1.Clinical practice guidelines for perioperative multimodality treatment of non-small cell lung cancer.
Wenjie JIAO ; Liang ZHAO ; Jiandong MEI ; Jia ZHONG ; Yongfeng YU ; Nan BI ; Lan ZHANG ; Lvhua WANG ; Xiaolong FU ; Jie WANG ; Shun LU ; Lunxu LIU ; Shugeng GAO
Chinese Medical Journal 2025;138(21):2702-2721
BACKGROUND:
Lung cancer is currently the most prevalent malignancy and the leading cause of cancer deaths worldwide. Although the early stage non-small cell lung cancer (NSCLC) presents a relatively good prognosis, a considerable number of lung cancer cases are still detected and diagnosed at locally advanced or late stages. Surgical treatment combined with perioperative multimodality treatment is the mainstay of treatment for locally advanced NSCLC and has been shown to improve patient survival. Following the standard methods of neoadjuvant therapy, perioperative management, postoperative adjuvant therapy, and other therapeutic strategies are important for improving patients' prognosis and quality of life. However, controversies remain over the perioperative management of NSCLC and presently consensus and standardized guidelines are lacking for addressing critical clinical issues in multimodality treatment.
METHODS:
The working group consisted of 125 multidisciplinary experts from thoracic surgery, medical oncology, radiotherapy, epidemiology, and psychology. This guideline was developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The clinical questions were collected and selected based on preliminary open-ended questionnaires and subsequent discussions during the Guideline Working Group meetings. PubMed, Web of Science, Cochrane Library, Scopus, and China National Knowledge Infrastructure (CNKI) were searched for available evidence. The GRADE system was used to evaluate the quality of evidence and grade the strengths of recommendations. Finally, the recommendations were developed through a structured consensus-building process.
RESULTS:
The Guideline Development Group initially collected a total of 62 important clinical questions. After a series of consensus-building conferences, 24 clinical questions were identified and corresponding recommendations were ultimately developed, focusing on neoadjuvant therapy, perioperative management, adjuvant therapy, postoperative psychological rehabilitation, prognosis assement, and follow-up protocols for NSCLC.
CONCLUSIONS
This guideline puts forward reasonable recommendations focusing on neoadjuvant therapy, perioperative management, adjuvant therapy, postoperative psychological rehabilitation, prognosis assessment, and follow-up protocol of NSCLC. It standardizes perioperative multimodality treatment and provides guidance for clinical practice among thoracic surgeons, medical oncologists, and radiotherapists, aiming to reduce postoperative recurrence, improve patient survival, accelerate recovery, and minimize postoperative complications such as atelectasis.
Humans
;
Carcinoma, Non-Small-Cell Lung/therapy*
;
Lung Neoplasms/therapy*
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Combined Modality Therapy
;
Perioperative Care
2.Exploration of basket trial design with Bayesian method and its application value in traditional Chinese medicine.
Si-Cun WANG ; Mu-Zhi LI ; Hai-Xia DANG ; Hao GU ; Jun LIU ; Zhong WANG ; Ya-Nan YU
China Journal of Chinese Materia Medica 2025;50(3):846-852
Basket trial, as an innovative clinical trial design concept, marks the transformation of medical research from the traditional large-scale and single-disease treatment to the precise and individualized treatment. By gradually incorporating the Bayesian method during development, the trial design becomes more scientific and reasonable and increases its efficiency. The fundamental principle of the Bayesian method is the utilization of prior knowledge in conjunction with new observational data to dynamically update the posterior probability. This flexibility enhances the basket trial's capacity to effectively adapt to variations during the research process. Consequently, it enables researchers to dynamically adjust research strategies based on accumulated data and improve the predictive accuracy regarding treatment responses. In addition, the design concept of the basket trial aligns with the traditional Chinese medicine(TCM) principle of "homotherapy for heteropathy". The principle of "homotherapy for heteropathy" emphasizes that under certain conditions, different diseases may have the same treatment. Similarly, basket trials allow using a uniform trial design across multiple diseases, offering enhanced operational and significant practical value in the realm of TCM, particularly within the context of syndrome-based disease research. By introducing basket trials, the design of TCM clinical studies will be more scientific and yield higher-quality evidence. This study systematically categorized various Bayesian methods and models utilized in basket trials, evaluated their strengths and weaknesses, and identified their appropriate application contexts, so as to offer a practical guide for designing basket trials in the realm of TCM.
Bayes Theorem
;
Humans
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Medicine, Chinese Traditional/methods*
;
Research Design
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Clinical Trials as Topic/methods*
;
Drugs, Chinese Herbal/therapeutic use*
3.Research on software development and smart manufacturing platform incorporating near-infrared spectroscopy for measuring traditional Chinese medicine manufacturing process.
Yan-Fei WU ; Hui XU ; Kai-Yi WANG ; Hui-Min FENG ; Xiao-Yi LIU ; Nan LI ; Zhi-Jian ZHONG ; Ze-Xiu ZHANG ; Zhi-Sheng WU
China Journal of Chinese Materia Medica 2025;50(9):2324-2333
Process analytical technology(PAT) is a key means for digital transformation and upgrading of the traditional Chinese medicine(TCM) manufacturing process, serving as an important guarantee for consistent and controllable TCM product quality. Near-infrared(NIR) spectroscopy has become the core technology for measuring the TCM manufacturing process. By incorporating NIR spectroscopy into PAT and starting from the construction of a smart platform for the TCM manufacturing process, this paper systematically described the development history and innovative application of the combination of NIR spectroscopy with chemometrics in measuring the TCM manufacturing process by the research team over the past two decades. Additionally, it explored the application of a validation method based on accuracy profile(AP) in the practice of NIR spectroscopy. Furthermore, the software development progress driven by NIR spectroscopy supported by modeling technology was analyzed, and the prospect of integrating NIR spectroscopy in smart factory control platforms was exemplified with the construction practices of related platforms. By integrating with the smart platform, NIR spectroscopy could improve production efficiency and guarantee product quality. Finally, the prospect of the smart platform application in measuring the TCM manufacturing process was projected. It is believed that the software development for NIR spectroscopy and the smart manufacturing platform will provide strong technical support for TCM digitalization and industrialization.
Spectroscopy, Near-Infrared/methods*
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Drugs, Chinese Herbal/analysis*
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Software
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Medicine, Chinese Traditional
;
Quality Control
4.Correlation between differences in starch gelatinization, water distribution, and terpenoid content during steaming process of Curcuma kwangsiensis root tubers by multivariate statistical analysis.
Yan LIANG ; Meng-Na YANG ; Xiao-Li QIN ; Zhi-Yong ZHANG ; Zhong-Nan SU ; Hou-Kang CAO ; Ke-Feng ZHANG ; Ming-Wei WANG ; Bo LI ; Shuo LI
China Journal of Chinese Materia Medica 2025;50(10):2684-2694
To elucidate the mechanism by which steaming affects the quality of Curcuma kwangsiensis root tubers, methods such as LSCM, RVA, dual-wavelength spectrophotometry, LF-NMR, and LC-MS were employed to qualitatively and quantitatively detect changes in starch gelatinization characteristics, water distribution, and material composition of C. kwangsiensis root tubers under different steaming durations. Based on multivariate statistical analysis, the correlation between differences in gelatinization parameters, water distribution, and terpenoid material composition was investigated. The results indicate that steaming affects both starch gelatinization and water distribution in C. kwangsiensis. During the steaming process, transformations occur between amylose and amylopectin, as well as between semi-bound water and free water. After 60 min of steaming, starch gelatinization and water distribution reached an equilibrium state. The content of amylopectin, the amylose-to-amylopectin ratio, and parameters such as gelatinization temperature, viscosity, breakdown value, and setback value were significantly correlated(P≤0.05). Additionally, the amylose-to-amylopectin ratio was significantly correlated with total free water and total water content(P≤0.05). Steaming induced differences in the material composition of C. kwangsiensis root tubers. Clustering of primary metabolites in the OPLS-DA model was distinct, while secondary metabolites were classified into 9 clusters using the K-means clustering algorithm. Differential terpenoid metabolites such as(-)-α-curcumene were significantly correlated with zerumbone, retinal, and all-trans-retinoic acid(P<0.05). Curcumenol was significantly correlated with isoalantolactone and ursolic acid(P<0.05), while all-trans-retinoic acid was significantly correlated with both zerumbone and retinal(P<0.05). Alpha-tocotrienol exhibited a significant correlation with retinal and all-trans-retinoic acid(P<0.05). Amylose was extremely significantly correlated with(-)-α-curcumene, curcumenol, zerumbone, retinal, all-trans-retinoic acid, and α-tocotrienol(P<0.05). Amylopectin was significantly correlated with zerumbone(P<0.05) and extremely significantly correlated with(-)-α-curcumene, curcumenol, zerumbone, retinal, all-trans-retinoic acid, and 9-cis-retinoic acid(P<0.01). The results provide scientific evidence for elucidating the mechanism of quality formation of steamed C. kwangsiensis root tubers as a medicinal material.
Curcuma/chemistry*
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Starch/chemistry*
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Multivariate Analysis
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Water/chemistry*
;
Terpenes/analysis*
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Plant Roots/chemistry*
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Plant Tubers/chemistry*
;
Drugs, Chinese Herbal/chemistry*
5.Development and Initial Validation of the Multi-Dimensional Attention Rating Scale in Highly Educated Adults.
Xin-Yang ZHANG ; Karen SPRUYT ; Jia-Yue SI ; Lin-Lin ZHANG ; Ting-Ting WU ; Yan-Nan LIU ; Di-Ga GAN ; Yu-Xin HU ; Si-Yu LIU ; Teng GAO ; Yi ZHONG ; Yao GE ; Zhe LI ; Zi-Yan LIN ; Yan-Ping BAO ; Xue-Qin WANG ; Yu-Feng WANG ; Lin LU
Chinese Medical Sciences Journal 2025;40(2):100-110
OBJECTIVES:
To report the development, validation, and findings of the Multi-dimensional Attention Rating Scale (MARS), a self-report tool crafted to evaluate six-dimension attention levels.
METHODS:
The MARS was developed based on Classical Test Theory (CTT). Totally 202 highly educated healthy adult participants were recruited for reliability and validity tests. Reliability was measured using Cronbach's alpha and test-retest reliability. Structural validity was explored using principal component analysis. Criterion validity was analyzed by correlating MARS scores with the Toronto Hospital Alertness Test (THAT), the Attentional Control Scale (ACS), and the Attention Network Test (ANT).
RESULTS:
The MARS comprises 12 items spanning six distinct dimensions of attention: focused attention, sustained attention, shifting attention, selective attention, divided attention, and response inhibition.As assessed by six experts, the content validation index (CVI) was 0.95, the Cronbach's alpha for the MARS was 0.78, and the test-retest reliability was 0.81. Four factors were identified (cumulative variance contribution rate 68.79%). The total score of MARS was correlated positively with THAT (r = 0.60, P < 0.01) and ACS (r = 0.78, P < 0.01) and negatively with ANT's reaction time for alerting (r = -0.31, P = 0.049).
CONCLUSIONS
The MARS can reliably and validly assess six-dimension attention levels in real-world settings and is expected to be a new tool for assessing multi-dimensional attention impairments in different mental disorders.
Humans
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Adult
;
Male
;
Attention/physiology*
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Female
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Middle Aged
;
Reproducibility of Results
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Young Adult
;
Psychometrics
6.Case Analysis of MYH9 Related Disease with Non-Hodgkin Lymphoma Caused by Rare Mutations.
Xue-Ting KONG ; Dan-Yu WANG ; Ze-Lin LIU ; Zhao-Gui ZHOU ; Nan ZHONG ; Lei LIU ; Meng-Di JIN ; Hai-Yan CUI
Journal of Experimental Hematology 2025;33(4):1145-1149
OBJECTIVE:
To analyze the MYH9 gene sequence of a patient with hereditary thrombocytopenia and diffuse large B-cell lymphoma and his family members, and to explore the relationship between MYH9 gene and tumors.
METHODS:
Peripheral blood samples were collected from the patients and their family members for complete blood count analysis. The platelet morphology was observed under microscope. The MYH9 gene sequence was analyzed by Whole Exon Sequencing and Sanger Sequencing.
RESULTS:
The mutation site c.279C>A:p.(Asn93Lys) in exon 2 of the MYH9 gene were found in patient and his family members, both presenting as thrombocytopenia. The platelet count was significantly increased after the administration of Avatrombopag.
CONCLUSION
A novel mutation of MYH9 was found in this study, and the case was sensitive to Avatrombopag, by exploring the relationship between the MYH9 gene and tumors, suggesting that the MYH9 gene may be associated with the development of diffuse large B-cell lymphoma.
Humans
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Myosin Heavy Chains/genetics*
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Thrombocytopenia/genetics*
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Mutation
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Male
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Lymphoma, Non-Hodgkin/genetics*
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Lymphoma, Large B-Cell, Diffuse/genetics*
;
Molecular Motor Proteins/genetics*
;
Pedigree
7.Prevotella nigrescens exacerbates periodontal inflammation and impairs cognitive function in mice.
Qi CHEN ; Tiantian XIA ; Yongqiang ZHOU ; Mingyang CHANG ; Nan HU ; Yanmei YANG ; Zhong LI ; Yue GAO ; Bin GU
Journal of Southern Medical University 2025;45(3):453-460
OBJECTIVES:
To investigate the effects of periodontitis induced by Prevotella nigrescens (Pn) combined with ligation on cognitive functions in mice.
METHODS:
Twenty-four C57BL/6J mice were randomly divided into control group, ligation group, and ligation + Pn treatment (P+Pn) group. Experimental periodontitis was induced by silk ligation of the first molars followed by topical application of Pn for 6 weeks. After modeling, alveolar bone resorption was assessed using micro-CT and histological analysis. Learning and memory abilities of the mice were evaluated using open field test (OFT), novel object recognition test (NORT), and Morris water maze test (MWM). Seven weeks after the start of modeling, the mice were sacrificed for examining histopathological changes in the hippocampus using HE and Nissl staining.
RESULTS:
After 6 weeks of molar ligation, micro-CT revealed horizontal alveolar bone resorption and furcation exposure in the mice, and histological analysis showed apical migration of the junctional epithelium, epithelial ridge hyperplasia, and lymphocyte infiltration, and these changes were obviously worsened in P+Pn group. Alveolar bone height decreased significantly in both ligation groups compared to the control group. Cognitive tests showed that the mice in both of the ligation groups traveled shorter distances in OFT, showed reduced novel object preference in NORT, and exhibited longer escape latencies in MWM, and the mice in P+Pn group had significantly poorer performances in the tests. Histologically, obvious neuronal cytoplasmic degeneration, necrosis, nuclear pyknosis, vacuolation, and reduced Nissl bodies and viable neurons were observed in the hippocampal regions of the mice in the two ligation groups.
CONCLUSIONS
Pn infection aggravates alveolar bone destruction, accelerates necrosis and causes morphological abnormalities of neuronal cells in the hippocampus to reduce cognitive functions of mice with periodontitis.
Animals
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Periodontitis/microbiology*
;
Mice
;
Mice, Inbred C57BL
;
Cognition
;
Alveolar Bone Loss
;
Hippocampus/pathology*
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Male
;
Inflammation
;
Maze Learning
8.Value of alkaline phosphatase level after ursodeoxycholic acid treatment for one month and baseline red blood cell distribution width in predicting the treatment response of primary biliary cholangitis
Nan WANG ; Rong HU ; Shihui BIAN ; Wei ZHONG ; Pengfei ZHANG ; Youwen TAN
Journal of Clinical Hepatology 2024;40(3):496-501
ObjectiveTo investigate the value of baseline red cell distribution width (RDW) and alkaline phosphatase (ALP) level after ursodeoxycholic acid (UDCA) treatment for one month in predicting the response to UDCA treatment in patients with primary biliary cholangitis (PBC). MethodsA retrospective analysis was performed for the data of 127 patients with PBC who were diagnosed in Department of Hepatology, The Third People’s Hospital of Jiangsu University, from January 2015 to July 2022, with data collected at baseline, after one month of treatment, and after one year of follow-up. Based on the Paris-I criteria, the patients were divided into good response group and poor response group, and the two groups were analyzed in terms of clinical and laboratory features and their association with response to UDCA. The Logistic regression method was used to investigate the independent risk factors for response to UDCA treatment. The area under the ROC curve (AUC) was used to determine the optimal cut-off values of related indicators; the patients were divided into two groups based on such values, and the two groups were compared in terms of baseline indicators and response. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. ResultsCompared with the good response group, the poor response group had significantly higher levels of total bilirubin, aspartate aminotransferase/alanine aminotransferase, ALP, RDW, and RDW-CV at baseline and a significantly higher level of ALP after one month of UDCA treatment (Z=-4.792, -3.697, -2.399, -4.102, -3.220, and -4.236, all P<0.05). Compared with the good response group, the poor response group had significantly lower levels of albumin, hemoglobin, lymphocytes, hematocrit, and body mass index at baseline (Z=-3.592, -3.603, -2.602, -3.829, -2.432, all P<0.05), as well as significantly lower levels of prealbumin, albumin/globulin ratio, apolipoprotein A, and free triiodothyronine at baseline (t=4.530, 3.402, 3.485, and 3.639, all P<0.001). Compared with the poor response group, the good response group had a significantly lower proportion of patients with liver cirrhosis, gallstones/cholecystitis, or anemia (χ2=20.815, 3.892, and 12.283, all P<0.05). Baseline RDW (odds ratio [OR]=1.157, 95% confidence interval [CI]: 1.028 — 1.301, P=0.015) and ALP level after one month of treatment (OR=1.012, 95%CI: 1.005 — 1.020, P=0.002) were independent risk factors for response to UDCA, with an AUC of 0.713 and 0.720, respectively. The patients with baseline RDW≥upper limit of normal (ULN) and ALP≥2.2×ULN after one month of UDCA treatment had a lower UDCA response rate (42.6% vs 8.2%, χ2=20.813, P<0.001). ConclusionPatients with baseline RDW≥ULN and ALP≥2.2×ULN after one month of UDCA treatment tend to have a low biochemical response rate to UDCA.
9.The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation
Rui YUAN ; Yun-ping QU ; Yan WANG ; Ya-xuan ZHANG ; Wan-ling ZHONG ; Xiao-yu FAN ; Hui-juan SHEN ; Yun-nan MA ; Jin-hong YE ; Jie BAI ; Shou-ying DU
Acta Pharmaceutica Sinica 2024;59(8):2404-2411
This experiment aims to study the taste-masking effects of different kinds of corrigent used individually and in combination on ibuprofen oral solution, in order to optimize the taste-masking formulation. Firstly, a wide range of corrigent and the mass fractions were extensively screened using electronic tongue technology. Subsequently, a combination of sensory evaluation, analytic hierarchy process (AHP)-fuzzy mathematics evaluation, and Box-Behnken experimental design were employed to comprehensively assess the taste-masking effects of different combinations of corrigent on ibuprofen oral solution, optimize the taste-masking formulation, and validate the results. The study received ethical approval from the Review Committee of the Beijing University of Chinese Medicine (ethical code: 2024BZYLL0102). The results showed that corrigent fractions and types were screened separately through single-factor experiments. Subsequently, a Box-Behnken response surface design combined with AHP and fuzzy mathematics evaluation was used to fit a functional model:
10.In vitro oral simulation evaluation of palatability and chewability of chewable tablets
Aonan ZHONG ; Conghui LI ; Zengming WANG ; Xiaolu HAN ; Hui ZHANG ; Nan LIU ; He ZHANG ; Jintao LIN ; Chunyan LIU ; Aiping ZHENG
China Pharmacy 2024;35(14):1708-1714
OBJECTIVE To evaluate the palatability and chewability of chewable tablets, and provide reference for the quality evaluation of various types of chewable tablets. METHODS Using self-made Glucosamine hydrochloride chewable tablets as the model drug, the quality test was conducted. The in vitro simulation system for chewable tablets was established by using a texture analyzer and rheometer, and an oral simulation experiment was conducted on chewable tablets. The texture analyzer was used to measure the force required for chewing and simulate the static disintegration process of chewable tablets; the rheometer was adopted to measure the viscoelasticity, thixotropy, and deformability of chewable tablets during the chewing process. RESULTS The disintegration time limit, principal component content, and dissolution of self-made Glucosamine hydrochloride chewable tablets all met the limit requirements. The in vitro simulation results of the texture analyzer showed that self-made chewable tablets were easy to chew in both axial and radial directions, and the force required for chewing was within the range of the chewing force of the teeth; chewable tablets could disintegrate at an appropriate time without being chewed and only taken in the oral cavity. The in vitro simulation results of the rheometer showed that the chewable tablets in the oral cavity exhibited a behavior of elasticity as the main factor and viscosity as the secondary factor through the continuous stirring of the tongue, and the viscosity of the chewable tablets gradually decreased with tongue stirring or tooth chewing; when chewing with teeth, the internal force of the chewing tablets decreased, causing plastic deformation and crushing. After being crushed, the shape couldn’t be restored, making it easy to chew and swallow. CONCLUSIONS The combination of texture analyzer and rheometer can be used to simulate the oral chewing process and evaluate the palatability and chewability of self-made Glucosamine hydrochloride chewable tablets. This model can provide reference for the evaluation of various chewable tablets.

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