1.Staged Efficacy of Qijia Rougan Prescription Combined with Entecavir for Chronic Hepatitis B-related Hepatic Fibrosis with Qi Deficiency and Collateral Stasis Syndrome Based on "Zhu Ke Jiao" Theory
Baixue LI ; Xin WANG ; Jibin LIU ; Li WEN ; Cen JIANG ; Wenjun WU ; Dong WANG ; Shuwan LIU ; Huabao LIU ; Yongli ZHENG ; Liang HUANG ; Yue SU ; Song ZHANG ; Yanan SHANG ; Hang ZHOU ; Quansheng FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):180-188
ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory, Qijia Rougan prescription, combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted, and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis (CHB-HF) who met the diagnosis and inclusion criteria were randomly assigned to an observation group (Qijia Rougan prescription + entecavir) and a control group (entecavir). The treatment duration was 24 weeks. Liver stiffness measurement (LSM), fibrosis-4 index (FIB-4), portal vein diameter, hepatitis B serology, biochemical indicators, hepatic fibrosis markers in serum [hyaluronic acid (HA), laminin (LN), procollagen Ⅲ peptide (PⅢP), and type Ⅳ collagen (Ⅳ-C)], and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis, with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment, the observation group showed a significant reduction in LSM and FIB-4 (P<0.01), as well as notable improvements in LN, Ⅳ-C, and various TCM syndrome scores (P<0.05, P<0.01). When compared to the control group after treatment, the observation group demonstrated significant improvements in LSM, FIB-4, and various TCM syndrome score indicators (P<0.05, P<0.01), indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment, the observation group had better improvement in regression of stages F2 and F3 (P<0.05). When compared to the control group after treatment, the observation group exhibited superior improvement in regression of stage F3 (P<0.05). No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone, the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3, which is a potential “interception” point of the “Zhu Ke Jiao” theory.
2.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
3.Clinical effects and prognostic observation of dapagliflozin in patients with pulmonary hypertension associated with left heart disease
Lu LI ; Rongrong QIU ; Feng DONG
China Pharmacy 2026;37(11):1457-1461
OBJECTIVE To evaluate the clinical efficacy of dapagliflozin in patients with pulmonary hypertension associated with left heart disease (PH-LHD) and its effect on prognosis, and to provide evidence for its clinical application. METHODS A total of 135 hospitalized patients with PH-LHD admitted to Wuxi No. 2 People’s Hospital from January 1, 2023 to June 30, 2025 were retrospectively included. According to the treatment regimen, the patients were divided into a control group (74 cases, receiving conventional treatment) and a dapagliflozin group (61 cases, receiving dapagliflozin in addition to conventional treatment). Blood pressure [systolic blood pressure, diastolic blood pressure, and pulmonary artery systolic pressure (PASP)], echocardiographic cardiac function parameters [cardiac output, cardiac index, left ventricular ejection fraction (LVEF), right ventricular ejection fraction (RVEF), left atrial diameter, and left ventricular wall thickness], inflammatory factors [interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP)], brain natriuretic peptide (BNP), and 6-minute walking distance (6MWD) were compared between the two groups before treatment and after 12 weeks of treatment. All-cause mortality and the frequency of rehospitalization due to worsening heart failure during follow-up were also compared. RESULTS After 12 weeks of treatment, systolic blood pressure, diastolic blood pressure, PASP, left atrial diameter, IL-6, hs-CRP, and BNP levels were significantly decreased or shortened in both groups, while cardiac index and 6MWD were significantly increased or prolonged compared with those before treatment ( P <0.05). Cardiac output in the dapagliflozin group was significantly increased compared with that before treatment ( P <0.05). Systolic blood pressure, PASP, left atrial diameter, IL-6, hs-CRP, and BNP levels in the dapagliflozin group were significantly lower or shorter than those in the control group, while cardiac output, cardiac index, and 6MWD were significantly higher or longer than those in the control group ( P <0.05). There were no statistically significant differences in LVEF, RVEF, or left ventricular wall thickness between the two groups ( P >0.05). The median follow-up times in the control group and dapagliflozin group were 17.9 months and 17.3 months, respectively. During follow-up, all-cause mortality in the dapagliflozin group was lower than that i n the control group, but the difference was not statistically significant ( P >0.05); the frequency of rehospitalization due to worsening heart failure was significantly lower than that in the control group ( P <0.05). CONCLUSIONS On the basis of conventional treatment, the addition of dapagliflozin can further reduce pulmonary artery pressure, inflammatory factor levels, and BNP levels in patients with PH-LHD, improve some cardiac function-related parameters and exercise tolerance, and reduce the frequency of rehospitalization due to worsening heart failure.
4.Mechanisms on Chronicity of Infectious Diseases from Warm Disease Theory of Pathogen Invading Nutrient and Blood Aspects: Integrating Classical Wisdom with Innovative Perspectives
Baixue LI ; Hang ZHOU ; Jibin LIU ; Xia LI ; Xiyang LIU ; Haihui LIU ; Peijie WU ; Dong WANG ; Cen JIANG ; Wenjun WU ; Quansheng FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):60-69
The chronicity of infectious diseases is an important field in the collaborative research of traditional Chinese and Western medicine. The warm disease theory of pathogen invading nutrient and blood aspects in traditional Chinese medicine (TCM) takes the struggle between healthy Qi and pathogenic Qi and cementation of Yin as the core pathogenesis, providing a unique theoretical framework for explaining the common pathology of infectious chronic diseases. This theory originated from Yin-Yang interaction in the Internal Classic and was enriched with WU Youke's theory of intruding pathogen interacting and lingering in blood vessels and YE Tianshi's theory of long-term illness entering collaterals. Combining the theory with modern medical knowledge, our team has condensed the dynamic pathogenesis model of deficiency (nutrient and blood aspects) and excess (pathogen) interacting in the blood collaterals of Yin aspect, the core feature of which is the four-dimensional interactions of cause (pathogen characteristics), location (three Yin locations of diseases), nature (deficiency and excess), and potential (transmission trend). The common pathology of infectious chronic diseases is reflected in interactions. That is, the interactions between nutrient and blood deficiency (immune exhaustion and metabolic disorder) and pathogen excess (pathogen persistence and fibrous hyperplasia) in the liver collaterals (Jueyin), kidney collaterals (Shaoyin), lung collaterals (Taiyin) and other blood collaterals of Yin aspect form the pathological damage characterized by immune inflammatory response-continuous tissue damage with excessive repair. Taking the inheritance and innovative development of classics as the main line, this paper systematically discusses the scientific connotation of the theory of pathogen invading nutrient and blood aspects and the paths of inheritance and innovation and clarifies the original significance of this theory in the chronic development of infectious diseases. Furthermore, taking clinical diseases as an example, this paper reflects the guiding value of this classical theory in the modern diagnosis and treatment of infectious diseases with integrated traditional Chinese and Western medicine and the application potential of this theory in solving complex medical problems through the construction of the innovative paradigm of precise diagnosis and treatment with integrated traditional Chinese and Western medicine.
5.Investigating Molecular Mechanisms of Qijia Rougan Prescription and Its Key Effect or Ingredients Against Hepatic Fibrosis Based on Macrophage M2 Polarization
Li WEN ; Quansheng FENG ; Cen JIANG ; Baixue LI ; Dong WANG ; Jike LI ; Xia LI ; Fei WAN ; Yanfeng ZHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):155-165
ObjectiveBased on the regulation of macrophage M2 polarization, this study aims to explore the molecular mechanism and action targets of the Qijia Rougan prescription and its key effector ingredients in anti-fibrosis, thereby providing a basis and reference for the development of new drugs for hepatic fibrosis. MethodsA rat model of hepatic fibrosis was established by subcutaneous injection of 40%CCl4, followed by oral administration of Qijia Rougan granules. The volume of collagen fibers was detected using Masson staining, the fibrosis markers Collagen Ⅰ and α-SMA were detected using immunohistochemistry, the proportion of M2 macrophages was detected by flow cytometry. The expression levels of M2 macrophage phenotype markers CD163 and CD206 were detected using immunofluorescence double staining. Western blot was used to detect the levels of the transforming growth factor-β (TGF-β), platelet derived growth factor subunit B (PDGFB), interleukin-10 (IL-10), phosphorylated Janus kinase 1 (p-JAK1), and phosphorylated signal transducer and activator of transcription 6 (p-STAT6). Real-time fluorescent quantitative PCR was used to detect the relative expression levels of JAK1, STAT6, Arginase 1(Arg1), and Fizz1. Based on the theory of serum pharmacology, liquid chromatography-mass spectrometry and WENN analysis were used to obtain the active ingredients of Qijia Rougan prescription. Molecular docking and molecular dynamics simulation were performed to analyze the effector ingredients and their targets. The identified effector ingredients were interfered with IL-4-induced M2 polarization of RAW264.7 macrophage in vitro to validate the targets. ResultsQijia Rougan prescription significantly reduced the content of fibrosis markers α-SMA and Collagen Ⅰ, as well as collagen fiber content (P<0.05). It decreased the proportion of M2 macrophages and the levels of related cytokines IL-10, TGF-β and PDGFB, and up-regulated the levels of p-JAK1 and p-STAT6 (P<0.05). A total of 1 214 compounds were identified from Qijia Rougan prescription, medicated serum and blank serum, and 29 ingredients were finalized by Venn analysis, including 15 blood-entry prototypes and 14 drug metabolites. Molecular docking showed that enoxolone and berberine bound more strongly to JAK1, with binding free energies of -9.6 kcal·mol-1(1 cal≈4.184 J) and -9.1 kcal·mol-1, respectively. Molecular dynamics simulations showed that JAK1-enoxolone and JAK1-berberine exhibited stable simulation trajectories within 100 ns, with essentially identical conformations and high protein overlap before and after simulation. Their binding free energies were -25.18 5.0.81 kcal·mol-1 and -27.39 7.0.85 kcal·mol-1, respectively. The number of hydrogen bonds formed between JAK1 and enoxolone ranges from 0 to 5, and most of the time can be maintained at 2-3. In vitro intervention with enoxolone or berberine significantly reduced p-JAK1 and p-STAT6 levels (P<0.05). ConclusionQijia Rougan prescription inhibits M2 macrophage polarization in hepatic fibrosis. Enoxolone and berberine are the key effector ingredients of Qijia Rougan prescription to inhibit macrophage M2 polarization through targeting JAK1 and modulating the JAK1/STAT6 signaling pathway, thereby ameliorating hepatic fibrosis. This study provides a basis for prescription optimization, clinical application and new drug development, as well as a reference for monolithic anti-hepatic fibrosis research.
6.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
7.2024 annual report of interventional treatment for congenital heart disease
Changdong ZHANG ; Yucheng ZHONG ; Geng LI ; Jun TIAN ; Gejun ZHANG ; Nianguo DONG ; Yuan FENG ; Daxin ZHOU ; Yongjian WU ; Lianglong CHEN ; Xiaoke SHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):909-918
In recent years, with the continuous development and increasing maturity of interventional techniques, interventional treatment for congenital heart disease (CHD) has been progressively disseminated to county- and city-level hospitals in China. Concurrently, the standardized management of adult CHD (particularly patent foramen ovale) and the lifelong management of complex CHD are gaining increasing clinical attention, while the emergence of new techniques and products continuously advances the discipline. This article aims to review the new progress made in the field of interventional treatment for congenital heart disease in China during 2024. It specifically reviews and analyzes the following key aspects: (1) annual statistics on interventional closure procedures for CHD; (2) recent insights into patent foramen ovale closure; (3) advances in transcatheter pulmonary valve replacement; (4) interventional treatment and lifelong management strategies for complex CHD; (5) new interventional techniques for acquired heart disease; and (6) the application of artificial intelligence in CHD management. Through the synthesis and discussion of these topics, this article seeks to provide a detailed analysis of the current landscape of interventional treatment for CHD in China and project its future development trends.
8.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
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Crotonates/adverse effects*
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Toluidines/adverse effects*
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Nitriles
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Hydroxybutyrates
;
Female
;
Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
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Middle Aged
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Multiple Sclerosis, Relapsing-Remitting/genetics*
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Prospective Studies
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Young Adult
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Neoplasm Proteins/genetics*
;
East Asian People
9.Key technologies and challenges in online adaptive radiotherapy for lung cancer.
Baiqiang DONG ; Shuohan ZHENG ; Kelly CHEN ; Xuan ZHU ; Sijuan HUANG ; Xiaobo JIANG ; Wenchao DIAO ; Hua LI ; Lecheng JIA ; Feng CHI ; Xiaoyan HUANG ; Qiwen LI ; Ming CHEN
Chinese Medical Journal 2025;138(13):1559-1567
Definitive treatment of lung cancer with radiotherapy is challenging, as respiratory motion and anatomical changes can increase the risk of severe off-target effects during radiotherapy. Online adaptive radiotherapy (ART) is an evolving approach that enables timely modification of a treatment plan during the interfraction of radiotherapy, in response to physiologic or anatomic variations, aiming to improve the dose distribution for precise targeting and delivery in lung cancer patients. The effectiveness of online ART depends on the seamless integration of multiple components: sufficient quality of linear accelerator-integrated imaging guidance, deformable image registration, automatic recontouring, and efficient quality assurance and workflow. This review summarizes the present status of online ART for lung cancer, including key technologies, as well as the challenges and areas of active research in this field.
Humans
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Lung Neoplasms/radiotherapy*
;
Radiotherapy Planning, Computer-Assisted/methods*
10.Arsenic trioxide preconditioning attenuates hepatic ischemia- reperfusion injury in mice: Role of ERK/AKT and autophagy.
Chaoqun WANG ; Hongjun YU ; Shounan LU ; Shanjia KE ; Yanan XU ; Zhigang FENG ; Baolin QIAN ; Miaoyu BAI ; Bing YIN ; Xinglong LI ; Yongliang HUA ; Zhongyu LI ; Dong CHEN ; Bangliang CHEN ; Yongzhi ZHOU ; Shangha PAN ; Yao FU ; Hongchi JIANG ; Dawei WANG ; Yong MA
Chinese Medical Journal 2025;138(22):2993-3003
BACKGROUND:
Arsenic trioxide (ATO) is indicated as a broad-spectrum medicine for a variety of diseases, including cancer and cardiac disease. While the role of ATO in hepatic ischemia/reperfusion injury (HIRI) has not been reported. Thus, the purpose of this study was to identify the effects of ATO on HIRI.
METHODS:
In the present study, we established a 70% hepatic warm I/R injury and partial hepatectomy (30% resection) animal models in vivo and hepatocytes anoxia/reoxygenation (A/R) models in vitro with ATO pretreatment and further assessed liver function by histopathologic changes, enzyme-linked immunosorbent assay, cell counting kit-8, and terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay. Small interfering RNA (siRNA) for extracellular signal-regulated kinase (ERK) 1/2 was transfected to evaluate the role of ERK1/2 pathway during HIRI, followed by ATO pretreatment. The dynamic process of autophagic flux and numbers of autophagosomes were detected by green fluorescent protein-monomeric red fluorescent protein-LC3 (GFP-mRFP-LC3) staining and transmission electron microscopy.
RESULTS:
A low dose of ATO (0.75 μmol/L in vitro and 1 mg/kg in vivo ) significantly reduced tissue necrosis, inflammatory infiltration, and hepatocyte apoptosis during the process of hepatic I/R. Meanwhile, ATO obviously promoted the ability of cell proliferation and liver regeneration. Mechanistically, in vitro studies have shown that nontoxic concentrations of ATO can activate both ERK and phosphoinositide 3-kinase-serine/threonine kinase (PI3K-AKT) pathways and further induce autophagy. The hepatoprotective mechanism of ATO, at least in part, relies on the effects of ATO on the activation of autophagy, which is ERK-dependent.
CONCLUSION
Low, non-toxic doses of ATO can activate ERK/PI3K-AKT pathways and induce ERK-dependent autophagy in hepatocytes, protecting liver against I/R injury and accelerating hepatocyte regeneration after partial hepatectomy.
Animals
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Arsenic Trioxide
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Autophagy/physiology*
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Reperfusion Injury/prevention & control*
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Mice
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Male
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Proto-Oncogene Proteins c-akt/physiology*
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Arsenicals/therapeutic use*
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Oxides/therapeutic use*
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Liver/metabolism*
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Extracellular Signal-Regulated MAP Kinases/metabolism*
;
Mice, Inbred C57BL

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