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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

Raising New Hope for Controlling Seizures in Focal Cortical Dysplasia with Gene Therapy

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Neuroscience Bulletin 2024年第7期40卷 1028-1030页

作者： Yuanzhi Yang Yang Zheng zhong Chen Cenglin Xu Key Laboratory of Neuropharmacology and Translational Medicine of Zhejiang Province School of Pharmaceutical SciencesXinhua Hospital of Zhejiang ProvinceThe Second Affiliated Hospital of Zhejiang Chinese Medical UniversityZhejiang Chinese Medical UniversityHangzhou310053China

Focal cortical dysplasia(FCD)is characterized by abnormal cortical development and pharmacoresistant epilepsy,often accompanied by cognitive and behavioral malfunctions[1].According to the International League against Epilepsy(ILAE)classification proposed by Najm,Imad et *** 2022,FCD can be further divided into isolated forms(FCD type Ⅰ and Ⅱ)and another type associated with a principal lesion(FCD type Ⅲ)[2].

关键词： epilepsy al. Therapy

Recent progress and prospects of electrolytes for electrocatalytic nitrogen reduction toward ammonia

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Chinese Chemical Letters 2024年第4期35卷 3-16页

作者： Sajid Mahmood Haiyan Wang Fang Chen Yijun zhong Yong Hu Key Laboratory of the Ministry of Education for Advanced Catalysis Materials Department of ChemistryZhejiang Normal UniversityJinhua 321004China The Center for Applied Mathematics and Bioinformatics(CAMB) Gulf University for Science and TechnologyMishref 32093Kuwait Hangzhou Institute of Advanced Studies Zhejiang Normal UniversityHangzhou 311231China

Electrochemical nitrogen reduction reaction(ENRR) provides a promising strategy to achieve sustainable synthesis of ammonia. However, despite great efforts devoted to this research field, the problems such as low energy efficiency and weak selectivity still impede its practical implementation. Most of the research to date has been concentrated on creating sophisticated electrocatalysts, and adequate knowledge of electrolytes is still lacking. Herein, the recent progress in electrolytes for ENRR, including alkaline, neutral,acidic, water-in-salt, organic, ionic liquid, and mixed water-organic electrolytes, is thoroughly reviewed to obtain an in-depth understanding of their effects on electrocatalytic performance. Recently developed representative electrocatalysts in various types of electrolytes are also introduced, and future research priorities of different electrolytes are proposed to develop new and efficient ENRR systems.

关键词： Electrocatalytic nitrogen reduction Ammonia Electrolytes Production rate Faradaic efficiency

From Acupoints to Mylohyoid: Revealing the Neural Circuitry Basis of Electroacupuncture for Dysphagia

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Neuroscience Bulletin 2024年第1期40卷 139-142页

作者： Xiaoli Da Xuhong Jiang Lihong Li Cenglin Xu zhong Chen Key Laboratory of Neuropharmacology and Translational Medicine of Zhejiang Province School of Pharmaceutical ScienceZhejiang Chinese Medical UniversityHangzhou 310053China Department of Neurology the First Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou 310003China Department of Acupuncture the Second Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou 310000China

Acupuncturea representative and historical treatment in traditional Chinese medicine(TCM),has been used to cure diseases for Chinese people in the past *** the late 1990s,acupuncture has been further accepted *** World Health Organization(WHO)proposed Clinical Research Specification for acupuncture in 1995 and the US Food and Drug Administration(FDA)approved acupuncture as a complementary and alternative therapy for various kinds of diseases in 1996,with clinical advantages such as convenience and effectiveness[1].Cumulative evidence has proved that acupuncture could produce different degrees of efficacy for treating various kinds of diseases(such as neuropathic pain,migraine,Parkinson's disease et al.)and alleviate symptoms[2-4].However,unlike its evidence-based efficacies.

关键词： medicine(TCM) acupuncture Acupuncture

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

利妥昔单抗联合GDP方案治疗非霍奇金淋巴瘤患者的效果及对免疫功能的影响

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临床医学研究与实践 2024年第23期9卷 38-41页

作者：钟林达河南科技大学第一附属医院血液内科河南洛阳471000

目的探讨利妥昔单抗联合吉西他滨+顺铂+地塞米松(GDP)方案治疗非霍奇金淋巴瘤患者的效果及对免疫功能的影响。方法选取2020年3月至2022年8月我院收治的106例非霍奇金淋巴瘤患者,根据治疗方案不同将其分为对照组(53例)和观察组(53例)。... 详细信息

目的探讨利妥昔单抗联合吉西他滨+顺铂+地塞米松(GDP)方案治疗非霍奇金淋巴瘤患者的效果及对免疫功能的影响。方法选取2020年3月至2022年8月我院收治的106例非霍奇金淋巴瘤患者,根据治疗方案不同将其分为对照组(53例)和观察组(53例)。对照组采用GDP方案治疗,观察组在对照组基础上加用利妥昔单抗治疗。比较两组的治疗效果。结果观察组的疾病控制率(DCR)为96.23%,高于对照组的84.91%,差异具有统计学意义(P0.05)。结论利妥昔单抗联合GDP方案治疗非霍奇金淋巴瘤患者效果显著,可改善免疫功能,降低血清肿瘤标志物水平,且用药安全性高。

关键词：非霍奇金淋巴瘤利妥昔单抗免疫功能

Isolation,identification,and virulence gene analysis of pathogenic Aeromonas dhakensis in Macrobrachium rosenbergii and histopathological observation

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Journal of Oceanology and Limnology 2024年第2期42卷 664-675页

作者： Xin PENG Haihui TU Xinyi YAO Xuan LAN Zhenxiao zhong Jinping LUO Qiongying TANG Shaokui YI Zhenglong XIA Guoliang YANG Zhejiang Provincial Key Laboratory of Aquatic Resources Conservation and Development College of Life SciencesHuzhou UniversityHuzhou 313000China Jiangsu Shufeng Prawn Breeding Co. Ltd.Gaoyou 225654China

To identify the cause of mass mortality of adult Macrobrachium rosenbergii in a farm in Gaoyou City,Jiangsu Province,China,a dominant strain named DKQ-1 was isolated from the hepatopancreas of dying *** and identified as Aeromonas dhakensis by purification culture,biochemical characterization,and 16S rRNA and gyrB gene sequence *** results of the challenge test revealed that the strain was highly pathogenic and the 50%lethal dose(ld_(50))in 72 h to *** was 1.54×10^(5)CFU/*** amplification results of virulence genes show that strain DKQ-1 carried 9 virulence genes,including ascV,aexT,aer,act,lip,ompAI,gcaT,acg,and exu,supporting the strong virulence of strain DKQ-1 to *** observation of the hepatopancreas,gills,and intestines indicated that DKQ-1 injection into *** could cause serious tissue damage,which further supported the strong virulence of this *** addition,a drug susceptibility test revealed that strain DKQ-1 was sensitive to 16 kinds of antibiotics,resistant to 9 kinds of antibiotics,and had intermediate resistance to spectinomycin and *** study is the first report of *** isolated from *** and provided a reference for the pathogen identification of bacterial diseases in ***,and for the prevention and treatment caused by ***.

关键词： Aeromonas dhakensis histopathology virulence gene gyrB drug susceptibility test Macrobrachium rosenbergii

针灸治疗急性腰痛：“只用远程取穴”与“局部取穴为主配合远程取穴”之疗效比较随即对照研究（英文）

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Journal of Traditional Chinese Medical Sciences 2024年第3期11卷 351-356页

作者： Singleung Chan Shukyan Lam Sinyin Ho Wanyi Au Poyi Lin Waiming Chan Taking Yu Shungchi Tam Bacon F.L.Ng linda L.D.zhong 博爱医院香港浸会大学中医诊所暨教研中心(九龙城区) 中国香港香港医院管理局中医科香港浸会大学中医学院南洋理工大学生命科学学院

目的：本研究旨在比较“只用远程取穴”与“局部取穴为主配合远程取穴”治疗急性腰痛之疗效。方法：选取102位18-65岁、急性腰痛发病少于6周之符合标准患者，采用随机数字表法将患者按一比一的比例随机分为“只用远程取穴组”与“局部... 详细信息

目的：本研究旨在比较“只用远程取穴”与“局部取穴为主配合远程取穴”治疗急性腰痛之疗效。方法：选取102位18-65岁、急性腰痛发病少于6周之符合标准患者，采用随机数字表法将患者按一比一的比例随机分为“只用远程取穴组”与“局部取穴为主配合远程取穴组”。在4周治疗期间，“只用远程取穴组”将接受每周2次只用远程取穴(后溪[SI3]及腰痛穴[EX-UE7])之针灸治疗，而“局部取穴为主配合远程取穴组”则将接受局部取穴为主配合远程取穴(肾俞[BL 23]及大肠俞[BL 25]及委中[BL 40])之针灸治疗。两组均将于每次治疗前及随访期(完成第8次治疗后1个月及3个月时随访)接受评估。主要疗效指针为以视觉疼痛量表评估疼痛强度之变化；次要疗效指标为以欧氏失能量表评估失能程度。讨论：本研究比较“只用远程取穴”与“局部取穴为主配合远程取穴”之疗效以探索“只用远程取穴”治疗急性腰痛之可行性。

关键词：针灸急性腰痛运动针法远程取穴局部取穴

Outcome of the efficacy of Chinese herbal medicine for functional constipation:A systematic review and meta-analysis

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World Journal of Clinical Cases 2022年第15期10卷 4856-4877页

作者： Zipan Lyu Yibo Fan Yang Bai Tao Liu linda ld zhong Hui-Feng Liang Teaching and Research Division School of Chinese MedicineHong Kong Baptist UniversityHong Kong SAR 99977China Department of Cardiology Xiyuan Hospital of China Academy of Chinese Medical SciencesBeijing 100091China Department of Digestive Endoscope Center Longhua HospitalShanghai University of Traditional Chinese MedicineShanghai 200032China School of Chinese Medicine Hong Kong Baptist UniversityHong Kong 999077China The Institute for Science Technology and HumanitiesShanghai University of Traditional Chinese MedicineShanghai 201203China

BACKGROUND Functional constipation(FC)is a common and chronic gastrointestinal disease and its treatment remains *** To evaluate the efficacy and safety of Chinese herbal medicine(CHM)on efficacy rate,global symptoms,bowel movements and the Bristol Stool Scale score in patients with FC by summarizing current available randomized controlled trials(RCTs).METHODS RCTs with CHM to treat FC were identified by a systematic search of six databases from inception to October 20,*** independent reviewers assessed the quality of the included articles and extracted ***-analyses were performed to odds ratio(OR),mean differences(MD)and 95%confidence interval(CI)using random-effects *** analyses and sensitivity analyses were used to explore and interpret the sources of *** funnel plot,Begg’s test and Egger’s test were used to detect publication *** Ninety-seven studies involving 8693 patients were included in this *** was significantly associated with a higher efficacy rate(OR:3.62,95%CI:3.19-4.11,Pld not be reached because of the poor quality of the included *** trials with higher quality are required.

关键词： Functional constipation Chinese herbal medicine Efficacy Systematic review Meta-analysis