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THE LABORATORY AND clinical studies OF SULFONAMIDES

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中华医学杂志(英文版) 1980年第4期93卷 207-216页

作者：汪复张梅芳张敬德张志林顾亚明刘裕昆戴自英 clinical Research Laboratory of Antibiotics Huashan Hospital Shanghai First Medical College Shanghai

This paper reports the results of antibacterial, pharmacologic and clinical studies on the sulfonamides, trimethoprim (TMP) and sulfonamide-TMP combinations manufactured in China. Bacterial sensitivity tests of these drugs were carried out on 3,549 strains of pathogens, belonging to 18 bacterial species, isolated clinically. When combined with TMP, the antibacterial activities of the sulfonamides were greatly enhanced particularly on Staph. aureus, E. coli, Enterobacter aerogenes and proteus spp, which were approximately similar to those of kana mycin or gentamycin. Under similar conditions the blood and urine concentrations of 7 different kinds of sulfonamides and TMP administered orally, intramuscularly, and intravenously were determined in a group of healthy volunteers. The data indicate that sulfadiazine (SD), which for a long time had been considered as a short-acting drug and its dosage was greater than actually needed, is a medium-acting sulfonamide. In our study, SD was used in reduced dosage in the treatment of various infections, and favorable clinical results were obtained with much fewer side effects. Sulfonamides alone and their combination with TMP were used in 2,486 patients of typhoid fever, pneumonia, bacillary dysentery, acute and chronic urinary infections etc., the effective rates being 83.3% and 92.5% respectively. It is better to use sulfonamide compounds in patients suffering from various infections with the exception of meningococcal meningitis. In more severe cases, it is advisable to take the drug by parenteral routes at the start, in order that effective serum levels may be reached as early as possible. Preliminary data indicated that SD compound used instead of SMZ compound in various clinical situatiens is just as effective if not more so. Both the two sulfonamide compounds are commonly used in our clinics at present.

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EXPERIMENTAL AND clinical studies OF “SHEN YAN LING” IN TREATMENT OF CHRONIC GLOMERULONEPHRITIS

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Journal of Traditional Chinese Medicine 1989年第2期9卷 132-134页

作者：王淑琴杜雪荣吕惠文王泰玲李红 Department of TCM Third Clinical CollegeBethune Medical UniversityChangchun Department of Pathology Faculty of Basic Medical SciencesBethune Medical UniversityChangchun

“Shen Yan Ling”(SYL 肾炎灵) is a compoundherbal preparation consisting of 16 ingredients:HerbaEcliptae,Radix Rhemanniae,Rhizoma Cibotii,RadixAngelica Sinensis,Rhizoma Ligustici Chuanxiong,Radix Paeoniac Rubra,Rhizoma Diosocoreae,Poria,Radix Sanguisorbae,Radix Rubiae,Herba Portulacae,Fructus Gardeniae,Herba Cirsii Japonici,*** animal experiments,SYLwas shown to have therapeutic effect for Masugi’snephritis *** has also been used with satis-factory results in the treatment of 314 cases of chronicglomerulonephritis of the common type with manifes-tations of Yin deficiency and endogenous heat.

关键词： Radix 肾炎灵 glomerular Poria endogenous blank satis SHEN YAN LING factory markedly

Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies

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Medical Review 2023年第5期3卷 408-424页

作者： Han Cao Chen Yao Ying Yuan Department of Biostatistics Peking University First HospitalBeijingChina Medical Data Science Center Beijing Tsinghua Changgung HospitalSchool of Clinical MedicineTsinghua UniversityBeijingChina Department of Biostatistics Peking University First HospitalNo.8XishikudajieXicheng DistrictBeijing100034China Peking University clinical Research Institute Beijing 100083China Hainan Institute of Real World Data Qionghai 571437Hainan ProvinceChina Department of Biostatistics The University of Texas MD Anderson Cancer CenterHoustonUSA

Medical device technology develops rapidly,and the life cycle of a medical device is much shorter than *** is necessary to evaluate the safety and effectiveness ofamedical device in a timelymanner to keep upwith technology *** methods provides an efficient approach to addressing this *** this article,we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting,including Bayesian adaptive design,Bayesian diagnostic design,Bayesian multiregional design,and Bayesian label expansion *** illustrate these designs with medical devices approved by the US Food and Drug Administration(FDA).We also review several innovative Bayesian information borrowing methods,and briefly discuss the challenges and future directions of the Bayesian application in medical device *** objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.

关键词： medical device Bayesian design Bayesian information borrowing

HBV resistant to lamivudine: experimental and clinical studies

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Hepatobiliary & Pancreatic Diseases International 2002年第4期1卷 519-522页

作者： Dong-Yao Zhou Yong-Jian Cao Lian-Ying Lin Hong Wang Jian-Sheng Huang the Department of clinical Laboratory Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510120, China Institution of Molecular Biology Diagnostic Center, First Military Medical University, Guangzhou 510515, China Department of clinical Lab. Medicine Guangdong Prov. Hosp. Trad. Chinese Guangzhou 510120 China Inst. of Molec. Biol. Diagnost. Ctr. First Military Medical University Guangzhou 510515 China

Objective: To identify the impact of lamivudine on HBV e antigen (HBeAg) seroconversion and HBV DNA level, and the appearance of Tyr-Met-Asn-Asp (YMDD) resistants. Methods: Forty-seven hepatitis B patients were trea- ted with oral lamivudine. ALT level and HBeAg were detected in the treatment on the zero, 3rd, 6th and 9th month respectively. The levels of HBV DNA and YMDD resistants were analyzed with PCR mi- croplate hybridization-ELISA. Results: After 9 months of treatment, HBV DNA be- came negative and ALT level was normal in 74% pa- tients. Among these patients, 17% patients had HBeAg converted to negative and anti-HBe antibody positive, whereas another 15% patients showed HBeAg negative. YMDD resistants appeared in 19 % patients (9/47). One, three and five resistants were detected in the treatment on the 3rd, 6th and 9th month respectively. Conclusions: Most HBV DNA in serum became nega- tive after 9 months of treatment, and the rate of HBeAg seroconversion was 17% (HBV DNA level was lower than 100 pg/ml before treatment). YMDD resistants appeared in 19% patients.

关键词： lamivudine Tyr-Met-Asn-Asp mutants microplate hybridization HBeAg seroconversion

Key elements that determine the efficacy of cupping therapy:A bibliometric analysis and review of clinical studies

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Journal of Traditional Chinese Medical Sciences 2020年第4期7卷 345-354页

作者： Jiayin Tao Pei Zhao Tingting Mo Ruiming Zhao Nan Yang Myeong Soo Lee Jianping Liu Huijuan Cao Dongzhimen Hospital Beijing University of Chinese MedicineBeijing100700China Department of Respiration China-Japan Friendship HospitalBeijing100029China clinical Research Division Korea Institute of Oriental MedicineDaejeon34054South Korea Korean Convergence Medicine University of Science&TechnologyDaejeon34113South Korea Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing100029China

Objective:The aim of this review was to identify the possible mechanisms behind cupping therapy by employing an evidence-based approach,and to explore its possible regional and systemic effects in the human ***:We searched six electronic databases and four online trial registries for articles published up to January 1,*** studies on the mechanisms of retained cupping,flashing cupping,moving cupping,and vacuum cupping were considered for this *** methodological qualities of controlled studies were assessed using the National Institute for clinical Excellence methodology checklist,the Newcastle-Ottawa Scale,and the Cochrane risk of bias *** statistical description and qualitative summary of results were used for data ***:Thirty-eight studies(37 full texts and one abstract)were included in this *** to the clinical heterogeneity among the studies,we could not conduct a *** results showed that the key factors that contribute to the efficacy of cupping therapy are negative pressure and *** therapy mainly causes local and systemic changes in hemodynamics,immune regulation,metabolism,and pain ***:We identified negative pressure as the key element behind cupping *** therapy may cause redistribution of oxygen at the cupping site and in neighboring tissues,thereby inducing a therapeutic effect by increasing regional blood *** may also induce metabolic change,immunomodulation,and ***,additional rigorous clinical research needs to be conducted to further clarify the mechanism behind cupping therapy.

关键词： Cupping therapy Negative pressure Immunomodulation Temperature Hemodynamics Bibliometrics

The Potential Effects and Use of Chinese Herbal Medicine Pine Pollen(Pinus pollen):A Bibliometric Analysis of Pharmacological and clinical studies

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World Journal of Traditional Chinese Medicine 2020年第2期6卷 163-170页

作者： Shi-Bing Liang Ning Liang Fan-Long Bu Bao-Yong Lai Ya-Peng Zhang Hui-Juan Cao Yu-Tong Fei Nicola Robinson Jian-Ping Liu Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing College of Basic Medical Sciences Shanxi University of Traditional Chinese MedicineTaiyuan Institute of Basic Research in clinical Medicine China Academy of Chinese Medical SciencesBeijing The Third Affiliated Hospital of Beijing University of Chinese Medicine BeijingChina School of Health and Social Care London South Bank UniversityLondonUK Institute of Integrated Traditional Chinese Medicine and Western Medicine Guangzhou Medical UniversityGuangzhouChina

The objectives of this study are to conduct a comprehensive literature search and bibliometric analysis to identify the breadth and volume of pharmacological and clinical studies on pine pollen(Pinus pollen)and to identify the potential effects and the use of pine *** Chinese electronic databases and two English electronic databases were searched for pharmacological and clinical studies on pine *** were extracted and analyzed and included publication year,authors,study type,pharmacological research topics or clinical diseases/conditions,usage and type of preparation,authors’conclusions,and adverse *** 239 publications identified,180 were pharmacological studies,37 were clinical trials,and 22 were *** of publications increased particularly from 2004 *** top 10 most frequent topics in pharmacological studies were immune regulation,antisenility,antioxidation,liver protection,inhibiting prostate hyperplasia,inhibiting tumor cell proliferation,lowering blood glucose,lowering blood lipids,antifatigue,and improving intestinal *** top 10 most frequent clinical diseases treated or where pine pollen was used as an adjuvant were bedsores,diaper dermatitis,hyperlipidemia,oral mucositis,eczema,hyperplasia of prostate,hypertension,prostatitis,type 2 diabetes mellitus,and *** trials reported no adverse events associated with pine pollen,one reported mild gastrointestinal reactions,but symptoms disappeared without special *** have been an increasing number of publications on pine pollen during the past 20 *** studies have shown many potential benefits,and clinical studies have indicated some positive effects when it is either used as a single herb or as an adjuvant to treat *** use as a topical agent,especially for skin diseases,was notable.

关键词： Bibliometric analysis Chinese herbal medicine pine pollen Pinus pollen skin disease

Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of clinical studies

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Chinese Journal of Integrative Medicine 2021年第7期27卷 483-489页

作者： LIU Jun WANG Nian DANG Hai-xia CHEN Bing-wei ZHANG Li ZOU Chong ZHONG Cheng-liang HUANG Ju-kai LIU Qiong YU Ya-nan JIANG Meng LIANG Wei-xiong CHEN Qi-guang WANG Yong-yan SHEN Chun-ti WANG Zhong World Federation of Chinese Medicine Societies—Data Monitoring Committee for clinical studies Institute of Basic Research in clinical Medicine China Academy of Chinese Medical SciencesBeijing100700China China Academy of Chinese Medical Sciences Beijing100700China School of Public Health Southeast UniversityNanjing210009China Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Beijing100078China Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated Hospital of Nanjing University of Traditional Chinese MedicineNanjing210029China First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin300381China Guangdong Hospital of Traditional Chinese Medicine Guangzhou510120China Changzhou Traditional Chinese Medicine Hospital ChangzhouJiangsu Province213004China 不详

Although there is guidance from different regulatory agencies,there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee(DMC)for clinical studies of Chinese *** names it as a Chinese Medicine Data Monitoring Committee(CMDMC).A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of ***,a community standard on CMDMCs(T/CACM 1323-2019)was issued by the China Association of Chinese Medicine on September 12,*** paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs,which will further develop the scientific integrity and quality of clinical studies.

关键词： data monitoring committee Chinese Medicine Data Monitoring Committee clinical trial community standard Chinese medicine

PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM clinical PHARMACOLOGY studies

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中国临床药理学杂志 1988年第2期4卷 101-104页

作者： Jan Koch-Weser M.D. clinical Research F.Hoffmann-LA Roche & Co.Ltd.Switzerland

The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European *** is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-

关键词： PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM clinical PHARMACOLOGY studies

THE PROBLEMS AND COUNTERMEASURES IN IMPLEMENTING RANDOMIZED PROTOCOL FOR ACUPUNCTURE clinical studies

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Journal of Integrative Medicine 2014年第3期 278-278页

作者： Tian-cai Wen Shi-yan Yan Wen-jing Bai Li-yun He Bao-yan Liu Institute of Basic Research in clinical Medicine China Academy of Chinese Medical Sciences China Academy of Chinese Medical Sciences

Objective: Based on analyzing the randomized protocols and implementation of past acupuncture projects, this paper would figure out the problems and provide countermeasures to improve the randomization application in further clinical trials of ***: Seventeen acupuncture projects using a central randomized computer system for treatment assignment were selected In order to identify the complexity of randomized protocols, this paper analyzed the indicators for the above ***: In these 17 projects, the mean number was 436 for sample *** average number for groups was three, and the maximum number was nine.A site-stratified block method was used in 15 studies, which means each group had equal sample sizes for different ***, in another two projects using sample randomized method, the sample size ratio for groups had not satisfied with the projects’ protocols and the mean unequal rate among different groups were 15.72% and 14.01%, respectively For all these 17 projects, sometimes more than one randomized number were misused to same subject by clinical researchers because of error operation, and the mean misused number per project was *** randomized protocols were adjusted *** error case allocation existed in 8 projects(47%) using the disorder-randomized method than the other 9 projects using sequential-order-randomized method, and the mean error case allocations for the above two groups were one and two cases, ***: Randomized, controlled and open-label design is usually used in acupuncture clinical *** trial group number is always more than that in drug clinical *** disorder-randomized method could improve researchers’ *** block design method or dynamic randomized algorithm(e.g., minimization method) could be used to avoid program adjustment during study implementation and unbalanced sample sizes among different comparison groups.

关键词： THE PROBLEMS AND COUNTERMEASURES IN IMPLEMENTING RANDOMIZED PROTOCOL FOR ACUPUNCTURE clinical studies