1.Case analysis of 57 technical appraisals for medical malpractice
Hongxia WEN ; Lei YUAN ; Fangyuan HU
Journal of Navy Medicine 2025;46(11):1108-1113
Objective To analyze the medical malpractice technical appraisals accepted by a health administration department,and to provide suggestions for the work improvement of the health administration department and its affiliated medical institutions.Methods A total of 57 cases of technical appraisals for medical malpractice accepted from 2015 to 2023 were analyzed retrospectively.Yi fa hui's reasons for the failure of medical institutions were taken as the main classification basis of the medical fault.Results There were 51 cases of the first appraisal and 6 cases of the second appraisal.Among them,38 cases were completed,and the completion rate was 66.67%,involving 15 departments;17 cases were deemed medical accidents.The most frequent category was Grade 1 medical malpractice with minor liability borne by the healthcare provider,involving 8 types of faults.Conclusion The majority of appraisals accepted by a health administration department is the first appraisal,and the completion rate of appraisal needs to be improved.It is suggested that the health administration department should do well in the explanation and communication in the process of medical malpractice technical appraisal,and medical institutions should strengthen their supervision responsibility for clinical work.
2.Effect of acupuncture and moxibustion on post-stroke dysphagia from 1994 to 2023:a bibliometric analysis
Fangyuan XU ; Peijia HU ; Yu YE ; Fan DAI ; Hongliang CHENG
Chinese Journal of Rehabilitation Theory and Practice 2024;30(11):1299-1310
Objective To explore the current research situation,hotspots and development trend in the field of acupuncture and mox-ibustion intervention for post-stroke dysphagia(PSD). Methods The literature on acupuncture and moxibustion intervention for PSD was retrieved from CNKI,VIP and Wan-fang database from 1994 to December 31st,2023,and analyzed with VOSviewer and CiteSpace. Results A total of 1 816 articles were included,and the number of publications increased year by year,reaching a peak in 2021 with 180 articles.There were 274 core authors included in the literature,among which Cheng Hongliang,Zhou Hongfei and Feng Weixing were the authors with the highest publication volume.The First Affiliated Hos-pital of Tianjin University of Chinese Medicine was the most productive institution,and the connections between institutions were relatively scattered.The high-frequency keywords were swallowing dysfunction,stroke,acu-puncture and moxibustion therapy,as well as rehabilitation therapy,among which tongue triple acupuncture,elec-troacupuncture,nape acupuncture and scalp acupuncture were the most commonly used methods.In addition,acupuncture combined with rehabilitation training,electrical stimulation,or other methods for PSD and acupoint selection rules were also research hotspots.When evaluating the efficacy of acupuncture intervention for PSD,the focus gradually shifted from the effective rate to the use of videofluorographic swallowing study,water swal-lowing test,standardized swallowing assessment,surface electromyography and other indicators to evaluate the swallowing function and the severity of dysphagia. Conclusion Research on acupuncture and moxibustion interventions for PSD has developed rapidly,with hotspots in-cluding the selection of specific acupuncture and moxibustion techniques,the combination of acupuncture and moxibustion with other rehabilitation therapies,outcome indicators for acupuncture and moxibustion interven-tions in PSD,and the rules of acupoint selection.In the future,it is essential to strengthen academic exchanges and collaborations across institutions and regions.Greater emphasis should be placed on objective evaluation in-dicators of acupuncture and moxibustion therapies for improving the swallowing function in PSD patients,as well as on optimizing combinations of acupuncture and moxibustion with modern rehabilitation approaches,so as to better guide clinical practice.
3.Establishment of a Method for Galvanic Vestibular Stimulation-vestibular Evoked Myogenic Potentials in Healthy Children
Zichen CHEN ; Juan HU ; Feiyun CHEN ; Hui YANG ; Yanfei CHEN ; Tingting XUE ; Fangyuan YANG ; Yuzhong ZHANG ; Qiong WU ; Yulian JIN ; Xiaoyong REN ; Qing ZHANG
Journal of Audiology and Speech Pathology 2024;32(2):100-106
Objective To establish the methods of galvanic vestibular stimulation-vestibular evoked myogenic potentials(GVS-VEMPs)in healthy children and to obtain the normal value of GVS-cVEMP and GVS-oVEMP in these children in China.Methods Twenty(3~14 years)healthy children and 24 healthy adults(18~30 years)were enrolled for conventional examinations of GVS-cVEMP and GVS-oVEMP.Using the galvanic stimulation in-tensity under 3 mA/1 ms for children and 5 mA/1 ms for adults.The characteristics of elicitation and parameter re-sults of GVS-cVEMP and GVS-oVEMP in children and adults,as well as the pain scores and the elicitation of differ-ent stimulus intensities in the two age groups were recorded.Results The elicitation of GVS-cVEMP and GVS-oVEMP were both 100.0%in children and adult groups.The p1 latency,n1 latency and p1-n1 interval latency of GVS-cVEMP were 10.46±1.84 ms,16.98±2.12 ms and 6.52±1.42 ms respectively in children group,the n1 la-tency and p1-n1 interval latency were significantly shorter than the adult group(P<0.05).The n1 latency,p1 la-tency and p1-n1 interval latency of GVS-oVEMP were 8.87±1.40 ms,12.25±1.80 ms and 3.39±1.07 ms re-spectively in children group with no significant difference between the two groups.The thresholds of GVS-cVEMP and GVS-oVEMP in children group were significantly lower than adult group(P<0.01),but no differences were found in adult group regarding on the amplitude and interaural amplitude asymmetry ratio.In addition,with the in-crease of the intensity of galvanic stimulation,the correlation between pain scores and the elicitation rates of GVS-cVEMP and GVS-oVEMP also increased.Conclusion Using appropriate stimulus intensity and recording methods,GVS-cVEMP and GVS-oVEMP could be successfully assessed and detected in healthy children over 3 years old and adolescents.The latency of GVS-cVEMP in children is slightly shorter than that in adults,therefore we recommend selecting the matched age group for assessment in the children group.
4.Utility of immunochromatography in rapid detection of carbapenemases produced by Enterobacterales strains
Renru HAN ; Fen PAN ; Danan YIN ; Li DING ; Yan GUO ; Shi WU ; Yang YANG ; Fangyuan YU ; Jie JIANG ; Yingying SHI ; Fupin HU ; Hong ZHANG
Chinese Journal of Infection and Chemotherapy 2024;24(6):658-663
Objective To evaluate the performance of two immunochromatography kits (lateral flow immunoassay) in detecting carbapenemases in carbapenem-resistant Enterobacterales (CRE).Methods A total of 390 nonduplicate clinical isolates of Enterobacterales were collected and tested.The carbapenemase gene was identified by polymerase chain reaction (PCR).The five common carbapenemases were tested by two immunochromatography kits.Results Overall,213 of the 390 Enterobacterales isolates were CRE and 177 strains were carbapenem-susceptible based on antimicrobial susceptibility testing.PCR assay confirmed that 207 of the 213 CRE strains carried carbapenemase genes,including KPC genotype in 119 strains,NDM genotype in 71 strains,IMP genotype in 9 strains,OXA-48-like genotype in 7 strains,both KPC and NDM genes in 1 strain,while none of the five common carbapenemases in 6 CRE strains.Two immunochromatography kits were used simultaneously to test the production of carbapenemases.The results of the two commercial kits were 100% consistent with PCR results.The sensitivity and specificity of the two kits were 100% (95% CI,97.7%-100%) and 100% (95% CI,97.4%-100%) in detection of the five carbapenemases.Conclusions The immunochromatography method is rapid and easy to operate,and can be used to detect the production of carbapenmases in clinical isolates.
5.Utility of immunochromatography in rapid detection of carbapenemases produced by Enterobacterales strains
Renru HAN ; Fen PAN ; Danan YIN ; Li DING ; Yan GUO ; Shi WU ; Yang YANG ; Fangyuan YU ; Jie JIANG ; Yingying SHI ; Fupin HU ; Hong ZHANG
Chinese Journal of Infection and Chemotherapy 2024;24(6):658-663
Objective To evaluate the performance of two immunochromatography kits (lateral flow immunoassay) in detecting carbapenemases in carbapenem-resistant Enterobacterales (CRE).Methods A total of 390 nonduplicate clinical isolates of Enterobacterales were collected and tested.The carbapenemase gene was identified by polymerase chain reaction (PCR).The five common carbapenemases were tested by two immunochromatography kits.Results Overall,213 of the 390 Enterobacterales isolates were CRE and 177 strains were carbapenem-susceptible based on antimicrobial susceptibility testing.PCR assay confirmed that 207 of the 213 CRE strains carried carbapenemase genes,including KPC genotype in 119 strains,NDM genotype in 71 strains,IMP genotype in 9 strains,OXA-48-like genotype in 7 strains,both KPC and NDM genes in 1 strain,while none of the five common carbapenemases in 6 CRE strains.Two immunochromatography kits were used simultaneously to test the production of carbapenemases.The results of the two commercial kits were 100% consistent with PCR results.The sensitivity and specificity of the two kits were 100% (95% CI,97.7%-100%) and 100% (95% CI,97.4%-100%) in detection of the five carbapenemases.Conclusions The immunochromatography method is rapid and easy to operate,and can be used to detect the production of carbapenmases in clinical isolates.
6.Safety of interferon β-1a for treatment of COVID-19: a real-world study based on FAERS database
Rongqing YANG ; Yongqing GAO ; Fangyuan HU ; Yinghong ZHAI ; Kuiling WANG ; Chang LU ; Jia HE ; Haiying ZHANG
Shanghai Journal of Preventive Medicine 2023;35(6):549-554
ObjectiveTo systematically evaluate the safety of interferon β-1a for treatment of corona virus disease 2019 (COVID-19), and to provide references for interferon β-1a's clinical application. MethodsThis study was conducted with the database from US Food and Drug Administration adverse event reporting system (FAERS) from January 1, 2015 to March 31, 2021. Information component (IC) and reporting odds ratio (ROR) methods were applied for signal mining. ResultsA total of 463 700 records of COVID-19 were selected for analysis, and 45 positive drug adverse event signals were detected. Headache (IC025=1.09, ROR025=2.28), pyrexia (IC025=0.51, ROR025=1.51) and multiple sclerosis relapse (IC025=3.67, ROR025=14.71) were positive adverse events with higher frequency. Autoimmune disorder (IC025=4.42, ROR025=24.03), streptococcal infection (IC025=4.12, ROR025=19.82), and multiple sclerosis relapse (IC025=3.67, ROR025=14.71) were positive adverse events. Acute lung injury, cardio-respiratory arrest and metabolic acidosis were associated with a higher proportion and frequency of death. ConclusionThere are certain safety issues with interferon β-1a in the treatment of COVID-19, and some adverse events with high frequency and high death rate deserve further attention by medical staffs.
7.Clinical characteristics and treatment prognosis of ocular toxocariasis
Yongwei ZHOU ; Qiuming LI ; Jiahui WU ; Xiaoyan LU ; Ge YANG ; Zhirou HU ; Fangyuan ZHEN ; Shuqian DONG
Chinese Journal of Ocular Fundus Diseases 2023;39(6):483-488
Objective:To observe the clinical characteristics and treatment prognosis of patients with ocular toxocariasis (OT).Methods:A retrospective clinical trial. From March 2018 to September 2021, 40 eyes of 40 OT patients diagnosed by ophthalmic examination in the First Affiliated Hospital of Zhengzhou University were included in the study. All patients underwent best corrected visual acuity (BCVA) and scanning laser ophthalmoscope (SLO) examination. Color Doppler ultrasound flow imaging (CDFI), fluorescein fundus angiography (FFA) and optical coherence tomography (OCT) were performed in 25, 26 and 26 eyes, respectively. Among the 40 patients, there were 23 males (57.5%, 23/40) and 17 females (42.5%, 17/40). All patients were monocular. Thirty patients (75.0%, 30/40) were younger than 18 years old, with the mean age of (9.60±0.60) years. Ten patients (25.0%, 10/40) were great than or equal to 18 years old, with the mean age of (34.60±4.52) years. Thirty-three patients (82.5%, 33/40) lived in rural areas for a long time. There were 27 patients (67.5%, 27/40) with a history of contact with dogs and cats. In 40 eyes, peripheral granuloma (peripheral type), posterior pole granuloma (posterior pole type), vitreous opacity similar to endophthalmitis (turbid type) and hybrid type were 18(45.0%, 18/40), 11(27.5%, 11/40), 6(15.0%, 6/40) ang 5(12.5%,5/40), respectively. All patients were treated with drugs and/or surgery after definite diagnosis. There were 28 eyes of peripheral type, posterior pole type and hybrid type, 17 eyes were treated with surgery and 11 eyes with drug treatment, respectively. Five eyes with turbid type were only treated with drugs. In 40 patients, 33 patients participated in follow-up. The follow-up time after treatment was (18.78±9.44) months. The improvement of BCVA was observed. The number of eyes with different BCVA before and after treatment was compared by χ2 test or Fisher's test. Results:At the first visit, the BCVA ranged from light perception to 0.6, including 20 eyes with BCVA <0.1, 13 eyes with BCVA 0.1-0.3, and 7 eyes with BCVA >0.3. The posterior vitreous anterior limiting membrane was thickened in 24 eyes (60.0%, 24/40). There were 27 eyes (67.5%, 27/40) with lamellar vitreous opacity and 22 eyes (55.0%, 22/40) with peripheral/posterior pole granulomas. Among 25 eyes examined by CDFI, 14 eyes (56.0%, 14/25) showed characteristic stratified or diffuse opacity in vitreous body. Of the 26 eyes examined by FFA, 15 eyes (57.7%, 15/26) had "fern-like" leakage of retinal capillaries, and the lesion had a patchy non-perfused area. In 26 eyes examined by OCT, epiretinal membrane, cystoid macular edema and vitreoretinal traction were 8 (30.8%, 8/26), 5 (19.2%, 5/26) and 2 (7.7%, 2/26) eyes, respectively. At the last follow-up, compared with before treatment, the BCVA of 5 eyes with turbid type increased, and the difference was statistically significant ( P<0.05). In 28 eyes with peripheral type, posterior pole type and hybrid type, 17 eyes with surgical treatment improved BCVA, and the difference was statistically significant ( χ2=6.258, P<0.05). In 11 eyes only treated with drugs, BCVA remained unchanged, and the difference was not statistically significant ( χ2=0.594, P>0.05). Conclusions:OT patients are mostly children; retinal granulomas, gray-white hyperplastic membrane behind lens or vitreous stratified opacity are specific characteristics. OT is mainly treated by glucocorticoid drugs and vitrectomy.
8.Risk factors of early traumatic coagulopathy in elderly patients with thoracic trauma
Junhao GUO ; Zhi ZHAO ; Gang JIN ; Fangyuan NAN ; Yunsheng HU ; Qu HU
Journal of Clinical Surgery 2023;31(12):1205-1208
Objective To explore the risk factors of early traumatic coagulation(TIC)in elderly patients with chest trauma.Methods The data of 113 elderly patients with chest trauma admitted in a hospital from January 2016 to January 2022 were retrospectively analyzed.Patients were divided into TIC group and non-TIC group according to whether they had early TIC.The risk factors of early TIC in elderly patients with thoracic trauma were analyzed by single factor and multi factor methods.Analysis of the predictive value of early TIC in elderly patients with thoracic trauma using multifactor model.Result Of all the patients included in the study,27 were determined as TIC,and the rest 86 were non-TIC.The results of univariate analysis showed that there were statistically significant differences in the data of shock index,platelet count at admission and plasma fibrinogen at admission between patients in TIC group and non-TIC group(P<0.05).Multivariate analysis showed that the shock index at admission,platelet count at admission,and plasma fibrin at admission were all independent influencing factors of early TIC in elderly patients with chest trauma(all P<0.05).The P value of multivariate model and independent variables predict the early TIC of elderly patients with chest trauma.The Yoden index is 36.95%,42.89%,75.58%and 78.85%respectively.Conclusion The shock index,platelet count and plasma fibrin at the time of admission can affect the early occurrence of TIC in elderly patients with chest trauma.
9.Risk analysis of neurological adverse events related to CAR T-cell therapy with brexucabtagene autoleucel based on the US FDA Adverse Event Reporting System
Na ZHAO ; Xia YE ; Zhiyan WANG ; Chao LU ; Fangyuan HU ; Lei YUAN
Adverse Drug Reactions Journal 2023;25(8):454-459
Objective:To explore the neurological adverse events (AE) associated to brexucabtagene autoleucel (brexu-cel) and their risk of occurrence.Methods:Neurological AE reports related to brexu-cel were collected through the US FDA Adverse Event Reporting System database from July 1, 2020 to September 31, 2022. The AEs were classified and counted according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) 24.1. The information component ( IC) method and the reporting odds ratio ( ROR) method were used to perform signal mining. AEs with ≥3 reports and a lower limit of 95% confidence interval ( CI) for IC>0 or that for ROR>1 were defined as positive risk signals. The proportion of patients who suffered fatal outcomes after experiencing neurological AEs related to brexu-cel was analyzed. Results:A total of 1 960 neurological AE reports related to brexu-cel were collected, involving 559 patients and 22 PTs. Fifteen positive signals (PT) were detected by using the IC and ROR methods. The top 5 PTs in the number of AE reports were immune effector cell-associated neurotoxicity syndrome (153 reports), altered mental status (32 reports), encephalopathy (29 reports), tremor (27 reports), and aphasia (25 reports); the top 5 PTs with the high signal intensity were immune effector cell-associated neurotoxicity syndrome ( IC=7.81, ROR=235.74), encephalopathy ( IC=4.74, ROR=26.96), aphasia ( IC=4.28, ROR=19.58), cerebral edema ( IC=3.35, ROR=10.24), and incontinence ( IC=3.04, ROR=8.22); incontinence (6 cases, IC=3.04, ROR=8.22) was not recorded in the drug instruction. Patients involved in 17 PTs, out of the 22 PTs, had fatal outcomes, and the proportion of deaths from immune effector cell-associated neurotoxicity syndrome was 18% (28/153). The PTs with a proportion of patient deaths >50% were unresponsive to stimuli (80%, 4/5), brain oedema (75%, 6/8), cerebrovascular accident (67%, 2/3), lethargy (60%, 3/5), and seizure (57%, 4/7). Conclusions:Neurological AEs related to brexu-cel are common, of which incontinence is not yet recorded in the drug instruction. The clinical outcomes of some AEs (unrespontive to stimulus, brain oedema, and lethargy) are poor and should be closely monitored.
10.Risk analysis of neurological adverse events related to CAR T-cell therapy with brexucabtagene autoleucel based on the US FDA Adverse Event Reporting System
Na ZHAO ; Xia YE ; Zhiyan WANG ; Chao LU ; Fangyuan HU ; Lei YUAN
Adverse Drug Reactions Journal 2023;25(8):454-459
Objective:To explore the neurological adverse events (AE) associated to brexucabtagene autoleucel (brexu-cel) and their risk of occurrence.Methods:Neurological AE reports related to brexu-cel were collected through the US FDA Adverse Event Reporting System database from July 1, 2020 to September 31, 2022. The AEs were classified and counted according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) 24.1. The information component ( IC) method and the reporting odds ratio ( ROR) method were used to perform signal mining. AEs with ≥3 reports and a lower limit of 95% confidence interval ( CI) for IC>0 or that for ROR>1 were defined as positive risk signals. The proportion of patients who suffered fatal outcomes after experiencing neurological AEs related to brexu-cel was analyzed. Results:A total of 1 960 neurological AE reports related to brexu-cel were collected, involving 559 patients and 22 PTs. Fifteen positive signals (PT) were detected by using the IC and ROR methods. The top 5 PTs in the number of AE reports were immune effector cell-associated neurotoxicity syndrome (153 reports), altered mental status (32 reports), encephalopathy (29 reports), tremor (27 reports), and aphasia (25 reports); the top 5 PTs with the high signal intensity were immune effector cell-associated neurotoxicity syndrome ( IC=7.81, ROR=235.74), encephalopathy ( IC=4.74, ROR=26.96), aphasia ( IC=4.28, ROR=19.58), cerebral edema ( IC=3.35, ROR=10.24), and incontinence ( IC=3.04, ROR=8.22); incontinence (6 cases, IC=3.04, ROR=8.22) was not recorded in the drug instruction. Patients involved in 17 PTs, out of the 22 PTs, had fatal outcomes, and the proportion of deaths from immune effector cell-associated neurotoxicity syndrome was 18% (28/153). The PTs with a proportion of patient deaths >50% were unresponsive to stimuli (80%, 4/5), brain oedema (75%, 6/8), cerebrovascular accident (67%, 2/3), lethargy (60%, 3/5), and seizure (57%, 4/7). Conclusions:Neurological AEs related to brexu-cel are common, of which incontinence is not yet recorded in the drug instruction. The clinical outcomes of some AEs (unrespontive to stimulus, brain oedema, and lethargy) are poor and should be closely monitored.

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