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.Evaluation of performance of disposable medical protective clothing for resistance to infective agent penetration
Ke-Yang LIU ; Yan FENG ; Juan ZHANG ; Yue NIU ; Dan QIN ; Yong-Fu HUANG ; Guang-Yong HU
Chinese Medical Equipment Journal 2024;45(5):16-21
Objective To evaluate the performance of the disposable medical protective clothing in blocking the penetration of infectious agents,in order to provide data support for the setting of such performance indexes when the GB 19082 is revised.Methods Totally 10 batches of different brands and models of protective clothing were selected,and tests were carried out for penetration resistance to synthetic blood,phage,wet microorganisms,dry microorganisms and contaminated liquid aerosol and particle filtration efficiency according to YY/T 0700-2008,YY/T 0689-2008,YY/T 0506.6-2009,GB 19082-2009,YY/T 0506.5-2009 and YY/T 1799-2020.Results There were 2 batches of protective clothing with anti-synthetic blood penetration performance level 2,3,4,5 and 6,respectively;all the protective clothing had the highest level 6 for anti-wet microorganisms penetration,part of whom had the levels for the resistance to phage penetration lower than those for preventing anti-synthetic blood penetration;all of the protective clothing had the particle filtration efficiencies higher than 95%,and had the highest level 3 for anti-dry microorganisms penetration;there're 5 batches of protective clothing with the highest level 3 for contaminated liquid aerosol penetration,1 batch with level 2 and the remained 4 batches with undetermined levels,which all had an average logarithmic reduction higher than 4.5 after penetration.Conclusion Particle filtration efficiency and resistance to phage penetration may be involved in the requirements for resistance to infective agent penetration in revised GB 19082 for evaluating the ability of protective clothing materials to block microorganisms in airborne particles and liquid contaminants.[Chinese Medical Equipment Journal,2024,45(5):16-21]
3.Correlation between the expression of TLR4 and CHI3L1 in colon cancer tissue and the prognosis after radical surgery
Chun-Guang SONG ; Zhi-Xin NIU ; Feng HE ; Xi-Ming XU ; Chun-Hua YUE
Journal of Regional Anatomy and Operative Surgery 2024;33(10):863-867
Objective To investigate the correlation between the expression of Toll-like receptor 4(TLR4)and chitosanase 3-like protein 1(CHI3L1)in colon cancer tissue and the prognosis of patients after radical surgery.Methods A total of 152 patients who underwent radical colon cancer surgery in our hospital from January 2017 to May 2018 were collected and divided into the good prognosis group(n=97)and the poor prognosis group(n=47)according to the 5-year survival status after surgery.Immunohistochemical staining was applied to detect the expression levels of TLR4 and CHI3L1 in colon cancer tissues and adjacent tissues;the correlation between the expression of TLR4 and CHI3L1 in colon cancer tissue and the prognosis of patients was analyzed,and the influencing factors for prognosis of colon cancer patients were analyzed.Results The positive expression rates of TLR4 and CHI3L1 in colon cancer tissues were obviously higher than those in adjacent tissues(P<0.05).The expression of TLR4 in colon cancer tissue was related to the degree of tumor differentiation,clinical staging,and lymph node metastasis of colon cancer patients(P<0.05),the expression of CHI3L1 was related to the tumor diameter,degree of tumor differentiation,clinical staging,and lymph node metastasis of colon cancer patients(P<0.05).Compared with the good prognosis group,the poor prognosis group had higher proportions of patients with poorly differentiated tumor,clinical stageⅢ,lymph node metastasis,and positive expression of TLR4 and CHI3L1(P<0.05).The 5-year survival rate of patient with TLR4 positive expression was 60.38%,which was lower than that of 86.84% of patients with TLR4 negative expression(χ2=9.104,P<0.05);the 5-year survival rate of patients with CHI3L1 positive expression was 58.06%,which was lower than that of 84.31% of patients with CHI3L1 negative expression(χ2=10.935,P<0.05).The positive expression of TLR4 and CHI3L1,poorly differentiated tumor,clinical stage Ⅲ,and lymph node metastasis were the independent risk factors for the prognosis of colon cancer patients(P<0.05).Conclusion TLR4 and CHI3L1 are related to the occurrence and clinicopathological features of colon cancer,and the positive expression of TLR4 and CHI3L1 in colon cancer tissues is not conducive to the prognosis of patients,so both of them are expected to become clinical treatment targets.
4.Research progress of Wallis dynamic stabilization system for lumbar degenerative diseases.
Ji-Sheng LI ; Bing-Xiang WANG ; Sheng-Hua FENG ; Guang-Feng NIU
China Journal of Orthopaedics and Traumatology 2023;36(5):495-498
Wallis dynamic stabilization system is a surgical approach in the non-fusion technique of lumbar spine, consisting of interspinous blockers and dacron artificial ligaments that provide stability to the spine while maintaining a degree of motion in the affected segment. Recent studies have demonstrated the significant benefits of Wallis dynamic stabilization system in treating lumbar degenerative diseases. It not only improves clinical symptoms, but also effectively delays complications such as adjacent segmental degeneration. This paper aims to review the literature related to the Wallis dynamic stabilization system and degenerative diseases of the lumbar spine to describe the long-term prognostic effect of this system in the treatment of such diseases. This review provides a theoretical basis and reference for selecting surgical methods to treat degenerative diseases of the lumbar spine.
Humans
;
Spinal Fusion/methods*
;
Lumbar Vertebrae/surgery*
;
Lumbosacral Region
;
Decompression, Surgical/methods*
;
Intervertebral Disc Degeneration/surgery*
;
Treatment Outcome
5.Initial clinical experience of left bundle branch pacing after transcatheter aortic valve implantation.
Tian Jie FENG ; Guang Yuan SONG ; Jie ZHAO ; Yang CHEN ; Guan Nan NIU ; Zheng ZHOU ; Zhen Yan ZHAO ; Mo Yang WANG ; Yong Gang SUI ; Ke Ping CHEN ; Wei HUA ; Yong Jian WU
Chinese Journal of Cardiology 2022;50(2):142-149
Objective: To investigate the efficacy and safety of left bundle branch pacing(LBBP) in patients after transcatheter aortic valve implantation (TAVI). Methods: This is a retrospective study. A total of 35 patients underwent TAVI and received pacemaker implantation from January 2018 to December 2020 in Beijing Fuwai Hospital were enrolled. Patients were divided into LBBP group (n=12) and right ventricular apex pacing (RVAP) group (n=23) according to the pacing position. The success rate of operation in LBBP group was calculated, and the occurrence of complications were observed, and the parameters of pacemaker were measured on the 3rd day and 1, 3 and 6 months after operation. The N-terminal pro-B-type natriuretic peptide (NT-proBNP), echocardiographic and ECG indexes were compared between the two groups on the 3rd day and 1, 3, and 6 months after pacemaker implantation. Result: A total of 35 patients were included, The age was (76.4±7.7) years, including 19 males (54.3%). The procedure time ((86.58±17.10)min vs. (68.74±9.18)min, P<0.001) and fluoroscopy duration ((20.08±4.44)min vs. (17.00±2.26)min, P<0.001) were significantly longer in LBBP group compared with RVAP group. The operation success rate of LBBP group was 11/12. There was no serious operation related complications such as pneumothorax, hemothorax, electrode dislocation, infection, and lower limb bleeding. The patients were followed up for 7.43 (5.21, 9.84) months. The programmed parameters of pacemaker were in the ideal range and stable during follow-up. At 3 and 6 months after operation, the left ventricular ejection fraction in LBBP group was higher than that in RVAP Group (at 3 months: (60.75±2.89)% vs. (57.35±3.33)%, P=0.004; at 6 months: (63.17±3.33)% vs. (56.17±3.97)%, P<0.001), NT-proBNP values was lower in LBBP group than that in RVAP Group (at 3 months: 822 (607, 1 150)ng/L vs. 1 052 (902, 1 536)ng/L, P=0.006; at 6 months: 440 (330,679)ng/L vs. 783 (588, 1 023)ng/L, P=0.001). At 1, 3 and 6 months after operation, the QRS duration was shorter in LBBP group than that in RVAP group (1 month: 99 (97, 107)ms vs. 126(124, 130)ms, P<0.001; 3 months: 98(96, 105)ms vs. 129(128, 133)ms, P<0.001; 6 months: 96(94, 104)ms vs. 130(128, 132)ms, P<0.001). Conclusions: For patients with permanent pacemaker indications after TAVI, LBBP is feasible, safe and reliable. It could improve the cardiac function in the short term, the long-term effect of LBBP needs to be further observed.
Aged
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Aged, 80 and over
;
Bundle of His
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Cardiac Pacing, Artificial/methods*
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Electrocardiography/methods*
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Fluoroscopy
;
Humans
;
Male
;
Retrospective Studies
;
Stroke Volume
;
Transcatheter Aortic Valve Replacement/adverse effects*
;
Treatment Outcome
;
Ventricular Function, Left
6.Anatomical controversies involved in radical resection of rectal cancer.
Xu Hua HU ; Cui Li CAO ; Jian Feng ZHANG ; Wen Bo NIU ; Chao Xi ZHOU ; Guang Lin WANG ; You Qiang LIU ; Bao Kun LI ; Xiao Ran WANG ; Bin YU ; Gui Ying WANG
Chinese Journal of Gastrointestinal Surgery 2021;24(7):633-637
The concept of total mesorectal resection provides a quality control standard that can be followed for radical resection of rectal cancer, but some anatomical problems are still controversial. Compared with traditional open surgery, laparoscopic radical rectal surgery has better surgical vision, better neurological protection, better operating space. However, if the surgeon has insufficient understanding of the anatomy, collateral damage may occur, such as uncontrollable bleeding during the operation, postoperative urination and defecation dysfunction and so on. Based on the interpretation of the researches at home and abroad, combined with the clinical experience, we elucidate some associated issues, including anatomic variation of inferior mesenteric vessels, the controversy of inferior mesenteric artery ligation plane, the controversy of lymph node dissection in No. 253, the anatomical variation of middle rectal artery, and the anatomical controversy of lateral lymph node dissection in rectal cancer, in order to provide better cognitive process for the clinical front-line surgeons.
Humans
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Laparoscopy
;
Lymph Node Excision
;
Lymph Nodes
;
Mesenteric Artery, Inferior
;
Rectal Neoplasms/surgery*
;
Rectum
7.Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.
Jia-Bo WANG ; Zhong-Xia WANG ; Jing JING ; Peng ZHAO ; Jing-Hui DONG ; Yong-Feng ZHOU ; Guang YANG ; Ming NIU ; Xu ZHAO ; Tian-Jun JIANG ; Jing-Feng BI ; Zhe XU ; Ping ZHANG ; Dan WU ; Zhao-Fang BAI ; Yu-Ming GUO ; Si-Miao YU ; Yong-Qiang SUN ; Zi-Teng ZHANG ; Xiao-Yan ZHAN ; Peng-Yan LI ; Jin-Biao DING ; Peng-Fei ZHAO ; Xue-Ai SONG ; Jian-Yuan TANG ; Dong-Chu HE ; Zhu CHEN ; En-Qiang QIN ; Rui-Lin WANG ; Xiao-He XIAO
Chinese journal of integrative medicine 2020;26(9):648-655
OBJECTIVES:
To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS:
A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS:
An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS
Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Administration, Inhalation
;
Adult
;
China
;
Coronavirus Infections
;
diagnosis
;
drug therapy
;
mortality
;
Dose-Response Relationship, Drug
;
Drug Administration Schedule
;
Drugs, Chinese Herbal
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Integrative Medicine
;
Interferon-alpha
;
administration & dosage
;
Lopinavir
;
administration & dosage
;
Male
;
Middle Aged
;
Pandemics
;
Pneumonia, Viral
;
diagnosis
;
drug therapy
;
mortality
;
Risk Assessment
;
Severe Acute Respiratory Syndrome
;
diagnosis
;
drug therapy
;
mortality
;
Severity of Illness Index
;
Survival Rate
8.Infrapyloric lymph node metastasis pattern in middle/lower gastric cancer: an exploratory analysis of a multicenter prospective observational study (IPA-ORIGIN).
Tasiken BAHETI ; Ru-Lin MIAO ; Gang ZHAO ; Da-Guang WANG ; Feng-Lin LIU ; Jiang YU ; Shuang-Yi REN ; Kai YE ; Su YAN ; Kun YANG ; Wei-Dong ZANG ; Lin FAN ; Bin LIANG ; Jun CAI ; Wei-Hua FU ; Wei WANG ; Zheng-Rong LI ; Zhao-Jian NIU ; Jun YOU ; Xing-Feng QIU ; Wu SONG ; Lu ZANG
Chinese Medical Journal 2020;133(22):2759-2761
9.Influence of specification on chemical composition of dissolution and hepatocytes toxicity of Polygonum multiflorum.
Yu-Meng LI ; Rui-Yu LI ; Ming NIU ; Chun-Yu LI ; Zhao-Fang BAI ; Wu-Wen FENG ; Cong-En ZHANG ; Peng TAN ; Zhi-Pu HUANG ; Wei-Guang MA ; Jia-Bo WANG ; Xiao-He XIAO
China Journal of Chinese Materia Medica 2016;41(6):1033-1039
According to different toxicities of various aqueous extracts of Polygonum multiflorum on hepatocyte, the impacts of chemical composition on the safety of P. multiforum was studied. In this study, 8 main chemical compositions in aqueous extracts of P. multiflorum were determined by the established HPLC method; at the same time, the inhibition ratios of different aqueous extracts of P. multiflorum on L02 cell were determined. Afterwards, the potential compounds related to the toxicity of P. multiforum were tentatively found through a multiple correlation analysis. The results showed that P. multiforum with different chemical compositions exhibited great differences in dissolution. The hepatocyte toxicity of P. multiflorum powder was much greater than P. multiflorum lumps. In addition, three constituents closely related to toxicity of P. multiflorum were found by multiple correlation analysis. The study revealed that chemical composition of P. multiflorum is closely related to the hepatotoxicity, and the hepatotoxicity of P. multiflorum powder is greater than that of other dosage forms. This study indicates that P. multiflorum with different chemical compositions show varying toxicity, which therefore shall be given high attention.
10.Anti-tumor activity and mechanism of T03 in vitro and in vivo.
Ke TANG ; Han-Ze YANG ; Yan LI ; Kang TIAN ; Chao LI ; Wan-Qi ZHOU ; Fei NIU ; Zhi-Qiang FENG ; Xiao-Guang CHEN
Acta Pharmaceutica Sinica 2014;49(6):861-868
The purpose of this study is to investigate the activity and mechanism of a new anti-tumor agent T03. MTT and colony formation assay were performed to determine anti-proliferation activity of T03 in vitro. Antitumor activity was observed by Renca xenograft model in vivo. The effect of T03 on cell cycle and apoptosis were measured by FCM analysis. Western blotting was performed to investigate the expression level of proteins in HepG2 cell lines treated with T03. T03 had anti-tumor activity by inhibiting tumor cell growth and colony formation in vitro, especially on hepatocellular carcinoma cells (HCC). At the concentration of 10 micromol x L(-1), T03 induced cell apoptosis and cell cycle arrest in HCC. Moreover, it proved that T03 reduced the tumor weight with the rate of 42.30% without any obviously side effect in Renca xenograft model. At the concentration of 2.0 micromol x L(-1), T03 was able to reduce the level of p-c-Raf (Ser259), and thus blocked Raf/MEK/ERK and AKT signaling in HepG2 cell lines. The result suggested that T03 has the potential to inhibit cell proliferation and induce cell apoptosis both in vitro and in vivo, particularly active against HCC, indicating T03 and its analogues may serve as a new anti-cancer drug against hepatocellular carcinoma.
Animals
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Antineoplastic Agents
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pharmacology
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Apoptosis
;
drug effects
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Carcinoma, Hepatocellular
;
pathology
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Cell Cycle Checkpoints
;
drug effects
;
Cell Proliferation
;
drug effects
;
Hep G2 Cells
;
drug effects
;
Humans
;
Liver Neoplasms
;
pathology
;
Signal Transduction
;
drug effects
;
Xenograft Model Antitumor Assays

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