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Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration(SPIRIT-TCM Extension 2018)

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Chinese Journal of Integrative Medicine 2019年第1期25卷 71-79页

作者： DAI Liang cheng chung-wah TIAN Ran ZHONG Linda LD LI You-ping LYU Ai-ping CHAN An-wen SHANG Hong-cai BIAN Zhao-xiang Hong Kong Chinese Medicine Clinical Study Centre School of Chinese Medicine Hong Kong Baptist University Institute of Digestive Diseases Longhua Hospital Shanghai University of Traditional Chinese Medicine Chinese Evidence-Based Medicine Centre Sichuan University Women's Col ege Research Institute Women's Col ege Hospital University of Toronto Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital Beijing University of Chinese Medicine

Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.

关键词： SPIRIT traditional Chinese medicine clinical trial extension recommendation

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Whether Syndrome Differentiation Affects Treatment Result:Study Protocol of MaZiRenWan(麻子仁丸)for Functional Constipation in A Randomized Controlled Trial

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Chinese Journal of Integrative Medicine 2019年第3期25卷 175-181页

作者： cheng chung-wah ZHANG Li ZHAO Chen ZHONG Linda LD SHI Li-jie DAI Liang ZHENG Rui CHEN Jing LI Ge ZHAI Jing-bo KUN Wai LU Ai-ping SHANG Hong-cai BIAN Zhao-xiang Hong Kong Chinese Medicine Clinical Study Centre School of Chinese Medicine Hong Kong Baptist University Department of Clinical Pharmacology the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Department of Gastroenterology the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Graduate School Tianjin University of Traditional Chinese Medicine Department of Health Care Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine School of Traditional Chinese Medicine Tianjin University of Traditional Chinese Medicine Research Institute of Traditional Chinese Medicine Tianjin University of Traditional Chinese Medicine Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital Beijing University of Chinese Medicine

Background: Syndrome is one of the most important concepts in Chinese medicine(CM) theory. However, it was not well accounted in most of randomized controlled trials(RCTs). Objective: To determine whether CM syndrome differentiation affects the treatment results, functional constipation(FC) was selected as a target disease, and MaZiRenWan(麻子仁丸, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study. Methods: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW(f_MZRW) granule group, modified MZRW(m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements(CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events. Discussion: This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease.

关键词： functional constipation Chinese herbal medicine syndrome differentiation MaZiRenWan randomized controlled trial

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Crystallization Modulation and Holistic Passivation Enables Efficient Two‑Terminal Perovskite/CuIn(Ga)Se_(2)Tandem Solar Cells

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Nano-Micro Letters 2025年第1期17卷 205-215页

作者： Cong Geng Kuanxiang Zhang Changhua Wang chung Hsien Wu Jiwen Jiang Fei Long Liyuan Han Qifeng Han Yi‑Bing cheng Yong Peng State Key Laboratory of Advanced Technology for Materials Synthesis and Processing Wuhan University of TechnologyWuhan 430070People’s Republic of China Triumph Photovoltaic Materials Co. Ltd.No.1001 Yannan AvenueHigh‑Tech Development DistrictBengbuAnhui 233000People’s Republic of China College of Materials Science and Engineering Guilin University of TechnologyGuilin 541004People’s Republic of China State Key Laboratory of Metal Matrix Composites Shanghai Jiao Tong UniversityShanghai 200240People’s Republic of China

Two-terminal(2-T)perovskite(PVK)/CuIn(Ga)Se_(2)(CIGS)tandem solar cells(TSCs)have been considered as an ideal tandem cell because of their best bandgap matching regarding to Shockley–Queisser(S–Q)***,the nature of the irregular rough morphology of commercial CIGS prevents people from improving tandem device *** this paper,D-homoserine lactone hydrochloride is proven to improve coverage of PVK materials on irregular rough CIGS surfaces and also passivate bulk defects by modulating the growth of PVK *** addition,the minority carriers near the PVK/C60 interface and the incompletely passivated trap states caused interface recombination.A surface reconstruction with 2-thiopheneethylammonium iodide and N,N-dimethylformamide assisted passivates the defect sites located at the surface and grain ***,LiF is used to create this field effect,repelling hole carriers away from the PVK and C60 interface and thus reducing *** a result,a 2-T PVK/CIGS tandem yielded a power conversion efficiency of 24.6%(0.16 cm^(2)),one of the highest results for 2-T PVK/CIGS TSCs to our *** validation underscores the potential of our methodology in achieving superior performance in PVK/CIGS tandem solar cells.

关键词： PVK/CIGS TSCs Irregular rough surfaces Modulating the growth PVK/C60 interface recombination

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Fanlian Huazhuo formula:A promising therapeutic approach for metabolic associated steatotic liver disease

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World Journal of Gastroenterology 2025年第1期31卷 167-171页

作者： Chun-Han cheng Wen-Rui Hao Tzu-Hurng cheng Department of Medical Education Linkou Chang Gung Memorial HospitalTaoyuan 33305Taiwan Division of Cardiology Department of Internal MedicineShuang Ho HospitalMinistry of Health and WelfareTaipei Medical UniversityNew Taipei 23561Taiwan Division of Cardiology Department of Internal MedicineSchool of MedicineCollege of MedicineTaipei Medical UniversityTaipei 11002Taiwan Department of Biochemistry School of MedicineCollege of MedicineChina Medical UniversityTaichung 404328Taiwan

This article reviews the study,“Fanlian huazhuo formula alleviates high-fat-dietinduced nonalcoholic fatty liver disease by modulating autophagy and lipid synthesis signaling pathway”published in the World Journal of *** study explores the therapeutic potential of Fanlian Huazhuo formula(FLHZF)in treating metabolic-associated steatotic liver disease(MASLD),demonstrating that FLHZF reduces lipid accumulation,oxidative stress,and liver injury in MASLD models by modulating key signaling pathways involved in lipid metabolism and *** editorial emphasizes the potential of FLHZF as a treatment for MASLD and calls for further research to verify its clinical efficacy.

关键词： Fanlian Huazhuo formula Metabolic associated steatotic liver disease Autophagy Lipid metabolism Oxidative stress

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Systematic review of Chinese herbal medicine for functional constipation

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World Journal of Gastroenterology 2009年第39期15卷 4886-4895页

作者： chung-wah cheng Zhao-Xiang Bian Tai-Xiang Wu School of Chinese Medicine Hong Kong Baptist University Hong Kong China Department of ClinicalEpidemiology Chinese Evidence-Based Medicine Centre West China Hospital Sichuan University Chengdu 610041 Sichuan Province China

Constipation is a common gastrointestinal complaint in clinical practice, affecting an estimated 27% of the population. Many patients are disappointed by current conventional treatments and, therefore, seek help from complementary and alternative medicine （CAM）. Traditional Chinese medicine, is the most important part of CAM and has been practiced for treating diseases and promoting the health of humans for thousands of years, and has become a popular alternative choice. Although there are many Chinese herbal medicine （CHM interventions available, and some have been verified b＇ clinical trials, their efficacy and safety are still questioned by both patients and health care providers worldwide. The purposes of this review are, first, to appraise the qualities of individual study designs in the new Cochrane approach. Second, the benefits of individual CHM interventions or individual types of CHM intervention for the treatment of functional constipation are analyzed. Finally, valid and comprehensive conclusions are drawn, if applicable, in order to make clinical recommendations.

关键词： Chinese herbal medicine Functional constipation Systematic review

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Impact of psychological stress on irritable bowel syndrome

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World Journal of Gastroenterology 2014年第39期20卷 14126-14131页

作者： Hong-Yan Qin chung-wah cheng Xu-Dong Tang Zhao-Xiang Bian Department of Pharmacy First Hospital of Lanzhou University Lab of Brain and Gut Research School of Chinese Medicine Hong Kong Baptist University China Academy of Chinese Medical Sciences

Psychological stress is an important factor for the development of irritable bowel syndrome(IBS). More and more clinical and experimental evidence showed that IBS is a combination of irritable bowel and irritable brain. In the present review we discuss the potential role of psychological stress in the pathogenesis of IBS and provide comprehensive approaches in clinical treatment. Evidence from clinical and experimental studies showed that psychological stresses have marked impact on intestinal sensitivity, motility, secretion and permeability, and the underlying mechanism has a close correlation with mucosal immune activation, alterations in central nervous system, peripheral neurons and gastrointestinal microbiota. Stress-induced alterations in neuro-endocrine-immune pathways acts on the gut-brain axis and microbiota-gut-brain axis, and cause symptom flare-ups or exaggeration in IBS. IBS is a stresssensitive disorder, therefore, the treatment of IBS should focus on managing stress and stress-induced responses. Now, non-pharmacological approaches and pharmacological strategies that target on stress-related alterations, such as antidepressants, antipsychotics, miscellaneous agents, 5-HT synthesis inhibitors, selective 5-HT reuptake inhibitors, and specific 5-HT receptor antagonists or agonists have shown a critical role in IBS management. A integrative approach for IBS management is a necessary.

关键词： Psychological stress Irritable bowel syndrome Microbiota-gut-brain axis Immune activation

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Relationship between longitudinal changes in lipid composition and ischemic stroke among hypertensive patients

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World Journal of Clinical Cases 2025年第4期13卷 18-27页

作者： cheng-cheng Wei Yu-Qing Huang cheng-Hong Yu Department of Cardiology Tongxiang First People's HospitalTongxiang 314500Zhejiang ProvinceChina Department of Cardiology Guangdong Cardiovascular InstituteGuangzhou 510080Guangdong ProvinceChina

BACKGROUND Dyslipidemia was strongly linked to stroke,however the relationship between dyslipidemia and its components and ischemic stroke remained *** To investigate the link between longitudinal changes in lipid profiles and dyslipidemia and ischemic stroke in a hypertensive *** Between 2013 and 2014,6094 hypertension individuals were included in this,and ischemic stroke cases were documented to the end of *** changes of lipid were stratified into four groups:(1)Normal was transformed into normal group;(2)Abnormal was transformed into normal group;(3)Normal was transformed into abnormal group;and(4)Abnormal was transformed into abnormal *** examine the link between longitudinal changes in dyslipidemia along with its components and the risk of ischemic stroke,we utilized multivariate Cox proportional hazards models with hazard ratio(HR)and 95%*** The average age of the participants was 62.32 years±13.00 years,with 329 women making up 54.0%of the *** the course of a mean follow-up of 4.8 years,143 ischemic strokes *** normal was transformed into normal group was used as a reference,after full adjustments,the HR for dyslipidemia and ischemic stroke among abnormal was transformed into normal group,normal was transformed into abnormal group and abnormal was transformed into abnormal Wei CC et *** changed and ischemic stroke WJCC https://*** 2 February 6,2025 Volume 13 Issue 4 group were 1.089(95%CI:0.598-1.982;P=0.779),2.369(95%CI:1.424-3.941;P<0.001)and 1.448(95%CI:1.002-2.298;P=0.047)(P for trend was 0.233),*** In individuals with hypertension,longitudinal shifts from normal to abnormal in dyslipidemia-particularly in total and low-density lipoprotein cholesterol-were significantly associated with the risk of ischemic stroke.

关键词： Longitudinal change Hypertension Dyslipidemia Lipid profile Ischemic stroke

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Investigating Müller glia reprogramming in mice: a retrospective of the last decade, and a look to the future

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Neural Regeneration Research 2025年第4期20卷 946-959页

作者： Zhiyuan Yin Jiahui Kang Xuan cheng Hui Gao Shujia Huo Haiwei Xu Key Lab of Visual Damage and Regeneration&Restoration of Chongqing Southwest Eye HospitalSouthwest HospitalThird Military Medical University(Army Medical University)ChongqingChina

Müller glia,as prominent glial cells within the retina,plays a significant role in maintaining retinal homeostasis in both healthy and diseased *** lower vertebrates like zebrafish,these cells assume responsibility for spontaneous retinal regeneration,wherein endogenous Müller glia undergo proliferation,transform into Müller glia-derived progenitor cells,and subsequently regenerate the entire retina with restored ***,Müller glia in the mouse and human retina exhibit limited neural reprogramming.Müller glia reprogramming is thus a promising strategy for treating neurodegenerative ocular disorders.Müller glia reprogramming in mice has been accomplished with remarkable success,through various *** in molecular,genetic,epigenetic,morphological,and physiological evaluations have made it easier to document and investigate the Müller glia programming process in ***,there remain issues that hinder improving reprogramming efficiency and ***,understanding the reprogramming mechanism is crucial toward exploring factors that will improve Müller glia reprogramming efficiency,and for developing novel Müller glia reprogramming *** review describes recent progress in relatively successful Müller glia reprogramming *** also provides a basis for developing new Müller glia reprogramming strategies in mice,including epigenetic remodeling,metabolic modulation,immune regulation,chemical small-molecules regulation,extracellular matrix remodeling,and cell-cell fusion,to achieve Müller glia reprogramming in mice.

关键词： cell fusion chemical small-molecules epigenetic extracellular matrix immune metabolic mice Müller glia neurodegenerative diseases reprogramming retina regeneration

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Three-dimensional fracture of UO2 ceramic pellets by phase field modeling

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Science China(Physics,Mechanics & Astronomy) 2025年第1期Mechanics & Astronomy) .卷 169-180页

作者： Wei Xiong Xuan Ye Hongzhang cheng Xiaoming Liu Institute of Nuclear and New Energy Technology Collaborative Innovation Center of Advanced Nuclear Energy Technology Key Laboratory of Advanced Reactor Engineering and Safety of Ministry of Education Tsinghua University State Key Laboratory of Nonlinear Mechanics Institute of Mechanics Chinese Academy of Sciences School of Engineering Science University of Chinese Academy of Sciences

Fracture is the primary failure type for the UO2ceramic pellets,which are operated under irradiation and thermal processes,and physically confined by the *** this work,by combining closely coupled physical processes of heat conduction,heat transfer,and mechanical deformation with the cohesive phase field framework,we proposed a high-precision modeling of quasistatic cracking of three-dimensional （3D） UO2ceramic fuel pellets under high temperature and *** simulation results agree well with the experimental results,indicating that the proposed method has the potential to capture 3D crack modes in the interested time ***,we studied the relation of the 3D fracture patterns of fuel pellets with the peak power *** was found that the power level plays a critical role in determining the competition between radial and circumferential cracks,as well as transverse penetrating cracks.

关键词： phase field method nuclear fuel pellet coupled thermo-mechanical model thermal fracture

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Facile synthesis of hybridized Co/Fe-ZIF under solvent-free conditions for efficient oxidation evolution reaction electrocatalysis

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Nano Research 2025年第1期18卷 362-372页

作者： YinSheng Xu Zihan Li Zhonghan cheng Somboon Chaemchuen State Key Laboratory of Advanced Technology for Materials Synthesis and Processing Wuhan University of TechnologyWuhan 430070China Department of Chemical Engineering Faculty of EngineeringMahidol UniversityNakhon Pathom 73170Thailand State Key Laboratory of Silicate Materials for Architectures Wuhan University of TechnologyWuhan 430070China School of Materials Science and Engineering Wuhan University of TechnologyWuhan 430070China

Developing non-noble catalyst synthesis under green conditions with efficient electrochemical reactions is a challenging task in green energy *** meet this challenge,the synthesis of hybridized non-noble cobalt and iron in the zeolitic-imidazole framework(Co/Fe-ZIF)through a solid-state thermal(SST)method is *** the obtained Co/Fe-ZIF structure,iron atoms are uniformly dispersed and randomly hybridized with primary cobalt atoms and imidazole linker,similar to the structure of *** hybridized Co/Fe-ZIF shows potential as an electrocatalyst for oxidation evolution reaction(OER).The optimal iron-incorporating catalyst,Co/Fe_(0.2)-ZIF,demonstrates remarkable performance with a minimized overpotential of 285 mV at the current density(j)of 10 mA·cm^(-2)in 1 M *** synergistic effect of iron and cobalt ions on the catalyst provides active sites that bind to intermediate(OOH^(*))more strongly and facilitate high electron charge transfer,enhancing efficient ***,the synergistic Co/Fe_(0.2-)ZIF catalyst demonstrates excellent durable reaction time compared to non-iron catalyst(ZIF-67)and conventional catalyst(RuO_(2)).

关键词： zeolitic-imidazole frameworks solid-state thermal method solvent-free synthesis electrocatalyst oxidation evolution reaction

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