Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35]

Objective:To report the nationwide surveillance results of pathogenic profiles and antimicrobial resistance patterns of Gram-positive bloodstream infections in China in 2023.Methods:The clinical isolates of Gram-posttive bacteria from blood cultures were collected in member hospitals of National Bloodstream Infection Bacterial Resistant Investigation Collaborative System（BRICS）during January to December 2023. Antimicrobial susceptibility testing was performed using the dilution method recommended by the Clinical and Laboratory Standards Institute（CLSI）. Statistical analyses were conducted using WHONET 5.6 and SPSS 25.0 software.Results:A total of 4 385 Gram-positive bacterial isolates were obtained from 60 participating center. The top five pathogens were Staphylococcus aureus（ n=1 544，35.2%），coagulase-negative Staphylococci（ n=1 441，32.9%）， Enterococcus faecium（ n=574，13.1%）， Enterococcus faecalis（ n=385，8.8%），and α-hemolytic Streptococci（ n=187，4.3%）. The prevalence of methicillin-resistant Staphylococcus aureus（MRSA）and methicillin-resistant coagulase-negative Staphylococci（MRCNS）was 26.2%（405/1 544）and 69.8%（1 006/1 441），respectively. Notably，all Staphylococci remained susceptible to glycopeptide or daptomycin. Staphylococcus aureus demonstrated excellent susceptibility（>97.0%）to cephalobiol，rifampicin，trimethoprim-sulfamethoxazole，linezolid，minocycline，tigecycline，and eravacycline. No Enterococcus exhibiting resistance to linezolid were detected. Glycopeptide resistance was uncommon but more frequent in Enterococcus faecium（resistance to vancomycin and teicoplanin：both 1.7%）compared to Enterococcus faecalis（both 0.3%）. The detection rates of MRSA and MRCNS exhibited significant regional variations across the country（ χ2=17.674 and 148.650，respectively，both P<0.001）. No vancomycin-resistant Enterococci were detected in central China. Institutional comparison demonstrated higher prevalence of MRSA（ χ2=14.111， P<0.001）and MRCNS（ χ2=4.828， P=0.028）in provincial hospitals than that in municipal hospitals. Socioeconomic analysis identified elevated detection rates of both MRSA（ χ2=18.986， P<0.001）and MRCNS（ χ2=4.477， P=0.034）in less developed regions（per capita GDP

Objective:To report the results of bacterial resistant investigation collaborative system（BRICS）on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2023，and provide reference for clinical tretment of bloodstream infections and prevention and control of bacterial resistance.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of BRICS were collected during January 2023 to December 2023. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute（CLSI）. WHONET 5.6 and SPSS 25.0 were used to analyze the data.Results:During the study period，11 492 strains of Gram-negative bacteria were collected from 60 hospitals，of which 10 098（87.9%）were Enterobacterales and 1 394（12.1%）were non-fermentative bacteria. The top 5 bacterial species were Escherichia coli（50.0%）， Klebsiella pneumoniae（26.1%）， Pseudomonas aeruginosa（5.1%）， Acinetobacter baumannii complex（5.0%）and Enterobacter cloacae complex（4.1%）. The ESBL-producing rates in Escherichia coli， Klebsiella pneumoniae and Proteus mirablilis were 46.8%（2 685/5 741），18.3%（549/2 999）and 44.0%（77/175），respectively. The prevalence of carbapenem-resistant Escherichia coli（CREC）and carbapenem-resistant Klebsiella pneumoniae（CRKP）were 1.3%（76/5 741）and 15.0%（450/2 999）；32.9%（25/76）and 78.0%（351/450）of CREC and CRKP were sensitive to ceftazidime/avibactam combination，respectively. 94.7%（72/76）and 90.2%（406/450）of CREC and CRKP were sensitive to aztreonam/avibactam combination. Furthermore，57.9%（44/76）and 79.1%（356/450）were sensitive to imipenem/relebactam combination. The prevalence of carbapenem-resistant Acinetobacter baumannii（CRAB）complex was 64.6%（370/573），while more than 80.0% of CRAB complex was sensitive to tigecycline，eravacycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa（CRPA）was 17.0%（99/581）. There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of important Gram-negative bacteria resistance among different regions in China，with statistically significant differences in the prevalence of CREC，CRKP，CRPA and CRAB complex（ χ2=10.6，28.6，10.8 and 19.3， P<0.05）. The prevalence of ESBL-producing Escherichia coli， CREC，CRAB complex and CRKP were higher in provincial hospitals than those in municipal hospitals（ χ2=12.5，9.8，12.7 and 57.8，all P<0.01）. Conclusions:Gram-negative bacteria are the main pathogens causing bloodstream infections in China，and Escherichia coli is ranked in the top，while the trend of Klebsiella pneumoniae increases continuously with time. CRKP infection shows a slow upward trend，CREC infecton maintains a low prevalence level，and CRAB complex infection continues to exhibit a high prevalence rate. The composition and resistance patterns of pathogens causing bloodstream infections vary to some extent across different regions and levels of hospitals in China.

Objective:To explore the safety and efficacy of shunt reduction using the Interlock-35 fibered interlocking detachable coil (IDC) occlusion system in the treatment of refractory hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS).Methods:From August 2022 to December 2023, at the Department of Gastroenterology of the Air Force Medical Center, the clinical data of patients with refractory HE after TIPS who were treated with shunt reduction using the Interlock-35 fibered IDC occlusion system were retrospectively collected, which included portal vein pressure gradient (PVPG), HE grades, blood ammonia levels, prothrombin time (PT), liver function parameters, and other related indicators. The primary indicators related to the efficacy of the shunt reduction included symptom improvement, and changes in PVPG, blood ammonia levels, and Child-Pugh score. The safety of shunt reduction was analyzed based on the incidence of complications such as gastrointestinal bleeding and ascites during the follow-up period. Paired t-test was used for statistical analysis. Results:A total of 21 patients were enrolled. Prior to shunt reduction, there were 5 cases with HE of grade 3 and 16 cases with HE of grade 2. Before operation, the blood ammonia was (103.14±27.69) mol/L; and the liver function Child-Pugh grade of 1 case was classified as grade A, 16 cases as grade B, and 4 cases as grade C. Shunt reduction was performed between 7 and 1 879 d, with a median time of 99 (54, 806) d after TIPS. The procedure was technically successful in all patients, with a total of 25 coils implanted. Before shunt reduction, the PVPG was (14.02±5.28) cmH 2O (1 cmH 2O=0.098 kPa), after shunt reduction procedure, the PVPG increased to (25.05±6.04) cmH 2O, and the difference was statistically significant ( t=-11.26, P<0.001). After operation, 16 patients returned to the hospital for follow-up examinations, with a median follow-up time of 114 (46, 195) d, the blood ammonia levels, PT, and Child-Pugh scores during the follow-up were all lower than those before operation ((78.19±27.85) μmol/L vs. (105.00±30.53) μmol/L, (14.09±1.65) s vs. (15.41±2.35) s, and 6.88±1.59 vs. 8.13±1.75, respectively), and the differences were statistically significant ( t=2.23, 3.23, and 2.61; P=0.040, <0.001, =0.020). There was no statistically significant in PVPG between during follow-up and immediately post-procedure ((28.91±6.20) cmH 2O vs. (25.22±5.92) cmH 2O, P>0.05). During the follow-up period, HE symptoms disappeared in 12 patients among the 16 patients who returned to hospital for follow-up, however gastrointestinal bleeding occurred in 5 patients and ascites occurred in 3 patients; additionally, 4 patients experienced intermittent HE symptoms (grade 1 in 3 cases, grade 2 in 1 case). After operation, 5 patients were followed up via telephone, among them, 3 patients died, and 2 patients experienced intermittent HE (grade 1) which could be spontaneously restored with dietary adjustments and(or) medication. Conclusions:Interlock-35 fibered IDC occlusion system for shunt reduction is a feasible and effective treatment for refractory HE after TIPS. It can effectively improve symptoms and decrease liver function score. After shunt reduction, early follow-up and adjustment of flow reduction can help reduce the occurrence of severe complications.

Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.

Aim To investigate the regulatory mecha-nisms of donepezil on the expression and enzymatic ac-tivity of cytochrome P450 3A4(CYP3A4),elucidate the synergistic impact of hypoxia on CYP3A4 function,and reveal its potential association with drug-induced cardiotoxicity,particularly QT interval prolongation.Methods Western blot,co-immunoprecipitation,and gene knockdown techniques were employed to evaluate the effects of donepezil and hypoxia on CYP3A4 pro-tein expression.CYP3A4 enzymatic activity was as-sessed using an in vitro incubation system with rat liver microsomes combined with high-performance liquid chromatography(HPLC),and the half-maximal inhib-itory concentration(IC50)was determined.Results Donepezil(10 μmol·L-1)and hypoxia reduced CYP3A4 protein expression to 31.75％and 45.90％of the control levels,respectively.Both interventions activated the gp78-mediated ubiquitin-proteasome path-way,significantly increasing CYP3A4 ubiquitination levels by 2.1-fold compared to the control group,thereby promoting proteasomal degradation.Donepezil inhibited CYP3A4 enzyme activity with an IC50 of 83.4μmol·L-1,and hypoxia synergistically enhanced this inhibitory effect,reducing the IC50 to 20.79 μmol·L-1.Conclusion Donepezil downregulates CYP3A4 function through dual mechanisms involving ubiquitin-mediated proteasomal degradation and direct enzymatic inhibition.Hypoxia potentiates this effect,leading to impaired metabolism of CYP3A4 substrate drugs,ele-vated plasma drug concentrations(1.6-2.3-fold in-crease compared to normal metabolic conditions),and an increased risk of QT interval prolongation and other forms of cardiotoxicity.

Objective:To compare the efficacy of linaclotide and procalcitide in the treatment of adult constipation IBS-C.Methods:A retrospective study was conducted on 80 IBS-C patients admitted from May 2021 to May 2024.All patients were treated with novel secretagogues,and were divided into four groups according to the different treatment methods:linarotinib group and Pucanapide group,with 40 patients in each group.The clinical efficacy of oral administration of 290 μg of Nallotide capsules and 3 mg of Pucanapeptide in the Linalotide group and Pucanapeptide group was compared after one month of continuous treatment.The scores of IBS-C symptoms related to stool frequency,stool characteristics,upper abdominal pain,early satiety,and bloating were evaluated before and Post-treatment.Enzyme linked immunosorbent assay(ELISA)was used to detect the levels of vasoactive intestinal peptide(VIP),substance P(SP),5-hydroxytryptamine(5-HT),motilin,and gastrin IBS-C related serum markers in feces.The 16s rDNA fluorescence quantitative polymerase chain reaction method was used to detect Escherichia coli and lactate in feces.Compare the incidence of adverse reactions between the two groups based on the levels of Bacillus and Bifidobacterium.Results:There was no difference in the total effective rate between linagliptin group and Pucanotide group(P＞0.05);Post-treatment,the fecal frequency scores of the linaclotide group and the procalcitonin group were higher than pretherapy,while the fecal characteristics,upper abdominal pain,early satiety,and fullness scores were lower than pretherapy(P＜0.05).There was no difference in the fecal frequency,fecal characteristics,early satiety,and fullness scores between the linaclotide group and the procalcitonin group(P＞0.05),and the upper abdominal pain score of the linaclotide group was lower than that of the procalcitonin group(P＜0.05);Post-treatment,VIP,SP,5-HT,motilin and gastrin levels in linagliptin group and Pucanotide group were all lower than that pretherapy(P＜0.05),and there was no significant difference between linagliptin group and Pucanotide group(P＞0.05);Post-treatment,the levels of Escherichia coli in the linaclotide group and the procaine group were lower than pretherapy,while the numbers of Lactobacilli and Bifidobacteria were higher than pretherapy(P＜0.05).There was no difference between the linaclotide group and the procaine group(P＞0.05);There was no difference in the incidence of headache,bloating/abdominal pain between the linaclotide group and the procaine group(P＞0.05),and the incidence of diarrhea in the procaine group was lower than that in the linaclotide group(P＜0.05).Conclusion:Linalotide and Pucanatide have similar therapeutic effects in treating adult IBS-C,both of which can improve patients' clinical symptoms,serum biomarker levels,and intestinal microbiota structure.However,Linalotide has a better effect on improving abdominal pain,while Pucanatide can reduce the risk of diarrhea.Therefore,the clinical application of different new secretagogue drugs can be determined based on individualized symptoms and diarrhea risk of patients.

Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35]

Objective:To compare the efficacy of linaclotide and procalcitide in the treatment of adult constipation IBS-C.Methods:A retrospective study was conducted on 80 IBS-C patients admitted from May 2021 to May 2024.All patients were treated with novel secretagogues,and were divided into four groups according to the different treatment methods:linarotinib group and Pucanapide group,with 40 patients in each group.The clinical efficacy of oral administration of 290 μg of Nallotide capsules and 3 mg of Pucanapeptide in the Linalotide group and Pucanapeptide group was compared after one month of continuous treatment.The scores of IBS-C symptoms related to stool frequency,stool characteristics,upper abdominal pain,early satiety,and bloating were evaluated before and Post-treatment.Enzyme linked immunosorbent assay(ELISA)was used to detect the levels of vasoactive intestinal peptide(VIP),substance P(SP),5-hydroxytryptamine(5-HT),motilin,and gastrin IBS-C related serum markers in feces.The 16s rDNA fluorescence quantitative polymerase chain reaction method was used to detect Escherichia coli and lactate in feces.Compare the incidence of adverse reactions between the two groups based on the levels of Bacillus and Bifidobacterium.Results:There was no difference in the total effective rate between linagliptin group and Pucanotide group(P＞0.05);Post-treatment,the fecal frequency scores of the linaclotide group and the procalcitonin group were higher than pretherapy,while the fecal characteristics,upper abdominal pain,early satiety,and fullness scores were lower than pretherapy(P＜0.05).There was no difference in the fecal frequency,fecal characteristics,early satiety,and fullness scores between the linaclotide group and the procalcitonin group(P＞0.05),and the upper abdominal pain score of the linaclotide group was lower than that of the procalcitonin group(P＜0.05);Post-treatment,VIP,SP,5-HT,motilin and gastrin levels in linagliptin group and Pucanotide group were all lower than that pretherapy(P＜0.05),and there was no significant difference between linagliptin group and Pucanotide group(P＞0.05);Post-treatment,the levels of Escherichia coli in the linaclotide group and the procaine group were lower than pretherapy,while the numbers of Lactobacilli and Bifidobacteria were higher than pretherapy(P＜0.05).There was no difference between the linaclotide group and the procaine group(P＞0.05);There was no difference in the incidence of headache,bloating/abdominal pain between the linaclotide group and the procaine group(P＞0.05),and the incidence of diarrhea in the procaine group was lower than that in the linaclotide group(P＜0.05).Conclusion:Linalotide and Pucanatide have similar therapeutic effects in treating adult IBS-C,both of which can improve patients' clinical symptoms,serum biomarker levels,and intestinal microbiota structure.However,Linalotide has a better effect on improving abdominal pain,while Pucanatide can reduce the risk of diarrhea.Therefore,the clinical application of different new secretagogue drugs can be determined based on individualized symptoms and diarrhea risk of patients.