Improving the Selection Model of Essential Medicines in China by Evidence-based Thinking

Objective To sort out the problems in the selection model of essential medicines in China,and to put forward some suggestions to optimize the selection model to ensure the rationality of the medicines in the essential medicines list.Methods The domestic and foreign literature on the selection of essential medicines was reviewed.Then,the opinions on the selection methods and results of essential medicines from foreign literature were investigated to make a comparison with the selection of essential medicines in China.Finally,the general and special laws of the selection process of the essential medicines were explored.Results and Conclusion It is recommended that the selection model of essential medicines in China should be further optimized,and the evidence-based thinking and methods should be utilized to enhance the scientific nature of the selection process.

Research in spinal surgery: Evaluation and practice of evidence-based medicine

Evidence-based medicine(EBM) is a common concept among medical practitioners, yet unique challenges arise when EBM is applied to spinal surgery. Due to the relative rarity of certain spinal disorders, and a lack of management equipoise, randomized controlled trials may be difficult to execute. Despite this, responsibility rests with spinal surgeons to design high quality studies in order to justify certain treatment modalities. The authors therefore review the tenets of implementing evidencebased research, through the lens of spinal disorders. The process of EBM begins with asking the correct question.An appropriate study is then designed based on the research question. Understanding study designs allows the spinal surgeon to assess the level of evidence provided.Validated outcome measurements allow clinicians to communicate the success of treatment strategies, and will increase the quality of a given study design. Importantly,one must recognize that the randomized controlled trial is not always the optimal study design for a given research question. Rather, prospective observational cohort studies may be more appropriate in certain circumstances, and would provide superior generalizability. Despite the challenges involved with EBM, it is the future of medicine. These issues surrounding EBM are important for spinal surgeons, as well as health policy makers and editorial boards, to have familiarity.

Application of evidence-based medicine methods in integrative oncology research

To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.

Clinical Observation and Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for Dermatosis

[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.

The artificial intelligence evidence-based medicine pyramid

Several studies exist in the literature regarding the exploitation of artificial intelligence in intensive care.However,an important gap between clinical research and daily clinical practice still exists that can only be bridged by robust validation studies carried out by multidisciplinary teams.

Comparative Evaluation of Antitumor Chinese Patent Medicine Injections Based on Evidence-Based Medicine and Markov Model

Objective: The objective of this study was to explore the safety, efficacy, economy, and other aspects of frequently-used antitumor Chinese patent medicine injections through a comprehensive evaluation of evidence-based medical research to provide scientific information and decision-making basis for drug selection, rational drug use, public awareness of safe drug use, and medical insurance. Materials and Methods: The names of five frequently used antitumor Chinese patent medicine injections were used as search terms, including the compound Sophora flavescens injection, Kangai injection, Aidi injection, Kanglaite injection, and Brucea javanica oil emulsion injection. Relevant evidence-based medical research was extracted from the databases. A descriptive evaluation was conducted, and the Markov model was used for the cost-benefit analysis. Finally, the above injections are ranked by comprehensive scores using the multi-criteria decision analysis and Delphi method. Results: The five injections had their own advantages in enhancing the effectiveness of anti-tumor treatments, improving the quality of life for cancer patients, and reducing the incidence of adverse reactions. From the perspective of economy and other attributes, compound S. flavescens was superior to B. javanica oil, Aidi, Kangai, and Kanglaite. After a comprehensive evaluation of the above five injections, the compound S. flavescens injection received the highest score. Conclusions: Compound S. flavescens, Kangai, Aidi, B. javanica oil, and Kanglaite have their own advantages in effectiveness and no significant difference in safety. Compound S. flavescens injection has the highest comprehensive score. Clinical attention should be paid to monitoring the initial stage of medication and special groups.

循证医学(Evidence-based Medicine)——临床研究与实践的新时代

80年代以来的大规模、随机、双盲、多中心、安慰剂对照临床试验证明,以经验和推论,如以一些临床化验指标为依据的传统临床试验不能反映病人的长期预后。为了对新药和已上市药物作出恰当的评价,应当从所谓“众说纷坛”转向注重和评价病人预后,包括总死亡率、重要心脑血管事件、生活质量、卫生经济学等的“循证医学”。反过来,“循证医学”和临床治疗指南的发展将对新药的研究与开发、医生的临床实践、药物经济学、医疗保健服务决策等带来积极和正面的影响。

Traditional Chinese Medicine as a Treatment for Rheumatoid Arthritis:From Empirical Practice to Evidence-Based Therapy

Rheumatoid arthritis(RA)is a common autoimmune condition with an elusive etiology.Conventional and biological disease-modifying drugs sometimes fail or produce only partial responses.Traditional Chinese medicine(TCM)has long been used in China as a treatment for RA and is achieving everincreasing acceptance worldwide.TCM treatments are traditionally guided by the theory of treatment based on TCM syndrome differentiation;however,they remain a matter of empirical practice relying on TCM theories and doctors’own experience,which places severe restrictions on worldwide TCM application.Nevertheless,TCM is a treasure trove for drug discovery,particularly as a treatment for complicated human conditions.The discoveries of artemisinin as a treatment for malaria and of TCM–arsenic trioxide(As2O3)combination therapy as a treatment for acute promyelocytic leukemia(APL)are excellent examples of the great value of TCM.Regarding RA treatments,many Chinese medicinal herbs and their formulas,extracts,ingredients,and even single compounds have been used in clinical applications.Several Chinese proprietary medicines(CPMs)derived from TCM formulas or herbal bioactive components,such as the controlled-release ZhengQingFengTongNing(ZQFTN)Tablets,Tripterygium Glycoside Tablets,and Total Glucosides of Peony(TGP)Capsules,have been included in the National Health Insurance Directory of China,and show comparable therapeutic efficacies to those of western chemical drugs with fewer side effects.As TCM research has advanced,particularly in the use of multidisciplinary technologies,the scientific foundations and characteristics of the use of TCM to treat RA have been revealed,and the quality of TCM treatments have been increasingly enhanced.However,TCM generally lacks sufficient clinical and laboratory data to be consistent with international standards for quality,safety,and efficacy in order to support its application worldwide.Therefore,intensive basic and clinical studies on TCM are required.In particular,investigations that use cutting-edge technologies in analytical chemistry,biology,and biomedical sciences,and the development of randomized clinical trials(RCTs)and personalized pragmatic randomized controlled trials(PPRCTs)are necessary.Researchers should also collaborate to advance TCM from empirical practice to evidence-based therapy,thus consistently promoting TCM development and globalization in a vital,beneficial,and contributable manner.

Optimization of evidence-based research in the prevention and treatment of coronary heart disease with traditional Chinese medicine:A comprehensive review

Coronary heart disease(CHD) has severely impacted the lives and health of patients for ages. Although the modern methods used for the prevention and treatment of CHD have been increasingly perfected,clinical problems remain that require solutions. In the prevention and treatment of CHD with traditional Chinese medicine(TCM), great therapeutic advantages have been demonstrated. However, the expression of its advantages relies on scientific evidence-based research and evaluation, which require further optimization and improvement. Therefore, this review aims to comprehensively emphasize our understanding of the current deficiencies in TCM evidence-based studies and the necessity of adopting scientific evidence-based optimization methods for use in research. In this process, evidence should be produced in a standard manner, and the advantages of TCM patterns should be accurately stated because these factors contribute to efficient transformation and proper verification of the obtained evidence.Additionally, focusing on patient-oriented medicine and doctor-patient relationships is also essential.These methods are of great significance to prove the clinical efficacy of TCM and promote its development.

Biological Evaluation of ChuangYuLing Dressing—A Multifunctional Medicine Carrying Biomaterial

The safety of Chuangyuling (CYL) dressing—a multifunctional medicine carrying biomaterial was evaluated in order to provide foundation for the application of CYL as material used in the wound healing. The traditional Chinese medicine (TCM) extract solution was compounded with scaffolds (gelatin and Bletilla hyacinthine gum), and then frozen and dried to form spongy and porous material CYL. According to the standard of biological evaluation of medical devices that was instituted by the ministry of health of China \, the biological evaluation of CYL dressing was conducted. The results showed that all the contents of biological evaluation test consisting of acute toxicity, skin irritation, sensitization and cytotoxicity met the requirement of standards. It was concluded that the biomaterial carrying TCM (CYL dressing) is safe for application of wound healing.

Calling into Question the Efficacy of Evidence-Based Medicine: Is It Always the Best Approach? Is That Really the Placebo Effect?

The techniques of evidence-based medicine (EBM) are being frequently used recently. The generally accepted theory is that if a medicine is not absorbed by the body, it will have no effect. However, the author has noticed that even when substances, including medicines, are not absorbed by the body, they can have a marked effect. In some cases, just bringing the substance close to the body can have an effect;in such cases, the efficacy of EBM for estimating the therapeutic value of medicines may be debatable. Therefore, a more accurate evaluation method should be devised. The author proposes that another group be introduced into trials. This group would include subjects who were exposed to but did not have an opportunity to absorb the medicine being tested.

Evidence-Based Medicine Research on Prescriptions in Synopsis of the Golden Chamber in the Treatment of Pelvic Inflammatory Disease

Purpose: Based on the National Natural Science Foundation of China, we collect and sort out the literature published in approximately the last 30 years, which use prescriptions in Synopsis of the Golden Chamber to treat pelvic inflammatory disease (PID). This study provides theoretical basis for the treatment of PID;we recommend this achievement to colleagues. Method: Firstly, we searched and collected the literatures from last three decades in CNKI, Wanfang and VIP databases, which are about classical prescriptions treating endometriosis. Then, by screening all the literatures, we obtained the clinical research literatures and individual case reports. Finally, we went through the internal quality of the two categories of literatures to get the dominant prescriptions. Using a retrospective study of evidence-based medicine research, we comprehensively collect literature, standardize the disease spectrum, classify the evidence, and then evaluate the internal quality. Results: We refine 4 prescriptions which commonly are used in the treatment of PID;in other words, they are also the clinical symptoms of PID: Gui Zhi Fu Ling Wan symptom, which manifests blood stasis and cold-damp stagnancy;Dang Gui Shao Yao San symptom, which manifests disharmony of liver and spleen, qi-blood stasis and damp obstruction;Da Huang Mu Dan Tang symptom, which manifests the gathering toxic heat and qi-blood stasis;Yi Yi Fu Zi Bai Jiang San symptom, which manifests the internal toxic heat and qi-blood injury. Conclusion: This study is gospel for the patients with recurrent episodes of PID who can’t often use antibiotics. At the same time, it is also a green therapeutics which Chinese ancients dedicated to human medicine.

Accelerating the comprehensive and systematic evaluation of clinical evidence for Chinese medicine using a whole-evidence approach

Modern Chinese medicine is rooted in classical literature and the legacies provided by ancient doctors and their patients.It is also grounded in the practices of expert clinicians and increasingly informed by clinical and experimental research.Considering Chinese medicine's stage of international development,a whole-evidence approach is an appropriate method for compiling and synthesizing different types and levels of evidence for specific types of interventions.This approach can be used for the wide range of clinical conditions that Chinese medicine commonly treats.

Validity and reliability of the evaluation tool of TCM confidence in students with TCM learning experience

Objective:This study aimed to design an evaluation scale of traditional Chinese medicine(TCM)confidence and then evaluate its validity and reliability.Methods:Three parallel samples with TCM learning experience were included in this current study.Randomly selected 500 nursing students were included factor analysis and reliability and validity analyses.After 4 weeks,200 nursing students were recruited to retest the reliability.The evaluation tool of TCM confidence included 6 dimensions and 25 entries.Results:Cronbach's a coefficient of the evaluation scale was 0.95 and that of the 6 observed aspects were higher than 0.90,and splithalf reliability was 0.81.For the retest reliability,Cronbach's a coefficient of the evaluation scale was 0.93 and that of the 6 examined aspects was all over 0.80.The index of content validity Scale Content Validity Index(S-CVI)was 0.92 and Item Content Validity Index(I-CVI)was 0.83–1.00.Conclusions:Observed results may indicate that the designed tool can be used to assess the TCM confidence level of students with TCM studied experience and also can evaluate results of TCM education during studying TCM lectures.

Quality Evaluation on Traditional Chinese Medicine Nursing Plan for Stroke in Acute and Recovery Phases

OBJECTIVE: To formulate the quality evaluation questionnaire of Traditional Chinese Medicine(TCM) nursing plan for stroke in acute and recovery phases, and to evaluate the quality of TCM nursing plan for stroke by clinical nurses. METHODS: The questionnaire was designed by referring to the Applicability Questionnaire of TCM Clinical Diagnosis and Treatment Guideline, and the expert consultation was used to assess the content validity. In addition, the results of the questionnaire were processed and analyzed with SPSS20.0 software. RESULTS: The content validity of the self-designed questionnaire was 0.94 for the S-CVI/Ave score. The results of the questionnaire demonstrated that the overall content of the plan was "better than the original routine nursing plan"(59.18%); the recognition degree of "common symptoms"(36.70%) and "syndrome classification"(36.70%) of the plan was the lowest. CONCLUSION: The plan is supposed to be further improved in the future in order to be coincident with clinical reality.

Systematic evaluation of traditional Chinese medicine for treating Parkinson's disease

BACKGROUND：To evaluate the quality of the literature addressing traditional Chinese medicine for treating Parkinson＇s disease.DATA SOURCE：A computer-based online search of Chinese publications from January 2001 to July 2008 was conducted in Chinese Biology Medical Disc Database and China National Knowledge Infrastructure. Search key words were Parkinson＇s disease, integrated traditional Chinese and Western medicine, traditional Chinese medicine therapy, and Chinese herb therapy.DATA SELECTION：Articles describing randomized, controlled trials and quasi-randomized, controlled trials were included. Literature quality was assessed using the criteria-Systematic evaluation of clinical literature related to treatment of Parkinson＇s disease with traditional Chinese medicine. This included methodology, interventions in the treatment/control group, evaluation criterion of outcomes, and frequency.MAIN OUTCOME MEASURES：Evaluation criterion of outcomes （various score methods and evaluation scales）, methodological quality, and frequency distribution were all measured.RESULTS：A total of 33 articles with randomized, controlled trials were included. Of these, six described a random method, and the remaining did not describe random allocation methods or random sequence generation methods. None of the studies estimated sample size. Case descriptions of withdrawal and loss to follow-up were unclear. Both the Unified Parkinson＇s Disease Rating Scale and Webster scale were used in the eligible studies as evaluation criteria.CONCLUSION：There are no high-quality studies that address traditional Chinese medicine therapy and integrated traditional Chinese and Western medicine for treating Parkinson＇s disease in China. Eligible studies were not performed in accordance with Consolidated Standards of Reporting Trials statement or Standards for Reporting Interventions in Controlled Trials of Acupuncture criteria, and the literature quality was low. The presently used criteria for evaluating therapeutic effects do not completely assess outcomes of traditional Chinese medicine for treating Parkinson＇s disease. The identification of precise outcomes should be verified using randomized, controlled studies with adequate controls and proper designs.

Under the narrative medicine theory to establish the evidence-based medical record written by doctors and patients through integrated therapy of traditional Chinese and western on digestive system diseases

目的:遵循叙事循证医学理念,抽提医患共建式循证病历的理论,建立医患共建式循证病历的范本.方法:检索Pubmed等重要医学数据库,参照叙事医学的理念,咨询中西医消化内科及循证医学专家,初步达成共识.结果:本研究是一次叙事循证医学指导下医患共建式循证病历建立的有益尝试.思考与展望:医患共建式病历有可能成为叙事医学指导下的中西医合作治疗脾胃病相关疗效评价方法学体系的内容.

Discussion on the Quality Evaluation Method of Traditional Chinese Medicine Compound Preparations

As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.

Thoughts on the Construction of Evidence-based Nursing Standard Plan for Dominant Diseases in Traditional Chinese Medicine

The evidence-based Traditional Chinese Medicine(TCM) nursing in standard plan is to be constructed by a combination of evidence-based thinking and expert consensus.(1) The symptoms of diseases with better curative effect in TCM and the nursing techniques of TCM based on scientific evidence can be preliminarily presented through bibliometric analysis.(2) Expert consultation letters can be developed based on bibliometric results, and symptoms of dominant diseases in TCM and TCM nursing techniques can be selected through those letters.(3) Based on the selected symptoms and TCM nursing techniques, the PICO can be determined, and then evidence search, evidence extraction, evidence analysis can be conducted and synthesized, and recommendations would be chosen.(4) The recommendation grade of each recommendation can be determined by applying the Delphi method and referring to GRADE.(5) The plan will be determined through discussions of experts. The construction of TCM nursing plan would make sure that TCM nursing is scientific, and internationalize TCM nursing.

Self Evaluation in Department of Communicable Diseases, Faculty of Medicine, Tehran University of Medical Sciences

Introduction: Self evaluation is a process that defines and collects required data to judge about decision making issues at educational system on whether the educational department is fit to educate students? The objective of this study was determining the quality of the structural elements of the department of Communicable Diseases & determining the strengths, weaknesses, opportunities and threats to improve the quality of activities in the department under research. Materials and Methods: The employed method was Mixed methods (qualitative & quantitative research), on the basis of 10 procedural steps and within 8 sections dealing with evaluated factors;such as 1) organizational and management structure 2) scientific board members 3) students 4) Manpower 5) Space of educational research and health care 6) Equipment 7) curriculum 8) satisfaction of graduates, which were studied using 61 criteria and 172 indicators. Five-point Likert Scale was used for the responses in the questionnaire (1 - 1.75 = undesirable, to 4.2 - 5 completely desirable). Finally the data were analyzed using descriptive statistics indices and the assessment software of the Educational Development Center of TUMS. The instruments used in this method included assessment software, interview, observation and self-prepared questionnaire which consisted of 7 questionnaires and 2 check lists. Finding: The results of the research showed that general average of 8 investigating sections was 56.9% as a rather desirable research work. Conclusions: Therefore, it was concluded that function of the educational management in that group was directly in line with evaluation process, but continuing the process of evaluation seems necessary.