1.Analysis of focus points in the review and evaluation of Blood Infusion Devices
Chenghong YE ; Li XIAO ; Yuxi YANG ; Liyu LI ; Juntai ZHU
China Medical Equipment 2025;22(9):139-142
Hemoperfusion device is widely used in the field of blood purification because of its good adsorption properties to some substances in the body.By combing the principle,structure and other characteristics of the hemoperfusion device,searching the approval status of the currently listed products,this paper summarized the main application fields,application scenarios and research frontiers of the hemopoeia product,combined with the current status of the product declaration and product characteristics,and discussed the main concerns of product review,such as product chemical residue and its risk assessment methods,performance verification,etc.In order to provide reference for the product development of relevant product development institutions and the supervision of regulatory agencies.
2.Analysis of focus points in the review and evaluation of Blood Infusion Devices
Chenghong YE ; Li XIAO ; Yuxi YANG ; Liyu LI ; Juntai ZHU
China Medical Equipment 2025;22(9):139-142
Hemoperfusion device is widely used in the field of blood purification because of its good adsorption properties to some substances in the body.By combing the principle,structure and other characteristics of the hemoperfusion device,searching the approval status of the currently listed products,this paper summarized the main application fields,application scenarios and research frontiers of the hemopoeia product,combined with the current status of the product declaration and product characteristics,and discussed the main concerns of product review,such as product chemical residue and its risk assessment methods,performance verification,etc.In order to provide reference for the product development of relevant product development institutions and the supervision of regulatory agencies.
3.The earlier, the better? A review of neoadjuvant immunotherapy in resectable non-small-cell lung cancer
Fajiu LI ; Ying CHEN ; Juanjuan WU ; Chenghong LI ; Shi CHEN ; Ziyang ZHU ; Wei QIN ; Min LIU ; Bingzhu HU ; Shuang LIU ; Wenzhao ZHONG
Chronic Diseases and Translational Medicine 2022;08(2):100-111
Immune checkpoint inhibitors (ICIs) have revolutionized the approach to advanced and locally advanced non-small-cell lung cancer (NSCLC). Antibodies blocking inhibitory immune checkpoints, such as programmed death 1 (PD-1) and its ligand (PD-L1), have remarkable antitumor efficacy and have been approved as a standard first- or second-line treatment in non-oncogene-addicted advanced NSCLC. The successful application of immunotherapy in advanced lung cancer has motivated researchers to further evaluate its clinical role as a neoadjuvant setting for resectable NSCLC and for improved long-term overall survival and curative rates. In this review, we discuss the efforts that incorporate ICIs into the treatment paradigm for surgically resectable lung cancer. We reviewed the early-phase results from neoadjuvant clinical trials, the landscape of the majority of ongoing phase III trials, and discuss the prospects of ICIs as a curative therapy for resectable lung cancer. We also summarized the potential biomarkers and beneficiaries involved in the current study, as well as the remaining unresolved challenges for neoadjuvant immunotherapy.
4.Non-Ischemic, Non-Hypoxic Myocardial Injury, and Long-Term Mortality in Patients with Coronavirus Disease 2019: A Retrospective Cohort Study
Fajiu LI ; Xijie ZHU ; Ziyang ZHU ; Yinjian YANG ; Zhuang TIAN ; Duolao WANG ; Shi CHEN ; Xiaoyan GAO ; Yalin XU ; Bo ZHANG ; Wei YU ; Min LIU ; Xiqi XU ; Chenghong LI ; Shuyang ZHANG
Cardiology Discovery 2022;02(2):77-82
Objective::Cardiac damage is commonly reported in patients with coronavirus disease 2019 (COVID-19) but its prevalence and impact on the long-term survival of patients remain uncertain. This study aimed to explore the prevalence of myocardial injury and assess its prognostic value in patients with COVID-19.Methods::A single-center, retrospective cohort study was performed at the Affiliated Hospital of Jianghan University. Data from 766 patients with confirmed COVID-19 who were hospitalized from December 27, 2019 to April 25, 2020 were collected. Demographic, clinical, laboratory, electrocardiogram, treatment data and all-cause mortality during follow-up were collected and analyzed.Results::Of the 766 patients with moderate to critically ill COVID-19, 86 (11.2%) died after a mean follow-up of 72.8 days. Myocardial injury occurred in 94 (12.3%) patients. The mortality rate was 64.9% (61/94) and 3.7% (25/672) in patients with and without myocardial injury, respectively. Cox regression showed that myocardial injury was an independent risk factor for mortality (hazard ratio: 8.76, 95% confidence interval: 4.76-16.11, P < 0.001). Of the 90 patients with myocardial injury with electrocardiogram results, sinus tachycardia was present in 29, bundle branch block in 26, low voltage in 10, and abnormal T-wave in 53. Conclusions::COVID-19 not only involves pneumonia but also cardiac damage. Myocardial injury is a common complication and an independent risk factor for mortality in COVID-19 patients.
5.The earlier, the better? A review of neoadjuvant immunotherapy in resectable non-small-cell lung cancer
Fajiu LI ; Ying CHEN ; Juanjuan WU ; Chenghong LI ; Shi CHEN ; Ziyang ZHU ; Wei QIN ; Min LIU ; Bingzhu HU ; Shuang LIU ; Wenzhao ZHONG
Chronic Diseases and Translational Medicine 2022;08(2):100-111
Immune checkpoint inhibitors (ICIs) have revolutionized the approach to advanced and locally advanced non-small-cell lung cancer (NSCLC). Antibodies blocking inhibitory immune checkpoints, such as programmed death 1 (PD-1) and its ligand (PD-L1), have remarkable antitumor efficacy and have been approved as a standard first- or second-line treatment in non-oncogene-addicted advanced NSCLC. The successful application of immunotherapy in advanced lung cancer has motivated researchers to further evaluate its clinical role as a neoadjuvant setting for resectable NSCLC and for improved long-term overall survival and curative rates. In this review, we discuss the efforts that incorporate ICIs into the treatment paradigm for surgically resectable lung cancer. We reviewed the early-phase results from neoadjuvant clinical trials, the landscape of the majority of ongoing phase III trials, and discuss the prospects of ICIs as a curative therapy for resectable lung cancer. We also summarized the potential biomarkers and beneficiaries involved in the current study, as well as the remaining unresolved challenges for neoadjuvant immunotherapy.
6.Non-Ischemic, Non-Hypoxic Myocardial Injury, and Long-Term Mortality in Patients with Coronavirus Disease 2019: A Retrospective Cohort Study
Fajiu LI ; Xijie ZHU ; Ziyang ZHU ; Yinjian YANG ; Zhuang TIAN ; Duolao WANG ; Shi CHEN ; Xiaoyan GAO ; Yalin XU ; Bo ZHANG ; Wei YU ; Min LIU ; Xiqi XU ; Chenghong LI ; Shuyang ZHANG
Cardiology Discovery 2022;02(2):77-82
Objective::Cardiac damage is commonly reported in patients with coronavirus disease 2019 (COVID-19) but its prevalence and impact on the long-term survival of patients remain uncertain. This study aimed to explore the prevalence of myocardial injury and assess its prognostic value in patients with COVID-19.Methods::A single-center, retrospective cohort study was performed at the Affiliated Hospital of Jianghan University. Data from 766 patients with confirmed COVID-19 who were hospitalized from December 27, 2019 to April 25, 2020 were collected. Demographic, clinical, laboratory, electrocardiogram, treatment data and all-cause mortality during follow-up were collected and analyzed.Results::Of the 766 patients with moderate to critically ill COVID-19, 86 (11.2%) died after a mean follow-up of 72.8 days. Myocardial injury occurred in 94 (12.3%) patients. The mortality rate was 64.9% (61/94) and 3.7% (25/672) in patients with and without myocardial injury, respectively. Cox regression showed that myocardial injury was an independent risk factor for mortality (hazard ratio: 8.76, 95% confidence interval: 4.76-16.11, P < 0.001). Of the 90 patients with myocardial injury with electrocardiogram results, sinus tachycardia was present in 29, bundle branch block in 26, low voltage in 10, and abnormal T-wave in 53. Conclusions::COVID-19 not only involves pneumonia but also cardiac damage. Myocardial injury is a common complication and an independent risk factor for mortality in COVID-19 patients.
7.Compilation and reliability and validity test of hospital nursing treatment capacity scale for patients with nuclear radiation damage
Ruibo LI ; Rufu JIA ; Qi YE ; Chenghong ZHU ; Xiuyan SUN ; Wei ZHANG
Chinese Journal of Radiological Health 2021;30(5):611-615
Objective The nursing treatment ability scale of patients with nuclear radiation damagein the hospital was developed to provide an evaluation basis for improving the nursing ability of nurses with nuclear radiation damage. Methods The scale was prepared by literature review, expert interview and expert consultation, and a total of 330 clinical nurses from a third-class hospital was randomly selected as the research objects. The scales were issued for item analysis and reliability and validity test. Results The scales were divided into 6 dimensions, including basic knowledge of nuclear radiation damage, specialized equipment use ability, specialized ward management ability, basic nursing ability, specialized nursing ability and self-ability recognition, with 51 items. After exploratory factor analysis, there were 6 principal components, and the cumulative interpreted variance was 70.757%. The χ2, df, χ2/df, CFI, IFI, TLI, NFI, PNFI, PCFI, RMSEA fitting indexes of confirmatory factor analysis were all acceptable. Cronbach's α coefficient was 0.976, the retest reliability was 0.823, and the S-CVI (S-CVI/UA) was 0.84. The evaluation content validityS-CVI (S-CVI/AVE) was 0.98, and the content validity I-CVI of the item level was 0.78~1.00. Conclusion The items and dimension Settings of this scale have been tested, and all indicators met the requirements. The reliability and validity test results were good. It can be used as a scale for preliminary evaluation of hospital nursing ability of patients with nuclear radiation damage.
8.Clinical features of 109 cases with corona virus disease 2019
Shi CHEN ; Juanjuan WU ; Zhiming LI ; Di XU ; Ziyang ZHU ; Chuanhai WANG ; Chenghong LI ; Peng HE
Chinese Journal of Infectious Diseases 2020;38(3):145-149
Objective:To observe the epidemiology, clinical manifestations, laboratory tests, imaging findings, treatment and prognosis of patients with corona virus disease 2019.Methods:Clinical data of 109 patients with suspected and definite corona virus disease 2019 admitted to the Sixth Hospital of Wuhan from December 24, 2019 to January 28, 2020 were retrospectively analyzed. Statistical analysis was performed by using t test or chi-square test. Results:Among the 109 patients, 54(49.5%) patients had definite contact history. Among the 109 patients, 104(95.4%) presented with fever, 37(33.9%) with headache, 78(71.6%) with general pain, 88(80.7%) with fatigue and poor appetite, 23(21.1%) with diarrhea, 94(86.2%) with coughing, 23(21.1%) with shortness of breath, 57(52.3%) with palpitation, 45(41.3%) with chest distress, 4(3.7%) with chest pain, 40(36.7%) with lung rales. Forty-two cases (38.5%) had leukocyte count <4×10 9/L, 58 cases (53.2%) had lymphocyte count <1.5×10 9/L, 27 cases (24.8%) had hemoglobin <120 g/L, 37 cases (33.9%) had lactic dehydrogenase (LDH) >230 mmol/L, 29 cases (26.6%) had pro-brain natriuretic peptide>300 ng/mL, 87 cases (79.8%) had hypersensitive C reactive protein>10 mg/L, 26 cases (23.9%) had D-dimer>0.5 mg/L, 35 cases (32.1%) had coagulation disorder. On admission, chest computed tomography showed that 27 cases (24.8%) of pneumonia were unilateral, 82 cases (75.2%) were bilateral, and most of them were ground glass. The leukocyte counts, LDH, pro-brain natriuretic peptide and D-dimer of severe/critical cases ((11.33±4.87)×10 9/L, (527.51±260.87) mmol/L, (722.88±189.56) μg/L, (4.24±1.89) mg/L, respectively) were all higher than those of common cases ((4.02±1.49)×10 9/L, (159.75±30.31) mmol/L, (428.22±124.76) μg/L and (0.41±0.22) mg/L, respectively), while the lymphocyte count of severe/critical cases ((0.60±0.17)×10 9/L) was lower than common cases ((1.13±0.43)×10 9/L) ( t=11.36, 11.33, 9.81, 2.81 and 7.77, respectively, all P<0.05). The comprehensive treatment included antiviral drugs, prevention of bacterial infection and supportive treatment, and glucocorticoid and respiratory support treatment were administrated when necessary. Conclusions:The corona virus disease 2019 is characterized by highly infectious, rapid progression, and diverse clinical and imaging features. Early diagnosis and active comprehensive treatment could improve the prognosis and reduce the mortality.
9.The study of puncture wound infections from the high pressure resistant injectable PICC catheter in patients undergoing hematopoietic stem cell transplantation
Xueqing YANG ; Chenghong ZHU ; Zheng ZHANG ; Yanfang ZHENG ; Zhaohua DANG ; Yufei GUO ; Yanjun LIU ; Chengzhu WANG
Chinese Journal of Geriatrics 2020;39(8):910-913
Objective:To analyze the causes of puncture wound infections induced by the high pressure resistant injectable PICC catheter in patients undergoing hematopoietic stem cell transplantation and management measures.Methods:linical data of 75 patients undergoing hematopoietic stem cell transplantation who were treated with the high pressure resistant injectable PICC catheter in our hospital from Nov.2017 to Nov.2019 were retrospectively analyzed.According to whether there were puncture wound infections, patients were divided into the infection group(n=26)and the non-infection group(n=49). Bacterial culture results of the infection group were recorded, and the related factors for puncture wound infections caused by the injectable PICC catheter were analyzed.Effective strategies to prevent high-risk factors, treatment frequency, treatment effect and healing time for patients with different degrees of puncture wound infections were discussed.Results:There were 26 patients in the infection group.The proportions of bacteria types associated with PICC catheter-related infections, in descending order, were as follows: Staphylococcus aureus(46.51%), Klebsiella pneumoniae(30.77%), Corynebacterium(15.38%)and others(7.69%). Significant differences were found in materials used, season of tube placement, timing of dressing changes, duration of catheterization, success rate of first tube placement and condition of dressing films between the non-infection and infection groups( t=5.5, 4.9, 5.0, 13.6, 9.4 and 6.2, all P<0.05). Logistic multi-factor analysis showed that non-U-shaped fixation, delay in dressing changes, long duration of tube placement, low success rate of first tube placement, and loose dressing films were the high-risk factors for PICC catheter-related infections( OR=2.78, 2.42, 3.16, 2.66 and 2.32, all P<0.05). Compared with patients with moderate and mild infections, patients with severe infections had a higher frequency of treatment, a lower total effectiveness rate and a longer healing time( F=10.353, 8.775 and 12.341, all P<0.05). Conclusions:Materials, timing of dressing changes, catheterization time, success rate of first tube placement and condition of dressing films are the high-risk factors for puncture wound infections caused by high pressure resistant injectable PICC catheters in patients undergoing hematopoietic stem cell transplantation.Developing effective intervention strategies can help control the incidence of wound infections.
10. Clinicopathological features of ovarian Brenner tumors
Pingping ZHONG ; Li ZHU ; Lihong ZHANG ; Xingzheng ZHENG ; Tianbao CHEN ; Fei XU ; Yang ZHAN ; Chenghong YIN ; Yulan JIN
Chinese Journal of Pathology 2019;48(8):615-619
Objective:
To investigate the clinicopathological characteristics and diagnosis of ovarian Brenner tumors.
Methods:
Forty-seven cases of ovarian Brenner tumors were enrolled from January 2012 to May 2018 at Beijing Obstetrics and Gynecology Hospital, Capital Medical University. Clinical data, imaging examination, histopathological characteristics and immunohistochemical phenotype were analyzed.
Results:
The age of the patients ranged from 30-73 years and the mean age was 55 years. Thirty-nine patients (83.0%) were postmenopausal. Forty cases (85.1%) of the Brenner tumors were benign, five (10.6%) borderline and two (4.3%) malignant. Usual tumor markers of ovarian carcinoma, including CA199 and CA125 were normal or mild elevated in the 47 cases. Imaging before surgery was not specific to Brenner tumors. Microscopically, benign Brenner tumors were composed of nests of bland, transitional-type cells within a fibromatous stroma. In our 5 cases of borderline Brenner tumors, mildly atypical transitional-type cells were projected into the cyst lumens and lack of stromal invasion. In 2 cases of malignant Brenner tumors, different degrees of nuclear atypial transitional-type cells exhibited stromal invasion. Immunohistochemical stains for CK7, GATA3, p63 and CK5/6 were positive in all cases. Ki-67 was less than 5% in Brenner tumors, and up to 20%-30% in malignant Brenner tumors.
Conclusion
Brenner tumors are mostly seen in postmenopausal patients and are usually benign. Imaging examination and usual ovarian tumor markers do not provide diagnostic value. Diagnosis and classification of Brenner tumors depend on histopathological evaluation.

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