1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
2.Literature review on the risk assessment and timing of aortic valve replacement for asymptomatic severe aortic stenosis.
Xiao Teng MA ; Yu Jing CHENG ; Sai LYU ; Yan SUN ; Hua SHEN ; Zhi Jian WANG ; Xiao Li LIU ; Yu Yang LIU ; Dong Mei SHI ; Yu Jie ZHOU
Chinese Journal of Cardiology 2021;49(5):528-534
3. Efficacy and safety of active transfer of plaque versus provisional stenting with drug-eluting stents for the treatment of coronary bifurcation lesions
Hua SHEN ; Lixia YANG ; Zhijian WANG ; Zheng JI ; Bin LIU ; Xueqi LI ; Shaobin JIA ; Qing YANG ; Sai LYU ; Yujie ZHOU
Chinese Journal of Cardiology 2019;47(7):549-553
Objective:
To compare the efficacy and safety of active transfer of plaque (ATP) versus provisional stenting (PS) with drug-eluting stents (DES) for the treatment of coronary bifurcation lesions.
Methods:
A total of 1 136 patients with bifurcation lesions hospitalized in 6 selected hospitals between January 2010 and January 2014 were included in this prospective observational trial, patients were divided into either ATP (
4.Roles of transforming growth factor - β1 and heat shock protein 47 in progression of Schistosoma japonicum-induced hepatic fibrosis
Yong-Hua ZHOU ; Chen XU ; Ying-Ying YANG ; Cong-Jin MEI ; Pan-Pan DONG ; Xue SAI ; Yong-Liang XU ; Xiao-Lin FAN ; Jun-Qi YANG ; Li-Juan SHEN
Chinese Journal of Schistosomiasis Control 2019;31(4):382-387
Objective To investigate the dynamic expression of transforming growth factor-β1 (TGF-β1) and heat shock protein 47 (HSP47) and explore their roles in the progression of hepatic fibrosis induced by Schistosoma japonicum infection. Methods Fifty female mice of the ICR strain were randomly divided into the infection group and the normal control group, of 25 mice in each group. Each mouse in the infection group was infected with 20 ± 1 cercariae of S. japonicum via the abdominal skin, while uninfected animals served as normal control. Five mice were sacrificed 4, 6, 8, 10 and 12 weeks post-infection and liver tissues were sampled. Serum HSP47 and TGF-β1 was determined using enzyme-linked immunosorbent assay (ELISA), and the pathological changes of liver specimens were observed with hematoxylin & eosin (HE) staining. In addition, the synthesis of alpha 1 chain of type I collagen (COL1A1) was measured using Masson staining, and the mRNA expression of TGF-β1, HSP47 and COL1A1 was determined using real-time fluorescent quantitative PCR (qPCR) assay. Results During the period of S. japonicum-induced hepatic fibrosis, the serum HSP47 and TGF-β1 levels and the mRNA expression of TGF - β1, HSP47 and COL1A1 gradually increased with the progression of hepatic fibrosis. The serum levels of HSP47 and TGF-β1 were (179.26 ± 29.87) pg/mL and (22.37 ± 5.21) ng/mL 6 weeks post-infection, respectively, which were significantly greater than those [(150.29 ± 34.91) pg/mL and (18.54 ± 7.78) ng/mL, respectively] in the normal control group (both P values < 0.05). In addition, the mRNA expression of HSP47, COL1A1 and TGF-β1 was (0.86 ± 0.04), (1.17 ± 0.06) and (0.64 ± 0.13) in mouse liver specimens, which was significantly higher than that (0.23 ± 0.03, 0.20 ± 0.02 and 0.38 ± 0.02) in the normal control group (all P values < 0.01). Conclusions The expression of TGF-β1 and HSP47 during the period of S. japonicum-induced hepatic fibrosis is consistent with the progression of the hepatic fibrosis, and exhibits the same tendency with type I collagen expression. HSP47 is a novel promising diagnosis marker and therapeutic target for S. japonicum-induced hepatic fibrosis.
5.The Application of Magnetic Resonance Functional Imaging in Efficacy Assessment ofNeoadjuvant Chemotherapy for Breast Cancer
Sai-Hua SUN ; Chun-Wu ZHOU ; Jing LI
Medical Journal of Peking Union Medical College Hospital 2017;8(2):95-99
Breast cancer is one of the common diseases in women,and its mortality now ranks first among the female malignancies in China.Therefore,early detection,early diagnosis and early treatment have become the focus of the treatment for breast diseases.Neoadjuvant chemotherapy is a standard treatment for locally progressive breast cancer,and magnetic resonance imaging (MRI) is superior to ultrasonography,X-ray and clinical examination in evaluating the efficacy of neoadjuvant chemotherapy for breast cancer.MRI can provide not only structural imaging,but also functional imaging.MRI dynamic contrast enhanced imaging,diffusion weighted imaging,perfusion weighted imaging and magnetic resonance spectroscopy have received extensive attention in the evaluation of therapeutic efficacy for breast cancer.
6.Studies on genotype of human cytomegalovirus glycoprotein H from infantile clinical isolates.
Shan GUO ; Meng-Meng YU ; Ge LI ; Hua ZHOU ; Feng FANG ; Sai-Nan SHU
Chinese Journal of Pediatrics 2013;51(4):260-264
OBJECTIVETo investigate the genetic polymorphism of human cytomegalovirus (HCMV) glycoprotein H (gH) from infantile clinical isolates, to analyze the genotypic distribution of gH in different diseases of HCMV infection and try to find the correlations between the diseases and genotypes.
METHODFresh urine specimens were collected from the hospitalized children with different diseases whose blood HCMV-IgM and HCMV-IgG were positive. Virus was isolated from these specimens. Glycoprotein H of harvest clinical isolates was genotyped by nested-PCR combined with restriction fragment length polymorphism (RFLP), the purified PCR products were digested by restriction endonuclease HhaI. The digested products were genotyped by polyacrylamide gel electrophoresis and silver staining. Classification and results of sequencing were compared.
RESULTTotally 102 HCMV clinical isolates were obtained. Glycoprotein H gene of these clinical isolates (43 cases had infantile hepatitis syndrome, 38 cases had anicteric hepatitis, 13 pneumonia, 7 thrombocytopenic purpura, and 1 congenital CMV infection) were positive by nested-PCR, whose positive rate was 100%. The results showed that 62 strains were gH1 genotypes (60.8%), while 40 strains were gH2 (39.2%), mixed type or new genotype was not observed. In infantile hepatitis syndrome (26 clinical isolates were gH1 genotypes, 17 clinical isolates were gH2 genotypes), anicteric hepatitis (25 were gH1, 13 were gH2) and pneumonia (9 were gH1, 4 were gH2), the distribution of HCMV gH genotypes of infantile clinical isolates was consistent with the overall trend (χ(2) = 0.357, P > 0.05). However , the gH2 was more common than gH1 in the clinical isolates of patients with thrombocytopenic purpura (6 were gH2, 1 were gH2, χ(2) = 6.083, P < 0.05).
CONCLUSIONGenotype 1 was the dominant genotype of glycoprotein H in HCMV clinical isolates from our hospital infants. There was no significant difference between the distribution of gH genotypes in infantile hepatitis syndrome, anicteric hepatitis and pneumonia. However, gH2 was the dominant genotype in thrombocytopenic purpura. These findings suggested that there may be a certain relevance between gH genotype and different clinical manifestations.
Amino Acid Sequence ; Base Sequence ; Child, Preschool ; Cytomegalovirus ; classification ; genetics ; isolation & purification ; Cytomegalovirus Infections ; virology ; DNA Primers ; DNA, Viral ; genetics ; Female ; Genotype ; Hepatitis ; virology ; Humans ; Infant ; Infant, Newborn ; Male ; Pneumonia, Viral ; virology ; Polymerase Chain Reaction ; Polymorphism, Genetic ; Polymorphism, Restriction Fragment Length ; Urine ; virology ; Viral Envelope Proteins ; genetics
7.Viral etiology of 1165 hospitalized children with acute lower respiratory tract infection.
Ni-Guang XIAO ; Bing ZHANG ; Zhao-Jun DUAN ; Zhi-Ping XIE ; Qiong-Hua ZHOU ; Li-Li ZHONG ; Han-Chun GAO ; Xiao-Fang DING ; Sai-Zhen ZENG ; Han HUANG ; Yun-De HOU
Chinese Journal of Contemporary Pediatrics 2012;14(1):28-32
OBJECTIVETo explore the viral etiology of acute low respiratory tract infection (ALRTI) among hospitalized children in Changsha of Hunan Province of China.
METHODSNasopharyngeal aspirates were collected from 1165 hospitalized children with ALRTI in Changsha from September 2007 to August 2008. Respiratory syncytin virus (RSV), human rhinovirus (HRV), influenza virus A (IFVA), influenza virus B (IFVB), parainfluenza 1-3 (PIV 1-3), human metapneumovirus (hMPV), human coronaviruses NL63 (HCoV-NL63), and human coronaviruses HKU1 (HCoV-HKU1) were detected by reverse transcription polymerase chain reaction (RT-PCR). Adenovirus (ADV) and human bocavirus (HBoV) were detected by standard polymerase chain reaction (PCR). WU polyomaviruses (WUPyV) and KI polyomaviruses(KIPyV) were detected by nested PCR. The positive samples further underwent genetic sequencing.
RESULTSAmong the 1165 nasopharyngeal aspirates, viruses were detected in 871 samples (74.76%), among which RSV (27.03%) was the most common virus, followed by HRV (17.33%), PIV3 (13.73%), HBoV (8.67%) and hMPV (6.52%). The overall positive rate of viral detection showed no significant differences between males and females (X2=2.241, P=0.134), whereas the positive rates of PIV3, hMPV, and HBoV in males were higher than in females. The positive rate of viral detection showed significant differences among different age groups (X2=10.934, P=0.027), and the highest positive rate was noted in the age group of 6 months to 1 year. Furthermore, the overall positive rate of viral detection showed a significant difference in term of seasonal distribution, with a peak prevalence in winter.
CONCLUSIONSVirues predominate in the etiology of pediatric ALRTI in Changsha, and RSV, HRV and PIV3 are the main viruses for ALRTI. HBoV and hMPV have become increasingly important. Viral infection-associated ALRTI shows a prevail in the age group of 6 months to 1 year as well as in winter.
Adolescent ; Age Distribution ; Child ; Child, Hospitalized ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Nasopharynx ; virology ; Respiratory Tract Infections ; etiology ; virology ; Seasons ; Sex Distribution ; Viruses ; isolation & purification
8.Clinical analysis of 8 cases with acute invasive pulmonary aspergillosis in younger children.
Hua ZHOU ; Yong-jian HUANG ; Sai-nan SHU ; Sheng-xuan LIU ; Hao HUANG ; Xu-fang LI ; Feng FANG
Chinese Journal of Pediatrics 2011;49(10):788-792
OBJECTIVESTo analyze the clinical features of acute invasive pulmonary aspergillosis in younger children, in order to improve the levels of early recognition, diagnosis and management of this disease.
METHODClinical data of 8 patients aged below 15 months who were diagnosed as acute invasive pulmonary aspergillosis from August 2010 to February 2011 in general pediatric wards in our hospital were retrospectively analyzed for the high-risk factors of the hosts, clinical manifestations, laboratory findings and lung CT imaging, the processes of diagnosis and treatment, and the outcomes.
RESULTFive cases were tested for serum GM test absorbent index (GMI) ranged from 1.92 to 3.27; in 2 cases sputum culture was positive for Aspergillus fumigatus for twice, and 1 infant was serum GMI 2.85 and a sputum culture was positive for Aspergillus fumigatus positive, all these findings were accordant with the clinical diagnosis. Seven cases had a history of receiving intravenously broad-spectrum antibiotics or plus corticosteroids (6 hospitalized, 1 out-patient), and one was only 1 month old, whose parents had severe tinea pedis. 4 patients of high-fever type had sustained high temperature, severe changes of lungs without obvious respiratory symptoms and signs in early phase, and significant increase of the rod granulocyte rate (0.25 - 0.68), which was apparently discordant with the normal WBC count and high sensitivity C-reactive protein (hs-CRP) value. Another 4 cases of non-high-fever type were present with normal WBC count, hs-CRP value and the percentage of rod granulocyte. Among them, 3 infants had low-grade fever, with serious respiratory symptoms and signs and changes of lungs CT. Another 1-month-old case only showed lower vigor and response. Lung CT imaging often showed multiple irregular large nodules, patches and streaks of density (6 cases) and unilateral lobar consolidation (1 case), with some involving the pleura; one appeared severe peri-main bronchus lesions with stenoses of bilateral main bronchi. The first case died of multiple organ failure because of severe sepsis complication. Another 7 cases were treated with voriconazole promptly after clinical or suspected diagnosis, and the state of patients relieved rapidly within 1 - 3 d.
CONCLUSIONThe abuse of broad-spectrum antibiotics and corticosteroids may increase the risk of invasive pulmonary aspergillosis in younger children. There may be the risk of nosocomial infection and spread of aspergillus in general pediatric wards. Cases of high-fever type in early period of disease had two inconsistency: few symptoms and signs, while severe changes of lungs CT; apparent increase of peripheral rod granulocyte, while normal WBC count and hs-CRP value. Preemptive voriconazole therapy could obtain significant effect and reduce the mortality rate.
Acute Disease ; Adrenal Cortex Hormones ; adverse effects ; Anti-Bacterial Agents ; adverse effects ; Aspergillus fumigatus ; isolation & purification ; Female ; Humans ; Infant ; Invasive Pulmonary Aspergillosis ; diagnosis ; therapy ; Male ; Retrospective Studies ; Risk Factors
9.Construction and application of a genechip method for detection of hepatitis B virus lamivudine-resistant mutants and basal core promotor/Pre-C mutants
Bing LI ; Bo-Ping ZHOU ; Jin-Fu PENG ; Li-Yan CHEN ; Wen ZHANG ; Wei TANG ; Zhao-Qin WANG ; Zhong-Hua YIN ; Liu-Mei XU ; Rui-Ling LUO ; Xiao-He LI ; Sai-Yun LIU
Chinese Journal of Experimental and Clinical Virology 2009;23(4):309-312
Objective The objective of this research is to construct a clinic-usable genechip method for detection of hepatitis B virus lamivudine-resistant mutants and basal core promotor/Pre-C mutants, compare this method with DNA sequencing to investigate this genechip's character (semity, specificity, stability and practicability in clinic) and apply it in clinic. Methods This genechip detection method can detect the DNA and 8 mutative site of HBV, include 3 lamivudine-resistant mutation site (No. 180, 204, 207 site in DNA polymerase gene) ,5 HBeAg escape-related mutation site(nt 1896, 1899, 1862, 1764, 1762 site in BCP/Pre-C region).The results of genechip method was verified by DNA sequncing. Results In detecting HBV DNA, the results of genechip were agree with 100% of the results of DNA sequencing. In detecting HBV mutants, 251 sites (in 32 samples, 256 sites) showed the same results using both methods, and only 5 sites were not completely match(P >0.05). In these 5 sites, genechip methods got multi-infection results, but sequencing got single-infection results.Conclusion These results suggest that genechip method has the same positive rate and almost these same specificity with DNA sequencing method, and is better than DNA sequencing method in detecting multi-infected HBV strains.
10.Establishment and control of a storehouse and logistics system for medical consumable materials.
Qing-Li ZHOU ; Chuan JIANG ; Hui TIAN ; Sai-Hua ZHOU
Chinese Journal of Medical Instrumentation 2008;32(4):299-301
In the paper, we introduce a store-house and logistics management system for medical consumable materials based on the 2-dimensional bar code and wireless computer application technology. The system has a friendly interface and is easy to use. It can improve work efficiency and lower errancy by using PDA.
Automatic Data Processing
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Disposable Equipment
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supply & distribution
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Hospital Information Systems
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Software
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User-Computer Interface

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