1.Establishment of graded management standards for off-label use of Shenqi fuzheng injection
Min WU ; Mei YU ; Shengnan YIN ; Dongmei LIU
China Pharmacy 2026;37(5):650-654
OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection. METHODS Systematic searches were conducted in databases including CNKI, PubMed and the Cochrane Library to retrieve guidelines/consensuses, systematic reviews/meta-analyses, and randomized controlled trials (RCTs) of Shenqi fuzheng injection. The quality of evidence was evaluated using AGREE Ⅱ, AMSTAR Ⅱ, and the Risk of Bias 1.0 tool recommended by Cochrane Collaboration, and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the Thomson grading system. RESULTS A total of 534 articles were involved, including 11 guidelines, 22 systematic reviews/meta-analysis, and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection: cancer-related fatigue, colorectal cancer and breast cancer, all with high-quality evidence were classified under grade A management (grade Ⅰ commendation), allowing all physicians across the hospital to prescribe relevant treatments; five diseases, such as ovarian cancer, liver cancer, leukemia, heart failure and cerebral infarction, were classified under grade B management (grade Ⅱa commendation), with prescription restricted to physicians with intermediate or higher professional titles in specific departments; eleven diseases, including sepsis, cervical cancer, esophageal cancer, etc., were classified under grade C management (grade Ⅱb commendation), requiring strict evaluation by senior physicians before prescription; the use of Shenqi fuzheng injection for other conditions was explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent. The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the clinical application of traditional Chinese medicine injections and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions.
2.Engineered Bacteriophages for The Treatment of Multidrug-resistant Bacterial Infections
Yu-Ying CHEN ; Chun-Mei HUANG ; Jin-Zhi PAN ; De-Liang LIU ; Yang ZHOU ; Gui-Qin DAI ; Peng-Fei ZHAO ; Hong-Zhou LU ; Ming-Bin ZHENG
Progress in Biochemistry and Biophysics 2026;53(6):1581-1596
Multidrug-resistant (MDR) bacterial infections have emerged as a serious challenge of global public health crisis. The overuse and misuse of conventional antibiotics have dramatically accelerated the emergence, evolution and worldwide spread of drug-resistant bacterial strains, necessitating urgent exploration of novel antibacterial strategies. Bacteriophages serve as natural bacterial predators offering distinct advantages including high host specificity, autonomous self-replication capabilities and cost-effective large-scale production. However, wild-type phages present significant clinical limitations due to their narrow host ranges, susceptibility to rapid immune clearance and poor penetration of bacterial biofilms, which severely restrict their therapeutic applications. The convergence of synthetic biology, nanotechnology and advanced gene editing technologies has accelerated the development of engineered bacteriophage platforms, providing programmable, scalable and clinically translatable pathways to overcome these inherent biological constraints. Here, we systematically delineate four fundamental strategies for engineered bacteriophage development. Chemical modification utilizes reactive functional groups such as amino, carboxyl and thiol moieties on capsid proteins through esterification, amidation or click chemistry reactions to achieve precise drug conjugation and surface functionalization. In vivo editing encompasses ultraviolet or chemical mutagenesis for random mutation induction, homologous recombination for targeted genetic alterations, recombineering methodologies including electroporation-mediated bacteriophage recombination engineering, and CRISPR-Cas systems for precise genome editing to enable exact genetic reconstruction and host range reprogramming. In vitro synthesis leverages genome engineering platforms where intact phage genomes are transferred into yeast or host bacteria to facilitate highly efficient homologous recombination, enabling large DNA fragment assembly and cross-gene host range expansion without bacterial toxicity constraints. Directed evolution combines artificial selection through mutation library screening with rational design approaches involving chimeric receptor binding protein construction or site-specific mutagenesis, effectively balancing the discovery of unknown adaptive pathways with targeted host specificity modification. Moreover, we comprehensively discuss therapeutic applications across diverse clinical scenarios. Engineered bacteriophage effectively disrupt bacterial biofilms through sophisticated functionalized delivery platforms including nanozyme-conjugated phages, phage-liposome nanoconjugates and bio-responsive hydrogels, demonstrating significantly enhanced bactericidal efficiency compared to unmodified free phages. These bioengineered vectors attenuate bacterial virulence and resensitize pathogens to antibiotics by delivering CRISPR-Cas systems or base editors to disrupt critical virulence factors such as pili, capsule synthesis machineries and quorum sensing systems, or by inactivating antibiotic resistance determinants including beta-lactamase genes. As an intelligent nanomedicine delivery platform, engineered bacteriophage enable precise pathogen elimination an through photocatalytic reactive oxygen species generation, immunomodulatory interventions, or controlled release of antibacterial drugs. Furthermore, oral administration of engineered bacteriophage facilitates microbiota modulation, which selectively eliminate intestinal pathogens while preserve beneficial commensal microbiota, thereby restoring microbial community balance and preventing complications associated with dysbiosis. Finally, we critically analyze persistent challenges including host strain matching complexity, evolution of bacterial resistance mechanisms, pharmacokinetic optimization requirements, optimal administration route selection, large-scale production quality control standards and clinical dosing determination protocols. Through multidisciplinary integration of synthetic biology, infectious disease medicine and immunology, future translational medicine studies of bacteriophage should establish comprehensive technical platforms encompassing rapid phage screening, intelligent rational design, rigorous in vivo evaluation and standardized clinical validation processes, ultimately advancing engineered bacteriophage from laboratory innovations to clinically approved therapeutics for effectively combating MDR bacterial infections.
3.Resistance of Aedes albopictus to common insecticides in Zhejiang Province, 2024
Qin-mei LIU ; Jin-na WANG ; Tian-qi LI ; Ming-yu LUO ; Zhou GUAN ; Zhen-yu GONG ; Ji-min SUN
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):96-100
Objective In order to understand the current resistance status of Aedes albopictus(Ae. albopictus) adult population to commonly used insecticides and the resistance dynamics development in Zhejiang Province and provide a theoretical basis for the scientific and rational use of hygienic insecticides. Methods Resistance determination was carried out using the diagnostic dose method(GB/T 26347-2010)recommended by WHO in the adult mosquito contact cylinder method to monitor the resistance of Ae. albopictus field populations in 11 cities and districts in Zhejiang Province in 2024. Results The monitoring result showed that adult Ae. albopictus in 11 areas were resistant or suspected resistant populations to both cis-cypermethrin and permethrin; suspected and resistant populations to the organophosphate insecticide malathion were as high as 81.82%; while suspected resistance to the carbamate insecticide residual carbofuran accounted for 45.45%, and the rest of the monitoring sites were sensitive to it. Conclusions The result suggest that the generalized resistance of Ae. albopictus populations to pyrethroids and organophosphorus insecticides in the field in Zhejiang Province needs to be highly emphasized. In future mosquito vector and mosquito-borne disease control, insecticides should be selected based on the resistance monitoring information, while following scientific guidelines for insecticide use.
4.Efficacy and safety of Shuganning injection in treatment of liver injury: A clinical analysis
Qiaoxin WEI ; Mei LIU ; Daimeng SHI ; Shaoli YOU ; Yu CHEN ; Shuangsuo DANG ; Dongliang YANG ; Yuemin NAN ; Mingliang CHENG ; Zhongping DUAN
Journal of Clinical Hepatology 2026;42(6):1349-1357
ObjectiveTo investigate the efficacy and safety of Shuganning injection in the treatment of liver injury by observing the clinical outcome of patients with liver injury after treatment with Shuganning injection and comparing it with reduced glutathione (GSH). MethodsThis study was conducted among 175 patients with liver injury who attended 6 hospitals in China (Beijing YouAn Hospital, Capital Medical University; Nanyang First People’s Hospital; The Second Affiliated Hospital of Xi’an Jiaotong University; The Fifth Medical Center of Chinese PLA General Hospital; The Third Hospital of Hebei Medical University; The Affiliated Hospital of Guizhou Medical University) from April 25, 2019 to February 28, 2022. The patients were divided into experimental group (89 patients treated with Shuganning injection) and control group (86 patients treated with GSH), and the course of treatment was 4 weeks for both groups. Related indicators were recorded before treatment, after treatment, and after drug withdrawal for 8 weeks, including liver function parameters, blood biochemical parameters, blood lipids, coagulation profiles, liver fibrosis markers, traditional Chinese medicine (TCM) syndrome score, and ultrasound findings, as well as adverse events during treatment. The Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups. The Wilcoxon signed-rank test was used for comparison of observation indicators before treatment, at week 4 of treatment, and after drug withdrawal for 8 weeks. When the efficacy evaluation of TCM syndromes was used as the outcome, a pooled analysis was performed for the effective cases and the markedly effective cases, and a Logistic regression model was used to calculate the odds ratio (OR) and its 95%CI. ResultsAfter 4 weeks of treatment with Shuganning injection, the patients showed significant reductions in TCM syndrome score (P<0.001) and the levels of aspartate aminotransferase, alanine aminotransferase, total bilirubin, and direct bilirubin (all P<0.001) and a significant increase in the level of albumin (P=0.002), and these significant improvements persisted after drug withdrawal for 8 weeks. Furthermore, compared with the control group, the experimental group had a significantly higher proportion of patients assessed as effective or markedly effective cases (48.31% vs 32.56%, P=0.033). Compared with the control group, the experimental group had a significantly greater change in TCM syndrome score at weeks 1-4 of treatment and after drug withdrawal for 8 weeks (P<0.05). At week 4 of treatment, the experimental group had a significantly greater reduction in alanine aminotransferase than the control group (P<0.05), and at week 8 after drug withdrawal, the experimental group had a significantly greater reduction in alanine aminotransferase and aspartate aminotransferase than the control group (all P<0.05). One patient in the experimental group (1.12%) experienced an adverse event, which was determined to be associated with the progression of viral hepatitis. ConclusionShuganning injection can effectively improve liver injury, with good long-term efficacy and a low incidence rate of adverse reactions.
5.Objective characteristics of tongue manifestation in different stages of damp-heat syndrome in diabetic kidney disease
Zhaoxi DONG ; Yang SHI ; Jiaming SU ; Yaxuan WEN ; Zheyu XU ; Xinhui YU ; Jie MEI ; Fengyi CAI ; Xinyue ZANG ; Yan GUO ; Chengdong PENG ; Hongfang LIU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):398-411
Objective:
To investigate the objective characteristics of tongue manifestation in different stages of damp-heat syndrome in diabetic kidney disease (DKD).
Methods:
A cross-sectional study enrolled 134 patients with DKD G3-5 stages who met the diagnostic criteria for damp-heat syndrome in DKD. The patients were treated at Dongzhimen Hospital, Beijing University of Chinese Medicine, from May 2023 to January 2024. The patients were divided into three groups: DKD G3, DKD G4, and DKD G5 stage, with 53, 33, and 48 patients in each group, respectively. Clinical general data (gender, age, and body mass index) and damp-heat syndrome scores were collected from the patients. The YZAI-02 traditional Chinese medicine (TCM) AI Tongue Image Acquisition Device was used to capture tongue images from these patients. The accompanying AI Open Platform for TCM Tongue Diagnosis of the device was used to analyze and extract tongue manifestation features, including objective data on tongue color, tongue quality, coating color, and coating texture. Clinical data and objective tongue manifestation characteristics were compared among patients with DKD G3-5 based on their DKD damp-heat syndrome status.
Results:
No statistically significant difference in gender or body mass index was observed among the three patient groups. The DKD G3 stage group had the highest age (P<0.05). The DKD G3 stage group had a lower score for symptoms of poor appetite and anorexia(P<0.05) than the DKD G5 group. No statistically significant difference was observed in damp-heat syndrome scores among the three groups. Compared with the DKD G5 stage group, the DKD G3 stage group showed a decreased proportion of pale color at the tip and edges of the tongue (P<0.05). The DKD G4 stage group exhibited an increased proportion of crimson at the root of the tongue, a decreased proportion of thick white tongue coating at the root, a decreased proportion of pale color at the tip and edges of the tongue, an increased hue value (indicating color tone) of the tongue color in the middle, an increased brightness value (indicating color lightness) of the tongue coating color in the middle, and an increased thickness of the tongue coating (P<0.05). No statistically significant difference was observed in other tongue color proportions, color chroma values, body characteristics, coating color proportions, coating color chroma values, and coating texture characteristics among the three groups.
Conclusion
Tongue features differ in different stages of DKD damp-heat syndrome in multiple dimensions, enabling the inference that during the DKD G5 stage, the degree of qi and blood deficiency in the kidneys, heart, lungs, liver, gallbladder, spleen, and stomach is prominent. Dampness is more likely to accumulate in the lower jiao, particularly in the kidneys, whereas heat evil in the spleen and stomach is the most severe. These insights provide novel ideas for the clinical treatment of DKD.
6.Development and validation of a clinical prediction model for postoperative pulmonary complications in elderly patients following general anesthesia
Jingjun ZHANG ; Lili JIA ; Mingwei SHENG ; Ying SUN ; Mei DING ; Weihua LIU ; Hongxia LI ; Yiqi WENG ; Wenli YU
Chinese Journal of Emergency Medicine 2025;34(9):1237-1244
Objective:To develop and validate a clinical prediction model for assessing the risk of postoperative pulmonary complications (PPCs) in elderly patients undergoing surgery with general anesthesia.Methods:This prospective observational study enrolled patients aged ≥65 years who underwent general anesthesia with mechanical ventilation duration >3 hours across six tertiary hospitals between December 2022 and August 2023. Based on follow-up outcomes (until discharge or postoperative day 7), patients were categorized into a non-PPCs group and a PPCs group. Detailed records included baseline patient characteristics, preoperative comorbidities, surgical information (type, duration), and bedside lung ultrasound scores (LUS) assessed within 24 hours postoperatively using a standardized 12-zone protocol. Predictor selection was performed using LASSO regression. Significant predictors identified were incorporated into a multivariate logistic regression analysis to build the prediction model, visualized as a nomogram. Internal validation was conducted via bootstrap resampling (1 000 repetitions). Model performance was evaluated using the area under the receiver operating characteristic curve (AUC) for discrimination, calibration curves for calibration accuracy, and decision curve analysis (DCA) for clinical utility.Results:A total of 130 eligible elderly surgical patients were included. PPCs occurred in 17 patients (incidence rate: 13.1%). Multivariate analysis identified LUS ( OR=1.248, 95% CI: 1.099-1.417, P=0.001) and elective surgery type ( OR=0.206, 95% CI: 0.043-0.988, P=0.048) as independent predictors of PPCs. The nomogram model demonstrated an AUC of 0.867 (95% CI: 0.775-0.959) upon initial testing. Internal validation confirmed good discrimination (AUC=0.863, 95% CI: 0.778-0.972). Calibration curves indicated excellent agreement between predicted probabilities and observed outcomes. Decision curve analysis demonstrated significant clinical net benefit across a wide range of threshold probabilities (0.03-0.89). Conclusions:The clinical prediction model, developed using early postoperative LUS scores and surgical type, effectively predicts the risk of postoperative pulmonary complications in elderly patients following surgery under general anesthesia. The model exhibits strong discrimination, calibration, and clinical utility, providing clinicians with a reliable tool for individualized risk assessment to support clinical decision-making and potentially reduce PPC incidence.
7.Research Progress in the Function and Regulation of Sirtuin 3 in Sepsis-Related Diseases.
Jun-Jie LI ; Hong MEI ; Xin-Xin LIU ; Kun YU ; Bang-Hai FENG ; Bao FU ; Song QIN
Acta Academiae Medicinae Sinicae 2025;47(4):601-610
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection,with a high mortality rate.Sirtuin 3,a deacetylase within mitochondria,plays an important regulatory role in cellular metabolism,oxidative stress,and inflammatory responses.In recent years,significant progress has been made in the study of the function and regulatory role of sirtuin 3 in sepsis-related diseases.Research has shown that sirtuin 3 can alleviate organ damage caused by sepsis by regulating mitochondrial function,reducing oxidative stress,and inhibiting inflammatory responses.The specific mechanisms include the regulation of mitochondrial bioenergetics,activation of antioxidant enzyme systems,and inhibition of inflammatory mediator expression.In addition,sirtuin 3 plays a protective role in the pathological process of sepsis by interacting with multiple signaling pathways.This article summarizes the functions and regulatory mechanisms of sirtuin 3 in various sepsis-related diseases,aiming to provide new targets and strategies for the prevention and treatment of sepsis in the future.
Sepsis/metabolism*
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Sirtuin 3/physiology*
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Humans
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Animals
;
Oxidative Stress
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Mitochondria/metabolism*
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Signal Transduction
8.Regional Differences and Source Apportionment of Atmospheric Volatile Organic Compounds in A Typical Industrial City During Summer
Yu-Ting REN ; Li-Juan YANG ; Yang-Yang LIU ; Min XU ; Mei WANG
Chinese Journal of Analytical Chemistry 2025;53(10):1714-1721,中插45-中插53
A method for determining volatile organic compounds(VOCs)in environmental air samples using thermal desorption-gas chromatography/mass spectrometry(TD-GC/MS)was developed.The qualitative and quantitative analyses of 103 kinds of VOC species were achieved under the optimal conditions such as cold trap desorption temperature and time during the thermal desorption process,combined with full-scan data acquisition using an electron impact ionization source.With a sampling volume of 3.0 L,the method exhibited detection limits of 0.1-0.5 μg/m3 and quantitation limits of 0.4-2.0 μg/m3.At spiked concentrations of 1.0 μg/m3 and 10.0 μg/m3,the recoveries ranged from 60.5%to 118.0%,with relative standard deviations varying from 2.37%to 18.70%.Furthermore,all target compounds showed correlation coefficients(R2)exceeding 0.997 across their respective concentration ranges,demonstrating that the method had high accuracy and reliability.Using this method,a study was conducted to investigate the spatial variations and source apportionment of VOCs across urban,suburban,and rural sites in Anyang,a representative industrial city,during the summer season.The results revealed significant differences in VOC concentrations among the three regions.The urban site recorded the highest concentration at 40.1 μg/m3,followed by the rural site at 23.5 μg/m3,while the suburban site had the lowest concentration of 9.74 μg/m3.With regard to compositional characteristics,alkanes were the dominant components in the urban and rural areas,whereas oxygenated VOCs were predominant in the suburban site.The ozone formation potential(OFP)also varied significantly across regions:96.0 μg/m3 in urban areas,72.0 μg/m3 in rural areas,and only 27.6 μg/m3 in suburban areas.Alkenes were identified as the primary contributors to the total ozone formation potential(TOFP)in all regions,highlighting their critical role in atmospheric oxidation processes.Source apportionment analysis using the positive matrix factorization(PMF)model identified combustion sources,natural sources,chemical industry emissions,industrial emissions,solvent use,and vehicle emissions as the major sources of VOCs in Anyang during summer.Notably,chemical industry emissions and combustion sources were dominant in urban and rural areas,whereas combustion sources and natural sources were more prominent in the suburban area,reflecting distinct emission patterns and anthropogenic activities across the regions.
9.Rapid Screening of Etomidate and Its Analogues Using a Portable Mass Spec-trometer
Meng-Yao TANG ; Bo-Yu HUANG ; Cui-Mei LIU ; Xue-Yan LIU ; Wei JIA ; Zhen-Dong HUA
Journal of Forensic Medicine 2025;41(4):348-354
Objective To establish a rapid screening and analysis method for etomidate and its ana-logues using a portable mass spectrometer equipped with a thermal desorption-atmospheric pressure chemical ionization source-linear ion trap.Methods A 10 μL aliquot of a standard solution at a con-centration of 1 μg/mL was taken,and after the solvent evaporated,the sample was inserted into the in-let of the portable mass spectrometer for detection.By adjusting the collision-induced dissociation pa-rameters,the molecular ion peak and fragment ion peak information of the standard were obtained and used to establish a reference database.In addition,the method was applied to 29 seized liquid and plant samples.Results A screening system for etomidate and its analogues was established based on the portable mass spectrometer and the corresponding mass spectrometry library.The system enables qualitative screening analysis by identifying primary protonated molecular ions and secondary product ions of etomidate and its analogues.The limits of detection for etomidate and its 12 analogues ranged from 0.1 to 10 μg/mL.Etomidate and its analogues were detected in all 29 liquid and plant samples.However,this method could not distinguish between isomeric imidazole esters,such as isopropoxate and propoxate.Additionally,when testing 2-SH-etomidate,there was a false positive for the detection of etomidate.Conclusion This study established a rapid screening method for etomidate and its ana-logues using a portable mass spectrometer.The method combines the high sensitivity of mass spectrome-try with the on-site applicability of portable devices,significantly improving detection efficiency and meeting the on-site detection needs of etomidate and its analogues.
10.Four nutritional screening tools for evaluating the nutritional status of children with aplastic anemia
Memet GULIBAHAR ; Yu LIU ; Chuncan WU ; Changda ZHAO ; Yingbin YUE ; Mei YAN
International Journal of Pediatrics 2025;52(5):353-358
Objective:To evaluate the nutritional status of children with aplastic anemia(AA)using the children's nutritional risk index(CNRI),prognostic nutritional index(PNI),controlling nutritional status(CONUT),instant nutritional assessment(INA),and combined index(CI),in order to provide scientific evidence to support clinical diagnosis and treatment.Methods:A retrospective analysis was conducted on the clinical data of pediatric AA patients treated in the Department of Pediatrics,Ward 1,First Affiliated Hospital of Xinjiang Medical University from January 1st,2019 to April 30st,2024.Nutritional status was assessed using CNRI,PNI,CONUT,and INA,and integrated into CI.The agreement between different nutritional screening tools was evaluated using Kappa statistics. Results:A total of 68 pediatric AA patients were included,with an overall malnutrition prevalence of 44.1%.The malnutrition rates were 39.4% in the body mass index(BMI)normal group and 48.6% in the BMI abnormal group.Across disease severity groups,malnutrition was observed in 66.67% of very severe AA(VSAA)patients,54.17% of severe AA(SAA)patients,and 28.13% of non-severe AA(NSAA)patients,and the difference was statistically significant( χ2=6.778, P=0.034). Kappa analysis demonstrated the highest concordance between CONUT,INA,and CI,with Kappa values of 0.882( P<0.001). Conclusion:Pediatric AA patients have a high prevalence of malnutrition,and their nutritional status decline significantly with increasing disease severity.CONUT and INA are effective tools for assessing nutritional status in children with AA,providing reliable evidence for clinical evaluation.


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