1.Da Chaihutang for Treatment of Sepsis with Yang Syndrome:A Randomized Controlled Trial
Na HUANG ; Guangmei CHEN ; Xingyu KAO ; Zhen YANG ; Weixian XU ; Kang YUAN ; Junna LEI ; Jingli CHEN ; Mingfeng HE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):55-63
ObjectiveTo explore the clinical efficacy and safety of Da Chaihutang (DCH) for the treatment of sepsis with Yang syndrome. MethodsA total of 70 patients suffering from sepsis with Yang syndrome were randomly divided into an observation group and a control group, with 35 cases in each group. They both received standard Western medicine treatment. The observation group was additionally given a dose of DCH, which was boiled into 100 mL and taken twice. The control group was additionally given an equal volume and dosage of warm water. The intervention lasted for three days. The 28-day all-cause mortality and the changes in the following indicators before and after intervention were compared between the two groups, including sequential organ failure assessment (SOFA), acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score,white blood cell (WBC),the percentage of neutrophils (NEU%),C-reactive protein (CRP),procalcitonin (PCT),alanine transaminase (ALT),aspartate transaminase (AST),total bilirubin (TBil),creatinine (Cr),blood urea nitrogen (BUN),acute gastrointestinal injury (AGI) grade,gastrointestinal dysfunction score (GDS),serum intestinal fatty acid-binding protein (iFABP), citrulline (CR),platelet (PLT),prothrombin time(PT),activated partial thromboplastin time (APTT),fibrinogen (Fib),international normalized ratio (INR),and D-dimer (D-D). ResultsThere was no significant difference between the two groups regarding 28-day all-cause mortality. After the intervention,SOFA,WBC,PCT,and Cr were significantly decreased, and PLT was significantly increased in the control group (P<0.05). SOFA,APACHE Ⅱ,NEU%,CRP,PCT,ALT,AST,Cr,BUN,AGI grade,GDS,and serum iFABP and CR were significantly improved in the observation group (P<0.05). After the intervention,APACHE Ⅱ,PCT,AGI grade,GDS,and serum iFABP in the observation group were significantly lower than those in the control group ,while CR and PLT were higher (P<0.05,P<0.01). There were significant differences regarding the gap of SOFA,APACHE Ⅱ,AST,TBil,AGI grade,GDS,iFABP,CR, and PLT between the two groups (P<0.05,P<0.01). There were slight differences regarding PT,APTT,Fib,INR,and D-D between the two groups,which were in the clinical normal range. ConclusionOn the basis of Western medicine, DCH helped to reduce sepsis severity and improved multiple organ dysfunction with high clinical efficacy and safety, but further research on its impact on the prognosis of patients with sepsis is still required.
2.Construction and Verification of An Integrated Traditional Chinese and Western Medicine Model for Predicting Malignant Risk of Pulmonary Nodules
Qian YANG ; Jingmin XIAO ; Yuanbing CHEN ; Lei WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):129-139
ObjectiveThis study explored the risk factors for malignant risks of pulmonary nodules based on clinical data,constructed an integrated traditional Chinese and Western medicine model for predicting malignant risks of pulmonary nodules, and visualized the prediction results by using a nomogram. MethodsBased on a cross-sectional survey study design,patients with pulmonary nodules who were hospitalized in the Department of Respiratory and Cardiothoracic Surgery of Guangdong Provincial Hospital of Traditional Chinese Medicine from April 2023 to January 2024 were included. The dataset was randomly divided into a training set and a validation set according to 7∶3. In the training set,predictive factors were selected through univariate Logistic regression analysis and Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis,and Logistic regression models were built. The discriminative ability,calibration,and clinical decision-making curves of the Western medicine model and the integrated traditional Chinese and Western medicine prediction model were compared to select the optimal model,which was then visualized in a nomogram. ResultsThis study included a total of 366 patients,and they were divided into a training set (258 cases) and a validation set (108 cases). Seven predictive factors were considered including age,preference for fatty and greasy foods,history of environmental or occupational exposure,Qi deficiency,Yang deficiency,nodule density,and nodule diameter. A Logistic regression model was constructed. A Western medicine model,defined as model1,was created using only age,history of environmental or occupational exposure,nodule density,and nodule diameter as predictive factors. In addition,an integrated traditional Chinese and Western medicine model,defined as model2,was created by adding preference for fatty and greasy foods, Qi deficiency,and Yang deficiency as predictive factors. Model2 demonstrated better predictive performance in both the training and validation sets. Its accuracy in training set was 0.740,with precision of 0.825, recall of 0.829, F1 score of 0.827, the area under the curve (AUC)of 0.865 (95% confidence interval (CI):0.815-0.915), and a Brier score of 0.122. The accuracy in validation set was 0.731, with precision of 0.776, recall of 0.831, F1 score of 0.803, AUC of 0.852 (95%CI:0.776-0.927), and a Brier score of 0.149. The calibration curve and decision-making curve analysis showed that this model exhibited good consistency and clinical utility in prediction. The equation for the malignant probability of pulmonary nodules was defined as p=
3.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.
4.The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; LUI Yanming ; YUAN Yaozuo ; CHEN Ying ; DAI Hong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):051-057
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, and the total number has reached 387. 245 pharmaceutical excipients monographs have been revised, of which 109 monographs have only textual revisions and 136 monographs have substantive revisions. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
5.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
6.The introduction on standards system of the pharmaceutical packaging materials in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; YU Hui ; WANG Yan ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):067-076
The standard of Pharmaceutical packaging materials is an important part of the Chinese Pharmacopoeia. This article focuses on working background, general idea, working process, main framework, and its role and significance of the pharmaceutical packaging materials standards system in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia 2025 Edition.
7.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; WANG Lin ; ZHANG Gongchen ; MA Shihong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):077-082
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the standards system of Water for Pharmaceutical Purposes has been perfected. This article focuses on the Work Background, Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
8.Application of "balance-shaped sternal elevation device" in the subxiphoid uniportal video-assisted thoracoscopic surgery for anterior mediastinal masses resection
Jinlan ZHAO ; Weiyang CHEN ; Chunmei HE ; Yu XIONG ; Lei WANG ; Jie LI ; Lin LIN ; Yushang YANG ; Lin MA ; Longqi CHEN ; Dong TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):308-312
Objective To introduce an innovative technique, the "balance-shaped sternal elevation device" and its application in the subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for anterior mediastinal masses resection. Methods Patients who underwent single-port thoracoscopic assisted anterior mediastinal tumor resection through the xiphoid process at the Department of Thoracic Surgery, West China Hospital, Sichuan University from May to June 2024 were included, and their clinical data were analyzed. Results A total of 7 patients were included, with 3 males and 4 females, aged 28-72 years. The diameter of the tumor was 1.9-17.0 cm. The operation time was 62-308 min, intraoperative blood loss was 5-100 mL, postoperative chest drainage tube retention time was 0-9 days, pain score on the 7th day after surgery was 0-2 points, and postoperative hospital stay was 3-12 days. All patients underwent successful and complete resection of the masses and thymus, with favorable postoperative recovery. Conclusion The "balance-shaped sternal elevation device" effectively expands the retrosternal space, providing surgeons with satisfactory surgical views and operating space. This technique significantly enhances the efficacy and safety of minimally invasive surgery for anterior mediastinal masses, reduces trauma and postoperative pain, and accelerates patient recovery, demonstrating important clinical significance and application value.
9.Exploring Vascular Recruitment in Tracheobronchial Adenoid Cystic Carcinoma from Perspective of Abnormal Collateral
Jun TENG ; Lei LI ; Junyan XIA ; Yi LUO ; Qinyan HONG ; Shuiping CHEN ; Hongwu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):260-269
Tracheobronchial adenoid cystic carcinoma (TACC) is a low-grade malignant tumor originating from the airway mucosa. Despite its slow progression,it is characterized by high invasiveness,frequent recurrence,and a strong tendency for metastasis. Preclinical studies have shown that vascular-targeted therapy holds significant potential. However,an effective systemic treatment for TACC has not been established yet. This study explored TACC from the perspective of "Feiji" in traditional Chinese medicine (TCM) as the starting point. It deeply investigated the mechanisms of abnormal collaterals and tumor vascular recruitment and further elaborated on the theoretical connection between abnormal collaterals and tumor vascular recruitment. Firstly,collateral hyperactivity led to disordered and erratic pulmonary collaterals. Their abnormal structures were similar to the disorderly and tortuous nature of tumor (pseudo)angiogenesis. This resulted in imbalances in the functions of circulation,perfusion,and reverse injection of the pulmonary collaterals,and then led to unrestrained collateral dysfunction and the accumulation of pathogenic factors. Secondly,the remodeling of the extracellular matrix (ECM) and epithelial-mesenchymal transition (EMT) in TACC were critical processes in vascular co-option (VCO),representing the micro-level manifestation of the displacement of nutrient and defense. During this process,ECM remodeling made TACC cells more likely to hijack normal blood vessels,creating a complex vascular microenvironment conducive to tumor growth. In terms of treatment,this study proposed a TCM strategy of "regulating collaterals to expel pathogenic factors and nourishing collaterals to strengthen the healthy Qi",and listed potential TCM. These were intended to regulate the Qi and blood in the collaterals,repair the functions of abnormal collaterals,and intervene in the vascular recruitment process of TACC. Future research should focus on improving the TCM clinical syndrome characteristics of TACC. Through modern molecular biology techniques,it is necessary to deeply analyze the micro-level pattern of vascular recruitment in TACC. This would enrich the understanding of the profound connection between abnormal collaterals and tumor vascular recruitment,providing empirical evidence for TCM-targeted therapies for vascular recruitment in TACC.
10.Effects of serum containing Sanchong tongluo sanjie formula on the proliferation and apoptosis of Lewis lung cancer cells and its mechanism
Yang LI ; Lei CHEN ; Qiachun ZHANG ; Jing ZHANG ; Jingyu FENG ; Qi LIANG
China Pharmacy 2025;36(4):440-446
OBJECTIVE To study the effects of Sanchong tongluo sanjie formula on the proliferation and apoptosis of Lewis lung cancer cells. METHODS The rats were given Sanchong tongluo sanjie formula powder [0.946 g/(kg·d)], Sanchong tongluo sanjie formula decoction [2.730 g/(kg·d)], and normal saline intragastrically, and injected with Cisplatin injection (4.2 mg/kg) intra-peritoneally to prepare powder-containing serum, decoction-containing serum, positive control serum and negative control serum. Lewis lung cancer cells were divided into negative control serum group, positive control serum group, and 5%, 10%, 20% drug-containing serum groups. The cell proliferation inhibition rates at 24, 48, and 72 hours post- intervention were measured to screen the optimal intervention concentrations of powder-containing serum and decoction-containing serum. The cell invasion ability, metastasis ability and apoptotic rate were detected in the negative control serum group, positive control serum group, 20% powder-containing serum group, and 20% decoction-containing serum group. Protein expressions of vascular endothelial growth factor (VEGF), hypoxia-inducible factor-1α (HIF-1α), prolyl hydroxylase-2 (PHD2), matrix metalloproteinase-2 (MMP-2), extracellular regulated protein kinases (ERK),c-Jun N-terminal kinase (JNK) and p38 mitogen-activated protein kinase (p38 MAPK) were detected. RESULTS The cell proliferation inhibition rates for both the 20% powder-containing serum group and the 20% decoction-containing serum group, when intervened for 48 hours, were not less than 50%. Compared with negative control serum group, the number of invasive Lewis lung cancer cells and migration distance were decreased significantly, while the apoptotic rate was increased significantly (P<0.05); the apoptotic rate in the 20% powder- containing serum group was significantly higher than 20% decoction-containing serum group (P<0.05). The protein expressions of PHD2 and p38 MAPK were increased significantly in the 20% powder-containing serum group (P<0.05), while the protein expression of HIF-1α was decreased significantly in the 20% decoction-containing serum group (P<0.05). CONCLUSIONS Sanchong tongluo sanjie formula can inhibit the proliferation, invasion and metastasis of Lewis lung cancer cells while promoting their apoptosis. The mechanism of action may be related to regulating the PHD2/HIF-1α signaling pathway. Furthermore, the powder demonstrates superior efficacy compared to the decoction, suggesting that they may possess different mechanisms of action.

Result Analysis
Print
Save
E-mail