1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Stage Treatment of Squamous Cell Carcinoma Based on the Theory of Fire and Heat
Xinyi MA ; Luchang CAO ; Xinmiao WANG ; Guanghui ZHU ; Jie LI
Journal of Traditional Chinese Medicine 2025;66(6):575-580
It is believed that the occurrence and development of squamous cell carcinoma (SCC) is closely associated with inflammatory responses. The theory of fire and heat, advocated by LIU Wansu, provides significant clinical guidance for understanding the pathogenesis and treatment of SCC. Based on this theory, the pathological mechanisms and clinical characteristics of SCC at different stages were analyzed. In the precancerous and early stages, the primary pathogenesis is qi stagnation leading to internal generation of constrained heat; in post-surgery, the condition shifts to qi deficiency with latent yin fire; during the treatment phase, the pathogenesis involves accumulation of pathogenic factors, excess toxins, and severe heat toxicity; in the late stage, the main pathology is yin deficiency with toxic heat, and phlegm-stasis obstruction of the internal organs. Corresponding stage-based treatment strategies are proposed. In the early stage, regulating qi movement to dissipate constrained heat; for post-surgery, tonifying qi and raising yang to dispel latent fire; during treatment stage, clearing heat and detoxifying to eliminate cancerous toxins; and in the late stage, nourishing yin and unblocking the bowels to clear deficiency heat.
3.Acupuncture Treatment Strategies for Crohn's Disease Based on the Principle of "Shaoyang as the Pivot"
Chunhui BAO ; Jin HUANG ; Xinyi ZHU ; Zhou HAO ; Luyi WU ; Huirong LIU ; Huangan WU
Journal of Traditional Chinese Medicine 2025;66(10):1017-1022
The shaoyang meridian is an important pivot between the internal organs and meridians system, with the functions of regulating qi and blood, balancing yin and yang, and coordinating the ascending and descending movement of qi. Dysfunction of the shaoyang pivot can lead to spleen and kidney deficiency, impaired liver and gallbladder qi regulation, and stagnation of qi and blood. It is believed that the onset and progression of Crohn's disease are closely related to shaoyang pivot dysfunction, with the core pathogenesis characterized by shaoyang disharmony, spleen deficiency, dampness retention, and blood stasis. Based on this understanding, the treatment principle centers on harmonizing the shaoyang pivot, supplemented by methods such as warming and nourishing the spleen and stomach, tonifying shaoyang, and soothing the liver and benefiting the gallbladder. Acupuncture is employed to target key acupoints along the shaoyang meridian to restore its regulatory functions, improve spleen and stomach transformation and transportation, facilitate liver and gallbladder qi flow, and promote the circulation of qi and blood. This provides a practical therapeutic approach for acupuncture-based treatment of Crohn's disease.
4.A new method for flow cytometry-based detection of ABO antigen expression levels
Yuyu ZHANG ; Xi LIU ; Junhua XIE ; Bin CAO ; Jiewei ZHENG ; Xinyi ZHU ; Zhongying WANG ; Dong XIANG
Chinese Journal of Blood Transfusion 2025;38(5):665-672
Objective: To design and establish a new method for flow cytometry-based detection of commonly observed highly expressed antigens on red blood cells, and to further evaluate the differences and distribution characteristics of antigen expression levels between ABO blood type homozygotes and heterozygotes in healthy individuals. Methods: Residual blood samples after donor blood type identification by Shanghai Blood Center in April 2024 were collected. Among them, samples of 19 homozygous and 19 heterozygous individuals of type A and type B were selected. Then the expression level of ABO antigen on red blood cells were detected using the new method established in this study and the traditional aldehyde fixed red blood cell method. Both methods were tested independently three times and the results were compared. Results: The mean values of the three detection results of the new method was (×10
/RBC): AA homozygous 3.3±0.5, AO heterozygous 2.8±0.3, BB homozygous 3.6±0.3, BO heterozygous 3.1±2.8. The mean values of the three detection results of the aldehyde fixation method were AA homozygous 5.9±0.9, AO heterozygous 5.0±1.4, BB homozygous 3.8±0.6, and BO heterozygous 3.3±0.4. The average antigen distribution of each genotype followed a normal distribution. Comparing the average antigen expression levels of homozygotes and heterozygotes, both methods showed that A/B homozygotes had higher antigen levels than heterozygotes, with AA being 1.17 to 1.18 times that of AO and BB being 1.15 to 1.16 times that of BO. Comparing the inter batch differences in the three test results of two methods, the new method showed no significant difference in the three test results for four genotypes (P>0.05). The aldehyde fixation method showed significant differences in the test results for all three genotypes (P<0.01) except for BB homozygotes (P>0.05). The reliability and reproducibility of the new method were better than those of the traditional aldehyde fixation method. Conclusion: The antigen expression level of ABO homozygotes is higher than that of heterozygotes, and the difference in antigen level between type A homozygotes and heterozygotes is slightly higher than that of type B. The new method is superior to traditional aldolization fixation methods.
5.Surveillance and analysis of microbial contamination in commercially available ready-to-eat foods in Songjiang District, Shanghai from 2017 to 2022
Xiang QIU ; Yuxing ZHU ; Xinyi GU ; Fengsong SHENG ; Yuanqiang JIANG
Shanghai Journal of Preventive Medicine 2025;37(3):255-259
ObjectiveTo investigate the microbial contamination status of commercially available ready-to-eat (RTE) foods in Songjiang District of Shanghai, to verify the potential food safety hazards, so as to provide a scientific basis for the local regulation of RTE foods and the prevention of foodborne diseases. MethodsA total of 882 food samples from 9 categories of RTE foods were collected in Shanghai from 2017 to 2022. Salmonella, Listeria monocytogenes, Vibrio parahaemolyticus, Staphyloccus aureus and Bacillus cereus were detected according to the standard operating procedures in the Manual for China National Food Contamination and Harmful Factors Risk Monitoring, and which were determined with reference to relevant standards. ResultsA total of 77 samples were found to carry foodborne pathogens, with a total detection rate of 8.73%. Among the 5 foodborne pathogens, Bacillus cereus had the highest detection rate (8.35%), followed by Vibrio parahaemolyticus (5.05%), and the difference of detection rates among the 5 foodborne pathogens was statistically significant (χ2=112.307, P<0.001). Among the 9 categories of RTE food products, the detection rate of foodborne pathogens in RTE fermented/non-fermented soybean products was the highest (27.50%), followed by cold noodles (17.33%) and raw edible aquatic products (9.50%), and the difference in the detection rates of foodborne pathogens among different RTE food categories was statistically significant (χ2=45.909, P<0.001). The detection rate of foodborne pathogens in the third quarter of the year was 10.99%, significantly higher than that in other quarters (χ2=10.329, P=0.016). The detection rate of foodborne pathogens in samples from supermarkets was highest (15.08%), followed by snack bars (11.58%), with a statistically significant difference (χ2=14.108, P=0.015). ConclusionFoodborne pathogens contamination is found in commercially available RTE foods in Songjiang District of Shanghai, especially in RTE fermented/non-fermented soybean products, RTE cold noodles and raw edible aquatic products from supermarkets, snack bars and farm products markets during summer and autumn. Therefore, it is crucial to strengthen supervision and management to avoid the foodborne diseases.
6.Hemolytic disease of the fetus and newborn caused by Rh system anti-c antibodies: a case report and literature review
Luyan CHEN ; Dong XIANG ; Dingfeng LYU ; Zhenyun LIU ; Xinyi ZHU ; Shuan TAO ; Qiming YING ; Wei LIANG
Chinese Journal of Blood Transfusion 2025;38(6):843-848
Objective: To summarize the laboratory findings of a case of hemolytic disease of the fetus and newborn (HDFN) caused by Rh system anti-c antibodies and to review the literature, so as to explore the characteristics of anti-c HDFN. Methods: The ABO blood type, Rh blood type, direct antiglobulin test (DAT) results, and the presence of unexpected antibodies and their titers were determined by serological methods. The cases of anti-c HDFN in our laboratory in China and abroad were statistically analyzed, and the incidence of severe HDFN caused by anti-c, anti-D and anti-E was compared. Results: The blood type of the child was B (Rh CcDee) with a positive DAT. Anti-c antibody was detected in both serum and eluate, with a serum antibody titer of 4. The mother’s blood type was AB (Rh CCDee) with a negative DAT, and anti-c antibody was detected in the serum with a titer of 128. Among 20 cases of anti-c HDFN, 17 were DAT positive, and 9 (45%, 9/20) underwent blood transfusion or exchange transfusion. The incidence of severe HDFN was 47.60% (10/21) for anti-c, 47.60% (10/21) for anti-D and 31.30% (5/16) for anti-E. Conclusion: Maternal pregnancy and/or blood transfusion are the main reasons for the production of Rh alloantibodies such as anti-c. The prevention and management of anti-c should be similar to that of anti-D. Rh antigen-matched (five antigens of Rh blood group) transfusion is necessary for women of childbearing age to avoid antibody production, and Rh typing and antibody screening during prenatal examination is recommended to ensure early detection, intervention and treatment.
7.Genetic Homology Analysis of Bloodstream Infection Secondary to Intestinal Colonization with Carbapenem-Resistant Klebsiella Pneumoniae
Xinyue LI ; Hongjuan ZHANG ; Xiaoyan ZHU ; Meijia HUANG ; Yunmin XU ; Xundie LI ; Xinyi ZHENG ; Shaoxuan LI ; Bin SHAN
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1138-1147
To investigate the genetic relatedness between carbapenem-resistant A retrospective analysis was conducted on clinical data from patients screened for carbapenem-resistant Among 12 878 patients screened for CRE, 60 (0.47%) were identified with intestinal CRKP colonization. Of these, 6 (10.0%) developed bloodstream infections, with an all-cause mortality rate of 66.7% (4/6) during hospitalization. The predominant strain type among paired isolates was ST11-KL64 producing KPC-2, accounting for 91.7%(11/12) of cases. Except for one patient(with a categorical agreement of 82.6%), colonizing and bloodstream isolates from the same patient showed complete agreement (100% categorical agreement) in antimicrobial susceptibility profiles for all antibiotics except tigecycline. Intraclass correlation coefficients for biofilm formation and siderophore production were both > 0.75 of all paired strains, indicating high phenotypic consistency. Except for one patient, core genome single nucleotide polymorphism (SNP) analysis and phylogenetic reconstruction revealed high genetic homology between colonizing and bloodstream isolates from the same patient (SNP difference < 10). Clonal relatedness was also observed among colonizing strains from different departments (SNP difference < 120). Although the intestinal colonization rate of CRKP is low, it poses a high mortality risk once bloodstream infection occurs. The high consistency in antimicrobial resistance profiles, biofilm formation, siderophore production, and genomic homology between colonizing and bloodstream isolates suggests that intestinal colonization is the direct source of subsequent invasive infection. Enhanced early screening, dynamic monitoring, risk-stratified prevention, and optimized intervention strategies are recommended to reduce the risk of CRKP infection and mortality.
8.Opportunities and challenges of marginal donor liver
Xinyi LU ; Fei TENG ; Hong FU ; Yuanyu ZHAO ; Liye ZHU ; Jiayong DONG ; Jiaxi MAO ; Wenyuan GUO
Organ Transplantation 2024;15(3):463-468
With persistent breakthrough and maturity of surgical procedures and postoperative immunosuppressive therapy, the survival rate of liver transplant recipients and grafts has been significantly increased. The shortage of donor liver has become the main obstacle for clinical development of liver transplantation. How to expand the source of donor liver has become an urgent issue. Groundbreaking progresses have been made in the use of common marginal donor livers in clinical liver transplantation, such as elderly donor liver, steatosis donor liver, viral hepatitis donor liver and liver from donation after cardiac death. Nevertheless, multiple restrictions still exist regarding the use of marginal donor liver. Consequently, the definition of marginal donor liver and research progress in the application of common marginal donor livers were reviewed, and the opportunities and challenges of mariginal donoor liver were illustrated, aiming to provide reference for expanding the donor pool for clinical liver transplantation and bringing benefits to more patients with end-stage liver disease.
9.Spatial-temporal graph convolutional neural network for schizophrenia recognition
Xinyi XU ; Bin LI ; Geng ZHU ; Yuxing ZHOU ; Ping LIN ; Xiao'ou LI
Chinese Journal of Medical Physics 2024;41(2):227-232
A spatial-temporal convolutional neural network-based method is proposed for schizophrenia classification.Unlike the mainstream methods that only analyze the temporal frequency features in EEG and ignore the spatial features between brain regions,the model mainly obtains the spatial-frequency features by convolving the adjacency matrix composed of wavelet coherence coefficients between different channels and EEG sequences,and then extracts the temporal-frequency features through one-dimensional temporal convolution.The processed matrix is flattened after multiple convolutions and input to the classification model.Experimental results show that the method has a classification accuracy of 96.32%on the publicly available dataset Zenodo,demonstrating its effectiveness and exhibiting the advantages of fusing temporal-frequency and spatial-frequency features for schizophrenia diagnosis.
10.Analysisof HPV infection gene subtypes in the gynecology outpatient clinic of a hospital in Huadu district,Guangzhou
Siyi LI ; Hanbin HU ; Xueping LUO ; Weiwei HUANG ; Dongyun ZHU ; Xinyi CHEN
Modern Hospital 2024;24(5):803-805,809
Purpose To analyze the gene subtypes and characteristics of human papilloma virus(HPV)infection among women attending outpatient and physical examination centers at our hospital.Methods We utilized Polymerase Chain Reaction(PCR)combined with reverse dot hybridization to detect 28 HPV gene subtypes.Results HPV infection rate among the women was 24.15%.The five most prevalent high-risk(HR)and low-risk(LR)HPV gene subtypes were HPV 52,16,53,58,39,and HPV 61,81,54,42,44,respectively.Single and double infections accounted for 68.97%and 20.72%,with no signifi-cant difference found in the combination of multiple infection types.When stratified by age,the highest HPV infection rate was found among the group aged ≤25 years,followed by the group aged ≥66 years and then the group aged 56-65 years.This pattern of HPV infection rates across age groups revealed an approximate U-shaped curve.Conclusion The majority of female HPV in-fections in Huadu district are single infections,primarily affecting young and middle-aged women.HPV gene subtypes exhibit the characteristics of population or region-specific distribution.The overall infection rate of HPV is 24.15%,with the most common types being 52,16,and 53.The three peak age groups for HPV infection ranges are ≤25 years,56-65 years,and ≥66 years.

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