1.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
2.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
3.Clinical application value of low-dose scan combined with deep learning reconstruction in CT on chest of overweight or obese patient
Xiujing AN ; Zhe WU ; Chao JIANG ; Ning LI ; Jubing WAN ; Sen WANG ; Dongyao LI ; Lufeng TIAN
China Medical Equipment 2025;22(3):37-42
Objective:To explore the feasibility of using low-dose computed tomography(LDCT)with deep learning reconstruction(DLR)on the chest for the screening of lung nodules,and to compare the image quality and detection rate of nodules between LDCT and routine dose CT(RDCT)-DLR.Methods:A total of 104 overweight or obese patients[body mass index(BMI)≥25 kg/m2]who received CT examination on chest due to pulmonary nodule screening from September to December 2023 were included to conduct prospective study.All patients underwent respectively RDCT(120 kV)and LDCT(100 kV)scans,all of the two scans used the modulation of automatic tube current,and adopted deep learning AI algorithm ClearInfinity to conduct reconstruction(RDCT:CI 40%,LDCT:CI 50%).Radiation dose and nodules number of them were recorded.At the T8 vertebral level,CT values(Hounsfield Units,HU)of mediastinal fat and lung parenchyma in the right lower lobe were measured,along with image noise(standard deviation,SD).The signal-to-noise ratio(SNR)and contrast-to-noise ratio(CNR)were subsequently calculated.Two radiologists independently performed subjective evaluations of image quality and pulmonary nodules using a Likert 4-point scale.Paired t-tests or Wilcoxon rank-sum test were employed to compare differences in radiation dose,objective image noise,and subjective scores between LDCT and RDCT.Results:A total of 104 patients were enrolled,including 54 males and 50 females,with a mean age of 52±13 years and a BMI of(27.77±2.64)kg/m2.The effective radiation dose of LDCT demonstrated a statistically significant reduction compared to RDCT(Z=-8.853,P<0.001),with a mean effective radiation dose reduction of 77.86%.The differences in lung CT value,lung noise,fat noise,lung parenchyma SNR,fat SNR and CNR of images between two groups were significant(Z=-3.022,-2.327,-4.785,-2.059,-3.765,-4.013,P<0.05),while there were not significant differences in the comparisons for fat CT value and lung parenchyma SNR(P>0.05).The image contrast,image noise,and subjective score for image quality of lung nodule of LDCT were lower than those of RDCT(t=2.877,2.387,5.096,P<0.05),but all subjective scores of that were>3,which can meet the requirements of clinical diagnosis.In terms of nodule detection,RDCT found out about 418 nodules,while LDCT found out about 421,the false positive rate of LDCT only was 0.72%.Conclusion:In overweight or obese patients,LDCT that combined with DLR algorithm on chest is equivalent to RDCT on image quality and the detection rate of lung nodule,and it significantly reduce radiation exposure on patients at the same time.
4.Root causes of quality changes in cultivated Chinese materia medica and countermeasures for high-quality production.
Chao-Geng LYU ; Chuan-Zhi KANG ; Ya-Li HE ; Zhi-Lai ZHAN ; Sheng WANG ; Xiu-Fu WAN ; Lan-Ping GUO
China Journal of Chinese Materia Medica 2025;50(13):3529-3535
In order to support the implementation of the Opinions on Improving the Quality of Traditional Chinese Medicine and Promoting the High-Quality Development of the Traditional Chinese Medicine Industry and fundamentally promote the high-quality development of Chinese materia medica(CMM) industry, this article analyzed the quality and safety issues arising during the transition of CMM from wild harvesting to cultivation. Root causes of these issues were identified, including changes in the habitats of medicinal plants caused by inappropriate field cultivation patterns, excessive use of chemical inputs such as fertilizers and pesticides, and shortened cultivation periods due to rising economic costs. To address the above issues, the following countermeasures and suggestions were proposed to advance the high-quality development of CMM:(1) comprehensively adjust the cultivation patterns, vigorously promote ecological cultivation of CMM, and ensure production quality and safety of CMM from the source;(2) strengthen the breeding of high-quality, stress-resistant CMM varieties, improve cultivation techniques to reduce the use of fertilizers and pesticides, and improve the quality and efficiency of ecological cultivation of CMM;(3) systematically design the production, operation, and supervision models for ecological cultivation of CMM, carry out demonstrations of "high quality with fair price", and ensure the sustainable development of ecological cultivation of CMM.
Drugs, Chinese Herbal/standards*
;
Quality Control
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Plants, Medicinal/chemistry*
;
Plant Roots/chemistry*
;
China
;
Fertilizers/analysis*
;
Materia Medica/standards*
;
Medicine, Chinese Traditional/standards*
5.Molecular targeted therapy for progressive low-grade gliomas in children.
Yan-Ling SUN ; Miao LI ; Jing-Jing LIU ; Wen-Chao GAO ; Yue-Fang WU ; Lu-Lu WAN ; Si-Qi REN ; Shu-Xu DU ; Wan-Shui WU ; Li-Ming SUN
Chinese Journal of Contemporary Pediatrics 2025;27(6):682-689
OBJECTIVES:
To evaluate the efficacy of molecular targeted agents in children with progressive pediatric low-grade gliomas (pLGG).
METHODS:
A retrospective analysis was conducted on pLGG patients treated with oral targeted therapies at the Department of Pediatrics, Beijing Shijitan Hospital, Capital Medical University, from July 2021. Treatment responses and safety profiles were assessed.
RESULTS:
Among the 20 enrolled patients, the trametinib group (n=12, including 11 cases with BRAF fusions and 1 case with BRAF V600E mutation) demonstrated 4 partial responses (33%) and 2 minor responses (17%), with a median time to response of 3.0 months. In the vemurafenib group (n=6, all with BRAF V600E mutation), 5 patients achieved partial responses (83%), showing a median time to response of 1.0 month. Comparative analysis revealed no statistically significant difference in progression-free survival rates between the two treatment groups (P>0.05). The median duration of clinical benefit (defined as partial response + minor response + stable disease) was 11.0 months for vemurafenib and 18.0 months for trametinib. Two additional cases, one with ATM mutation treated with olaparib for 24 months and one with NF1 mutation receiving everolimus for 21 months, discontinued treatment due to sustained disease stability. No severe adverse events were observed in any treatment group.
CONCLUSIONS
Molecular targeted therapy demonstrates clinical efficacy with favorable tolerability in pLGG. Vemurafenib achieves high response rates and induces early tumor shrinkage in patients with BRAF V600E mutations, supporting its utility as a first-line therapy.
Humans
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Glioma/genetics*
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Male
;
Female
;
Child
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Child, Preschool
;
Retrospective Studies
;
Brain Neoplasms/genetics*
;
Molecular Targeted Therapy/adverse effects*
;
Adolescent
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Infant
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Proto-Oncogene Proteins B-raf/genetics*
;
Pyrimidinones/therapeutic use*
;
Mutation
6.A Study of Flow Sorting Lymphocyte Subsets to Detect Epstein-Barr Virus Reactivation in Patients with Hematological Malignancies.
Hui-Ying LI ; Shen-Hao LIU ; Fang-Tong LIU ; Kai-Wen TAN ; Zi-Hao WANG ; Han-Yu CAO ; Si-Man HUANG ; Chao-Ling WAN ; Hai-Ping DAI ; Sheng-Li XUE ; Lian BAI
Journal of Experimental Hematology 2025;33(5):1468-1475
OBJECTIVE:
To analyze the Epstein-Barr virus (EBV) load in different lymphocyte subsets, as well as clinical characteristics and outcomes in patients with hematologic malignancies experiencing EBV reactivation.
METHODS:
Peripheral blood samples from patients were collected. B, T, and NK cells were isolated sorting with magnetic beads by flow cytometry. The EBV load in each subset was quantitated by real-time quantitative polymerase chain reaction (RT-qPCR). Clinical data were colleted from electronic medical records. Survival status was followed up through outpatient visits and telephone calls. Statistical analyses were performed using SPSS 25.0.
RESULTS:
A total of 39 patients with hematologic malignancies were included, among whom 35 patients had undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). The median time to EBV reactivation was 4.8 months (range: 1.7-57.1 months) after allo-HSCT. EBV was detected in B, T, and NK cells in 20 patients, in B and T cells in 11 patients, and only in B cells in 4 patients. In the 35 patients, the median EBV load in B cells was 2.19×104 copies/ml, significantly higher than that in T cells (4.00×103 copies/ml, P <0.01) and NK cells (2.85×102 copies/ml, P <0.01). Rituximab (RTX) was administered for 32 patients, resulting in EBV negativity in 32 patients with a median time of 8 days (range: 2-39 days). Post-treatment analysis of 13 patients showed EBV were all negative in B, T, and NK cells. In the four non-transplant patients, the median time to EBV reactivation was 35 days (range: 1-328 days) after diagnosis of the primary disease. EBV was detected in one or two subsets of B, T, or NK cells, but not simultaneously in all three subsets. These patients received a combination chemotherapy targeting at the primary disease, with 3 patients achieving EBV negativity, and the median time to be negative was 40 days (range: 13-75 days).
CONCLUSION
In hematologic malignancy patients after allo-HSCT, EBV reactivation commonly involves B, T, and NK cells, with a significantly higher viral load in B cells compared to T and NK cells. Rituximab is effective for EBV clearance. In non-transplant patients, EBV reactivation is restricted to one or two lymphocyte subsets, and clearance is slower, highlighting the need for prompt anti-tumor therapy.
Humans
;
Hematologic Neoplasms/virology*
;
Herpesvirus 4, Human/physiology*
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Epstein-Barr Virus Infections
;
Hematopoietic Stem Cell Transplantation
;
Virus Activation
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Lymphocyte Subsets/virology*
;
Flow Cytometry
;
Killer Cells, Natural/virology*
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Male
;
Female
;
B-Lymphocytes/virology*
;
Viral Load
;
Adult
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T-Lymphocytes/virology*
;
Middle Aged
7.Comparison of setup errors between two postural fixation methods in radiotherapy for breast cancer
Fukui HUAN ; Yu ZHAO ; Chao LIU ; Gengqiang ZHU ; Ruiao ZHAO ; Yongtai ZHENG ; Yandong GE ; Bao WAN ; Bin LIANG
Chongqing Medicine 2025;54(4):921-925
Objective To compare the positioning errors and the motion of acromioclavicular joint in breast cancer patients with integrated cervicothoracic thermoplastic membrane and breast bracket fixation,and to provide reference for accurate irradiation of upper and lower clavicular region.Methods Sixty-three pa-tients with breast cancer who were treated in the radiotherapy center of the hospital from November 1,2021 to August 9,2023 were selected as the study objects,and were divided into the integrated cervicothoracic thermo-plastic membrane group(n=32)and breast bracket group(n=31)according to different positioning meth-ods.The translation errors of left and right direction(X),head and foot direction(Y)and ventral and dorsal direction(Z)and the rotation errors of sagittal plane(Rx),cross section(Ry)and coronal plane(Rz)of the two groups were analyzed,and the movement amplitude and three-dimensional displacement of acromioclavic-ular joint were measured respectively.Results Compared with the breast bracket group,X translation errors[(0.18±0.14)cm vs.(0.15±0.12)cm]and Z translation errors[(0.19±0.14)cm vs.(0.16±0.14)cm]of the cervicothoracic thermoplastic memberane group were greater,Z translation error[(0.21±0.17)cm vs.(0.22±0.21)cm]and Rx rotation error of cervical and sternoclavicular joints[(0.93±0.87)° vs.(1.08±0.92)°]were smaller,Rz rotation error[(1.00±0.94)° vs.(0.95±0.86)°]was greater,and the motion ΔX of acromioclavicular joint[(0.18±0.15)cm vs.(0.25±0.21)cm]was smaller,the difference was statistically significant(P<0.05).Conclusion Integrated cervicothoracic thermoplastic membrane can be used as a solu-tion for prophylactic irradiation of breast cancer in the upper and lower clavicular region and for radiation leak-age in the presence of metastasis.
8.Obesity-driven oleoylcarnitine accumulation in tumor microenvironment promotes breast cancer metastasis-like phenotype.
Chao CHEN ; Hongxia ZHANG ; Lingling QI ; Haoqi LEI ; Xuefei FENG ; Yingjie CHEN ; Yuanyuan CHENG ; Defeng PANG ; Jufeng WAN ; Haiying XU ; Shifeng CAO ; Baofeng YANG ; Yan ZHANG ; Xin ZHAO
Acta Pharmaceutica Sinica B 2025;15(4):1974-1990
Obesity is a significant risk factor for cancer and is associated with breast cancer metastasis. Nevertheless, the mechanism by which alterations in systemic metabolism affect tumor microenvironment (TME) and consequently influence tumor metastasis remains inadequately understood. Herein, we found that perturbations in circulating metabolites induced by obesity promote metastasis-like phenotypes in breast cancer. Oleoylcarnitine (OLCarn) concentrations were elevated in the serum of obese mice and humans. Administration of exogenous OLCarn induces metastasis-like characteristics in breast cancer cells. Mechanistically, OLCarn directly interacts with the Arg176 site of adenylate cyclase 10 (ADCY10), leading to the activation of ADCY10 and enhancement of cAMP production. Mutations at Arg176 prevent OLCarn from binding to ADCY10, disrupting the ADCY10-mediated activation of cyclic adenosine monophosphate (cAMP) signaling pathway. This activation promotes transcription factor 4 (TCF4)-dependent kinesin family member C1 (KIFC1) transcription, thereby driving breast cancer metastasis. Conversely, the neutralization of both ADCY10 and KIFC1 through knockdown or pharmacological inhibition abrogates the oncogenic effects mediated by OLCarn. Hence, obesity-induced systemic environmental changes lead to the aberrant accumulation of OLCarn within the TME, making it a potential therapeutic target and biomarker for breast cancer.
9.Protein C activator derived from snake venom protects human umbilical vein endothelial cells against hypoxia-reoxygenation injury by suppressing ROS via upregulating HIF-1α and BNIP3.
Ming LIAO ; Wenhua ZHONG ; Ran ZHANG ; Juan LIANG ; Wentaorui XU ; Wenjun WAN ; Chao Li Shu WU ; 曙 李
Journal of Southern Medical University 2025;45(3):614-621
OBJECTIVES:
To investigate the antioxidative mechanism of snake venom-derived protein C activator (PCA) in mitigating vascular endothelial cell injury.
METHODS:
Human umbilical vein endothelial cells (HUVECs) were cultured in DMEM containing 1.0 g/L D-glucose and exposed to hypoxia (1% O2) for 6 h followed by reoxygenation for 2 h to establish a cell model of oxygen-glucose deprivation/reoxygenation (OGD/R). The cell model was treated with 2 μg/mL PCA alone or in combination with 2-ME2 (a HIF-1α inhibitor) or DMOG (a HIF-1α stabilizer), and intracellular production of reactive oxygen species (ROS) and protein expression levels of HIF-1α, BNIP3, and Beclin-1 were detected using DCFH-DA fluorescence probe, flow cytometry, and Western blotting. The OGD/R cell model was transfected with a BNIP3-specific siRNA or a scrambled control sequence prior to PCA treatment, and the changes in protein expressions of HIF-1α, BNIP3 and Beclin-1 and intracellular ROS production were examined.
RESULTS:
In the OGD/R cell model, PCA treatment significantly upregulated HIF-1α, BNIP3 and Beclin-1 expressions and reduced ROS production. The effects of PCA were obviously attenuated by co-treatment with 2-ME2 but augmented by treatment with DMOG (a HIF-1α stabilizer). In the cell model with BNIP3 knockdown, PCA treatment increased BNIP3 expression and decreased ROS production without causing significant changes in HIF-1α expression. Compared with HUVECs with PCA treatment only, the cells with BNIP3 knockdown prior to PCA treatment showed significantly lower Beclin-1 expression and higher ROS levels.
CONCLUSIONS
Snake venom PCA alleviates OGD/R-induced endothelial cell injury by upregulating HIF-1α/BNIP3 signaling to suppress ROS generation, suggesting its potential as a therapeutic agent against oxidative stress in vascular pathologies.
Humans
;
Reactive Oxygen Species/metabolism*
;
Hypoxia-Inducible Factor 1, alpha Subunit/metabolism*
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Human Umbilical Vein Endothelial Cells/drug effects*
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Membrane Proteins/metabolism*
;
Proto-Oncogene Proteins/metabolism*
;
Up-Regulation
;
Cell Hypoxia
;
Cells, Cultured
;
Snake Venoms/chemistry*
;
Beclin-1
10.Gallstones, cholecystectomy, and cancer risk: an observational and Mendelian randomization study.
Yuanyue ZHU ; Linhui SHEN ; Yanan HUO ; Qin WAN ; Yingfen QIN ; Ruying HU ; Lixin SHI ; Qing SU ; Xuefeng YU ; Li YAN ; Guijun QIN ; Xulei TANG ; Gang CHEN ; Yu XU ; Tiange WANG ; Zhiyun ZHAO ; Zhengnan GAO ; Guixia WANG ; Feixia SHEN ; Xuejiang GU ; Zuojie LUO ; Li CHEN ; Qiang LI ; Zhen YE ; Yinfei ZHANG ; Chao LIU ; Youmin WANG ; Shengli WU ; Tao YANG ; Huacong DENG ; Lulu CHEN ; Tianshu ZENG ; Jiajun ZHAO ; Yiming MU ; Weiqing WANG ; Guang NING ; Jieli LU ; Min XU ; Yufang BI ; Weiguo HU
Frontiers of Medicine 2025;19(1):79-89
This study aimed to comprehensively examine the association of gallstones, cholecystectomy, and cancer risk. Multivariable logistic regressions were performed to estimate the observational associations of gallstones and cholecystectomy with cancer risk, using data from a nationwide cohort involving 239 799 participants. General and gender-specific two-sample Mendelian randomization (MR) analysis was further conducted to assess the causalities of the observed associations. Observationally, a history of gallstones without cholecystectomy was associated with a high risk of stomach cancer (adjusted odds ratio (aOR)=2.54, 95% confidence interval (CI) 1.50-4.28), liver and bile duct cancer (aOR=2.46, 95% CI 1.17-5.16), kidney cancer (aOR=2.04, 95% CI 1.05-3.94), and bladder cancer (aOR=2.23, 95% CI 1.01-5.13) in the general population, as well as cervical cancer (aOR=1.69, 95% CI 1.12-2.56) in women. Moreover, cholecystectomy was associated with high odds of stomach cancer (aOR=2.41, 95% CI 1.29-4.49), colorectal cancer (aOR=1.83, 95% CI 1.18-2.85), and cancer of liver and bile duct (aOR=2.58, 95% CI 1.11-6.02). MR analysis only supported the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer. This study added evidence to the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer, highlighting the importance of cancer screening in individuals with gallstones.
Humans
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Mendelian Randomization Analysis
;
Gallstones/complications*
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Female
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Male
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Cholecystectomy/statistics & numerical data*
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Middle Aged
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Risk Factors
;
Aged
;
Adult
;
Neoplasms/etiology*
;
Stomach Neoplasms/epidemiology*

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