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Regulatory Concerns on Herbal Medicine Studies

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Regulatory Concerns on Herbal Medicine Studies

第十二届全国数学药理学术大会

作者： Haitang Xie anhui provincial center for drug clinical evaluation,Yijishan Hospital

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Exploratory screening study on anti-depresive activity of Helicid wN7-6 and its derivatives

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Exploratory screening study on anti-depresive activity of He...

中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： TONG Jiu-cui XIE Hai-tang JIANG Si-yan YANG Bin RUI Jia-liang anhui provincial center for drug clinical evaluation,Yijishan Hospital of Wannan Medical College,wuhu 241001,anhui,china

AIM:To search some compounds that have anti-depres- sive activity from Helicid WN7-6 and its derivatives,and to explore their structure-function relationship. METHODS:21 compounds including WN7-6,the lead compound were screened for antidepressant effect by the behavioral despair models(tail suspension test and the forced swimming test).And to study their stimulative ef- fect on central nerve system(CNS)by mice autonomic ac- tivity test. RESULTS:Results shown that 11 of these compounds could decrease immobile time in suspend tail tail and 6 compounds had the similar effect in force swimming test, compared with that of control group,the immobile time was obviously reduced(P＜0.05,P＜0.01).The re- sults of autonomic activity test indicated that only 7 com- pounds could inhibit the activities of CNS(P＜0.05,P ＜0.01). CONCLUSION:30%-50% of these derivatives have anti-depressive activities,and much attention should be paid to further researches.

关键词： Helicid anti-depressive screen suspend tail test forced swimming test automomic activity

Contrast study on optimizing antibacterial lead compounds from three kinds of derivates in vitro

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Contrast study on optimizing antibacterial lead compounds fr...

中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： LI Juan XIE Hai-tang SUN Rui-yuan TONG Jiu-cui anhui provincial Centre for drug clinical evaluation,Yijishan Hospital,Wannan Medical College,wuhu 241001,anhui,china

AIM:To choose at least one kind of better derivate from 81 novel compounds for further structure-function relation- ship researches by contrast study on antibacterial activity of three kinds of derivates developed from decanoyl acetalde- hyde,a certain kind of ethnodrug and pure synthetics. METHODS:Three quality control strains,staphylococcus aureus ATCC25923,bacillus coil ATCC25922 and bacillus aeruginosus ATCC27853 were used in the preliminary screening in *** active derivates were selected to carry out the minimal bactericidal concentration test,kill- ing curve test,and the effect of cultivation parameters on minimal inhibitory concentration on clinical separated staphylococcus aureus and *** toxicity test of a few promising derivates were tested preliminarily by intra- gastric administration to mice. RESULTS:There were significant differences of the anti- bacterial activity for the three different kinds of derivatives compared to the quality control *** shown that 15 percent of the 53 compounds developed from decanoyl acetaldehyde had special activity of inhibiting staphylococ- cus aureus *** optimized derivatives had better activity to clinical separated staphylococcus aureus and MRSA compared to the positive control drug decanoyl *** the derivates showed stronger inhibitive action to the staphylococcus aureus in basylous circum- stance than in acid ***,among 20 derivates developed from a certain kind of ethnodrug,there were 90 percents shown fairly strong and broad antibacteri- al activity to staphylococcus aureus ATCC25923 and bacil- lus coil ATCC25922 with high toxicity in *** 8 samples of pure synthetics showed weak antibacterial activ- ity. CONCLUSION:The derivates developed from natural products showed fairly well antibacterial *** the derivates related to decanoyl acetaldehyde had lower toxcity than that of derivates obtained from the *** pure synthetic compounds

关键词： decanoyl acetaldehyde derivate ethnodrug active monome derivate antibacterial primer/derivate in vitro antibacterial activity minimal inhibitory concentration

Pharmacokinetic analysis of combined multibottle infusion in an exponential decay pattern

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Pharmacokinetic analysis of combined multibottle infusion in...

中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： XIE Hai-tang~1 HUANG Xiao-hui~2 SONG Jian-guo~3 SUN Rui-yuan~1 1 anhui provincial Centre for drug clinical evaluation,Yijishan Hospital,Wannan Medical College,wuhu 241001,anhui,china 2 center of Pharmacokinetics,College of Pharmacy,anhui Medical University,Hefei 230032,anhui,china 3 Department of Pharmacology,Wannan Medical College,wuhu 241000,anhui,china

To study the rational and scientific way of adminis- trating the drugs whose pharmacokinetics conform to three- compartment open *** on the double-bottle ex- ponential decay infusion introduced by Sun Rui-yuan and Song Jian-guo,this manuscript describe the comabined multi-bottle exponential decay infusion(CMI)in achieving optimal plasma drug concentration thai ensure adequate therapeutic effects in the absence of significant side effects and a rapid return of ***’s transformation was applied to verify group of equations listed according to the specific apparatus and the three compartments with elimination occurs mainly through central compartment, which yields the following equations used in calculating the volumes and concentration of bottle A,B and P respective- ly: C=(CssVK/d);Cbo=(CadK/αβ)(α+β-K);Vb =(d/K);Cpo=(Caπ)/10;Vp=(d/K;C(t)=(dCa/KV)(1-e). It is estirnated that the plasma concentration against time curve of the CMI is the function in mathematics of pai(π), the fast distribution rate constant while in the situation of conventional mono-bottle infusion,the C-T curve is the function in mathematics of beta(β),the slow distribution rate *** pharmacokinetic parameters were obtained and used for calculating the appropriate volumes and concentrations of each bottle *** has verified by animal experiment that the target plasma propofol levels (measured using HPLC)were rapidly attained and main- mined as desired,thus provided an alternative method of drug delivery.

关键词： Combined Multi-bottle Infusion(CMI) exponential decay propofol HPLC

Expert consensus on the clinical application of antibody‐drug conjugates in the treatment of malignant tumors(2021 edition)

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Cancer Innovation 2022年第1期1卷 3-24页

作者： Professional Committee on clinical Research of Oncology drugs,Chinese Anti‐Cancer Association Expert Committee for Monitoring the clinical Application of Antitumor drugs Breast Cancer Expert Committee of National Cancer Quality Control center| Cancer Chemotherapy Quality Control Expert Committee of Beijing Cancer Treatment Quality Control and Improvement center Fei Ma Binghe Xu 不详 Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China DepartmentofMedical Oncology andclinicalTrialcenter National CancerCenter/NationalClinical Research CenterforCancer/Cancer HospitalChineseAcademyofMedical Sciences andPekingUnionMedical CollegeBeijing100021China

Antibody‐drug conjugates(ADCs)are targeted biological agents composed of a cytotoxic drug linked to a monoclonal antibody through a *** monoclonal antibody targets tumor cells and transports small‐molecule cytotoxic drugs for specific delivery and minimal off‐target side *** is necessary for clinicians to understand the molecular characteristics and mechanisms of ***'survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse *** consensus provides a systematic review of commercially available ADCs and further discusses the clinical application and management of ADCs.

关键词： malignant tumors antibody‐drug conjugates monoclonal antibodies cytotoxic drugs safety management

安徽省成人癌症疼痛护理专家共识(2024年版)

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安徽医学 2024年第11期45卷 1341-1349页

作者：安徽省癌痛护理专科联盟专家组安徽省疼痛质量控制中心丁金霞顾康生葛朝亮王立奎胡少华不详安徽医科大学第一附属医院肿瘤内科安徽医科大学第一附属医院药剂科安徽省疼痛质量控制中心安徽医科大学第一附属医院护理部

疼痛是癌症患者常见和难以忍受的症状之一,严重影响患者生活质量。随着医学发展和患者对生活质量的要求不断提高,癌症疼痛综合管理成为评价医疗护理质量、提高患者满意度和治疗依从性的重要指标。近年来,国家和各省级层面对癌症疼痛的... 详细信息

疼痛是癌症患者常见和难以忍受的症状之一,严重影响患者生活质量。随着医学发展和患者对生活质量的要求不断提高,癌症疼痛综合管理成为评价医疗护理质量、提高患者满意度和治疗依从性的重要指标。近年来,国家和各省级层面对癌症疼痛的规范化管理提出了相关要求,具有较强的指导作用,但随着诊疗技术不断进步,以及医疗服务和创新能力不断提升,需要减少癌症疼痛临床管理的差异性,才能促进规范诊疗。为此,安徽省癌痛护理专科联盟牵头,制定《安徽省成人癌症疼痛护理专家共识》。本共识系统检索国内外成人癌症疼痛护理相关文献,结合安徽省对疼痛管理的相关政策要求,进一步梳理了癌症疼痛的相关概念、筛查评估方法和流程、临床护理、健康教育、患者随访等内容,以推动安徽省癌症疼痛护理同质化发展。

关键词：癌症疼痛护理专家共识

山东省医疗机构抗菌药物集中带量采购管理专家共识

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医药导报 2024年第11期43卷 1711-1717页

作者：山东第一医科大学附属省立医院山东省药学会抗菌药物临床应用专业委员会山东省医院感染管理质量控制中心山东省细菌真菌耐药监测质控中心邹东娜沈承武不详山东第一医科大学附属省立医院

随着国家药品集中带量采购(集采)工作进入常态化、制度化,进入集采目录的抗菌药物品种数也随之增加,集采背景下的抗菌药物合理使用已成为行业关注热点。山东省药学会抗菌药物临床应用专业委员会、山东省医院感染管理质量控制中心和山东... 详细信息

随着国家药品集中带量采购(集采)工作进入常态化、制度化,进入集采目录的抗菌药物品种数也随之增加,集采背景下的抗菌药物合理使用已成为行业关注热点。山东省药学会抗菌药物临床应用专业委员会、山东省医院感染管理质量控制中心和山东省细菌真菌耐药监测质控中心组织山东省内专家,依据国家及山东省相关政策法规,结合前期集采管理工作经验,经反复研讨凝练完成《山东省医疗机构抗菌药物集中带量采购管理专家共识》。该共识主要包括抗菌药物集采管理体系建立、抗菌药物目录遴选规则及管理、抗菌药物集采品种报量及任务分解、医疗机构抗菌药物使用监测及管理、基于真实世界的集采抗菌药物临床应用综合评价、培训及宣教、企业责任等内容,以期为山东省乃至国内医疗机构的抗菌药物集采工作提供参考。

关键词：抗菌药物医疗机构集中带量采购专家共识

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我国城市地区人群癌症筛查需求调查分析

中华流行病学杂志 2018年第3期39卷 289-294页

作者：雷海科董佩周琦邱五七孙宗祥黄慧瑶任建松刘国祥白亚娜王德斌孙晓杰廖先珍郭兰伟兰莉刘玉琴龚继勇杨莉邢晓静宋冰冰买玲朱琳杜灵彬张永贞周金意秦明芳吴寿岭齐啸孙校华娄培安蔡波张凯赫捷代敏毛阿燕石菊芳无重庆市肿瘤研究所 400030 中国医学科学院医学信息研究所北京100020 哈尔滨市疾病预防控制中心 150056 国家癌症中心、中国医学科学院北京协和医学院肿瘤医院北京100021 哈尔滨医科大学 150081 兰州大学公共卫生学院流行病与卫生统计学研究所 730000 安徽医科大学合肥230032 山东大学卫生管理与政策研究中心济南250012 湖南省肿瘤医院长沙410006 河南省肿瘤医院郑州450008 甘肃省肿瘤医院兰州730050 山东省肿瘤医院济南250117 广西医科大学南宁530021 辽宁省肿瘤医院沈阳110042 哈尔滨医科大学附属肿瘤医院 150081 新疆医科大学附属肿瘤医院乌鲁木齐830011 浙江省肿瘤医院杭州310022 山西省肿瘤医院太原030013 江苏省疾病预防控制中心南京210009 云南省肿瘤医院昆明650118 开滦总医院唐山063000 唐山市人民医院 063001 宁波市第二医院 315010 徐州市疾病预防控制中心 221006 南通市肿瘤医院 226000 城市癌症早诊早治项目卫生经济学评价工作组

目的了解未参加过城市癌症早诊早治项目及其他国家级癌症筛查项目的城市社区居民对癌症筛查服务的接受意愿及对服务模式细化需求，从筛查潜在服务需求方的角度探索癌症筛查工作可持续性的影响要素。方法基于城市癌症早诊早治项目的16个... 详细信息

目的了解未参加过城市癌症早诊早治项目及其他国家级癌症筛查项目的城市社区居民对癌症筛查服务的接受意愿及对服务模式细化需求，从筛查潜在服务需求方的角度探索癌症筛查工作可持续性的影响要素。方法基于城市癌症早诊早治项目的16个省份现场，采用方便抽样对当地40～69岁居民开展问卷调查，内容包括筛查服务需求意向等。结果最终完成合格访谈16394份，调查对象年龄（53．8±8．0）岁，男性占44．6％。若不考虑费用等因素，4831名（29．5％）居民对癌症筛查服务没有需求，常见原因包括要等身体出现异常后才行动（61．8％）、所在单位已提供类似体检（36．8％）、自己不先做风险评估而直接去做筛查（33．O％）等。10795名（65．8％）居民对癌症筛查服务有需求，但对筛查机构类型选择倾向不同：43．7％希望提供筛查的机构是综合性医院，36．5％希望是肿瘤专科医院；居民对于机构级别选择也有差异：61．4％的居民希望提供筛查的机构级别越高越好，36．4％则认为机构达到一定级别即可。关于筛查流程，61．5％未接收过筛查的居民认同“先问卷评估阳性后再临床检查”的模式。结论大多数居民对癌症筛查服务有需求且倾向筛查机构级别越高越好。应普及癌症筛查知识宣传，并合理引导居民对筛查机构类型及级别的选择期望，建议加强基层筛查能力建设，合理分流居民对筛查机构的选择意愿。

关键词：肿瘤筛查服务需求

Chemoprophylaxis, diagnosis, treatments, and discharge management of COVID-19: An evidence-based clinical practice guideline(updated version)

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Military Medical Research 2020年第3期7卷 249-282页

作者： Ying-Hui Jin Qing-Yuan Zhan Zhi-Yong Peng Xue-Qun Ren Xun-Tao Yin Lin Cai Yu-Feng Yuan Ji-Rong Yue Xiao-Chun Zhang Qi-Wen Yang Jianguang Ji Jian Xia Yi-Rong Li Fu-Xiang Zhou Ya-Dong Gao Zhui Yu Feng Xu Ming-Li Tu Li-Ming Tan Min Yang Fang Chen Xiao-Ju Zhang Mei Zeng Yu Zhu Xin-Can Liu Jian Yang Dong-Chi Zhao Yu-Feng Ding Ning Hou Fu-Bing Wang Hao Chen Yong-Gang Zhang Wei Li Wen Chen Yue-Xian Shi Xiu-Zhi Yang Xue-Jun Wang Yan-Jun Zhong Ming-Juan Zhao Bing-Hui Li Lin-Lu Ma Hao Zi Na Wang Yun-Yun Wang Shao-Fu Yu Lu-Yao Li Qiao Huang Hong Weng Xiang-Ying Ren Li-Sha Luo Man-Ru Fan Di Huang Hong-Yang Xue Lin-Xin Yu Jin-Ping Gao Tong Deng Xian-Tao Zeng Hong-Jun Li Zhen-Shun Cheng Xiao-Mei Yao Xing-Huan Wang center for Evidence-Based and Translational Medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China National clinical Research center for Respiratory Diseases China-Japan Friendship HospitalBeijing 100029China Department of Pulmonary and Critical Care Medicine China-Japan Friendship HospitalBeijing 10029China Leishenshan Hospital in Wuhan Wuhan 430200China Department of Critical Care Medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China Institutes of Evidence-based Medicine and Knowledge Translation Henan UniversityKaifeng 475000HenanChina Department of Medical Imaging Guizhou Provincial People’s HospitalGuiyang 550002China Departments of Orthopedics Zhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Hepatobiliary Surgery Zhongnan Hospital of Wuhan UniversityWuhan 430071China National clinical Research center for Geriatrics West China Hospital of Sichuan UniversityChengdu 610041China Department of Geriatrics West China Hospital of Sichuan UniversityChengdu 610041China Department of Radiology Zhongnan Hospital of Wuhan UniversityWuhan 430071China Department of clinical Laboratory Peking Union Medical College Hospital(PUMCH)Peking Union Medical CollegeChinese Academy of Medical Sciences(CAMS)Beijing 100730China center for Primary Health Care Research Lund University and Region Skåne25002 MalmöSweden Emergency center Zhongnan Hospital of Wuhan UniversityWuhan 403371China Department of Allergology Zhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Radiation and Medical Oncology Zhongnan Hospital of Wuhan UniversityWuhan 43071China Department of Critical Care Medicine Renmin Hospital of Wuhan UniversityWuhan 430060China Department of Emergency Medicine and Chest Pain center Qilu Hospital of Shandong UniversityJinan 250002China Department of Respiratory and Critical Care Medicine Suizhou Central HospitalHubei University of MedicineSuizhou 441300HubeiChina Department of Clinic Pharmacy Second People’s Hospital of Huaihua Ci

The novel severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)is the cause of a rapidly spreading illness,coronavirus disease 2019(COVID-19),affecting more than seventeen million people around the *** and treatment guidelines for clinicians caring for patients are *** the early stage,we have issued"A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus(2019-nCoV)infected pneumonia(standard version)";now there are many direct evidences emerged and may change some of previous recommendations and it is ripe for develop an evidence-based *** formed a working group of clinical experts and *** steering group members proposed 29 questions that are relevant to the management of COVID-19 covering the following areas:chemoprophylaxis,diagnosis,treatments,and discharge *** searched the literature for direct evidence on the management of COVID-19,and assessed its certainty generated recommendations using the Grading of Recommendations,Assessment,Development and evaluation(GRADE)*** were either strong or weak,or in the form of ungraded consensus-based ***,we issued 34 *** them,6 were strong recommendations for,14 were weak recommendations for,3 were weak recommendations against and 11 were ungraded consensus-based *** covered topics of chemoprophylaxis(including agents and Traditional Chinese Medicine(TCM)agents),diagnosis(including clinical manifestations,reverse transcription-polymerase chain reaction(RT-PCR),respiratory tract specimens,IgM and IgG antibody tests,chest computed tomography,chest X-ray,and CT features of asymptomatic infections),treatments(including lopinavirritonavir,umifenovir,favipiravir,interferon,remdesivir,combination of antiviral drugs,hydroxychloroquine/chloroquine,interleukin-6 inhibitors,interleukin-1 inhibitors,glucocorticoid,qingfei paidu decoction,lianhua qingwen granules/capsules,convalescent plasma,lung

关键词： COVID-19 SARS-CoV-2 Recommendation Chemoprophylaxis Diagnosis Treatment Discharge management Traditional Chinese medicine guideline