Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.

Objective To investigate the effects of sugammadex on postoperative pulmonary com-plications(PPCs)and postoperative recovery after thoracoscopic lung resection surgery.Methods A total of 263 patients scheduled for thoracoscopic lung resection surgery between November 2021 and July 2023,112 males and 151 females,aged 18-64 years,BMI 18.5-28.0 kg/m2,ASA physical status Ⅰ-Ⅲ,were randomly divided into three groups:the sugammadex group(group S,n=88),the neostigmine group(group N,n=87),and the control group(group C,n=88).The patient was sent to postanesthesia care unit(PACU)after operation,when the train of four(TOF)count reached 2,group S was given sugamma-dex 2 mg/kg,group N was given neostigmine 0.04 mg/kg+atropine 0.02 mg/kg,and group C was given equal volume of normal saline.The incidence of PPCs from the end of the surgery to the time of discharge was recorded.The time from the end of surgery to extubation,the time from drug administration to recovery of the train of four ratio(TOFr)to 0.9,the TOFr immediately after extubation,the length of stay in PACU,hypoxemia after extubation(SpO2＜90％)were recorded,and the incidence rate of postoperative residual neuromuscular block(PRNB)was calculated.The time of first getting out of the bed for activity,the number of total and effective compressions by the analgesia pump within 48 hours after surgery,the inci-dence of rescue analgesia,the clinical pulmonary infection score(CPIS),the numbers of postoperative nau-sea and vomiting(PONV),total drainage of the chest tube,duration of the chest tube insertion,and the length of postoperative hospital stay were recorded.Results Compared with group C,the incidence of PPCs,PRNB and hypoxemia after extubation were significantly decreased,time from the end of surgery to extubation,time from drug administration to recovery of TOFr to 0.9,the length of stay in PACU,and the first postoperatively out of bed activity time were significantly shortened,the TOFr immediately after extuba-tion was significantly increased,and CPIS was significantly decreased in group S(P＜0.05);the time from the end of surgery to extubation,time from drug administration to recovery of TOFr to 0.9,the length of stay in PACU were significantly shortened,the TOFr immediately after extubation was significantly in-creased,PRNB after extubation were significantly decreased in group N(P＜0.05).Compared with group N,the incidence of PRNB after extubation were significantly decreased,the time from the end of surgery to extubation,the time from drug administration to recovery of TOFr to 0.9,the length of stay in PACU,and the first postoperatively out of bed activity time were significantly shortened,the TOFr immediately after ex-tubation was significantly increased in group S(P＜0.05).There was no significant difference in other in-dexes between the three groups.Conclusion Sugammadex can rapidly antagonize the residual muscle re-laxation,decrease the rate of PPCs and PRNB,and promote rapid recovery of patients after thoracoscopic lung resection surgery.

Based on the perspective of medical equipment safety culture,analyze the Global Patient Safety Report 2024 released by the World Health Organization(WHO)on May 30,and extract patient safety elements related to medical devices.Propose to initiate action plan for patient safety related to medical devices and discuss the pathway and measures to further ensure patient safety and strengthen safety management in the clinical use of medical devices,in conjunction with promoting high-quality development of hospitals.

OBJECTIVE To investigate the association between the functional GLCCI1 gene rs37973 polymorphism and inhaled corticosteroids （ICSs） response in patients with asthma-chronic obstructive pulmonary disease overlap （ACO）. METHODS Totally 173 newly diagnosed ACO patients were recruited from Shanghai Pudong New Area People’s Hospital during April 1st， 2019 to December 31st， 2020. All patients were treated with Salmeterol fluticasone inhalation powder， twice a day， for 24 weeks. The genotype of rs37973 locus was determined， and lung function indicators [forced expiratory volume in one second （FEV1）， FEV1/forced vital capacity （FVC）， the percentage of FEV1 to expected value （FEV1%pred）]， and lung function improvement （ΔFEV1 and ΔFEV1%pred） were all detected. RESULTS Totally 111 patients completed the whole 24-week follow-up and lung function detection. Among them， there were 42 cases of AA genotype， 52 cases of AG genotype， and 17 cases of GG genotype. After 12， 24 weeks of treatment， lung function indexes of patients were significantly better than baseline lung function indexes before treatment （P＜0.05）. After 24 weeks of treatment， ACO patients with AA and AG genotypes showed significantly better lung function improvement than GG genotype， and ΔFEV1%pred of AA genotype was significantly better than AG genotype （P＜ 0.05）. After 12， 24 weeks of treatment， the improvement of lung function in patients with a smoking history ≤20 pack year was significantly better than those with a smoking history ＞20 pack year， and among patients with a smoking history ≤20 pack year， only AA genotype had significantly better FEV1%pred than AG genotype （P＜0.05）. After 12 weeks of treatment， among patients with a smoking history ＞20 pack year， the improvement of lung function in AA genotype and AG genotype was significantly better than GG genotype， and the FEV1%pred in AA genotype was significantly better than AG genotype （P＜0.05）. After 24 weeks of treatment， the improvement of lung function of AA genotype and AG genotype was significantly better than GG genotype （P＜0.05）. CONCLUSIONS GG genotype of GLCCI1 gene rs37973 locus is associated with the poor treatment response to ICSs in patients with ACO， especially in patients with smoking history ＞20 pack year.

Objective:To analyze the disease spectrum of lysosomal storage disorders(LSDs) and explore the prevalent distributions of different LSD types in one center in Shanghai.Methods:A retrospective analysis was made.A total of 5 476 suspected LSD patients, including 3 415 males and 2 061 females, with a median age of 4 years(1 day to 72 years), were collected from Xinhua Hospital, Shanghai Jiaotong University School of Medicine from August 2008 to May 2022.The activity of different lysosomal enzymes was detected by fluorescent and biochemical methods.Results:A total of 1 520 patients were diagnosed with LSDs, including 972 males and 548 females, with a median age of 4 years(1 day to 59 years), involving 19 different subtypes.Mucopolysaccharidosis(MPS) was the most common type among LSDs, with a frequency of 45.46%(691/1 520), followed by sphingolipidoses [33.88%(515/1 520)] and glycogen storage disease type Ⅱ [16.05%(244/1 520)] successively.MPS Ⅱ was the most common type in MPS, with a frequency of 45.73%(316/691), followed by MPS ⅣA [22.87%(158/691)]. Niemann-Pick A/B, Gaucher, and Krabbe diseases were common in Sphingolipidoses patients, with frequencies of 37.09%(191/515), 34.37%(177/515), and 10.29%(53/515), respectively.Conclusions:LSDs are common genetic metabolic diseases, especially MPS and sphingolipidoses.Newborn screening for LSDs should be carried out timely so that the patients can be treated early and their prognosis can be improved.

OBJECTIVE To study active components and antitussive effect of aboveground part of Pinellia ternata （non- medicinal stems and leaves）， and compare them with the underground part of P. ternata （medicinal underground tubers）， providing scientific basis for the comprehensive utilization and product development of P. ternata. METHODS TLC， GC， HPLC and UPLC- MS/MS were used for qualitative and quantitative analysis of amino acids， volatile oil， total flavonoids and succinic acid from the aboveground and underground parts of P. ternata. The antitussive effects of the aboveground and underground parts of P. ternata were compared and studied through cough inducing experiment with concentrated ammonia water. RESULTS Results of TLC showed that at the corresponding positions on the chromatograms of the reference substances of P. ternata， and arginine， alanine， valine， leucine and rutin control， the aboveground and underground parts of P. ternata showed spots of the same color. Results of GC showed that the similarity among characteristic chromatograms of volatile oil from aboveground and underground parts of P. ternata was 0.767； results of HPLC and UPLC-MS/MS showed that compared with underground parts of P. ternata， the contents of succinic acid， quercetin， kaempferol and isorhamnetin increased by 0.15%， 0.15%， 0.09% and 0.03%， and aspartate content decreased by 2.5 mg/g. Pharmacodynamics results showed that compared with model control group， the cough incubation period of rats was prolonged significantly in administration groups （P＜0.05）， and the cough frequency within 3 min was significantly decreased （P＜0.05）； there was no statistical significance in the cough frequency within 3 min among administration groups （P＞0.05）. CONCLUSIONS The composition of amino acids， volatile oils and total flavonoids in aboveground part of P. ternata are similar to underground part of P. ternata， while the content of aspartic acid is lower than that in underground part. The aboveground part of P. ternata can prolong the cough incubation period of rats and reduce the number of coughs， which has a certain antitussive effect， but the effect is slightly weaker than that of the underground part.

Objective:To systematically review the teaching effect of problem-based learning (PBL) combined with evidence-based medicine (EBM) teaching mode on the standardized residency training.Methods:CNKI, Wanfang database, VIP database, SinoMed, Embase, PubMed and Web of SCI databases were searched, and the randomized controlled trial (RCT) studies of the application of EBM combined with PBL teaching in standardized residency training were collected. The retrieval time was from the establishment to 1st July, 2018. Two investigators independently extracted data and assessed the quality of the studies. After assessing the risk of bias of included studies, Meta-analysis was performed on RevMan 5.3.Results:In total, 4 studies were included in the review. Narrative assessment was adopted, because outcome indicators of these study were varied and the quality of the literatures could not meet the requirement of Meta-analysis. Our study suggested that the residents who were in PBL combined with EBM teaching mode group got higher scores in the standardized residency training, compared with those in the lecture-based learning (LBL) teaching mode group, especially in case analysis score, total score of examination, improvement of clinical thinking ability, communication and expression ability, organization and cooperation ability, etc.Conclusion:The current evidence suggests that the application of EBM combined with PBL teaching mode has a positive effect on the standardized residency training. Compared with the traditional LBL teaching, EBM can improve students' ability. However, limited by the quantity and quality of included studies, the above conclusions still need to be verified by more studies with larger samples and higher quality.

Objective:To investigate the spectrum of amino acid, organic acid, and fatty acid oxidative metabolic diseases in children diagnosed by detecting urinary organic acid levels using gas chromatography-mass spectrometry.Methods:From January 2005 to December 2021, clinical data of 2 461 children diagnosed with inherited metabolic diseases (IMD) by gas chromatography-mass spectrometry, in combination with tandem mass spectrometry and genetic testing in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine were retrospectively analyzed.Results:Among 2 461 children, 1 446 were male and 1 051 were female. A total of 32 types of IMD were detected among 2 461 patients, which included 10 amino acid disorders in 662 cases (26.9%), 6 common diseases were hyperphenylalaninemia, citrin deficiency, ornithine carbamoyltransferase deficiency, maple syrup urine disease, alkaptonuria, and tyrosinemia-I, 17 types of organic acidemias in 1 683 cases (68.4%), 6 common diseases were methylmalonic acidemia, propionic acidemia, valeric acidemia-type Ⅰ, isovaleric acidemia, 3-methylcrotonyl-CoA carboxylase deficiency and multiple carboxylase deficiency and 5 fatty acid β oxidative defects in 116 cases (4.7%), 2 common diseases were multiple acyl-CoA dehydrogenase deficiency and short-chain acyl-CoA dehydrogenase deficiency).Conclusion:Among the diseases diagnosed by analyzing urinary organic acid profiling with gas chromatography-mass spectrometry, the most common are organic acidemias, followed by amino acid disorders and fatty acid oxidation defects.

Background: Thyroid diseases are highly prevalent worldwide, but their diagnosis remains a challenge. We established reference intervals (RIs) for thyroid-associated hormones and evaluated the prevalence of thyroid diseases in China. Methods: After excluding outliers based on the results of ultrasound screening, thyroid antibody tests, and the Tukey method, the medical records of 20,303 euthyroid adults, who visited the Department of Health Care at Peking Union Medical College Hospital from January 2014 to December 2018, were analyzed. Thyroid-associated hormones were measured by the Siemens Advia Centaur XP analyzer. The RIs for thyroid-associated hormones were calculated according to the CLSI C28-A3 guidelines, and were compared with the RIs provided by Siemens. The prevalence of thyroid diseases over the five years was evaluated and compared using the chi-square test. Results: The RIs for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), total thyroxine (TT4), and total triiodothyronine (TT3) were 0.71–4.92 mIU/L, 12.2–20.1 pmol/L, 3.9–6.0 pmol/L, 65.6–135.1 nmol/L, and 1.2–2.2 nmol/L, respectively. The RIs of all hormones except TT4 differed significantly between males and females. The RIs of TSH increased with increasing age. The prevalence of overt hypothyroidism, overt hyperthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism was 0.5% and 0.8%, 0.2% and 0.6%, 3.8% and 6.1%, and 3.3% and 4.7% in males and females, respectively, which differed from those provided by Siemens. Conclusions Sex-specific RIs were established for thyroid-associated hormones, and the prevalence of thyroid diseases was determined in the Chinese population.

【Objective】 To investigate the related factors of allogeneic blood transfusion (ALBT) in total hip arthroplasty. 【Methods】 Thebasic information, surgical details and laboratory data of 258 patients who underwent total hip arthroplasty in Orthopedics Department of our hospital were collectedfrom the electronic medical record system and laboratorytest system. The factors concerningALBT were obtainedby single factor and multivariate logistic regression analysis. 【Results】 The ALBT rate in this study was 19%, and the differencesin such important factors affecting ALBT as gender, age, intraoperative blood loss, drainage volume, operation duration, preoperative hemoglobin (Hb), preoperative activated partial thromboplastin time (APTT), preoperative prothrombin time (PT) andhypertension between the two groupswere notable (P<0.05). Multivariate regression analysisrevealed that the independent related factors ofALBT were age ≥ 60 years (OR3.577), intraoperative blood loss (OR1.003), drainage volume (OR1.004)and preoperative PT (OR1.888). Preoperative Hb (OR0.94) was a protective factor. 【Conclusion】 Specific and individualized evaluation of ALBT, aimed atreducingunnecessary blood transfusion, can be provided through the analysis of relevant factors.