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.The structure,function and regulation mechanism of Vibrio fluvialis Type Ⅵ secretion system
Yu HAN ; Sai-Sen JI ; Qian CHENG ; Yuan-Ming HUANG ; Ran DUAN ; Wei-Li LIANG
Chinese Journal of Zoonoses 2024;40(6):571-577
Type Ⅵ secretion system(T6SS)is a lethal weapon that releases effectors in direct contact to kill eukaryotic predators or prokaryotic competitors.T6SS is of great significance in bacterial environmental adaptability,pathogenicity,and gene horizontal transfer.T6SS has been identified in about 25%of Gram-negative bacteria.Because of its widespread existence,T6SS is considered the key factor of ecological competition.T6SS effectors exerting biological functions have high diversity and do not have conserved sequences,and the regulatory mechanisms involved are complex.Therefore,it is a hot and difficult topic in T6SS research.Vibrio fluvialis(V.fluvialis)as a newly emerging foodborne pathogen,has unique characteristics in the quantity,composition,and physiological function of T6SS,which is related to its wide environmental adaptability and pathoge-nicity.This article mainly reviews the research progress of V.fluvialis T6SS,including its composition,structure,functional activity,and regulatory mechanism.
3.Application of “Cloud Pharmaceutical Service System”in the medication therapy management for chronic airway diseases
Yinping SHI ; Xue LIU ; Xiangqian WANG ; Sai DUAN ; Yan LI ; Xin HUANG ; Rui YANG
China Pharmacy 2023;34(7):878-882
OBJECTIVE To evaluate the effect of “Cloud Pharmacy Service System” electronic management platform in medication therapy management (MTM) of chronic airway diseases. METHODS MTM module setting of “Cloud Pharmaceutical Service System” was introduced. Totally 371 patients with chronic airway disease admitted to our hospital from January 2021 to March 2022 were selected for MTM based on the “Cloud Pharmacy Service System”. The standardization of inhalation device mastery and compliance of patients before and after intervention were compared with self-made inhalation device evaluation scale and Morisky medication adherence scale-8 (MMAS-8). The satisfaction of patients with pharmacist after intervention was investigated. RESULTS “Cloud Pharmaceutical Service System” is mainly divided into 4 modules, such as medication therapy review, pharmacist intervention, personal medication record and the medication-related action plan, other functions. Among 371 patients, there were 237 outpatients (142 cases of asthma, 95 cases of chronic obstructive pulmonary disease) and 134 inpatients (19 cases of asthma and 115 cases of chronic obstructive pulmonary disease). The score of the patients using inhalation device increased from 74.76±24.71 before intervention to 99.45±2.12 after intervention (P<0.05). MMAS-8 score increased from 7.14± 1.15 before intervention to 7.88±0.44 after intervention (P<0.05). The degree of patients’ satisfaction with pharmacists reached 100% after intervention. CONCLUSIONS “Cloud Pharmacy Service System” is helpful to improve the effects of pharmaceutical service for patients with chronic airway disease by providing whole-process, online, visual and immediate MTM.
4.Application of hemostatic bandage in wound management after transradial coronary angiography and/or interventional therapy
Juntao DUAN ; Sai ZHANG ; Congying LIU ; Run WANG ; Yanmin LI ; Lincheng YANG ; Yida TANG ; Sumei TONG
Chinese Journal of Practical Nursing 2023;39(9):663-669
Objective:To explore the clinical effectiveness of hemostatic bandage on wound safety and comfort after transradial coronary angiography and/or interventional therapy.Methods:This was a experimental study. A total of 400 consecutive patients who underwent transradial coronary angiography and/or interventional therapy in the Department of Cardiology, Peking University Third Hospital from July to October 2022 were enrolled and randomly divided into the hemostatic bandage group and the hemostatic balloon compressor group by the envelope method with 200 cases in each group. The hemostatic bandage group and the hemostatic balloon compressor group were treated with hemostatic bandage and hemostatic balloon compressor as transradial artery hemostatic device, respectively, to observe and compare postoperative hemostatic effect, hemostat use time, complication rate, postoperative pain, the degree of numbness in the finger on the operated side and wristband comfort between the two groups.Results:The hemostatic success rate was 98.5% (197/200) and 99.0% (198/200) in the hemostatic bandage and the hemostatic balloon compressor group, respectively, with no statistical difference ( χ2=0.20, P>0.05). The hemostat use time in the hemostatic bandage group and the hemostatic balloon compressor group was (6.23 ± 0.47) h and (17.01 ± 7.74) h, respectively, and the difference was statistically significant ( t=-19.66, P<0.01). The incidence of complications in the hemostatic bandage group and the hemostatic balloon compressor group was 13.5%(27/200) and 29.5%(59/200), respectively, and the difference was statistically significant ( χ2=8.01, P<0.05). Among the complications, swelling occurred in 21 individuals of the hemostatic bandage group and 54 individuals of the hemostatic balloon compressor group with statistically significant differences ( U=16 689.50, P<0.01). Besides, the hemostatic bandage group was significantly better than the hemostatic balloon compressor group with statistically significant differences in wound pain at immediate postoperative ( U=13 669.50, P<0.01), in finger numbness at immediate postoperative and 1-hour postoperative (immediate postoperative: U=17 838.00, P<0.05; 1-hour postoperative: U=13 342.50, P<0.01), in comfort at immediate postoperative, 4-hours, 8-hours and 12-hour postoperative(immediate postoperative: U=9 966.50, P<0.01; 4-hour postoperative: U=12 851, P<0.01; 8-hour postoperative: U=14 900, P<0.01; 12-hour postoperative: U=15 920, P<0.01). Conclusions:The hemostatic bandage shows better hemostatic effect, shorter compression time, lower complication rate, less wound pain, less numbness of the finger on the operation side, and higher comfort of the wrist band compared to hemostatic balloon compressor after transradial coronary angiography and/or interventional therapy, which is worthy of clinical promotion.
5.Correlation between serum ceruloplasmin level and elevated impulsivity in elderly patients with Parkinson′s disease
Sai QU ; Ruijuan DUAN ; Yuelong XING ; Xiaoling LIU ; Dan REN
Journal of Chinese Physician 2022;24(10):1488-1492
Objective:To investigate the correlation between serum ceruloplasmin level and elevated impulsivity in elderly patients with Parkinson′s disease (PD).Methods:227 elderly PD patients treated in Jinhua People′s Hospital from October 2019 to June 2021 were selected as the research objects. They were grouped according to the 75th percentile of serum ceruloplasmin. 0-75th percentile was defined as normal and >75th percentile was defined as high level. The differences of second-order and first-order factor scores of Barratt′s Impulsivity Scale Version 11 (BIS-11) between the two groups were observed. After balancing the general characteristics, the third part of Parkinson′s Disease Rating Scale (MDS-UPDRS), Hoehn&Yahr Scale, Addenbrooke Cognitive Examination Revised Edition (ACE-R), clinical treatment plan and other data, the correlation between ceruloplasmin and BIS-11 was observed.Results:According to the 75th percentile level of ceruloplasmin, 56 patients were included in the high-level group and 171 patients were included in the normal group. The level of ceruloplasmin, the ratio of female patients, MDS-UPDRS Ⅲ, Hoehn&Yahr Scale and ACE-R score in the high-level group were significantly higher than those in the normal group (all P<0.05). The second-order unplanned and corresponding first-order self-control and first-order self-knowledge complexity in the high-level group were higher than those in the normal group (all P<0.05). There was no significant difference in second-order attention, first-order attention, first-order cognitive instability, second-order motivation, first-order motivation, first-order stability and BIS-11 score between the two groups (all P>0.05). After removing the confounding factors by multifactor logistic analysis, ceruloplasmin was correlated with second-order unplanned and its corresponding first-order factors (self-control and self-knowledge complexity) (all P<0.05). Conclusions:The serum ceruloplasmin level in elderly PD patients is related to the elevated level of BIS-11 unplanned impulse.
6. Efficacy and safety of alfentanil hydrochloride injection in general anesthesia: A multicenter, double-blind, controlled study
Ming-Hua CHEN ; Yi FENG ; Kai-Ming DUAN ; Wen OUYANG ; Sai-Ving WANG ; Fu-Shan XUE ; Ming-Hua CHEN ; Fu-Shan XUE ; Yi FENG ; Ai-Lin LUO ; Qu-Lian GUO ; Ya-Ping WANG ; Deng-Bin AI ; Gong-Jian LIU ; Kai-Ming DUAN ; Wen OUYANG ; Sai-Ving WANG ; Ai-Lin LUO ; Qu-Lian GUO ; Ya-Ping WANG ; Deng-Bin AI ; Gong-Jian LIU
Chinese Pharmacological Bulletin 2022;38(10):1504-1510
Aim To investigate the effectiveness and safety of alfentanil in general anesthesia.Methods In this study, a multicenter randomized double-blind con¬trolled study was conducted.A total of 352 subjects were selected and randomly assigned to fentanyl group (group A, n =176) and alfentanil group (group 15, n = 176).Anesthesia induction: intravenous midazolam 0.03 mg • kg-1 + fentanyl 25 p.g • kg"'(group A) or alfentanil 4 p,g • kg-1 ( group 15) + propofol 2 mg • kg"1 + rocuronium 0.8 mg • kg"1.Sevoflurane + fent¬anyl ( group A ) or alfentanil ( group B ) + rocuronium were used for anesthesia.The vital signs of patients re¬covery time and extuhation time, anesthesia-related complications and the use of related remedial drugs during anesthesia induction and maintenance were compared between the two groups.Results During the induction and maintenance period of anesthesia, alfentanil and fentanyl could equally effectively inhibit the stress response induced by endotracheal intubation and surgical stimulation.Alfentanil also showed more effective inhibition on stress response induced by endo¬tracheal intubation and surgical stimulation than that of fentanyl ( P < 0.05 ) .However, there was no signifi¬cant difference in the incidence of intraoperative hypo¬tension and hypertension and the time of anesthesia re¬covery and extubation between the two groups.Conclu¬sions Both alfentanil and fentanyl can effectively in¬hibit the stress response induced by surgical stimulation and could be safely used in general anesthesia in sur¬gery.Alfentanil has more advantages in maintaining the stability of blood pressure and heart rate during an¬esthesia induction and maintenance.
7.Establishment of a real-time fluorescent quantitative RT-PCR rapid detection method for human astrovirus
Yue DU ; Sai TIAN ; Yinxia LI ; Hongbo LIU ; Shaofu QIU ; Guangcai DUAN
Chinese Journal of Microbiology and Immunology 2021;41(3):195-200
Objective:To establish a rapid detection method for human astrovirus based on TaqMan-probe real-time fluorescent quantitative reverse transcription-polymerase chain reaction (RT-PCR).Methods:According to the conservative sequence of human astrovirus ORF1 b gene, we designed the amplification primers and specific fluorescent probe to establish the human astrovirus TaqMan real-time fluorescent quantitative RT-PCR rapid detection method. The specificity, sensitivity and stability of the method were evaluated. We also used this method to detect human astrovirus in clinical samples. Results:The established human astrovirus TaqMan real-time fluorescent quantitative RT-PCR detection method has good specificity and repeatability for human astrovirus, and the sensitivity can reach 10 2 copies/μl. After testing the clinical samples, the detection rate of human astrovirus by our method was 100%. Conclusions:The human astrovirus TaqMan real-time fluorescent quantitative RT-PCR detection method established in this study is simple, rapid, sensitive, specific and stable. It can be used for clinical human astrovirus detection and epidemiological investigation.
8.Effects of care and nursing practice plan based on timing theory in primary caregivers of infants with infantile spasms
Lingfang TAN ; Shan ZENG ; Huayan LIU ; Yan LI ; Meili LIU ; Weiwei DUAN ; Shengnan HU ; Qiming YI ; Sai YANG
Chinese Journal of Modern Nursing 2021;27(30):4102-4109
Objective:To explore the effect of the care and nursing practice plan based on the timing theory in primary caregivers of infants with infantile spasms.Methods:From July 2019 to June 2020, 80 infants with infantile spasm and 80 primary caregivers in the Department of Neurology of Hunan Children's Hospital were selected as the research object. All infants with infantile spasms were numbered according to the time of admission. The odd-numbered infants were admitted to the First Department of Neurology as the observation group, and the even-numbered children were admitted to the Second Department of Neurology as the control group, with 40 infants and 40 primary caregivers in each group. The control group carried out conventional treatment and nursing, and the observation group implemented a care and nursing practice plan based on the timing theory on the basis of the control group. Before and after the intervention, the Caring Ability Inventory (CAI) , Family Caregiver Task Inventory (FCTI) , Caregiver Burden Inventory (CBI) , and Gesell Developmental Schedules (GDS) were used to evaluate the caring ability, caregiving ability, care load of the primary caregivers of the two groups of infants, and the cognition function of the two groups of infants.Results:After the intervention, the total CAI scores of the primary caregivers in the observation group were higher than those before intervention and those in the control group after the intervention, and the total scores of FCTI and CBI were lower than those before intervention and those in the control group after the intervention, and the differences were statistically significant ( P<0.05) . After the intervention, the developmental quotient (DQ) values of the five energy areas of GDS in the observation group were higher than those before the intervention, and the DQ values of the three energy areas of gross motor, fine motor, and language were higher than those of the control group after the intervention, and the differences were statistically significant ( P<0.05) . Conclusions:The care and nursing practice plan based on the timing theory can improve the caring ability and caregiving ability of the main caregivers of children with infantile spasms, reduce the care load, and improve the cognitive function of the children.
9.Dose-toxicity-effect relationship between licorice combined with rhubarb in purgation.
Yan-Yan CHEN ; Yu-Jie CAO ; Yu-Ping TANG ; Jia-Qian CHEN ; Shi-Jun YUE ; Jia-Jia LI ; Sai ZHANG ; Gui-Sheng ZHOU ; Jin-Ao DUAN
China Journal of Chinese Materia Medica 2019;44(10):2131-2138
The dose-toxicity-effect relationship between licorice combined with rhubarb in purgation was studied. A total of 108 ICR mice were divided into control group,model group,positive group,low,medium and high-dose rhubarb groups,and low,medium and high-dose rhubarb-liquorice decoction group. After 6 days of continuous administration of loperamide hydrochloride,the constipation model of mice was replicated,and each group was given lactulose,different doses of rhubarb and rhubarb-liquorice decoction for 14 days. After administration,the defecation characteristics,blood biochemistry,liver,kidney and colon pathological changes in each group were compared. Based on the objective weight given by factor analysis,the dose-toxicity-effect relationship was comprehensively analyzed by multi-index scoring method. Two common factors were extracted by factor analysis,representing effect and toxicity respectively. The results showed that rhubarb could exert a diarrhea effect at the dosage of 1/2,2 and 8 times of the high limit set forth in the Chinese Pharmacopoeia,increase the defecation volume and the intestinal tract propulsion rate,reduce the time of anal and the oral transmission,and increase the water content of feces. The combination with licorice could alleviate its diarrhea effect,especially at the dosage of 1/2 times of the high limit set forth in the Chinese Pharmacopoeia. However,rhubarb showed obvious hepatic and colon toxicities at the dosage of 2 and 8 times of the high limit set forth in the Chinese Pharmacopoeia,and the combination with licorice could significantly reduce its toxicity. It shows that licorice has a " mediating" effect on rhubarb by alleviating the purgation property and reducing the toxicity.
Animals
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Cathartics
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pharmacology
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Colon
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Dose-Response Relationship, Drug
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Glycyrrhiza
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chemistry
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Kidney
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Liver
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Mice
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Mice, Inbred ICR
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Plant Extracts
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pharmacology
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Rheum
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chemistry
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Toxicity Tests
10.Research thoughts and methods on grading identification and transmission change law of traditional Chinese medicine(TCM) Q-marker.
Yu-Ping TANG ; Er-Xin SHANG ; Yan-Yan CHEN ; Shi-Jun YUE ; Jie YANG ; Sai ZHANG ; Jia-Jia LI ; Jin-Ao DUAN
China Journal of Chinese Materia Medica 2019;44(14):3116-3122
The quality marker( Q-maker) of traditional Chinese medicine( TCM) has been the core concept of TCM quality evaluation and control in recent years. Based on the knowledge and long-term practice of the researches on TCM quality,we put forward that " Taking the effectiveness as the core,the measurability and peculiarity as necessary conditions,and considering compatibility for TCM formulae,TCM Q-makers are selected and confirmed,and then the transmission and traceability should be investigated as its functional attributes". Selecting the commonly used representative TCM as the research object,based on the score of TCM effectiveness,measurability and peculiarity,a layered three-dimensional integrated technology was adopted for the quantitative evaluation and grading identification of the Q-markers for TCM. And after Q-markers for TCM are selected and confirmed,the transmission variation of the Q-markers is studied in the whole process from the formation of TCM to its function representation. Based on TCM chemical and biological characteristics as well as effectiveness,and integrating multidisciplinary techniques and methods,researches on innovative methods for system identification and confirmation of the TCM Q-makers are developed emphatically to form representative and exemplary extensive application,which will provide significant theoretical and methodological support for effectively improving the quality control level of TCM.
Biomarkers
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Drugs, Chinese Herbal
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standards
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Medicine, Chinese Traditional
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standards
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Quality Control

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