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Effect of Tanreqing Injection(痰热清注射液)on Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Chinese Medicine Syndrome of Retention of Phlegm and Heat in Fei(肺)

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Chinese Journal of Integrative Medicine 2010年第2期16卷 131-137页

作者：李文毛兵王刚王蕾常静张颖万美华郭佳郑玉琼 Department of Integ rated Chinese and Western Medicine West China HospitalSichuan University Department of Respi ratory Medicine the First People's Hospital of Chengdu City Department of Integrated Chinese and Western Medicine West China HospitalSichuan University Department of Respiratory Medicine the First People's Hospital of Chengdu City

Objective：To explore the effect of Tanreqing Injection（痰热清注射液,TRQI） on the treatment of acute exacerbation of chronic obstructive pulmonary disease（AECOPD） with Chinese medicine syndrome of retention of phlegm and heat in Fei（痰热阻肺证,RPHF）.Methods：In a prospective randomized controlled clinical trial,90 patients with AECOPD of RPHF syndrome were randomly assigned to 3 groups,TRQI and controls A and B,each with 30 *** TRQI group was administered with the intravenous injections of 20 mL TRQI once a day and conventional Western medicine *** group A was administered with the intravenous injection of 15 mg ambroxol hydrochloride twice a day and conventional Western medicine treatment,and control group B was administered with conventional Western medicine treatment *** treatments were administered for 10 *** medical symptoms and signs were scored,and plasma concentrations of interleukin（IL）-8 and neutrophil elastase（NE） were ***：（1） The Chinese medical symptoms （cough,sputum amount,expectoration,dyspnea and fever） and signs（tongue and pulse） improved significantly in the TRQI group（P〈0.05 or P〈0.01）,and improvements in cough,sputum amount and expectoration were better in the TRQI group than control group B（P〈0.05）;there was no significant difference between the TRQI group and control group A（P〉0.05）.The sign of tongue was also improved significantly in the TRQI group （P〈0.05）.（2） The overall effects in the TRQI group and control group A were significantly better than in control group B（P〈0.05）,with no significant differences between the TRQI group and control group A（P〉0.05）.There was no significant difference in the total effective rate among the three groups（P〉0.05）.（3） After treatment, the plasma concentrations of IL-8 and NE decreased in the TRQI group and control group A（P〈0.05）,and the concentration of IL-8 in control group B decreased（P〈0.05）.The difference in IL-8 was greater in the TRQI group than in control group A an

关键词： Tanreqing Injection acute exacerbation of chronic obstructive pulmonary disease retention of phlegm and heat in Fei randomized controlled trial interleukin-8 neutrophil elastase

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Effectiveness of rehabilitation based on recreational activities:A systematic review

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World Journal of Meta-Analysis 2013年第1期1卷 27-46页

作者： Hiroharu Kamioka Kiichiro Tsutani Minoru Yamada Hyuntae Park Hiroyasu Okuizumi Takuya Honda Shinpei Okada Sang-Jun Park Jun Kitayuguchi Shuichi Handa Yoshiteru Mutoh Faculty of Regional Environment Science Tokyo University of Agriculture Tokyo 156-8502 Japan Department of Drug Policy and Management Graduate School of Pharmaceutical Sciences University of TokyoTokyo 113-0033 Japan Human Health Sciences Kyoto University Graduate School of Medicine Kyoto 606-8507 Japan Department of Functioning Activation National Center for Geriatrics and Gerontology Aichi 474-8511 Japan Mimaki Onsen(Spa) Clinic Nagano 389-0402 Japan Japan Society for Promotion of Science Kyoto 619-0288 Japan Physical Education and Medicine Research Foundation Nagano 389-0402 Japan Physical Education and Medicine Research Center Unnan Shimane 690-2404 Japan Research Institute of Nippon Sport Science University Tokyo 158-0081 Japan

AIM: To summarize the evidence from randomized controlled trials(RCTs) on the rehabilitation effects of recreational ***: Studies were eligible if they were RCTs. Studies included one treatment group in which recreational activity was applied. We searched the following databases from 1990 to May 31, 2012: MEDLINE via Pub Med, CINAHL, Web of Science, and Ichushi-Web. We also searched all Cochrane Databases and Campbell Systematic Reviews up to May 31, 2012. RESULTS: Eleven RCTs were identified, which included many kinds of target diseases and/or symptoms such as stroke, dementia, Parkinson's disease, acquired brain injury,chronic non-malignant pain, adolescent obesity, high-risk pregnancy, and the frail elderly. Various intervention methods included gaming technology, music, dance, easy rider wheelchair biking, leisure education programs, and leisure tasks. The RCTs conducted have been of relatively low quality. A meta-analysis(pooled sample; n = 44, two RCTs) for balance ability using tests such as "Berg Balance Scale" and "Timed Up and Go Test" based on game intervention revealed no significant difference between interventions and controls. In all other interventions, there were one or more effects on psychological status, balance or motor function, and adherence as primary or secondary ***: There is a potential for recreational activities to improve rehabilitation-related outcomes, particularly in psychological status, balance or motor function, and adherence.

关键词： Recreation activities randomized controlled trial Rehabilitation effect

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Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices

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Asian Journal of Social Pharmacy 2021年第3期16卷 230-237页

作者： Huang Xianqin Chen Chuhan Dong Li School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in *** Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United *** and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical *** addition,the RWE has a wide range of applications in the field of medical devices in *** recent years,the RWE has received extensive attention in the medical field in the United *** FDA has issued related guidelines,and its applications have gradually formed a complete *** on RWE will become the development trend of clinical evaluation of medical devices in the *** attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.

关键词： real-world evidence randomized controlled trial medical device supervision

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Clinical Assessment of a Pharmaceutical Polyphenol Fruit Extract Gel to Inhibit Dental Plaque

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Pharmacology & Pharmacy 2021年第9期12卷 177-189页

作者： Steven P. Goh David M. Goh E. Russell Vickers Suite 1 76A Archer St Chatswood NSW 2067 Australia Clinical Stem Cells Sydney Australia

Oral bacteria (e.g. Porphyromonas gingivalis) are associated and potentially co-causative in several medical conditions including Alzheimer’s disease and increased cardiovascular risk. Naturally occurring polyphenols are a developing class of antimicrobial pharmaceutical agents. The use of plant-based polyphenol compounds is an attractive area of medical and dental research due to their high safety factor from their presence in vegetables and fruits. This preliminary study evaluated polyphenols found in berries to reduce bacterial dental plaque accumulation. The study was an in vivo single blind randomized controlled trial of seven subjects with a novel tooth gel using validated measurements. Results showed a significant reduction in plaque accumulation (p = 0.005) and a non-significant trend to reduce gingivitis (p = 0.08). The bioactive gel showed no local or systemic adverse effects and was well tolerated by subjects.

关键词： Dental Plaque Gingivitis Polyphenol Quercetin randomized controlled trial

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Efficacy and prognosis of mastoscopic axillary lymph node dissection for breast cancer:a systematic evaluation and meta-analysis

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TMR Cancer 2021年第4期4卷 18-27页

作者： Hong-Yi Lan Yi-Hua Fan Yang Chen Wan-Ting Cui Wen-Han Li Hao-Fang Guan Xin-Ju Li Tianjin University of Traditional Chinese Medicine Tianjin301617China First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin300193China National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin300381China Tianjin University of Traditional Chinese Medicine No.10 PoYang Lake RoadWest DistrictTuanbo New TownJing-Hai DistrictTianjin301617China

Objective:To systematically evaluate the efficacy and prognosis of breast lumpectomy axillary lymphatic dissection for the treatment of breast ***:We use computer to search PubMed,The Cochrane Library,EMBASE,Web of Science,China Knowledge Network,Wanfang database,VIP database and CBM for randomized controlled trials(RCTs)of breast lumpectomy in axillary lymphatic dissection for breast *** search time frame was from the database establishment to July ***-analysis was performed using Revman 5.4.1 software after 2 investigators independently screened the literature,extracted information,and evaluated the risk of bias of the included ***:A total of 20 RCTs including 2672 patients were *** axillary lymph node dissection(MALND)was used in the trial group and conventional axillary lymph node dissection(CALND)was used in the control *** results showed that the trial group was more effective in controlling bleeding volume[MD=-54.72,95%CI(-79.73,-29.71),P<0.00001],postoperative drainage[MD=-98.99,95%CI(-128.83,-69.15),P<0.00001],length of hospital stay[MD=-2.75,95%CI(-4.67,-0.83),P=0.005],and incidence rate of adverse reaction[RR=0.30,95%CI(0.19,0.45),P<0.00001]were superior to the control group,and the differences were statistically ***:Current evidence suggests that MALND can achieve better outcomes compared with *** is more advantageous in controlling the bleeding volume,postoperative drainage,length of hospital stays,and incidence rate of adverse events.

关键词： Axillary lymph node dissection Breast lumpec-tomy Breast cancer randomized controlled trial Meta-analysis

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Meta-analysis of traditional Chinese medicine and western medicine in treating retinal vein occlusion complicated by macular edema

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Journal of Hainan Medical University 2020年第17期26卷 32-38页

作者： Zi-Qiang Liu Huan Meng Lu-Qi Nong Meng-Yu Han Ying-Xin Zi Yu Deng Xin-Ke Ji Ming Jin 无 Beijing University of Chinese Medicine Beijing 100029 China Department of ophthalmology China-Japan Friendship HospitalBeijing 100029 China

Objective:TMeta-analysis was performed to evaluate the clinical efficacy of the combination of traditional Chinese medicine and western medicine in treating patients with retinal vein occlusion(RVO)complicated by macular edema(ME).Methods:We searched The CNKI,Wanfang Data,PubMed and Cochrane Library from *** of randomized controlled trials(RCTs)of the combination of traditional Chinese medicine and western medicine in treating patients with RVO complicated by ME were *** Revman5.3 software were used for ***:A total of 30 trials involving 1943 patients and 1976 eyes were ***-analysis showed that compared with western medicine,the combination of traditional Chinese medicine and western medicine can significantly improve the best corrected visual acuity[(MD=0.08,95%CI=0.07~0.10,P<0.00001)(MD=-0.16,95%CI=-0.24^-0.08,P=0.0002)(MD=5.78,95%CI=1.30~10.25,P=0.01)],reduce the central macular thickness(MD=-54.6,95%CI=-73.76^-35.43,P<0.00001),and improve the clinical effective rate(RR=1.32,95%CI=1.22~1.43,P<0.00001).Conclusion:The combination of traditional Chinese and western medicine in treating patients with RVO complicated by ME was superior to western medicine in improving the best corrected visual acuity,reducing the thickness of macular fovea and improving the clinical efficacy.

关键词： Combination of traditional Chinese medicine and western medicine Retinal vein occlusion Macular edema randomized controlled trial Meta-analysis

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Why meta-analyses are important for complementary and alternative medicine research

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World Journal of Meta-Analysis 2015年第1期3卷 1-3页

作者： Holger Cramer Department of Internal and Integrative Medicine Kliniken Essen-Mitte Faculty of Medicine University of Duisburg-Essen

Complementary and alternative medicine(CAM) is defined as a group of interventions that are not generally considered part of conventional medicine. This definition already implies that CAM interventions are often not systematically studied; and the research evidence from single trials on CAM is often limited by small sample sizes, unclear methodology, and inadequate statistics. As a result, both, significant and insignificant results are oftenhard to interpret based on single trials. Summarizing the evidence from single CAM trials, qualitative systematic reviews still have to deal with the same problems as individual trials as they can only rely on the original reports. Thus, effects of CAM interventions are often underestimated or overestimated based on single trials or qualitative systematic reviews. While meta-analyses still are limited by the methodological shortcomings of the included studies, a well-conducted meta-analysis can deal with two common problems of CAM trials: inadequate statistics that rely on within-group comparisons and small underpowered sample sizes. Although large and high quality trials are urgently needed for most CAM interventions, funding often is limited. Until higher quality research is available, meta-analyses provide a useful tool to investigate the actual level of evidence of currently published CAM trials. This editorial presents examples of meta-analyses in the field of CAM and discusses how they contribute to the consolidation of evidence.

关键词： Complementary therapies Meta-analysis Review randomized controlled trial Bias

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Evaluation of the Clinical Efficacy of Qingqiao Capsule (清窍胶囊) in Treating Patients with Secretory Otitis Media

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Chinese Journal of Integrated Traditional and Western Medicine 2005年第4期11卷 243-248页

作者：孙永东陈隆晖胡文健姜玉良陈小林张世波 Depart ment of Otolaryngology the Sixth People s Hos-pital of Zigong Sichuan 643020 Depart ment of Oto-laryngology the Second Affiliated Hospital of Luzhou Med-ical College Depart ment of Preparation the Second Af-filiated Hospital of Luzhou Medical College

Objective： To observe the clinical efficacy of Qingqiao Capsule （清窍胶囊, QQC） in treating patients with secretory otitis media （SOM）. Methods： A total of 90 patients were randomly assigned into the treated group （n：45） and the control group （n=45）. Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5g each time for adult, 3 times a day, or 20mg/（kg·d） for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. Results：（1） The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference （P〈0.01）; （2） Comparison of the efficacies in patients of three different TCM syndrome types （the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type） showed no statistically significant difference（P〉0.05）; （3） The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant （P〈0.05 or P〈0.01）, only those of earache, otopiesis and abnornal pulse figure were insignificantly different between the two groups （P〉0.05）. Conclusion： QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.

关键词： Qingqiao Capsule secretory otitis media integrated traditional Chinese and Western medical treatment randomized controlled trial

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局部麻醉药物治疗早泄的疗效和安全性：系统性回顾和荟萃分析

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Asian Journal of Andrology 2013年第4期15卷 497-502,I0008页

作者： Jia-Dong Xia You-Feng Hart Liu-Hua Zhou Yun Chen Yu-Tian Dai Division of Andrology Nanjing Drum Tower Hospital Nanjing Medical University Nanjing 210008 China and Division of Andrology The Affiliated Drum Tower Hospital of Nanjing University School of Medicine Nanjing 210008 China

To assess the efficacy and safety of local anaesthetics for premature ejaculation （PE）, a systematic review of the literature was performed using the Cochrane Library, PUBMED and EMBASE. We screened and retrieved the randomized controlled trials on the treatment of PE with local anaesthetics. End points included intravaginal ejaculation latency time （IELT）, patient-reported outcome assessments and adverse events. Meta-analyses were conducted with Stata 11.0. In total, seven publications involving 566 patients with local anaesthetics and 388 with placebos strictly met our eligibility criteria. Meta-analyses showed that after the patients were treated with the local anaesthetics, the value of the standardized mean difference of the changes in IELT was 5.02 （95% Ch 3.03- 7.00）. A higher rate of adverse events occurred compared with placebos （odds ratio： 3.30, 95% Ch 1.71-6.36）, but these events were restricted to local side effects. In addition, significantly greater improvement was observed in patient-reported outcomes. In summary, local anaesthetics can prolong IELT and improve ejaculatory control and sexual satisfaction.

关键词： local anaesthetics premature ejaculation (PE) randomized controlled trial systematic review

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Acupuncture and Fluoxitine versus Fluoxitine for Depression:A Systematic Review

Acupuncture and Fluoxitine versus Fluoxitine for Depression:...

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安徽省药理学会2012年学术年会

作者： Ling-li Zhu Department of Pharmacy Anqing Medical and Pharmaceutical College

Objective To assess the efficacy of acupuncture and fluoxitine versus fluoxitine in the treatment of *** randomized controlled trials(RCTs) involving acupuncture and fluoxitine versus fluoxitine in the treatment of depression in China were identified from CNKI(1990～2012),VIP(1990～2012),WANFANG Database(2000～2012) and CBM(1978～2012). We also hand searched relevant journals and conference *** were extracted and evaluated by two reviewers independently with a specially designed extraction *** Cochrane Collaboration’s RevMan5.1 software was used for data *** A total of 8 trials involving 306 patients were ***-analyses showed:(1) The total effective rate in the acupuncture with fluoxetine group was above compared with fluoxetine [OR=3.92,95%CI(2.17,7.08)].There were significant difference.(2)The cure rate in the acupuncture with fluoxetine group was higher compared with fluoxetine[OR=2.43,95%CI(1.44, 4.11)].There were significant difference.(3)For the HAMD scores at week 2,4 and after treatment, there were significant difference between acupuncture with fluoxetine and fluoxetine [WMD=-3.40,95%CI(-5.59,-1.21)],[WMD=-3.69,95%CI(-5.86,-1.52)]and[WMD=-3.55, 95%CI(-5.16,-1.93)].(4)In terms of the SDS score at after treatment,no significant differences were noted between acupuncture with fluoxetine and *** Acupuncture with fluoxetine is superior to *** large-scale trials are required to define the role of acupuncture in the treatment of depression.

关键词： Acupuncture fluoxitine Depression randomized controlled trial Systematic revie

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