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.Construction and Application Evaluation of an Integrated Traditional Chinese and Western Medicine Risk Prediction Model for Readmission in Patients with Stable Angina of Coronary Heart Disease:A Prospective Study Based on Real-World Clinical Data
Wenjie HAN ; Mingjun ZHU ; Xinlu WANG ; Rui YU ; Guangcao PENG ; Qifei ZHAO ; Jianru WANG ; Shanshan NIE ; Yongxia WANG ; Jingjing WEI
Journal of Traditional Chinese Medicine 2025;66(6):604-611
ObjectiveBy exploring the influencing factors of readmission in patients with stable angina of coronary heart disease (CHD) based on real-world clinical data, to establish a risk prediction model of integrated traditional Chinese and western medicine, in order to provide a basis for early identification of high-risk populations and reducing readmission rates. MethodsA prospective clinical study was conducted involving patients with stable angina pectoris of CHD, who were divided into a training set and a validation set at a 7∶3 ratio. General information, traditional Chinese medicine (TCM)-related data, and laboratory test results were uniformly collected. After a one-year follow-up, patients were classified into a readmission group and a non-readmission group based on whether they were readmitted. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for readmission. A risk prediction model of integrated traditional Chinese and western medicine was constructed and visualized using a nomogram. The model was validated and evaluated in terms of discrimination, calibration, and clinical decision curve analysis. ResultsA total of 682 patients were included, with 477 in the training set and 205 in the validation set, among whom 89 patients were readmitted. Multivariate logistic regression analysis identified heart failure history [OR = 6.93, 95% CI (1.58, 30.45)], wiry pulse [OR = 2.58, 95% CI (1.42, 4.72)], weak pulse [OR = 3.97, 95% CI (2.06, 7.67)], teeth-marked tongue [OR = 4.38, 95% CI (2.32, 8.27)], blood stasis constitution [OR = 2.17, 95% CI (1.06, 4.44)], phlegm-stasis mutual syndrome [OR = 3.64, 95% CI (1.87, 7.09)], and elevated non-high-density lipoprotein cholesterol [OR = 1.30, 95% CI (1.01, 1.69)] as influencing factors of readmission. These factors were used as predictors to construct a nomogram-based risk prediction model for readmission in patients with stable angina. The model demonstrated moderate predictive capability, with an area under the receiver operating characteristic curve (AUC) of 0.818 [95% CI (0.781, 0.852)] in the training set and 0.816 [95% CI (0.779, 0.850)] in the validation set. The Hosmer-Lemeshow test showed good calibration (χ² = 4.55, P = 0.80), and the model's predictive ability was stable. When the threshold probability exceeded 5%, the clinical net benefit of using the model to predict readmission risk was significantly higher than intervening in all patients. ConclusionHistory of heart failure, teeth-marked tongue, weak pulse, wiry pulse, phlegm-stasis mutual syndrome, blood stasis constitution, and non-high-density lipoprotein cholesterol are influencing factors for readmission in patients with stable angina of CHD. A clinical prediction model was developed based on these factors, which showed good discrimination, calibration, and clinical utility, providing a scientific basis for predicting readmission events in patients with stable angina.
3.Baicalein mitigates ferroptosis of neurons after subarachnoid hemorrhage
Ting ZHU ; Tingting YUE ; Yue CUI ; Yue LU ; Wei LI ; Chunhua HANG
Chinese Journal of Tissue Engineering Research 2025;29(1):52-57
BACKGROUND:Ferroptosis is a mode of programmed cell death distinct from apoptosis,necrosis,and other novel cellular deaths,which occurs mainly due to accumulated lipid peroxidation.Ferroptosis has been shown to be involved in the pathological process following subarachnoid hemorrhage.Baicalein,serving as an adept sequestered of iron,evinces its prowess by quelling lipid peroxidative cascades.Nonetheless,the enigma lingers as to whether baicalein possesses the capacity to ameliorate neuronal ferroptosis,elicited in the wake of early brain injury after subarachnoid hemorrhage. OBJECTIVE:To investigate the effect and mechanism of baicalein on neuronal ferroptosis after subarachnoid hemorrhage. METHODS:Primary neuronal cells were extracted from C57BL/6L fetal mice at 16-17 days of gestation.Hemoglobin was used to stimulate primary neuronal cells to simulate an in vitro subarachnoid hemorrhage model.The viability of primary neuronal cells treated with baicalein at concentrations of 5,15,25,50,and 100 μmol/L for 24 hours was detected by CCK-8 assay to determine the optimal concentration of baicalein.Primary neuronal cells were divided into control group,hemoglobin group,and hemoglobin+baicalein group.The levels of reactive oxygen species and malondialdehyde in cells were detected by kits.The mRNA expressions of ferroptosis-related markers PTGS2,SLC7A11,and glutathione peroxidase 4 were detected by RT-PCR.The primary neuronal cells were further divided into control group,SLC7A11 inhibitor Erastin group,hemoglobin group,hemoglobin+baicalein group,and hemoglobin+baicalein+Erastin group.The expression of the ferroptosis related markers SLC7A11 and glutathione peroxidase 4 was detected by western blot assay. RESULTS AND CONCLUSION:(1)Baicalein(25 μmol/L)was selected as the following experimental concentration.(2)Compared with the hemoglobin group,the level of malondialdehyde and the level of reactive oxygen species were significantly decreased(P<0.05)in the hemoglobin+baicalein group.(3)Compared with the hemoglobin group,the mRNA expression of PTGS2 significantly decreased,and the mRNA expression of SLC7A11 and glutathione peroxidase 4 significantly increased(P<0.000 1)in the hemoglobin+baicalein group.(4)SLC7A11 inhibitor Erastin could reverse the baicalin-improved ferroptosis effect to a certain extent(P<0.05).(5)The results showed that baicalein could alleviate the ferroptosis of neuronal cells after subarachnoid hemorrhage through the SLC7A11/GPX4 pathway.
4.Stress and morphological characteristics of intervertebral foramen of cervical rotation-traction manipulation for treating cervical spondylotic radiculopathy:a three-dimensional finite element analysis
Xu WANG ; Haimei WANG ; Songhao CHEN ; Tianxiao FENG ; Hanmei BU ; Liguo ZHU ; Duanduan CHEN ; Xu WEI
Chinese Journal of Tissue Engineering Research 2025;29(3):441-447
BACKGROUND:Cervical rotation-traction manipulation is effective and safe in the treatment of cervical spondylotic radiculopathy,and has been widely used in clinical work.However,its effects on the biomechanics of cervical vertebra and intervertebral disc and the area of intervertebral foramen have not been systematically clarified. OBJECTIVE:Based on the finite element analysis technique,a relevant research and analysis were carried out to provide digital evidence for the mechanism of effect of cervical rotation-traction manipulation in the treatment of cervical spondylotic radiculopathy. METHODS:The CT image data of a volunteer with no neck diseases were selected as the finite element model material at its left-handed physiological limit position.The initial construction of the finite element model was completed by Mimics 19.0 software,Geomagic Studio 2013 software,Hypermash 14.0 software,and ANSYS Workbench 2020 R2 software,respectively.Based on the literature,the grid division of cervical structure and the assignment of elastic modulus and elastic coefficient were completed.Based on the previous work of the team,the mechanical effects of cervical rotation-traction manipulation were simulated on the model.Effects of cervical rotation-traction manipulation on the mechanical parameters of each vertebral body and intervertebral disc in C3-T1 segment and on the cervical lateral foramen area were analyzed. RESULTS AND CONCLUSION:(1)During cervical rotation-traction manipulation,the stress of bone structure was significantly higher than that of soft tissue such as intervertebral disc.(2)When operating the technique,the stress at the top of each cervical vertebra was higher,the stress at the bottom was lower,and the stress at the facet joint and transverse process was lower.The stress at the top of the intervertebral disc was lower,the stress at the bottom was higher,but the highest point of the intervertebral disc stress was outside the top.(3)In addition,after loading the lifting force,the projected area of the C6/C7 intervertebral foramen increased significantly compared with that before loading.(4)It is indicated that the cervical rotation-traction manipulation has the mechanical characteristics of changing the stress structure of the cervical spine itself,and can expand the C6/7 intervertebral cervical foramen area on the opposite side of the patient's cervical rotation,so as to achieve the purpose of treating cervical spondylotic radiculopathy.
5.Analgesic effect of acupuncture in a rat model of lumbar disc herniation
Fang ZHI ; Manhua ZHU ; Wei XIONG ; Xingzhen LIN
Chinese Journal of Tissue Engineering Research 2025;29(5):936-941
BACKGROUND:Acupuncture is an effective method for lumbar pain in lumbar disc herniation,but its mechanism has not yet been clarified.Factors related to the JAK2/STAT3 signaling pathway regulate the body's inflammatory response and are involved in the process of neuropathic pain. OBJECTIVE:To study the mechanism of acupuncture on lumbar disc herniation in a rat model based on the JAK2/STAT3 signaling pathway. METHODS:Forty Sprague-Dawley rats were randomly divided into four groups:sham operation group,model group,acupuncture group,and acupuncture+agonist group,with 10 rats in each group.Animal models of L5 lumbar disc herniation was constructed through autologous disc cell transplantation in the model group,acupuncture group,and acupuncture+agonist group.Rats in the acupuncture group and the acupuncture+agonist group received acupuncture treatment(Yanglingquan,Shenshu,Huantiao,and Dachangshu acupoints)at 3 days after modeling,and acupuncture treatment was given once a day,20 minutes each,for 15 consecutive days.Rats in the acupuncture+agonist group were injected intrathecally with coumermycin A1,a JAK2 agonist,into the L4/L5 intervertebral space,once a day,20 minutes each,prior to the acupuncture at 6,12,and 18 days after modeling.Paw withdrawal mechanical threshold was detected before and 3,6,9,12,15,and 18 days after modeling.At 18 days after modeling,serum inflammatory factor levels were detected,hematoxylin-eosin staining was performed to observe the morphology of L5-L6 tissues,RT-PCR was performed to detect the expression of JAK2 and STAT3 mRNAs in L5-L6 tissues,and western blot was performed to detect the expression of JAK2,p-JAK2 and p-STAT3 proteins in L5-L6 tissues. RESULTS AND CONCLUSION:The paw withdrawal mechanical thresholds of rats in the model group at different time points after modeling were lower than those in the sham operation group(P<0.05),the paw withdrawal mechanical thresholds of rats in the acupuncture group were higher than those in the model group at 9,12,15,and 18 days after modeling(P<0.05),and the paw withdrawal mechanical thresholds of rats in the acupuncture+agonist group were lower than those in the acupuncture group at 9,12,15,and 18 days after modeling(P<0.05).The levels of interleukin 6,tumor necrosis factor α,neurotransmitter substance P,and brain neuropeptide Y were elevated in the model group compared with the sham operation group(P<0.05);the levels of all four inflammatory factors were reduced in the acupuncture group compared with the model group(P<0.05);and the levels of all four inflammatory factors were elevated in the acupuncture+agonist group compared with the acupuncture group(P<0.05).Hematoxylin-eosin staining showed that lumbar degeneration was obvious in the model group but reduced in the acupuncture group and the acupuncture+agonist group.Moreover,the reduction was more obvious in the acupuncture group compared with the acupuncture+agonist group.The JAK2 and STAT3 mRNA expression as well as the p-JAK2 and p-STAT3 protein expression were elevated in the model group compared with the sham operation group(P<0.05),were decreased in the acupuncture group compared with the model group(P<0.05),and were increased in the acupuncture+agonist group compared with the acupuncture group(P<0.05).To conclude,acupuncture can alleviate inflammation to exert analgesic effects in the rat model of lumbar disc herniation,and its mechanism of action may be related to the inhibition of the JAK2/STAT3 signaling pathway.
6.Mitophagy regulates bone metabolism
Hanmin ZHU ; Song WANG ; Wenlin XIAO ; Wenjing ZHANG ; Xi ZHOU ; Ye HE ; Wei LI
Chinese Journal of Tissue Engineering Research 2025;29(8):1676-1683
BACKGROUND:In recent years,numerous studies have shown that autophagy and mitophagy play an important role in the regulation of bone metabolism.Under non-physiological conditions,mitophagy breaks the balance of bone metabolism and triggers metabolism disorders,which affect osteoblasts,osteoclasts,osteocytes,chondrocytes,bone marrow mesenchymal stem cells,etc. OBJECTIVE:To summarize the mechanism of mitophagy in regulating bone metabolic diseases and its application in clinical treatment. METHODS:PubMed,Web of Science,CNKI,WanFang and VIP databases were searched by computer using the keywords of"mitophagy,bone metabolism,osteoblasts,osteoclasts,osteocytes,chondrocytes,bone marrow mesenchymal stem cells"in English and Chinese.The search time was from 2008 to 2023.According to the inclusion criteria,90 articles were finally included for review and analysis. RESULTS AND CONCLUSION:Mitophagy promotes the generation of osteoblasts through SIRT1,PINK1/Parkin,FOXO3 and PI3K signaling pathways,while inhibiting osteoclast function through PINK1/Parkin and SIRT1 signaling pathways.Mitophagy leads to bone loss by increasing calcium phosphate particles and tissue protein kinase K in bone tissue.Mitophagy improves the function of chondrocytes through PINK1/Parkin,PI3K/AKT/mTOR and AMPK signaling pathways.Modulation of mitophagy shows great potential in the treatment of bone diseases,but there are still some issues to be further explored,such as different stages of drug-activated mitophagy,and the regulatory mechanisms of different signaling pathways.
7.Over 20-year Follow-up Result of Total Knee Arthroplasty for Knee Arthropathy: A Single Center Cohort Study
Yiming XU ; Mingwei HU ; Wei ZHU ; Muyang YU ; Jin LIN ; Jin JIN ; Wenwei QIAN ; Bin FENG ; Xisheng WENG
Medical Journal of Peking Union Medical College Hospital 2025;16(1):35-41
To evaluate long-term survival and clinical outcomes of patients with knee osteo-arthritis undergoing total knee arthroplasty (TKA) through long-term follow-up. This study was based on a previous cohort study that had completed follow-up. We retrospectively collected clinical data of patients with knee arthropathy (including knee osteoarthritis and knee rheumatoid arthritis) who received the first TKA operation in Peking Union Medical College Hospital from 1993 to 2002 and were followed up for more than 20 years, and conducted a unified follow-up on them in November 10, 2024 (the last follow-up). Kaplan-Meier curve was used to evaluate the survival rate. Hospitals for special surgery (HSS) scores and joint range of motion (ROM) were compared before surgery, 10 years after surgery and at the last follow-up to evaluate the clinical efficacy of TKA. Likert scale was used to evaluate patient satisfaction at the last follow-up. A total of 226 patients (246 knees) received their first TKA in Peking Union Medical College Hospital from 1993 to 2002 and were followed up for more than 10 years. Among them, 104 patients (131 knees) were included in the study at the last follow-up, including 21 patients (24 knees) with prosthesis in place, 18 patients (18 knees) who underwent reoperation for various reasons, and 65 patients (89 knees) who died from non-TKA surgical causes. Up to the last follow-up, there were 29 patients (35 knees) with an average follow-up of more than 20 years, and 12 patients (16 knees) completed HSS score, ROM measurement and patient satisfaction evaluation. Kaplan-Meier curve showed that the 10-year, 15-year, 20-year, and 25-year survival rates were 93.6%, 92.4%, 89.8%, and 71.8%, respectively. The HSS score at the last follow-up was lower than that at 10- year postoperative follow-up[(84.69±11.03) scores TKA treatment for knee arthropathy has high long-term prosthesis survival rate, significant improvement of knee joint function and high patient satisfaction.
8.Early Postoperative Safety of Total Hip Arthroplasty in Systemic Lupus Erythematosus Patients
Xingdong YANG ; Muyang YU ; Yiming XU ; Wei ZHU ; Mingwei HU ; Xisheng WENG ; Bin FENG
Medical Journal of Peking Union Medical College Hospital 2025;16(1):42-49
To analyze the occurrence of early complications after total hip arthroplasty (THA) in patients with systemic lupus erythematosus (SLE). The data of patients who underwent THA at Peking Union Medical College Hospital from June 2012 to April 2024 were retrospectively and consecutively collected. The patients were categorized into SLE group and control group based on the presence or absence of SLE. Using propensity score matching, we matched patients in the two groups at a 1∶1 ratio according to gender, age, and surgical side. Subsequently, we compared the clinical characteristics, incidence of major complications within 30 days postoperatively, and allogeneic blood transfusion rates between the two groups. A total of 270 patients in the SLE group who met the inclusion and exclusion criteria were selected. Within 30 days postoperatively, 18 cases (6.67%) experienced major complications, including 2 cases (0.74%) of upper respiratory tract infection, 2 cases (0.74%) of pulmonary infection, 3 cases (1.11%) of urinary tract infection, 2 cases (0.74%) of other systemic infection, 5 cases (1.85%) of poor wound healing, 1 case (0.37%) of wound infection, 1 case (0.37%) of gastrointestinal complications, 1 cases (0.37%) of shock, and 1 case (0.37%) of SLE flare-up. The allogeneic blood transfusion rate was 22.59% (61/270). After propensity score matching, 163 cases from SLE and control groups were included for analysis. (1) Regarding medical complications, compared with control group, SLE group showed significant differences in osteoporosis, respiratory system disorders, gastrointestinal diseases, urinary system disorders, hematologic abnormalities, and secondary or concomitant rheumatic diseases (all The incidence of major complications within 30 days following THA in patients with SLE was significantly higher than that in non-SLE patients, while the rate of allogeneic blood transfusion remained comparable. To ensure the safety of THA surgery for patients with SLE, it is important to optimize the patient's condition and achieve stabilization prior to surgery. Additionally, strict perioperative management must be forced.
9.Epidemiological investigation of a maternal Listeria monocytogenes ST2 infection case
XU Wei ; LIN Yun ; ZHU Guoying ; SONG Hejia ; JIA Juanjuan ; SUN Yangming
Journal of Preventive Medicine 2025;37(2):189-191
Abstract
On September 26, 2024, a municipal hospital in Jiaxing City reported a maternal case of Listeria monocytogenes infection. In order to clarify the source of infection, the Jiaxing Center for Disease Control and Prevention immediately conducted the epidemiological investigation, laboratory testing and related disposal work. The case presented with fever (37.9 ℃), gradually intensifying paroxysmal abdominal pain without obvious cause, and went to hospital on the day of onset. Due to fetal intrauterine distress, a male infant was delivered by cesarean section on the same day. The epidemiological investigation identified that the case usually consumed fruits, often store fruits such as watermelon and grapes in the refrigerator alongside raw meat, and the refrigerator had never been cleaned or disinfected, posing a risk of cross contamination. Laboratory tests on amniotic fluid sample from the pregnant woman, infant blood sample showed positive results for Listeria monocytogenes infection. One strain of Listeria monocytogenes was detected in a smear sample from the inner wall of the refrigerator, and all the strains were ST2 type. Consuming fruits contaminated with Listeria monocytogenes may be the main source of infection. Food safety education for pregnant women and their family members should be strengthened to reduce the risk of infection.
10.Regulation of Signaling Pathways Related to Myocardial Infarction by Traditional Chinese Medicine: A Review
Wenjun WU ; Chidao ZHANG ; Jingjing WEI ; Xue LI ; Bin LI ; Xinlu WANG ; Mingjun ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):321-330
The pathological changes of myocardial infarction (MI) are mainly characterized by progressive myocardial ischemic necrosis, decline in cardiac diastolic function, thinning of the ventricular wall, and enlargement of the ventricles. The clinical manifestations include myocardial ischemia, heart failure, arrhythmia, shock, and even sudden cardiac death, rendering MI one of the most perilous cardiovascular diseases. Currently, the clinical treatment for MI primarily involves interventional procedures and drug therapy. However, due to their significant side effects and high complication rates associated with these treatments, they fail to ensure a satisfactory quality of life and long-term prognosis for patients. On the other hand, traditional Chinese medicine has demonstrated remarkable potential in improving patient prognosis while reducing side effects. Research has elucidated that various signaling pathways such as nuclear transcription factor-κB (NF-κB), adenosine 5̒-monophosphate-activated protein kinase (AMPK), transforming growth factor-β (TGF-β)/Smads, mitogen-activated protein kinase (MAPK), Wnt/β-catenin (β-catenin), and phosphatidylinositol 3-kinase (PI3K)/protein kinase B(Akt) play crucial roles in regulating the occurrence and development of MI. Effectively modulating these signaling pathways through its therapeutic interventions, traditional Chinese medicine can enhance MI management by inhibiting apoptosis, providing anti-inflammatory properties, alleviating oxidative stress levels, and resisting myocardial ischemia. Due to its notable efficacy and favorable safety, it has become an area of focus in clinical practice.


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