1.Reflection and Practice on Exemption from Ethical Review
Yingshuo HUANG ; Xu ZUO ; Yue LI ; Lihan XING ; Shuilong GUO ; Miaorong XIE
Chinese Medical Ethics 2023;36(10):1116-1121
According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.
2.Diagnostic value of different imagines for choledocholithiasis abdominal pain
Hanyu ZHANG ; Di WU ; Guoxing WANG ; Miaorong XIE ; Chunsheng LI
Journal of Chinese Physician 2021;23(10):1444-1447
Objective:To evaluate direct bilirubin /total bilirubin(D/T), B-mode ultrasound(BUS), multislice spiral computed tomography (MSCT), magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) in the diagnosis of choledocholithiasis abdominal pain (CAP).Methods:We retrospectively analyzed the materials of patients who were diagnosed with choledocholithiasis abdominal pain by above imagines in the emergency department of Beijing Friendship Hospital during March 2016 to December 2018. The stones were taken out by endoscopic retrograde cholangiopancreatography or surgical operation as the golden standard.Results:Among 256 patients, 195 cases, 138 cases, 107 cases and 26 cases were diagnosed by EUS, MRCP, CT and BUS, respectively. The sensitivity were 0.86, 0.62, 0.45, 0.13, respectively. The specificity were 0.86, 0.81, 0.75, 0.87. The positive predictive value were 0.97, 0.96, 0.91, 0.83.The negative predictive value were 0.55, 0.19, 0.21, 0.16. The accuracy rate were 0.88, 0.64, 0.48, 0.30, respectively. The sensitivity of D/T and D/T combined with EUS in the diagnosis of CAP were 0.57 and 0.67, and the accuracy were 0.16 and 0.56, respectively.Conclusions:EUS has a high diagnostic value for CAP. MRCP is superior to CT in the value of diagnosis of CAP. BUS in imaging diagnosis of CAP value is relatively low, but D/T combined with BUS can improve the sensitivity and accuracy of diagnosis for CAP.
3.Overexpression of programmed cell death-1 (PD-1) affects circulatory Th1 and Th2 cells in patients with cardiac arrest in the early period after the return of spontaneous circulation.
Yanan YU ; Miaorong XIE ; Jiabao LI ; Chenchen HANG ; Fei SHAO ; Chunsheng LI
Chinese Medical Journal 2021;135(1):95-97
4.Great role and position of emergency department in the prevention and control of infectious diseases
Wei GU ; Guoqiang ZHANG ; Miaorong XIE
Chinese Critical Care Medicine 2020;32(3):261-263
The emergency department is not only the place of treating emergency and critically ill patients, but also the frontline of identification and treatment of infectious disease. To ensure the treatment of the acute and critical diseases and the safety of the hospital, the emergency department should be included in the prevention and control system of infectious diseases. Therefore, we should attach great importance to the role of emergency department in the prevention and control system of infectious diseases, by establishing standardized protocols of ward layout, treatment procedure, management and training. We suggest that it is essential to strengthen the integrated management with the infectious diseases department, and jointly build a new emergency medical service system to deal with infectious diseases.
5.Survey and analysis on clinical teaching and scientific research achievements of visiting scholars in general hospitals funded by medical foundation
Jiayuan WANG ; Yu ZHENG ; Hong YOU ; Xiaofei LV ; Miaorong XIE
Chinese Journal of Medical Science Research Management 2020;33(2):151-155
Objective:To explore the achievements of clinical teaching and scientific research acquired by visiting scholars funded by medical foundation, which will be benefit for the improvement for cultivation of innovative talents in general hospitals.Methods:Questionnaire data of 132 visiting scholars supported by Beijing Li Huanying Medical Foundation from 2010 to 2016 were analyzed and applied by descriptive statistics.Results:Study abroad has played a positive role in promoting clinical skills, teaching level, and scientific research capacity building. Visitors have significantly improved their teaching titles, mentor positions, paper publishing and approved funding projects, in which there was a year-on-year growth trend high level projects funded.Conclusions:Study abroad is conducive to stimulating the enthusiasm and creativity of medical talents, and also an effective way to enhance the overall strength of the hospital. The foundation exerts the overall planning and leadership role of talent construction, and provides full-chain service and management for overseas study personnel, which is the key to maximize the teaching and research output of medical personnel.
6.Prognostic significance of myocardial markers and echocardiography in elderly patients with sepsis
Hanyu ZHANG ; Yanjun DENG ; Zhenhua LI ; Xuelian SUN ; Guoxing WANG ; Miaorong XIE ; Chunsheng LI
Journal of Chinese Physician 2018;20(5):644-648
Objective To explore the relationship between those myocardial markers serum cardiac troponin T (cTNT),serum cardiac troponin I (cTNI),N-terminal pro-brain natriuretic peptide (NT-proBNP),echocardiography and myocardial injury in the oldest-old septic patients,as well as to evaluate prognosis in the oldest-old septic patients.Methods 140 oldest-old septic patients hospitalized in Beijing Friendship Hospital from January 1 st,2015 to Jun 31st,2017 were collected and analyzed retrospectively.They were divided into survival group (90 cases) death group (50 cases)according to their survival time.Serum cTNT,cTNI and NT-proBNP level at 1,3 and 7d post-diagnosis were collected and echocardiography left ventricular diastolic diameter (EDD),left ventricular systolic diameter (ESD),right ventricular diameter (RV),left ventricular ejection fraction (EF) was performed.Results 140 oldest-old septic patients were enrolled in the analysis.There were 90 cases in survival group and 50 cases in death group.Mean values of cTNT,cTNI,NT-proBNP,EDD,ESD in survival group were obviously higher than those in death group (P < 0.05),left ventricular ejection fraction (LVEF) in survival group was lower than that in death group (P < 0.01).But there were no difference in E/A and RV between survival group and death group (P > 0.05).There were positive correlation between cTNT,cTNI,NT-proBNP and EDD,ESD (P < 0.05),negative correlation between cTNT,cTNI,NT-proBNP and LVEF (P < 0.05),and no correlation between cTNT,cTNI,NT-proBNP and E/A,RV (P >0.05).There were obviously correlation between cTNT,cTNI,NT-proBNP,EDD,ESD and mortality rate (OR > 1,P < 0.05).It was shown the prognosis value of cTNT,cTNI,NT-proBNP,EDD,ESD to mortality rate in oldest-old septic patient.The prognosis value was cTNT > NT-proBNP > cTNI > EDD > ESD.Conclusions There were obviously correlation between cT NT,cTNI,NT-proBNP,EDD,ESD and myocardium restrain,heart dysfunction as well as mortality rate.cTNT was the best prognosis indicator in sensitivity,and NT-proBNP was the best prognosis indicator in specificity.The combination of cTNT and NT-proBNP can better forecast the prognosis of the oldest-old septic patient.
7.Efficacy and safety of itraconazole on the advanced age patients with acute exacerbation of chronic obstructive pulmonary disease complicated with pulmonary fungal infection
Hanyu ZHANG ; Miaorong XIE ; Guoxing WANG
Adverse Drug Reactions Journal 2017;19(3):208-212
Objective To evaluate the efficacy and safety of itraconazole on the advanced age patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with pulmonary fungal infection.Methods Beijing Friendship Hospital information system was searched and the clinical data of patients with AECOPD complicated with pulmonary fungal infection who were hospitalized in Department of Emergency Medicine, Beijing Friendship Hospital from January 1st, 2013 to January 1st, 2016 were collected and analyzed retrospectively.The patients were divided into the advanced age group (≥ 80 year-old) and the middle age group (40-60 year-old).The dosage regimen included IV infusion of itraconazole 200 mg once per 12 hours in the first 2 days, then 200 mg once daily until to the end of observation in the Department of Emergency Medicine or changed to take itraconazole orally for consolidation.The clinical efficacy rate, fungal clearance rate and incidence of adverse drug reactions (ADR) were compared between the patients in the 2 groups.Results A total of 132 patients were enrolled in the analysis.There were 60 and 72 cases in the advanced age group and the middle age group, respectively.The average time of using itraconazole in the advanced age group and the middle age group were (19±5)d and (16±3)d, the difference was statistically significant (P<0.01).The patients in the 2 groups received the symptomatic treatments which included meropenem or imipenem and cilastatin sodium for anti-infection, dyphylline for preventing asthma, and ambroxol hydrochloride for eliminating phlegm at the same time.The results of sputum culture showed that the case number of candida infection and aspergillus infection were 35 (58.3%) and 25 (41.7%) in the advanced age group, 48 (66.7) and 24 (33.3%) in the middle age group, respectively.At the end of intravenous medication of itraconazole, the body temperature, white blood cell count, and neutrophile granulocyte proportion in the 2 groups were lower than those before medication (all P<0.05), but the difference between them was not statistically significant (P>0.05).The proportion of cases with the symptoms or sign of cough, gasp for breath, and pulmonary rale in the 2 groups were lower than those before medication (all P<0.01), but the difference between 2 groups was not statistically significant (P>0.05).Imaging examination results were better obviously than those before medication, the difference was statistically significant (P<0.01).The clinical effective rate and the fungal clearance rate in the advanced age group and the middle age group were 78.3%(47/60) and 75.0%(45/60) , 80.6%(58/72) and 80.6%(58/72), respectively.The differences were not statistically significant (all P>0.05).One case in each group appeared gastrointestinal reactions on day 5 and 10 of IV infusion of itraconazole, respectively.The adverse reactions were disappeared on day 2 and 7 of symptomatic treatments, respectively.Conclusion Itraconazole has an affirmatory curative effect and also is safe in treatment of advanced patient who with AECOPD complicated with pulmonary fungal infection.
8.Efficacy and safety of itraconazole on the advanced age patients with acute exacerbation of chronic obstructive pulmonary disease complicated with pulmonary fungal infection
Hanyu ZHANG ; Miaorong XIE ; Guoxing WANG
Adverse Drug Reactions Journal 2017;19(3):208-212
Objective To evaluate the efficacy and safety of itraconazole on the advanced age patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with pulmonary fungal infection.Methods Beijing Friendship Hospital information system was searched and the clinical data of patients with AECOPD complicated with pulmonary fungal infection who were hospitalized in Department of Emergency Medicine, Beijing Friendship Hospital from January 1st, 2013 to January 1st, 2016 were collected and analyzed retrospectively.The patients were divided into the advanced age group (≥ 80 year-old) and the middle age group (40-60 year-old).The dosage regimen included IV infusion of itraconazole 200 mg once per 12 hours in the first 2 days, then 200 mg once daily until to the end of observation in the Department of Emergency Medicine or changed to take itraconazole orally for consolidation.The clinical efficacy rate, fungal clearance rate and incidence of adverse drug reactions (ADR) were compared between the patients in the 2 groups.Results A total of 132 patients were enrolled in the analysis.There were 60 and 72 cases in the advanced age group and the middle age group, respectively.The average time of using itraconazole in the advanced age group and the middle age group were (19±5)d and (16±3)d, the difference was statistically significant (P<0.01).The patients in the 2 groups received the symptomatic treatments which included meropenem or imipenem and cilastatin sodium for anti-infection, dyphylline for preventing asthma, and ambroxol hydrochloride for eliminating phlegm at the same time.The results of sputum culture showed that the case number of candida infection and aspergillus infection were 35 (58.3%) and 25 (41.7%) in the advanced age group, 48 (66.7) and 24 (33.3%) in the middle age group, respectively.At the end of intravenous medication of itraconazole, the body temperature, white blood cell count, and neutrophile granulocyte proportion in the 2 groups were lower than those before medication (all P<0.05), but the difference between them was not statistically significant (P>0.05).The proportion of cases with the symptoms or sign of cough, gasp for breath, and pulmonary rale in the 2 groups were lower than those before medication (all P<0.01), but the difference between 2 groups was not statistically significant (P>0.05).Imaging examination results were better obviously than those before medication, the difference was statistically significant (P<0.01).The clinical effective rate and the fungal clearance rate in the advanced age group and the middle age group were 78.3%(47/60) and 75.0%(45/60) , 80.6%(58/72) and 80.6%(58/72), respectively.The differences were not statistically significant (all P>0.05).One case in each group appeared gastrointestinal reactions on day 5 and 10 of IV infusion of itraconazole, respectively.The adverse reactions were disappeared on day 2 and 7 of symptomatic treatments, respectively.Conclusion Itraconazole has an affirmatory curative effect and also is safe in treatment of advanced patient who with AECOPD complicated with pulmonary fungal infection.
9.The effects of glucocorticoid on myocardial apoptosis in septic rats
Hanyu ZHANG ; Lipei YANG ; Miaorong XIE
Chinese Journal of Emergency Medicine 2014;23(10):1105-1108
Objective To observe the occurrence of myocardial apoptosis and discussing the mechanism of the effects of glucocorticoid on myocardial apoptosis in septic rats in order to provide the rationale for clinical strategy.Methods A total of 60 Wistar rats weighing 230-280 g were randomly (random number) divided into control group and experimental group (n =30 in each group).Cecal ligation and puncture (CLP) was performed in rats to induce sepsis,and Cefoperazone Sodium/Sulbactam Sodium (200 mg/kg) was injected into caudal vein 4 hours after CLP,twice a day.In addition,glucocorticoid was given to rats of experimental group.After rats sacrificed,their left ventricular myocardia were rapidly taken out and myocardial apoptosis rate was measured and the level of Bcl-2 was assayed at 6 h,24 h,and 72 h after CLP.Measured data were analyzed with independent-samples t-test and One-Way ANOVA.Results The rates of myocardial apoptosis in experimental group were obviously lower than those in control groups respectively (F=9.11,t=5.681,P<0.01) (6ht=11.416,P<0.01; 24ht=6.217,P<0.01; 72 h t =3.76,P <0.01).The rates of myocardial apoptosis in 24 h in control and 72 h control groups were distinctively higher than those in 6 h control group,respectively (F =13.254,sig =0.000,P <0.01 ; sig =0.004,P < 0.01).The rates ofmyocardial apoptosis in group 24 h control were higher than those in 72 h control group (sig =0.039,P < 0.05).The rates of myocardial apoptosis make no difference among experimental group (F =2.488,6/24 h sig =0.132,P > 0.05 ; 24/72 h sig =0.549,P > 0.05 ; 6/72 h sig =0.053,P > 0.05).Conclusions The rate of myocardial apoptosis is peaked at 24 h in sepsis rat,and the rate of myocardial apoptosis can be obviously decreased by administration of glucocorticoid.
10.Acute interstitial pneumonia caused by interleukin-2 and interferon α-2b therapy for renal cell carcinoma: a case report and clinical study.
Chinese Medical Journal 2014;127(23):4154-4156
Aged, 80 and over
;
Carcinoma, Renal Cell
;
drug therapy
;
Female
;
Humans
;
Interferon-alpha
;
adverse effects
;
therapeutic use
;
Interleukin-2
;
adverse effects
;
therapeutic use
;
Lung Diseases, Interstitial
;
chemically induced
;
diagnosis
;
Recombinant Proteins
;
adverse effects
;
therapeutic use

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