,PINK1,and Parkin protein expression levels decreased significantly(P<0.01),the PINK1 mRNA expression level decreased(P<0.05),while the protein and mRNA expression levels of USP30 increased(P<0.05)in the model group.Compared with the model group,the ORP score in the acupuncture group and the acupuncture + moxibustion group increased(P<0.05);the expression level of LC3-Ⅱ/LC3-Ⅰ protein in the acupuncture + moxibustion group and the Western medicine group increased(P<0.05);the protein expression levels of p62,PINK1,and Parkin increased(P<0.05),while the USP30 protein expression level decreased significantly(P<0.01)in the acupuncture group,the acupuncture + moxibustion group,and the Western medicine group;the Parkin mRNA expression level in the acupuncture group and the acupuncture + moxibustion group increased(P<0.05);the USP30 mRNA expression level in the acupuncture + moxibustion group decreased(P<0.05). Conclusion:Acupuncture and moxibustion regulate the related molecule expression levels of PINK1/Parkin signaling pathway in the Thy1-αSyn transgenic PD model mice and promote the autophagy degradation of αSyn to exert the protective effect of dopaminergic neurons.

Objective:To investigate the effects of exogenous hydrogen sulfide on myocardial fibrosis and apoptosis in rats after myocardial infarction and the underlying mechanisms.Methods:Forty-three Sprague Dawley(SD)rats were divided into 4 groups according to the random number table method: a control group(n=12), a myocardial infarction group(MI group, n=13), an hydrogen sulfide(H 2S)group(n=6)and an MI+ H 2S group(n=12). The rat model of acute myocardial infarction was established by intraperitoneal injections of isoproterenol(50 mg/kg, once a day, for 2 days). Electrocardiogram and troponin changes were recorded 48 h after the last drug administration to determine whether the rat model was successfully constructed.After successful establishment of the model, rats in the MI group and the MI+ H 2S group were intraperitoneally injected with sodium hydrosulfide(56 μmol/kg, once a day, for 6 weeks).6 weeks later, echocardiogram and Masson's trichrome staining were performed to assess changes in cardiac function and collagen volume fraction in each group.Terminal deoxynucleotidyl transferase(TdT)dUTP nick end labeling(TUNEL)was used to detect the myocardial apoptosis rate in each group, and Western-blot was used to detect protein expression of Yes-related protein 1(YAP1), WW domain containing transcriptional regulator1(TAZ), mammalian Ste20-like kinase 2(MST2), Bcl-2-associated X protein(Bax), cysteine protease 3(caspase-3), the ratio of matrix metalloproteinase 3(MMP3)/matrix metalloproteinase inhibitor 2(TIMP2), and B-cell lymphoma factor(Bcl-2). Results:Compared with the control group, myocardial collagen volume fraction was increased( P<0.05), the myocardial cell apoptosis rate was increased( P<0.05), and myocardial YAP1, TAZ, MST2, Bax, caspase-3 protein expression and MMP3/TIMP2 ratio were increased in the MI group(all P<0.05), while the expression of Bcl-2 protein was decreased( P<0.05). Compared with the MI group, collagen volume fraction and the cardiomyocyte apoptosis rate were significantly decreased in the MI+ H 2S group( P<0.05). Also, protein expression of YAP1(2.406±0.024 vs.2.830±0.063), TAZ(0.964±0.090 vs.1.329±0.018), MST2(0.780±0.082 vs.1.788±0.097), Bax(1.500±0.008 vs.0.613±0.003)and caspase-3(0.620±0.024 vs.0.780±0.012)and the MMP3/TIMP2 ratio were decreased(all P<0.05), while protein expression of Bcl-2 was increased( P<0.05)in myocardial tissue. Conclusions:H 2S can mitigate myocardial fibrosis after myocardial infarction, through inhibiting the activation of the YAP1/TAZ signaling pathway, thus reducing apoptosis of cardiomyocytes.

Objective:To investigate the risk factors for futile recanalization in patients with acute anterior circulation large vessel occlusion after endovascular mechanical thrombectomy (EMT), and establish a nomogram model predicting futile recanalization in these patients.Methods:One hundred and eighty-eight patients with acute anterior circulation large vessel occlusion after EMT were enrolled from Department of Neurology, Zhongshan Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine from January 2018 to December 2021. Patients were divided into futile recanalization group and effective recanalization group according to whether futile recanalization occurred; futile recanalization was defined as successful recanalization showed by immediate postoperative DSA (modified thrombolysis in cerebral infarction [mTICI] ≥2b), but poor functional outcome (modified Rankin Scale [mRS] scores>2 90 d after surgery). The clinical data were compared between futile recanalization group and effective recanalization group. Multivariate Logistic regression analysis was used to screen the risk factors for futile recanalization. R software was used to establish a nomogram model for futile recanalization. C-index was used to evaluate the differentiation of the model, and correction curve was used to evaluate the accuracy of the line graph model prediction. Receiver operating characteristic (ROC) curve was used to evaluate the predictive efficiency of the nomogram model.Results:Ninety-two patients had futile recanalization. Compared with the effective recanalization group, futile recanalization group had significantly older age, significantly higher hemoglobin A1c on admission, significantly longer time from puncture to vascular recanalization, significantly higher proportions of patients with hypertension history and poor collateral circulation, and significantly different severities of stroke and white matter hyperintensities (WMHs) and distribution of occlusive sites ( P<0.05). Multivariate Logistic regression analysis showed that age, history of hypertension, time from puncture to vascular recanalization, poor collateral circulation, severe WMHs, and moderate-severe stroke were independent risk factors for futile recanalization after EMT in patients with acute anterior circulation large vessel occlusion ( P<0.05). A nomogram model of futile recanalization was established according to the above 6 factors, with C-index of 0.862 ( 95%CI: 0.809-0.914); the calibration curve of the model was highly coordinated to the ideal model curve; area under the ROC curve of futile recanalization was 0.862 ( 95%CI: 0.809-0.914, P<0.001). Conclusions:Acute anterior circulation large vessel occlusion patients with older age, history of hypertension, longer time from puncture to vascular recanalization, poor collateral circulation, severe WMHs, and moderate-severe stroke trend to have futile recanalization after EMT. This nomogram can predict futile recanalization after EMT.

Infertility in women with cirrhosis is overcome with the help of modern assisted conception techniques and systemic liver disease treatment. Hemodynamic changes during pregnancy are necessary to meet fetal growth needs, but can exacerbate portal hypertension, which can lead to life-threatening complications, such as esophagogastric varices bleeding and liver failure. Therefore, the complex clinical dilemma of pregnancy with portal hypertension presents us with a special challenge. Complications of portal hypertension during pregnancy mainly include esophagogastric varices bleeding and liver failure. Prepregnancy counseling and risk prediction scores can reduce the incidence of complications. At the same time, endoscopic treatment is currently recognized as the first-line treatment for esophageal and gastric variceal bleeding.