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.Toxicity evaluation of zinc oxide nanoparticles in vitro and in vivo on cornea
Xiao-Lu HOU ; Dong-Mei CUI ; Ling-Zhi NIU ; Xiao-Tong SUN ; Tao YU ; Yu-Hang ZHAO ; Ai-Ping SONG ; Wei LI
International Eye Science 2023;23(7):1080-1086
AIM:To observe the toxic effects of zinc oxide nanoparticles(ZnO NPs)on cornea by constructing intoxicated model in vivo and in vitro.METHODS:Human corneal epithelial cells(HCEpiC)were cultured in vitro and exposed to different concentrations(0.5, 5, 12.5, 25, 50, 100, 250 μg/mL)of ZnO NPs for 24h. The cell culture medium without nano-solution was used as the blank control group. The viability of the cells was assessed by MTT assay. Three different concentrations(25, 50 and 100 μg/mL)of ZnONPs dispersions were exposed to the conjunctival sac of anesthetized mice three times a day for 7d consecutively. The phosphate buffered saline(PBS)eye group was the PBS control group. Corneal morphology was observed on 1, 3, 5 and 7d, and the eyes were removed on 8d for various laboratory examinations, including corneal pathological changes and expression levels of inflammatory factors(TNF-α, IL-6).RESULTS:After treatment of HCEpiC cells with different concentrations of ZnO NPs for 24h, the MTT results showed that Zno NPs cause damage to cells at 0.5 μg/mL, and the cell survival rate was about 80%(P<0.05). Half of the cells were killed at a dose of 5 μg/mL, the damaging effect on cells in the concentration range of 5~250 μg/mL was concentration-dependent(P<0.0001). After 7d of conjunctival capsule spotting in mice, dot-like staining of fluorescein was seen in the 25 μg/mL ZnO NPs and 50 μg/mL ZnO NPs groups. Localized circular fluorescein stained areas were seen in the corneas of the 100 μg/mL ZnO NPs group. HE staining showed that the corneal epithelial layer, stromal layer thickness and stromal layer immune cell number did not change significantly in the 25 μg/mL and 50 μg/mL ZnO NPs groups(all P>0.05), while the corneal epithelial layer thinned, the corneal stromal layer thickened and the stromal layer immune cells increased significantly in the 100 μg/mL ZnO NPs group(all P<0.05). Immunohistochemical staining showed that the number of corneal stromal immune cells producing TNF-α and IL-6 and the mean integral optical density(IOD)values of TNF-α and IL-6 were significantly higher in the 100 μg/mL ZnO NPs group than in the PBS control group(P<0.05), and the degree of inflammation response was concentration-dependent. Compared with the PBS control group, no significant increase in immune cell count and IOD values in the 25 μg/mL ZnO NPs and 50 μg/mL ZnO NPs groups(P>0.05).CONCLUSION:The toxic damaging effect of ZnO NPs on the cornea was confirmed from both in vitro and in vivo, which provided a theoretical basis for the ocular safety evaluation of ZnO NPs.
3.A new cyclopeptide from Selaginella tamariscina.
Xin-Jia YAN ; Jing WEN ; Yang SONG ; Dong-Mei SHA ; Ma-Li-Niu SHA ; Shao-Shan ZHANG ; Yuan LIU
China Journal of Chinese Materia Medica 2022;47(16):4391-4394
One new cyclopeptide was isolated from the ethyl acetate fraction of the 75% EtOH extract of Selaginella tamariscina by various column chromatography methods(HP-20, polyamide and semi-preparative HPLC). Its structure was identified as selapeptin A(1) by extensive spectroscopic analysis(HR-ESI-MS, 1 D and 2 D NMR). Compound 1 was evaluated for cytotoxic activities by MTT assay. It showed potent cytotoxic activity against B16 F10 with the inhibition rate of 51.57%±4.34% at 40 μmol·L~(-1) while had no impacts on MDA-MB-231 and MDA-MB-468 at 100 μmol·L~(-1).
Chromatography, High Pressure Liquid
;
Magnetic Resonance Spectroscopy
;
Molecular Structure
;
Peptides, Cyclic/pharmacology*
;
Selaginellaceae/chemistry*
4.Research progress on chemical constituents,pharmacological activities,and quality control of Patrinia villosa.
Yu FAN ; Dong-Mei SHA ; Ma-Li-Niu SHA ; Jian-Long LAN ; Lai-Yue-Bu HAI ; Bie-Jun-Zhang QU ; Xin-Jia YAN ; Yuan LIU
China Journal of Chinese Materia Medica 2022;47(22):6005-6019
Patrinia villosa, regarding its functions in clearing heat and detoxification and eliminating carbuncles and pus, is widely used as a traditional medicinal herb that contains rich nutrition and substances such as various amino acids, vitamins, and soluble su-gar, and it is also an edible wild herb in Chinese folk tradition for 2 000 years. In 1973, Japanese scholars firstly separated three iridoids from Japanese P. villosa, and by 2021, chemical components such as flavonoids, iridoids, organic acids, triterpenoids, phenylpropanoids, and steroids have been found, which have multiple pharmacological effects, including antioxidant, antitumor, anti-diarrhea, antibacterial, sedative, and liver protection capabilities. Studies indicate that flavonoids, saponins, phenylpropanoids, and triterpenoids in P. villosa are vital substances for its pharmacological activities. However, the quality of this medicinal material cannot be controlled due to the unclear records in ancient books in the past dynasties and different drug use habits in different places, and thus its circulation is chaotic. At present, researchers have used flavonoids, organic acids, phenylpropanoids, triterpenoid saponins, and other compounds to conduct studies in this regard. Therefore, on the basis of the existing literature resources, we comprehensively summarize the chemical constituents, pharmacological activities, and quality control of P. villosa to further provide a reference for the safety and effectiveness of clinical drug use and lay a foundation for the follow-up experimental research.
Patrinia/chemistry*
;
Flavonoids/pharmacology*
;
Saponins
;
Triterpenes/pharmacology*
;
Iridoids
;
Quality Control
5.Risk assessment of Cronobacter sakazakii in infant formula powder.
Wei SUN ; Jun YAN ; Xiao Jie YU ; Ye Ru WANG ; Qing Li DONG ; Hong Mei NIU ; Chengyu XUE
Chinese Journal of Preventive Medicine 2022;56(12):1803-1808
Objective: To assess the risk of foodborne diseases caused by Cronobacter sakazakii in infant formula powder from retail to feeding and provide formulate suggestions for safe feeding of infants at home. Methods: This study used the special monitoring and risk monitoring data of infant formula powder in Heilongjiang Province and combined data at home and abroad. The @RISK software was used to evaluate the disease risk caused by Cronobacter sakazakii in the process of infant formula powder from retail to feeding. Results: According to the results of this quantitative risk assessment, the risk of foodborne diseases caused by Cronobacter sakazakii at the current consumption pattern in Heilongjiang Province was 5.158×10-5 persons/million (40.0 ℃ and 50.0 ℃), 1.072×10-7 persons/million (60.0 ℃), 5.544×10-14 persons/million (70.0 ℃). When the feeding time of infant formula powder was adjusted to 0-2 h and 2-3 h respectively, the above prediction results did not change. When it was adjusted to 3-4 h, the risk increased. If it was adjusted to 4-24 h, the number of Cronobacter sakazakii increased by 14-24 orders of magnitude at room temperature. If the initial pollution concentration (after flushing) was adjusted to 1 MPN/ml, the average disease risk per meal was 805.7 persons/million (40.0 ℃ and 50.0 ℃), 1.7 persons/million (60.0 ℃) and 9.1 × 10-7 persons/million (70.0 ℃). The results of sensitivity analysis showed that the water temperature (70.0 ℃), initial pollution concentration, room storage time and temperature were important factors of risk. Conclusion: Controlling the contamination level of Cronobacter sakazakii in infant formula powder, controlling the feeding time within 3 h, storing in refrigerator and mixing with water with temperature not lower than 70.0 ℃ are effective measures to prevent infants from eating infant formula powder infected by Cronobacter sakazakii.
Infant
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Humans
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Cronobacter sakazakii
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Infant Formula
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Food Microbiology
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Powders
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Risk Assessment
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Foodborne Diseases
6.Heterotopic ossification after arthroscopy for hip impingement syndrome.
Guan-Ying GAO ; Xin ZHANG ; Ling-Hui DAI ; Hong-Jie HUANG ; Rui-Qi WU ; Xiao-Dong JU ; Yu MEI ; Xing-Yue NIU ; Jian-Quan WANG ; Yan XU
Chinese Medical Journal 2019;132(7):827-833
BACKGROUND:
Heterotopic ossification (HO) is a known complication of hip arthroscopy. We investigated incidence of HO after hip arthroscopy and determined whether revision for HO improved outcome.
METHODS:
A retrospective study was conducted on 242 patients (140 men and 102 women, mean age: 36.2 ± 9.5 years) who underwent hip arthroscopy for femoroacetabular impingement (FAI) between January 2016 and January 2018. The average follow-up period was 22.88 ± 11.74 months (range: 11-34 months). Thirteen (5.37%) cases of HO (six men and seven women, five left hips and eight right hips; mean age: 37.5 ± 4.7 years) were observed. Among them, four cases with HO with obvious pain symptoms and persistent non-remission underwent revision surgery to remove HO. Monthly follow-up was conducted. Visual analog scale (VAS), modified Harris Hip Score (mHHS), and non-Arthritis Hip Score (NAHS) were evaluated and compared between HO and non-HO patients. Independent sample t test, Mann-Whitney U test and the Chi-square test were used for inter-group comparisons. HO degree was evaluated using Brooker classification. Symptoms and function were evaluated before and after revision.
RESULTS:
A total of 242 patients were involved in this study. Thirteen cases (5.4%) had imaging evidence of HO. Nine (9/13) were classified as Brooker stage I, three (3/13) Brooker stage II, and one (1/13) Brooker stage III. HO was detected by ultrasonography as early as 3 weeks after operation. After primary surgery, the mHHS of the HO group and non-HO group increased by 13.00 (8.50, 25.50) and 24.00 (14.00, 34.50) points (Z = -1.80, P = 0.08), NAHS increased by 18.00 (9.50, 31.50) and 26.00 (13.50, 36.00) points (Z = -1.34, P = 0.18), and VAS decreased by 3.00 (2.00, 4.00) and 4.00 (3.00, 4.50) points (Z = -1.55, P = 0.12). Average follow-up time after revision was 9.00 ± 2.94 months; mHHS increased by 34.75 points (t = -55.23, P < 0.01) and NAHS by 28.75 points (t = -6.03, P < 0.01), and VAS decreased by 4 points (t = 9.80, P < 0.01). HO and non-HO patients were similar for demographic and surgical data, and clinical and functional scores.
CONCLUSION
HO incidence after arthroscopic treatment of FAI is similar to that found in previous studies. Most HO have no effect on clinical symptoms. Patients who undergo revision HO resection show improvement in pain and joint function.
Adult
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Arthroscopy
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adverse effects
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Female
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Femoracetabular Impingement
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surgery
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Hip Joint
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pathology
;
surgery
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Humans
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Male
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Middle Aged
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Ossification, Heterotopic
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diagnosis
;
etiology
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Retrospective Studies
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Treatment Outcome
7.Effects of Bruton's tyrosine kinase on the proliferation and differentiation of osteoclasts.
Hong ZHANG ; Li-Na WANG ; Mei-Na ZUO ; Ming DONG ; Dong-Mei SHI ; Hui-Jun XU ; Wei-Dong NIU
West China Journal of Stomatology 2019;37(4):361-365
OBJECTIVE:
To observe the effect of Bruton's tyrosine kinase (BTK) on the proliferation and differentiation of osteoclasts and to explore the mechanism of BTK on bone destruction in periapical periodontitis.
METHODS:
After RAW264.7 cells induced with 100 ng·L⁻¹ receptor activator for nuclear factor-κB ligand (RANKL) for 5 days, osteoclast induction was confirmed by light microscopy, tartrate-resistant acid phosphatase (TRAP) staining, and quantitative real-time PCR (RT-qPCR). Then, BTK-small interfering RNA (BTK-siRNA) was transfected into cells induced for 5 days. After 24 h, the expression of TRAP mRNA was measured using RT-qPCR, and the proliferation and differentiation of osteoclasts were detected using CCK-8 and TRAP activity assay. Statistical analysis was performed.
RESULTS:
After RAW264.7 was induced with RANKL for 5 days, a large number of round, ellipse, irregularly protuberant, and TRAP-positive macrophages were observed under light microscopy. The expression of TRAP mRNA significantly reduced after 24 h of BTK-siRNA transfection (P<0.05). The detection of CCK-8 and TRAP activities showed that the proliferation and differentiation of osteoclasts significantly decreased (P<0.05).
CONCLUSIONS
Silencing of BTK can inhibit the proliferation and differentiation of osteoclasts. BTK can be used as a new target for the inhibition of osteoclasts.
Agammaglobulinaemia Tyrosine Kinase
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Cell Differentiation
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Cell Proliferation
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Macrophages
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Osteoclasts
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RANK Ligand
8.Development of hypoxia control device for cell culture in vitro
LI Rong-rong ; ZHAO Yan-wen ; ZHOU Jun ; GAO Mei-juan ; NIU in-cheng ; LIU Dong-xu
Journal of Prevention and Treatment for Stomatological Diseases 2017;25(5):323-326
Objective:
To simulate the hypoxic environment of cells in vivo more approximately, a hypoxia control device which can control oxygen concentration automatically for cell culture in vitro was developed.
Methods:
In vitro cell cultur e hypoxia control device consisted of hardware and software which were controlled by computer. The hardware was composed of oxygen detection and control system, nitrogen gas pipeline, cell culture and anti-jamming device, and the software was based on Clanguage. When oxygen controlle rreads the oxygen concent ration more than the set value, the nitrogen gas pipeline opens and nitrogen enter into the incubator; when reaching the set value, the nitrogen gas pipeline closes and nitrogen is not allowed to pass through. Circularly, a constant oxygen concentration was reached and maintained. This device was further verified by comparing the set value of the equipment with figures of the oxygen meter and by monitoring fluctuation condition after the oxygen concentration reaching the set value.
Results :
There was no significant difference between the oxygen concentration set in the in vitro cell culture hypoxia control device and the actual oxygen concentration in the measured box (P > 0.05), and the accuracy of the device to set the value of the simulation up to ± 0.5% of the requirements to meet the system accuracy requirements, and can remain stable for a long time.
Conclusion
The device can effectively control the oxygen concentration to the required requirements, to meet the conditions in the hypoxic conditions for in vitro cell culture.
9.Bibliometric analysis of the long-term low-dose off -label use of erythromycin
Hui NIU ; He-Kun MEI ; Xue-Dong HU ; Bei-Bei LIANG ; Ming-Jing TANG ; Ke WEN ; Yan BAI ; Jin WANG ; Yong ZHANG
The Chinese Journal of Clinical Pharmacology 2015;(3):223-226
Objective To analyze the correlation analysis as on long-term low -dose off -label use of erythromycin with bibliometric approach, and to provide reference for study on off -label use of eryth-romycin.Methods Literatures were searched in PubMed, EmBase, Science Citation Index and CNKI data-bases from beginning to October 2014.EndNote was used to sort these articles and the bibliometric analy-sis was carried out in respect of published years, document type and research hotspot etc.Results The final document included a total of 694, including 451 foreign languages, Chinese 243.Among 694 papers, there were 545 pieces of original articles;the most frequently cited paper was cited for 275 times.First foreign language study on the long-term low-dose erythromycin treatment was published in 1974.Chinese from 1990 published his first articles.The research contents include clinical manifestations, present status of treatment,therapeutic effect and adverse drug reaction of long -term low -dose erythromycin application.Conclusion The current study found that long-term low-dose eryth-romycin on chronic inflammatory lung disease effectively, and erythromy-cin stomach action by promoting the use of pediatric clinical study is currently hot.
10.Study on the application of double-lumen power PICC in chemotherapy treatment
Lei DONG ; Jing LI ; Qiu-Mei NIU
Chinese Journal of Modern Nursing 2013;19(15):1852-1855
Objective To explore the clinical application values of new type of double-lumen power PICC in tumor patients.Methods A total of 83 cancer patients,38 patients in study group were treated with double-lumen Power PICC guided by ultrasound based on modified seldinger technique,and 45 patients in control group were treated with single-lumen silicone PICC from January 2012 to August 2012 in the first affiliated hospital of Zhengzhou university.Results No significant difference was found in the one-time success rate of puncture between study group and control group (89.5% vs 91.1%;P > 0.05).While significant difference of the incidence of complication was found between study group and control group (0% vs 28.9%;x2 =10.588,P =0.002).And patients' satisfaction in terms of daily life for the double-lumen Power PICC was higher than that for single-lumen silicone PICC,but lower in terms of economic burden.Conclusions The clinical application of the new type of double-lumen Power PICC placement can satisfy the complex needs of venous treatment.Patients who use Power PICC placement are much better than those use single-lumen silicone PICC for higher satisfaction,higher success rate of one-time puncture.So it's worth popularizing in cancer patients.


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