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.Mechanism of carvacrol on inhibiting biofilm formation of hypervirulent Klebsiella pneumoniae
Chun-Ping WEI ; Tian-Xin XIANG ; Yang LIU ; Na CHENG ; Fei HAN ; Li ZHOU ; Peng LIU ; Dan-Dan WEI
Chinese Journal of Infection Control 2024;23(7):833-839
		                        		
		                        			
		                        			Objective To explore the potential mechanism of carvacrol on inhibiting the formation of biofilm of hy-pervirulent Klebsiella pneumoniae(hvKP).Methods The possible mechanisms of carvacrol were analyzed based on the detection of its effects on the formation and morphology of biofilms,changes in extracellular polysaccharide and capsule polysaccharide content,as well as changes in the expression levels of biofilm-related genes rmpA2,mag A,mrkA,mrkB,and treC of hvKP.Results The minimum inhibitory concentration of carvacrol on hvKP was 512 μg/mL,with an obvious inhibitory effect on the biofilm formation of hvKP,presenting a concentration-depen-dent effect.Under the scanning electron microscope,it was observed that the biofilm structure was loose and the in-tercellular connections were not dense under the intervention of carvacrol.The Congo Red adsorption test and m-hydroxybiphenyl colorimetric method showed that carvacrol could reduce the content of capsule polysaccharides of hvKP,but didn't affect the total extracellular polysaccharide content.Fluorescence quantitative polymerase chain reaction(PCR)showed that under the effect of carvacrol at sub-inhibitory concentration,the synthesis of capsule polysaccharide,expression levels of sugar transport system and pili adhesion-related genes all decreased by more than 50%.Conclusion Carvacrol has a significant inhibitory effect on the formation of biofilm in hvKP,and its mechanism may be related to the decrease of synthesis of capsule polysaccharide as well as expression of biofilm-re-lated genes,such as sugar transport system and pili adhesion.
		                        		
		                        		
		                        		
		                        	
3.Analysis of titer stability and inactivation kinetics of harvest solution of SARS-CoV-2
GUO Bing-feng ; HAN Bin ; HAO Yi-nan ; WANG Kui ; YIN Ji-xiang ; LI Yan ; LI Nan ; LING Xiang-ping ; PAN Ruo-wen
Chinese Journal of Biologicals 2023;36(2):129-132+144
		                        		
		                        			
		                        			Objective To investigate the titer stability of the harvest solution of severe acute respiratory syndrome coronavirus2(SARS-CoV-2)at 2 ~ 8 ℃ and the inactivation effect of β-propiolactone inactivator on the virus.Methods Three batches of SARS-CoV-2 harvest solution(batch numbers:202111001,202111002 and 202111003)were stored at 2 ~ 8 ℃ for 12 d and sampled every 3 d(0,3,6,9 and 12 d)for detection of the titers by Karber method;Three batches of virus harvest solution equilibrated overnight at 2 ~ 8 ℃ were inactivated by adding β-propiolactone at a volume fraction of 1∶4 000 and detected for the titers at different inactivation time points(0,0.5,1,1.5,2,3,4,8,16 and 24 h),of which samples inactivated for 8,16 and 24 h were taken for inactivation verification,and samples inactivated for 24 h were observed by transmission electron microscope.Results The titers of SARS-CoV-2 decreased with the prolongation of storage time at 2 ~8 ℃,which showed no obvious decrease during 0 ~ 3 d,while decreased from the initial 7.75,6 and 7.5 lgCCID_(50)/mL to5.75,4.625 and 6.25 lgCCID_(50)/mL on day 12,indicating that the virus activity showed a gradual decrease trend at 2 ~8 ℃;With the inactivation time,the virus titer decreased continuously and could not be detected after inactivation for 3 h.Transmission electron microscope observation showed that the inactivated virus particles were intact and the spike protein was evenly distributed.Conclusion The virulence of SARS-CoV-2 stored at 2 ~ 8 ℃ was unstable,so the subsequent inactivation and purification process should be carried out as soon as possible;The titer of virus could not be detected after3 h of inactivation,which provided a reference for the determination of the inactivation process.
		                        		
		                        		
		                        		
		                        	
		                				4.Prokaryotic expression, subcellular localization and enzymatic activity analysis of DXS  gene from Platycodon grandiflorum 
		                			
		                			Nan DONG ; Han-wen YU ; Meng-li LIU ; Jing LI ; Bo-wen CHEN ; Xiang-wei CHANG ; Ju-tao WANG ; Liang-ping ZHA ; Shuang-ying GUI
Acta Pharmaceutica Sinica 2023;58(4):1059-1068
		                        		
		                        			
		                        			 1-Deoxy-
		                        		
		                        	
5.Meranzin Hydrate Improves Depression-Like Behaviors and Hypomotility via Ghrelin and Neurocircuitry.
Ya-Lin LIU ; Jian-Jun XU ; Lin-Ran HAN ; Xiang-Fei LIU ; Mu-Hai LIN ; Yun WANG ; Zhe XIAO ; Yun-Ke HUANG ; Ping REN ; Xi HUANG
Chinese journal of integrative medicine 2023;29(6):490-499
		                        		
		                        			OBJECTIVE:
		                        			To investigate whether meranzin hydrate (MH) can alleviate depression-like behavior and hypomotility similar to Chaihu Shugan Powder (CSP), and further explore the potential common mechanisms.
		                        		
		                        			METHODS:
		                        			Totally 120 Spraque-Dawley rats were randomly divided into 5-8 groups including sham, vehicle, fluoxetine (20 mg/kg), mosapride (10 mg/kg), CSP (30 g/kg), MH (9.18 mg/kg), [D-Lys3]-GHRP-6 (Dlys, 0.5 mg/kg), and MH+Dlys groups by a random number table, 8 rats in each group. And 32 mice were randomly divided into wild-type, MH (18 mg/kg), growth hormone secretagogue receptor-knockout (GHSR-KO), and GHSR+MH groups, 8 mice in each group. The forced swimming test (FST), open field test (OFT), tail suspension test (TST), gastric emptying (GE) test, and intestinal transit (IT) test were used to assess antidepressant and prokinetic (AP) effects after drug single administration for 30 min with absorbable identification in rats and mice, respectively. The protein expression levels of brain-derived neurotrophic factor (BDNF) and phosphorylated mammalian target of rapamycin (p-mTOR) in the hippocampus of rats were evaluated by Western blot. The differences in functional brain changes were determined via 7.0 T functional magnetic resonance imaging-blood oxygen level-dependent (fMRI-BOLD).
		                        		
		                        			RESULTS:
		                        			MH treatment improved depression-like behavior (FST, OFT) and hypomotility (GE, IT) in the acute forced swimming (FS) rats (all P<0.05), and the effects are similar to the parent formula CSP. The ghrelin antagonist [D-Lys3]-GHRP-6 inhibited the effect of MH on FST and GE (P<0.05). Similarly, MH treatment also alleviated depression-like behavior (FST, TST) in the wild-type mice, however, no effects were found in the GHSR KO mice. Additionally, administration of MH significantly stimulated BDNF and p-mTOR protein expressions in the hippocampus (both P<0.01), which were also prevented by [D-Lys3]-GHRP-6 (P<0.01). Besides, 3 main BOLD foci following acute FS rats implicated activity in hippocampus-thalamus-basal ganglia (HTB) circuits. The [D-Lys3]-GHRP-6 synchronously inhibited BOLD HTB foci. As expected, prokinetic mosapride only had effects on the thalamus and basal ganglia, but not on the hippocampus. Within the HTB, the hippocampus is implicated in depression and FD.
		                        		
		                        			CONCLUSIONS
		                        			MH accounts for part of AP effects of parent formula CSP in acute FS rats, mainly via ghrelin-related shared regulation coupled to BOLD signals in brain areas. This novel functionally connection of HTB following acute stress, treatment, and regulation highlights anti-depression unified theory.
		                        		
		                        		
		                        		
		                        			Rats
		                        			;
		                        		
		                        			Mice
		                        			;
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Brain-Derived Neurotrophic Factor/metabolism*
		                        			;
		                        		
		                        			Ghrelin/metabolism*
		                        			;
		                        		
		                        			Antidepressive Agents/therapeutic use*
		                        			;
		                        		
		                        			Hippocampus
		                        			;
		                        		
		                        			Stress, Psychological
		                        			;
		                        		
		                        			Mammals/metabolism*
		                        			
		                        		
		                        	
6.Preliminary survey report on the clinical validation of in-use electronic sphygmomanometers in China.
Xiang Hui ZHANG ; Yu Qing ZHANG ; Rong HU ; Ping SONG ; Xu HAN ; Shu Lin WEN ; Heng GUO ; Lin CHEN ; Shao Bo XIAO ; Yang Feng WU
Chinese Journal of Cardiology 2023;51(4):407-414
		                        		
		                        			
		                        			Objective: To explore the percentage of in-use electronic sphygmomanometers independently validated clinically in China. Methods: We conducted a cross-sectional survey and Beijing, Shenzhen, Shijiazhuang, Datong, and Shihezi were selected according to the geographical location and economic level. In each site, one tertiary hospital, two community health centers, and 20 families with electronic sphygmomanometers in use were chosen. The information of electronic sphygmomanometers including brand, model, manufacturer and production date were obtained by the trained staff. Ten electronic sphygmomanometers from each hospital, five electronic sphygmomanometers from each community health center, and one electronic sphygmomanometer from each family were surveyed, and the user's subjective judgment results and judgment basis on the accuracy of the electronic sphygmomanometer measurement were collected. We searched six registration websites (Medaval, Stride BP, dabl Educational Trust, British and Irish Hypertension Society, American Medical Association and Hypertension Canada) and two research databases (PubMed and CNKI) for the clinical validation status of each electronic sphygmomanometer. Results: A total of 200 electronic sphygmomanometers were investigated in this study, of which only 29.0% (58/200) passed independent clinical validation. When stratified by users, the percentage of being clinical validated was 46.0% (23/50) for electronic sphygmomanometers in hospitals, 42.0% (21/50) for those in community health centers and 14.0% (14/100) for those in home use, respectively, and the proportions between the three groups were significantly difference (P<0.001). Doctors in tertiary hospitals and community health service centers judged the accuracy of electronic sphygmomanometers mainly on the basis of "regular correction" (41.0% (41/100)) and "comparison with other electronic sphygmomanometers" (20.0% (20/100)), while among home users, 41.0% (41/100) were not clear about the accuracy of electronic sphygmomanometers, and 40.0% (40/100) made the judgment by "comparison with the devices in hospitals". Conclusion: The clinical validation of in-use electronic sphygmomanometers in China is low. Most of users, including healthcare professionals, are not aware of clinical validation of electronic sphygmomanometers.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Blood Pressure Determination
		                        			;
		                        		
		                        			Cross-Sectional Studies
		                        			;
		                        		
		                        			Sphygmomanometers
		                        			;
		                        		
		                        			Hypertension/diagnosis*
		                        			;
		                        		
		                        			China
		                        			;
		                        		
		                        			Electronics
		                        			;
		                        		
		                        			Blood Pressure
		                        			
		                        		
		                        	
7.Acupuncture for prevention of moderate to severe seasonal allergic rhinitis: a randomized controlled trial.
Ting-Ting SONG ; Xiang-Hong JING ; Wei GUO ; Guan-Xiong HAN ; Shuo DU ; Ji-Ping ZHAO
Chinese Acupuncture & Moxibustion 2023;43(2):123-127
		                        		
		                        			OBJECTIVE:
		                        			To observe the clinical efficacy of acupuncture for prevention of moderate to severe seasonal allergic rhinitis.
		                        		
		                        			METHODS:
		                        			A total of 105 patients with moderate to severe seasonal allergic rhinitis were randomly divided into an observation group (53 cases, 3 cases dropped off) and a control group (52 cases, 4 cases dropped off). The patients in the observation group were treated with acupuncture at Yintang (GV 24+), Yingxiang (LI 20), Hegu (LI 4), Zusanli (ST 36), Fengchi (GB 20), Feishu (BL 13), etc. 4 weeks before the seizure period, once every other day, 3 times a week for 4 weeks. The patients in the control group were not given any intervention before the seizure period. Emergency drugs can be given appropriately during the seizure period in both groups. After seizure period, the seizure rate was recorded in the two groups; before treatment and on week 1, 2, 4, 6 of seizure period after treatment, the rhinoconjunctivitis quality of life questionnaire (RQLQ) score and total nasal symptom score (TNSS) were observed in the two groups; the rescue medication score (RMS) was recorded on week 1-6 of seizure period in the two groups.
		                        		
		                        			RESULTS:
		                        			The seizure rate of the observation group was 84.0% (42/50), which was lower than 100.0% (48/48) in the control group (P<0.05). After treatment, the scores of RQLQ and TNSS at each time point of seizure period were decreased compared with before treatment in the observation group (P<0.01), which were lower than the control group (P<0.01). The RMS score at each time point of seizure period in the observation group was lower than the control group (P<0.05, P<0.01).
		                        		
		                        			CONCLUSION
		                        			Acupuncture can reduce the incidence of moderate to severe seasonal allergic rhinitis, relieve the symptoms, improve the quality of life and reduce the use of emergency drugs.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Rhinitis, Allergic, Seasonal
		                        			;
		                        		
		                        			Rhinitis, Allergic/therapy*
		                        			;
		                        		
		                        			Quality of Life
		                        			;
		                        		
		                        			Acupuncture Therapy
		                        			;
		                        		
		                        			Acupuncture Points
		                        			;
		                        		
		                        			Treatment Outcome
		                        			;
		                        		
		                        			Seizures
		                        			
		                        		
		                        	
8.Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version).
Wei-An YUAN ; Jun-Hua ZHANG ; Jian-Ping LIU ; Zhong-Qi YANG ; Jun-Ling CAO ; Xing LIAO ; Xiao-Yu XI ; Mei HAN ; Wen-Yuan LI ; Zhen-Wen QIU ; Shi-Yin FENG ; Yuan-Yuan GUO ; Lu-Jia CAO ; Xiao-Hong LIAO ; Yan-Ling AI ; Ju HUANG ; Lu-Lu JIA ; Xiang-Fei SU ; Xue WU ; Ze-Qi DAI ; Ji-Hua GUO ; Bing-Qing LU ; Xiao-Xiao ZHANG ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2023;48(1):256-264
		                        		
		                        			
		                        			Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
		                        		
		                        		
		                        		
		                        			Medicine, Chinese Traditional
		                        			;
		                        		
		                        			Nonprescription Drugs
		                        			;
		                        		
		                        			Consensus
		                        			;
		                        		
		                        			China
		                        			;
		                        		
		                        			Reference Standards
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			
		                        		
		                        	
9.Chemical and nutrient differences between medicinal material, residues, and residue compost of Moutan Cortex.
Rong-Qing ZHU ; Chun-Fang TIAN ; Xiao-Yan LAN ; Zi-Han WANG ; Xiang LI ; Li ZHOU ; Mei-Lan CHEN ; Li-Ping KANG
China Journal of Chinese Materia Medica 2023;48(23):6361-6370
		                        		
		                        			
		                        			Moutan Cortex(MC) residues produced after the extraction of MC can be re-extracted for active components and used to produce organic fertilizer and animal feed. However, they are currently disposed as domestic waste, which pollutes the environment. This study analyzed the chemical composition of the medicinal material, residues, and residue compost of MC by UPLC-UV-Q-TOF-MS. Furthermore, the nutrient composition of MC residues and the residue compost was analyzed. The results showed that:(1)MC residues had lower content of chemicals than the medicinal material, and content of paeonol, gallic acid, and galloylglucose in MC residues were about 1/3 of that in the medicinal material. The content of chemicals were further reduced after residue composting, and the quantitative compounds were all below the limits of detection.(2)Compared with MC residues, the residue compost showed the total nitrogen, total phosphorus, total potassium, and organic matter content increasing by 122.67%, 31.32%, 120.39%, and 32.06%, respectively. Therefore, we concluded that the MC residues can be used to re-extract active compounds such as paeonol, gallic acid, and galloylglucose. The MC residue compost is a high-quality organic fertilizer containing minimal content of chemicals and can be widely used in the cultivation of Chinese medicinal herbs.
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Composting
		                        			;
		                        		
		                        			Fertilizers
		                        			;
		                        		
		                        			Soil/chemistry*
		                        			;
		                        		
		                        			Hydrolyzable Tannins
		                        			;
		                        		
		                        			Nutrients
		                        			;
		                        		
		                        			Acetophenones
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			Paeonia
		                        			
		                        		
		                        	
10. Tanshinone IIA promotes reverse cholesterol transport to improve atherosclerosis
Yi-Fan ZHANG ; Min DU ; Jia-Rou WANG ; Si-Jin LI ; Xiao-Teng FENG ; Ping LIU ; Xiang-Hui HAN
Chinese Pharmacological Bulletin 2023;39(10):1835-1839
		                        		
		                        			
		                        			 Aim To explore the effect of tanshinone II A (Tan II A) on reverse cholesterol transport in atherosclerosis model mice and RAW264. 7 cells and the underlying mechanism. Methods Thirty-two male LDLR -/- mice were randomly divided into four groups. These mice were fed with normal diet or high fat diet for 12 weeks. The control group and model group were given normal saline. Tan II A group and atorvastatin group were given Tan II A solution and atorvastatin solution for 12 weeks. RAW264. 7 cells were induced with oxidized low-density lipoprotein (ox-LDL) 100 mg • L- 
		                        		
		                        		
		                        		
		                        	
            

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