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.Consensus of experts on the medical risk prevention for the patients with cardiovascular diseases during dental treatment (2022 edition).
Jing ZHANG ; Guan Hua SU ; Xiao Dong ZHANG ; Kai XU ; Zuo Min WANG ; Xu Liang DENG ; Ya Qin ZHU ; Yong Jin CHEN ; Cheng Zhi GAO ; Hong XIE ; Xuan PAN ; Lin YIN ; Bao Hua XU ; Wei FEI ; Jian ZHOU ; Dan SHAO ; Zhi Hong ZHANG ; Kai ZHANG ; Xia WANG ; Xiang CHENG ; Xiao WANG ; Li Li CHEN
Chinese Journal of Stomatology 2022;57(5):462-473
With the aging process of population in the society, the prevalence of cardiovascular diseases (CVD) in China is increasing continuously and the number of dental patients with CVD is increasing gradually too. Due to the lack of guidelines for dental patients with CVD in our country, how to implement standardized preoperative evaluation and perioperative risk prevention remains a problem to be solved for dentists at present. The present expert consensus was reached by combining the clinical experiences of the expert group of the Fifth General Dentistry Special Committee, Chinese Stomatological Association and respiratory and cardiology experts in diagnosis and treatment for CVD patients, and by systematically summarizing the relevant international guidelines and literature regarding the relationship between CVD and oral diseases and the diagnosis and treatment of dental patients with heart failure, hypertension and antithrombotic therapy. The consensus aims to provide, for the dental clinicians, the criteria on diagnosis and treatment of CVD in dental patients in China so as to reduce the risk and complications, and finally to improve the treatment levels of dental patients with CVD in China.
Cardiovascular Diseases/prevention & control*
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China/epidemiology*
;
Consensus
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Dental Care
;
Humans
;
Oral Medicine
3.Generation of αGal-enhanced bifunctional tumor vaccine.
Jian HE ; Yu HUO ; Zhikun ZHANG ; Yiqun LUO ; Xiuli LIU ; Qiaoying CHEN ; Pan WU ; Wei SHI ; Tao WU ; Chao TANG ; Huixue WANG ; Lan LI ; Xiyu LIU ; Yong HUANG ; Yongxiang ZHAO ; Lu GAN ; Bing WANG ; Liping ZHONG
Acta Pharmaceutica Sinica B 2022;12(7):3177-3186
Hepatocellular carcinoma (HCC) is a common malignant tumor with poor prognosis and high mortality. In this study, we demonstrated a novel vaccine targeting HCC and tumor neovascular endothelial cells by fusing recombinant MHCC97H cells expressing porcine α-1,3-galactose epitopes (αGal) and endorphin extracellular domains (END) with dendritic cells (DCs) from healthy volunteers. END+/Gal+-MHCC97H/DC fusion cells induced cytotoxic T lymphocytes (CTLs) and secretion of interferon-gamma (IFN-γ). CTLs targeted cells expressing αGal and END and tumor angiogenesis. The fused cell vaccine can effectively inhibit tumor growth and prolong the survival time of human hepatoma mice, indicating the high clinical potential of this new cell based vaccine.
4.Finite element analysis of the effect of plate placement angle on cervical spine stability in anterior cervical fusion surgery.
Jian-Chao WU ; Zheng-Wei SHI ; Yi-Xin PAN ; Shao-Ping LI ; Jian-Wei ZHOU ; Yu-Liang WANG
China Journal of Orthopaedics and Traumatology 2021;34(4):372-377
OBJECTIVE:
Using the method of finite element analysis, to compare the biomechanical properties between the plate deviating from the long axis of the cervical spine and the standard placement of the plate in the anterior cervical fusion surgery.
METHODS:
A healthy female volunteer was selected and CT scan (C
RESULTS:
The lower cervical spine (C
CONCLUSION
Little effect on the mechanical stability of the cervical spine was anticipated when the anterior cervical plate was not perfectly aligned with the long axis of the cervical spine. If the tilt of the plate in clinical surgery is less than 20°, there is no need to readjust the position of the plate.
Biomechanical Phenomena
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Cervical Vertebrae/surgery*
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Female
;
Finite Element Analysis
;
Humans
;
Range of Motion, Articular
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Reproducibility of Results
;
Spinal Fusion
5.Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder () in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial.
Hai HUANG ; Min-Jie ZHOU ; Ke-Xie WANG ; Chao YU ; Yu-Hang WANG ; Jun JI ; Wen PAN ; Jian YING ; Ling ZHAO
Chinese journal of integrative medicine 2021;27(3):170-176
OBJECTIVE:
To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder (, MDGP) in patients with chronic nonbacterial prostatitis (CNP).
METHODS:
A randomized, double-blind, placebo-controlled clinical trial was conducted among 72 patients with CNP. Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio, and received either MDGP external umbilicus treatment (MDGP group, 36 cases) or placebo control groupl (36 cases) at acupoints Shenque (CV 8), twice a week for 4 weeks. In addtion, patients all received herbal medicine treatment twice a day for 4 weeks. The primary outcomes was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index (NIH-CPSI) with a questionnaire at weeks 2 and 4. The secondary outcomes including prostatic fluid examination (white blood cells and lecithin bodies), the clinical efficacy evaluation, and the adverse events were also assessed during the entire trial.
RESULTS:
The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively. NIH-CPSI scores of symptom severity, total scores, the amount of leukocytes number in the prostatic fifluid in the MDGP group were significantly improved (P<0.05). There was no statistical difference in the urinary symptoms, quality of life, lecithin and other scores between two groups (P>0.05). The clinical effective rate was 73.53% (25/34) in the MDGP group, which was significally higher than the placebo control group with 48.39% (25/31, P<0.05). Patients were blinded successfully, and no serious adverse effects were found during the trial.
CONCLUSION
A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP (Trial registration No. ChiCTR1800014687).
6.Clinical application of supraclavicular fasciocutaneous island flap in the repair of tracheal defects.
Jia Zheng ZHAO ; Liang GUO ; Jian Lin LOU ; Xiang Rong TAN ; Wen ZHENG ; Hua Tao QUAN ; Chao PAN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2021;56(9):925-929
Objective: To explore the clinical application of supraclavicular fasciocutaneous island flap (SIF) in the repair of tracheal defect. Methods: From May 2016 to March 2021, the clinical data of 10 patients (8 males,2 females,aged 27-73 years old) were retrospectively analyzed who underwent repair surgery with SIF for trachea defects after resection of cervical or thoracic tumors, including 2 cases of laryngotracheal adenoid cystic carcinoma, 2 cases of laryngeal carcinoma, 3 cases of esophageal carcinoma, 2 cases of thyroid carcinoma and one case of parathyroid carcinoma. All of the primary tumors were at T4. The outcomes of 10 cases with tracheal defect repaired by SIF were evaluated. Results: The areas of the SIF were (3-7) cm × (6-10) cm, the thicknesses of the flaps were 8-11 mm, and the lengths of the pedicles were 10-15 cm. The blood supply of the SIF came from the transverse carotid artery. The skin defects of the donor areas of the shoulders were directly closed. After 1-60 months of follow-up, all the flaps survived. The flaps, tracheas as well as shoulder wounds healed well. Conclusion: The SIF is suitable for the repair of tracheal defects. It has perfect thickness compatible with the trachea. The technique is simple and microsurgical technique is not needed, with a good application prospect.
Adult
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Aged
;
Female
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Humans
;
Male
;
Middle Aged
;
Reconstructive Surgical Procedures
;
Retrospective Studies
;
Skin Transplantation
;
Surgical Flaps
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Trachea
;
Treatment Outcome
7.Comparison of the effects of injured vertebra pedicle fixation combined with vertebroplasty and vertebra pedicle screw fixation combined with vertebroplasty in the treatment of osteoporotic thoracolumbar burst fractures.
Wei-Yu JIANG ; Guo-Ping PAN ; Dan-Guo CHEN ; Xu-Dong HU ; Yun-Lin CHEN ; Nan-Jian XU ; Chao-Yue RUAN ; Yang WANG ; Wei-Hu MA
China Journal of Orthopaedics and Traumatology 2020;33(5):440-444
OBJECTIVE:
To assess the curative effects of injured vertebra pedicle fixation combined with vertebroplasty and short-segment pedicle screw fixation combined with vertebroplasty in treatment of osteoporotic thoracolumbar burst fractures.
METHODS:
Seventy patients with osteoporotic thoracolumbar burst fractures who met the inclusion criteria were collected in the study from January 2015 to December 2017. Among them, 35 patients were treated with injured vertebra pedicle fixation combined with vertebroplasty (group A), including 20 males and 15 females, aged from 55 to 74 years with an average of (64.03± 7.82) years. Twenty-six cases were type A3 and 9 cases were type A4 according to the AO typing;another 35 patients were treated with short segment pedicle screw fixation combined with vertebroplasty (group B), including 18 males and 17 females, aged from 54 to 72 years with an average of (62.78±6.40) years. Twenty-eight cases were type A3 and 7 cases were type A4 according to AO typing. Operation length, intraoperative bleeding volume, complication, imaging parameters and clinical effects were compared between the two groups.
RESULTS:
All the patients were followed up for at least 12 months. There were no significant differences in gender, age, injury site, preoperative VAS, Cobb angle, and injured vertebral height before surgery. There were no significant differences in operation length, intraoperative bleeding volume between two groups. In terms of VAS scores before surgery, 1 week after surgery, and at the final follow up, group A was 5.5 ±2.5, 1.8 ±0.8, 0.9 ±0.4, group B was 5.4 ± 2.3, 1.7±0.6, 1.2±1.8, respectively;injured vertebral height was (40.4±8.8)%, (92.0±4.9)%, (87.1±3.8)% in group A, and (41.2±6.6)%, (93.2±4.6)%, (80.0±4.3)% in group B;Cobb angle was (18.4±6.9) °, (2.8±2.2) °, (4.2±2.6) ° in group A, and (16.8±7.2) °, (2.7±2.5) °, (6.0±2.4) ° in group B. There were significant differences in the 3 parameters above before the operation and at the final follow up in all groups (<0.05). There were significant differences in the Cobb angle and injured vertebral height between 1 week after operation and at the final follow up (<0.05). At the final follow up, injured vertebral height in group A was obviously better than that in group B (<0.05). Internal fixation failure occurred in 2 cases from the group A, and occurred in 4 cases from the group B. There were no neurological complications in both groups.
CONCLUSION
For osteoporotic thoracolumbar vertebral burst fractures, injured vertebra pedicle fixation combined with vertebroplasty and vertebra pedicle screw fixation combined with vertebroplasty can achieve good clinical effects. However, injured vertebra pedicle fixation combined with vertebroplasty is better at maintaining postoperative vertebral height and sagittal arrangement, and reducing internal fixation related complications. The treatment strategy is worthy of application and promotion.
Aged
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Female
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Fracture Fixation, Internal
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Humans
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Lumbar Vertebrae
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Male
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Middle Aged
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Pedicle Screws
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Spinal Fractures
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Thoracic Vertebrae
;
Treatment Outcome
;
Vertebroplasty
8.Characteristics of intestinal flora in patients with primary Sj?gren syndrome.
Xin WANG ; Jian WANG ; Wenjing GUO ; Ying ZHOU ; Chao SUN ; Zhijun LI ; Linjie CHEN ; Xinlan PAN
Journal of Zhejiang University. Medical sciences 2020;40(7):949-957
OBJECTIVE:
To investigate changes in intestinal flora in patients with primary Sj?gren syndrome (pSS) and explore the relationship between pSS disease activity and intestinal flora structure.
METHODS:
Fecal samples were collected from 18 female pSS patients, including 9 patients with active disease (group A) and 9 with disease inactivity or low activity (group B), with 10 healthy subjects as the control group. The total bacterial DNA was extracted from the fecal samples for PCR amplification, and Illumina Hiseq 2500 high-throughput sequencing was performed for the v3-v4 region of 16Sr DNA gene to obtain the biological information of the intestinal flora. The intergroup OTU analysis, structural diversity analysis, significant difference analysis and LEFSE analysis were performed with information mining of the literature think tanks.
RESULTS:
The dilution curves generated based on the OTUshannon index for analysis of sample complexity showed that the measured data were relatively complete and could reflect the diversity of the microorganisms in the subjects. Analysis of the Alpha diversity index showed that the Shannon index differed significantly between group A and group B, and the Simpson index differed significantly between group A and group B and between group A and the control group ( < 0.05). Sequence analysis the 3 groups all consisted mainly of 4 phylum (, , , showed that the intestinal flora in and ) and 4 genera (, , , and ), all showing no significant differences among the 3 groups ( > 0.05) with the exception of genus, which differed significantly among the 3 groups ( < 0.05). The 16S v3-v4 region in the genus , , , , , , , , , , -, and differed significantly among the 3 groups ( < 0.05). The high-dimensional biometrics and genomic characteristics of the intestinal microorganisms differed significantly among the 3 groups ( < 0.05). According to the size of LDA SCORE (effect size), the core flora in group A included the genera , , -, , -, , , , and , as compared with the genera , , , , , -, , - and in the control group.
CONCLUSIONS
Patients with pSS have significant changes in the diversity of intestinal flora, especially in some specific bacteria in genus and in 16S v3-v4 region of the bacteria. The differences in the core bacteria in the intestinal flora of pSS patients suggest the role of flora structure changes in the pathogenesis of pSS.
Bacteria
;
classification
;
genetics
;
Biodiversity
;
DNA, Bacterial
;
genetics
;
Feces
;
microbiology
;
Gastrointestinal Microbiome
;
Humans
;
RNA, Ribosomal, 16S
;
genetics
;
Sjogren's Syndrome
;
microbiology
9.Characteristics of intestinal flora in patients with primary Sjögren syndrome.
Xin WANG ; Jian WANG ; Wenjing GUO ; Ying ZHOU ; Chao SUN ; Zhijun LI ; Linjie CHEN ; Xinlan PAN
Journal of Southern Medical University 2020;40(7):949-957
OBJECTIVE:
To investigate changes in intestinal flora in patients with primary Sj?gren syndrome (pSS) and explore the relationship between pSS disease activity and intestinal flora structure.
METHODS:
Fecal samples were collected from 18 female pSS patients, including 9 patients with active disease (group A) and 9 with disease inactivity or low activity (group B), with 10 healthy subjects as the control group. The total bacterial DNA was extracted from the fecal samples for PCR amplification, and Illumina Hiseq 2500 high-throughput sequencing was performed for the v3-v4 region of 16Sr DNA gene to obtain the biological information of the intestinal flora. The intergroup OTU analysis, structural diversity analysis, significant difference analysis and LEFSE analysis were performed with information mining of the literature think tanks.
RESULTS:
The dilution curves generated based on the OTUshannon index for analysis of sample complexity showed that the measured data were relatively complete and could reflect the diversity of the microorganisms in the subjects. Analysis of the Alpha diversity index showed that the Shannon index differed significantly between group A and group B, and the Simpson index differed significantly between group A and group B and between group A and the control group ( < 0.05). Sequence analysis the 3 groups all consisted mainly of 4 phylum (, , , showed that the intestinal flora in and ) and 4 genera (, , , and ), all showing no significant differences among the 3 groups ( > 0.05) with the exception of genus, which differed significantly among the 3 groups ( < 0.05). The 16S v3-v4 region in the genus , , , , , , , , , , -, and differed significantly among the 3 groups ( < 0.05). The high-dimensional biometrics and genomic characteristics of the intestinal microorganisms differed significantly among the 3 groups ( < 0.05). According to the size of LDA SCORE (effect size), the core flora in group A included the genera , , -, , -, , , , and , as compared with the genera , , , , , -, , - and in the control group.
CONCLUSIONS
Patients with pSS have significant changes in the diversity of intestinal flora, especially in some specific bacteria in genus and in 16S v3-v4 region of the bacteria. The differences in the core bacteria in the intestinal flora of pSS patients suggest the role of flora structure changes in the pathogenesis of pSS.
Bacteria
;
DNA, Bacterial
;
Feces
;
Female
;
Gastrointestinal Microbiome
;
Humans
;
RNA, Ribosomal, 16S
;
Sjogren's Syndrome
10.Expert consensus on clinical standardized application of high-flow nasal cannula oxygen therapy in adults.
Jian-Qiao XU ; Long-Xiang SU ; Peng YAN ; Xing-Shuo HU ; Ruo-Xuan WEN ; Kun XIAO ; Hong-Jun GU ; Jin-Gen XIA ; Bing SUN ; Qing-Tao ZHOU ; Yu-Chao DONG ; Jia-Lin LIU ; Pin-Hua PAN ; Hong LUO ; Qi LI ; Li-Qiang SONG ; Si-Cheng XU ; Yan-Ming LI ; Dao-Xin WANG ; Dan LI ; Qing-Yuan ZHAN ; Li-Xin XIE
Chinese Medical Journal 2020;133(11):1322-1324

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