OBJECTIVE To provide references for optimizing the review and approval system of clinically urgent overseas-marketed drugs in China. METHODS The characteristics of the review and approval system for clinically urgent overseas-marketed drugs were analyzed. A comparative research method was employed to examine differences between China and Australia， Switzerland， and Canada in three dimensions： qualification determination for clinical urgency （i.e.， access qualification）， review methods， and approval modalities. RESULTS & CONCLUSIONS In China’s current system， the legal nature of communication and consultation meetings is ambiguous， as the qualification determination function is embedded within technical consultation procedures without remedy channels. The pre-marketing clinical trial exemption for drugs is disconnected from the post-marketing confirmation obligation， and insufficient access to complete overseas review information weakens risk control effectiveness. A differentiated triage mechanism based on the timing of global approval has not been established， providing insufficient incentives for global simultaneous research and development. International typical regulatory models set access qualification， review methods， and approval modalities as independent modules， forming a quid pro quo relationship by relaxing pre-marketing access conditions and establishing post-marketing conditional approval mechanisms. It is recommended to formulate technical guidelines for the determination of clinically urgent drugs to clarify objective discretionary benchmarks， clarify the legal nature of communication and consultation meetings and allocate remedy channels， mandatorily include clinical trial-exempted varieties in the conditional approval procedure and establish a negative signal linkage mechanism， and implement differentiated triage based on approval timing， so as to improve China’s review and approval system.

AIM To evaluate the quality of Croci Stigma from different producing areas.METHODS The analysis was performed on a 25 ℃ thermostatic Waters Acquity UPLC HSS T3 column(2.1 mm× 100 mm,1.8μm),with the mobile phase comprising of 0.1％phosphoric acid-acetonitrile flowing at 0.35 mL/min in a gradient elution manner,and the detection wavelengths were set at 254,440 nm.The UPLC fingerprints were established,after which orthogonal partial least squares discriminant analysis was performed,picrocrocin,crocin-Ⅰ,crocin-Ⅱ,crocin-Ⅲ,crocin-Ⅳ contents and chromaticity values(L*,a*,b*,E*ab)were determined,Pearson correlation analysis was adopted in the investigation of correlations between chromaticity values and internal constituent contents.RESULTS There were 14 common peaks in the fingerprints for 22 batches of medicinal materials with the similarities of more than 0.98.Various batches of medicinal materials were clustered into 2 types,7 quality difference components were screened.crocin-Ⅰ content in medicinal materials from different producing areas demonstrated significant differences(P＜0.05);the redder the color of medicinal material,the higher the contents of crocins.Picrocrocin,crocin-Ⅰ,crocin-Ⅱ,crocin-Ⅳ contents displayed highly significant correlations with colorimetric values(P＜0.01),while crocin-Ⅲ content exhibited no significant correlation with the latter(P＞0.05).CONCLUSION This accurate and reliable method can provide references for the quality control and color-quality relationship elucidation of Croci Stigma.

OBJECTIVE To explore the clinical effect of Kangfuxin solution on wound healing,wound stromal cell-derived factor-1a(SDF-1a),vascular endothelial growth factor(VEGF)and angiopoietin-2(ANG-2)of the peri-anal abscess patients complicated with wound infection.METHODS A total of 118 perianal abscess patients compli-cated with postoperative wound infection who were treated in Wuhan Eighth Hospital from Jun.2018 to Oct.2023 were enrolled in the study and were randomly divided into the Kangfuxin solution group and the potassium per-manganate group,with 59 cases in each group.Both groups were treated with debridement of infection foci in a timely manner,the potassium permanganate group was given potassium permanganate for daily cleaning and treat-ment,and the Kangfuxin solution group was given Kangfuxin solution for daily treatment.The wound healing time,time of disappearance of wound edema and shedding time of slough were recorded,and the reduced rate of wound surface was determined after the treatment.The pain degree was evaluated by visual analogue scale(VAS)after the treatment,and the levels of wound SDF-1a,VEGF and Ang-2 levels were detected.RESULTS The wound healing time[(12.53±2.57)days],time of disappearance of wound edema[(6.89±1.06)days]and shed-ding time of slough[(3.06±0.68)days]were shorter in the Kangfuxin solution group than in the potassium per-manganate group(P＜0.05).The reduced rates of wound surface were higher after the treatment for 2,7 and 14 days,the VAS score was lower,and there were significant differences(P＜0.05).The levels of SDF-1a,VEGF and Ang-2 of the two groups were higher after the treatment than before the treatment,the levels of SDF-1a,VEGF and Ang-2 of the Kangfuxin solution group were higher than those of the potassium permanganate group,and there were significant differences(P＜0.05).CONCLUSIONS Kangfuxin solution can be used for wound repair of the perianal abscess patients complicated with wound infection,which may accelerate the wound healing.The action mechanisms may be associated with the regulation of expressions of wound SDF-1a,VEGF and Ang-2.

Objective:To investigate the neuroprotective effects of ginsenoside Rb1 in neonatal mice with Hypoxic Ischemia(HI)and analyze its potential molecular mechanisms.Methods:Seven-day-old C57BL/6 neonatal mice were randomly assigned to three groups:Sham group,hypoxic-ischemic(HI)model group,and HI model+ginsenoside Rb1 intervention group(HI+Rb1),with 10 mice per group.The modified Rice-Vannucci method was used to establish the HI model,and ginsenoside Rb1(20 mg/kg)was administered via intraperitoneal injection for 7 consecutive days post-surgery(once per day).Brain damage was assessed on days 7 and 14 post-surgery by evaluating cortical neurons and glial cell numbers,as well as the activation status of the ERK signaling pathway.Additionally,in utero electroporation(IUE)was used to overexpress the ERK signaling pathway in the cortical neurons,and the impact of ERK activation on glial cell development was observed.Further,IUE was used to overexpress ERK in the cortex of P0 neonatal mice,fol-lowed by the HI model on day 7 to analyze the effects of enhanced ERK signaling on oligodendrocyte development and myelin regeneration.Results:Compared to the HI group,the HI+Rb1 intervention group showed significant improve-ment in motor ability,reduction in brain injury area,less mature neuron loss,and increased newborn neurons.Addi-tionally,the number of oligodendrocytes in the cortex was increased,and the activation of the ERK signaling pathway was enhanced.In mice with overexpression of the ERK signaling pathway in the cortex,there was a significant increase in oligodendrocytes.In the HI model with ERK overexpression,an increased number of oligodendrocyte precursor cells were found around the brain injury area,consistent with the results of ginsenoside Rb1 intervention.Conclusion:Gin-senoside Rb1 exerts neuroprotective effects in neonatal mice with hypoxic-ischemic brain injury,potentially through the enhancement of ERK signaling,promoting oligodendrocyte proliferation and myelin regeneration.

Aim To investigate the protective effects of Tilianin on lipopolysaccharide(LPS)-induced septice-mia-induced myocardial injury in rats and to explore the related mechanisms.Methods Animals were ran-domly grouped and a rat septicemia-induced myocardial injury model was constructed.Echocardiography was used to assess the cardiac function of rats,left ventricu-lar internal diameter at end-diastole(LVIDd)and left ventricular internal diameter at end-systole(LVIDs)were measured,and left ventricular ejection fraction(LVEF)and left ventricular fractional shortening(LVFS)were calculated;the kits were used to detect the serum activity of the relevant cardiac enzymes and the level of inflammatory factors;HE staining was used to observe the morphological changes of myocardium;immunofluorescence staining of cardiac tissues was used to detect the nuclear translocation of NF-κB p65;Western blot was used to detect the expression of TLR4,MyD88,p-NF-κB p65,and NLRP3 proteins in cardiac tissues.Results Compared with the model group,each administration group differently upregulated LVEF,LVFS,and LVIDs,and improved the coordina-tion of LV wall fluctuations in the model group of rats;cardiac enzymes LDH and CK-MB levels increased,and levels of inflammatory factors TNF-α,IL-6,and IL-1 β were reduced,exerting cardioprotective effects;HE staining showed that myocardial tissue cell gap was re-duced,myocardial fiber breakage was reduced,cardio-myocyte arrangement tended to be normal,and inflam-matory cell infiltration was reduced;NF-κB p65 entry into the nucleus was reduced,and phosphorylated NF-κB p65(p-NF-κB p65)expression was reduced;and Western blot results showed that the expression of TLR4,MyD88,and NLRP3 proteins was reduced.Conclusions Tilianin pretreatment reduces serum my-ocardial enzymes and inflammatory factors and im-proves myocardial injury in rats with septicemia-in-duced myocardial injury,which may be related to the Tilianin anti-TLR4/NF-κB/NLRP3 inflammatory signa-ling pathway.

Objective To investigate the distribution and antimicrobial resistance profiles of common pathogens isolated from cerebrospinal fluid(CSF)in CHINET program from 2015 to 2021.Methods The bacterial strains isolated from CSF were identified in accordance with clinical microbiology practice standards.Antimicrobial susceptibility test was conducted using Kirby-Bauer method and automated systems per the unified CHINET protocol.Results A total of 14 014 bacterial strains were isolated from CSF samples from 2015 to 2021,including the strains isolated from inpatients(95.3％)and from outpatient and emergency care patients(4.7％).Overall,19.6％of the isolates were from children and 80.4％were from adults.Gram-positive and Gram-negative bacteria accounted for 68.0％and 32.0％,respectively.Coagulase negative Staphylococcus accounted for 73.0％of the total Gram-positive bacterial isolates.The prevalence of MRSA was 38.2％in children and 45.6％in adults.The prevalence of MRCNS was 67.6％in adults and 69.5％in children.A small number of vancomycin-resistant Enterococcus faecium(2.2％)and linezolid-resistant Enterococcus faecalis(3.1％)were isolated from adult patients.The resistance rates of Escherichia coli and Klebsiella pneumoniae to ceftriaxone were 52.2％and 76.4％in children,70.5％and 63.5％in adults.The prevalence of carbapenem-resistant E.coli and K.pneumoniae(CRKP)was 1.3％and 47.7％in children,6.4％and 47.9％in adults.The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)and Pseudomonas aeruginosa(CRPA)was 74.0％and 37.1％in children,81.7％and 39.9％in adults.Conclusions The data derived from antimicrobial resistance surveillance are crucial for clinicians to make evidence-based decisions regarding antibiotic therapy.Attention should be paid to the Gram-negative bacteria,especially CRKP and CRAB in central nervous system(CNS)infections.Ongoing antimicrobial resistance surveillance is helpful for optimizing antibiotic use in CNS infections.

Objective To investigate the antimicrobial resistance of clinical isolates from elderly patients(≥65 years)in major medical institutions across China.Methods Bacterial strains were isolated from elderly patients in 52 hospitals participating in the CHINET Antimicrobial Resistance Surveillance Program during the period from 2015 to 2021.Antimicrobial susceptibility test was carried out by disk diffusion method and automated systems according to the same CHINET protocol.The data were interpreted in accordance with the breakpoints recommended by the Clinical and Laboratory Standards Institute(CLSI)in 2021.Results A total of 514 715 nonduplicate clinical isolates were collected from elderly patients in 52 hospitals from January 1,2015 to December 31,2021.The number of isolates accounted for 34.3％of the total number of clinical isolates from all patients.Overall,21.8％of the 514 715 strains were gram-positive bacteria,and 78.2％were gram-negative bacteria.Majority(90.9％)of the strains were isolated from inpatients.About 42.9％of the strains were isolated from respiratory specimens,and 22.9％were isolated from urine.More than half(60.7％)of the strains were isolated from male patients,and 39.3％isolated from females.About 51.1％of the strains were isolated from patients aged 65-＜75 years.The prevalence of methicillin-resistant strains(MRSA)was 38.8％in 32 190 strains of Staphylococcus aureus.No vancomycin-or linezolid-resistant strains were found.The resistance rate of E.faecalis to most antibiotics was significantly lower than that of Enterococcus faecium,but a few vancomycin-resistant strains(0.2％,1.5％)and linezolid-resistant strains(3.4％,0.3％)were found in E.faecalis and E.faecium.The prevalence of penicillin-susceptible S.pneumoniae(PSSP),penicillin-intermediate S.pneumoniae(PISP),and penicillin-resistant S.pneumoniae(PRSP)was 94.3％,4.0％,and 1.7％in nonmeningitis S.pneumoniae isolates.The resistance rates of Klebsiella spp.(Klebsiella pneumoniae 93.2％)to imipenem and meropenem were 20.9％and 22.3％,respectively.Other Enterobacterales species were highly sensitive to carbapenem antibiotics.Only 1.7％-7.8％of other Enterobacterales strains were resistant to carbapenems.The resistance rates of Acinetobacter spp.(Acinetobacter baumannii 90.6％)to imipenem and meropenem were 68.4％and 70.6％respectively,while 28.5％and 24.3％of P.aeruginosa strains were resistant to imipenem and meropenem,respectively.Conclusions The number of clinical isolates from elderly patients is increasing year by year,especially in the 65-＜75 age group.Respiratory tract isolates were more prevalent in male elderly patients,and urinary tract isolates were more prevalent in female elderly patients.Klebsiella isolates were increasingly resistant to multiple antimicrobial agents,especially carbapenems.Antimicrobial resistance surveillance is helpful for accurate empirical antimicrobial therapy in elderly patients.

Objective:To investigate the neuroprotective effects of ginsenoside Rb1 in neonatal mice with Hypoxic Ischemia(HI)and analyze its potential molecular mechanisms.Methods:Seven-day-old C57BL/6 neonatal mice were randomly assigned to three groups:Sham group,hypoxic-ischemic(HI)model group,and HI model+ginsenoside Rb1 intervention group(HI+Rb1),with 10 mice per group.The modified Rice-Vannucci method was used to establish the HI model,and ginsenoside Rb1(20 mg/kg)was administered via intraperitoneal injection for 7 consecutive days post-surgery(once per day).Brain damage was assessed on days 7 and 14 post-surgery by evaluating cortical neurons and glial cell numbers,as well as the activation status of the ERK signaling pathway.Additionally,in utero electroporation(IUE)was used to overexpress the ERK signaling pathway in the cortical neurons,and the impact of ERK activation on glial cell development was observed.Further,IUE was used to overexpress ERK in the cortex of P0 neonatal mice,fol-lowed by the HI model on day 7 to analyze the effects of enhanced ERK signaling on oligodendrocyte development and myelin regeneration.Results:Compared to the HI group,the HI+Rb1 intervention group showed significant improve-ment in motor ability,reduction in brain injury area,less mature neuron loss,and increased newborn neurons.Addi-tionally,the number of oligodendrocytes in the cortex was increased,and the activation of the ERK signaling pathway was enhanced.In mice with overexpression of the ERK signaling pathway in the cortex,there was a significant increase in oligodendrocytes.In the HI model with ERK overexpression,an increased number of oligodendrocyte precursor cells were found around the brain injury area,consistent with the results of ginsenoside Rb1 intervention.Conclusion:Gin-senoside Rb1 exerts neuroprotective effects in neonatal mice with hypoxic-ischemic brain injury,potentially through the enhancement of ERK signaling,promoting oligodendrocyte proliferation and myelin regeneration.

Aim To investigate the protective effects of Tilianin on lipopolysaccharide(LPS)-induced septice-mia-induced myocardial injury in rats and to explore the related mechanisms.Methods Animals were ran-domly grouped and a rat septicemia-induced myocardial injury model was constructed.Echocardiography was used to assess the cardiac function of rats,left ventricu-lar internal diameter at end-diastole(LVIDd)and left ventricular internal diameter at end-systole(LVIDs)were measured,and left ventricular ejection fraction(LVEF)and left ventricular fractional shortening(LVFS)were calculated;the kits were used to detect the serum activity of the relevant cardiac enzymes and the level of inflammatory factors;HE staining was used to observe the morphological changes of myocardium;immunofluorescence staining of cardiac tissues was used to detect the nuclear translocation of NF-κB p65;Western blot was used to detect the expression of TLR4,MyD88,p-NF-κB p65,and NLRP3 proteins in cardiac tissues.Results Compared with the model group,each administration group differently upregulated LVEF,LVFS,and LVIDs,and improved the coordina-tion of LV wall fluctuations in the model group of rats;cardiac enzymes LDH and CK-MB levels increased,and levels of inflammatory factors TNF-α,IL-6,and IL-1 β were reduced,exerting cardioprotective effects;HE staining showed that myocardial tissue cell gap was re-duced,myocardial fiber breakage was reduced,cardio-myocyte arrangement tended to be normal,and inflam-matory cell infiltration was reduced;NF-κB p65 entry into the nucleus was reduced,and phosphorylated NF-κB p65(p-NF-κB p65)expression was reduced;and Western blot results showed that the expression of TLR4,MyD88,and NLRP3 proteins was reduced.Conclusions Tilianin pretreatment reduces serum my-ocardial enzymes and inflammatory factors and im-proves myocardial injury in rats with septicemia-in-duced myocardial injury,which may be related to the Tilianin anti-TLR4/NF-κB/NLRP3 inflammatory signa-ling pathway.

Objective To investigate the distribution and antimicrobial resistance profiles of common pathogens isolated from cerebrospinal fluid(CSF)in CHINET program from 2015 to 2021.Methods The bacterial strains isolated from CSF were identified in accordance with clinical microbiology practice standards.Antimicrobial susceptibility test was conducted using Kirby-Bauer method and automated systems per the unified CHINET protocol.Results A total of 14 014 bacterial strains were isolated from CSF samples from 2015 to 2021,including the strains isolated from inpatients(95.3％)and from outpatient and emergency care patients(4.7％).Overall,19.6％of the isolates were from children and 80.4％were from adults.Gram-positive and Gram-negative bacteria accounted for 68.0％and 32.0％,respectively.Coagulase negative Staphylococcus accounted for 73.0％of the total Gram-positive bacterial isolates.The prevalence of MRSA was 38.2％in children and 45.6％in adults.The prevalence of MRCNS was 67.6％in adults and 69.5％in children.A small number of vancomycin-resistant Enterococcus faecium(2.2％)and linezolid-resistant Enterococcus faecalis(3.1％)were isolated from adult patients.The resistance rates of Escherichia coli and Klebsiella pneumoniae to ceftriaxone were 52.2％and 76.4％in children,70.5％and 63.5％in adults.The prevalence of carbapenem-resistant E.coli and K.pneumoniae(CRKP)was 1.3％and 47.7％in children,6.4％and 47.9％in adults.The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)and Pseudomonas aeruginosa(CRPA)was 74.0％and 37.1％in children,81.7％and 39.9％in adults.Conclusions The data derived from antimicrobial resistance surveillance are crucial for clinicians to make evidence-based decisions regarding antibiotic therapy.Attention should be paid to the Gram-negative bacteria,especially CRKP and CRAB in central nervous system(CNS)infections.Ongoing antimicrobial resistance surveillance is helpful for optimizing antibiotic use in CNS infections.