Exploration on the Development of Evidence-based Grading System for Chinese Medicine Interventional Clinical Evidence / 中医杂志

The grading of evidence is an important factor in clinical decision-making. The current evidence grading system based on western medicine is limited in the clinical practice of traditional Chinese medicine （TCM）， therefore we propose the solutions to the development of grading system for TCM interventional evidence， following the international evidence grading standards， taking into considerations of the unique characteristics of TCM practice， based on the Grades of recommendation， assessment， development and evaluation （GARDE） evaluation system， and integrating with grading system regarding TCM classical literature and empirical evidence from modern famous doctors. The evidence from classical literature is suggested to be evaluated from three aspects including source of ancient medical records， comprehensive of treatment details， and the inheritance. The qualification of famous doctors， content integrity， and inheritance of experiences will be used to evaluate the evidence from famous doctors' experience. The multi-sourced evidence such as TCM classical literature， experience of modern famous doctors， and modern researches is mainly integrated in a qualitative way， and the overall level of evidence of TCM interventions will be graded consistently with the GRADE system based on modern research. The evidence from classical literature and modern famous doctors' experience will be assessed and considered as supplementary evidence， which will make the evaluation of clinical evidence more objectively and comprehensively， thereby guiding clinical practice further.

Astragaloside IV for Heart Failure: Preclinical Evidence and Possible Mechanisms, A Systematic Review and Meta-Analysis / 中国结合医学杂志

OBJECTIVE@#To explore the cardioprotective effects of astragaloside IV (AS-IV) in heart failure (HF).@*METHODS@#PubMed, Excerpta Medica Database (EMBASE), Cochrane Library, Web of Science, Wanfang Database, Chinese Bio-medical Literature and Retrieval System (SinoMed), China Science and Technology Journal Database (VIP), and China National Knowledge Infrastructure (CNKI) were searched from inception to November 1, 2021 for animal experiments to explore AS-IV in treating HF in rats or mice. The left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), left ventricular weight-to-body weight (LVW/BW) and B-type brain natriuretic peptide (BNP) were recorded. The qualities of included studies were assessed by the risk of bias according to the Cochrane handbook. Meta-analysis was performed using Stata 13.0.@*RESULTS@#Twenty-one articles involving 558 animals were considered. Compared with the control group, AS-IV improved cardiac function, specifically by increasing LVEF (mean difference (MD)=6.97, 95% confidence interval (CI)=5.92 to 8.03, P<0.05; fixed effects model) and LVFS (MD=7.01, 95% CI=5.84 to 8.81, P<0.05; fixed effects model), and decreasing LVEDD (MD=-4.24, 95% CI=-4.74 to -3.76, P<0.05; random effects model) and LVESD (MD=-4.18, 95% CI=-5.26 to -3.10, P<0.05; fixed effects model). In addition, the BNP and LVW/BW levels were decreased in the AS-IV treatment group (MD=-9.18, 95% CI=-14.13 to -4.22, P<0.05; random effects model; MD=-1.91, 95% CI=-2.42 to -1.39, P<0.05; random effects model).@*CONCLUSIONS@#AS-IV is a promising therapeutic agent for HF. However, this conclusion needs to be clinically validated in the future.

Clinical Evidence on Treatment of Otorhinolaryngologic Diseases with Oral Chinese Patent Medicine： A Scoping Review / 中国实验方剂学杂志

This paper aims to systematically retrieve and summarize the clinical evidence on oral Chinese patent medicine in otorhinolaryngology by scoping review and analyze the distribution of the evidence， which is expected to serve as a reference for clinical practice and healthcare decision-making. Seven databases were searched （from inception to March 2022） for the clinical evidence of oral Chinese patent medicine in the prevention and treatment of otorhinolaryngologic diseases， and the distribution of the evidence was discussed. A total of 248 papers from core journals/SCI were included： 238 clinical studies （185 randomized controlled trials， 46 semi-/non-randomized controlled trials， 7 case series studies）， 5 systematic reviews， 4 guidelines/expert consensuses， and 1 pharmacoeconomic study. The papers covered 26 oral Chinese patent medicines and 40 otorhinolaryngological diseases （5 ear diseases， 22 nose diseases， and 13 throat diseases）. The majority of the clinical studies included 100-300 cases. The combination of Chinese patent medicine and western medicine is the common intervention in the experimental group. The outcomes were mainly “cure rate” and improvement of clinical symptoms. Common adverse events were nausea， vomiting， rash， headache， gastrointestinal discomfort， fatigue， etc. In summary， there is a lack of high-quality clinical evidence on oral Chinese patent medicine in otorhinolaryngology. In addition， the available studies have such problems as seldom use of recognized outcomes， low quality of clinical studies， and lack of pharmacoeconomic study. In future， efforts should be made to carry out more rigorous primary and secondary research and enhance the pharmacoeconomic evaluation， in a bid to explore the advantages of Chinese patent medicine in the treatment of otorhinolaryngologic diseases and promote the more rational allocation and application of health resources.

Clinical comprehensive evaluation of Ginkgolide Injection in treatment of cerebral infarction / 中国中药杂志

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.

Research progress on mechanism of acupuncture and moxibustion in treatment of irritable bowel syndrome / 中国针灸

The current clinical evidence and underlying mechanisms of acupuncture and moxibustion in the treatment of irritable bowel syndrome (IBS) were summarized, so as to better optimize clinical treatment. The relevant articles of acupuncture and moxibustion in the treatment of IBS in recent years were retrieved and summarized. We found that the clinical efficacy of acupuncture and moxibustion in the treatment of IBS was relatively reliable. However, the mutual relationships among various mechanisms of action such as abnormal gastrointestinal motility, high visceral sensitivity, intestinal microenvironment disorders, and abnormal intestinal-brain interactions need to be further explored. The authors believe that in-depth explorations of the bidirectional regulation of "gut-brain axis", the law of changes in the abundance and diversity of intestinal flora, and the establishment of a more ideal animal model of TCM syndrome differentiation are useful ideas for subsequent research.

Assessing the methodological quality of systematic reviews using the AMSTAR tool / ¿Cómo evaluar la calidad metodológica de las revisiones sistemáticas a través de la herramienta AMSTAR?

Abstract Introduction Making decisions based on evidence has been a challenge for health professionals, given the need to have the tools and skills to carry out a critical appraisal of the evidence and assess the validity of the results. Systematic reviews of the literature (SRL) have been used widely to answer questions in the clinical field. Tools have been developed that support the appraisal of the quality of the studies. AMSTAR is one of these, validated and supported by reproducible evidence, which guides the methodological quality of the SRL. Objectives To show a historical, theoretical and practical guide for critical assessment of systematic reviews using AMSTAR to guide the argumental bases for their use according to the components of this methodological structure in health research, and to provide practical examples of how to apply this checklist. Methods We conducted a non-exhaustive review of literature in Pubmed and Cochrane Library using "AMSTAR" and "Systematic Reviews" as free terms without language or publication date limit; we also collected information from experts in the evaluation of the quality of the evidence. Conclusions AMSTAR is an instrument used, validated and supported by reproducible evidence for the evaluation of the internal validity of systematic reviews of the literature. It consists of 16 items that assess the overall methodological quality of a SRL. It is currently used indiscriminately and favorably, but it is not exempt from limitations and future updates based on new reproducibility and validation studies.

Resumen Introducción Tomar decisiones basadas en la evidencia ha sido un reto para profesionales de la salud; se requiere tener herramientas y habilidades para apreciar la evidencia críticamente y evaluar la validez de los resultados. Las revisiones sistemáticas de la literatura (RSL) han sido muy usadas para dar respuesta a preguntas del ámbito clínico. Se han desarrollado herramientas que apoyan la apreciación de la calidad de los estudios. El AMSTAR es una de estas, validada y soportada por evidencia reproducible que orienta la calidad metodológica de las RSL. Objetivos Mostrar un abordaje histórico, teórico y de guía práctica para la apreciación crítica de las revisiones sistemáticas con el AMSTAR, orientar las bases argumentales para su uso, según los componentes de esta estructura metodológica en investigación en salud, y proporcionar ejemplos prácticos sobre cómo aplicar esta lista de chequeo. Métodos Realizamos una revisión no exhaustiva de literatura en PubMed y The Cochrane Library con los términos libres "AMSTAR" y "revisiones sistemáticas'', sin límite de idioma o año de publicación; también, recolectamos información de expertos en evaluación de la calidad de la evidencia. Conclusiones El AMSTAR es un instrumento validado y soportado por evidencia reproducible para la evaluación de la validez interna de las revisiones sistemáticas de la literatura. Consiste en 16 ítems que evalúan de manera global la calidad metodológica de una RSL. Actualmente, se usa de manera indiscriminada y predilecta, pero no está exenta de limitaciones y futuras actualizaciones basadas en nuevos estudios de reproducibilidad y validación.

Traditional Chinese medicine in COVID-19

COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread across the globe, posing an enormous threat to public health and safety. Traditional Chinese medicine (TCM), in combination with Western medicine (WM), has made important and lasting contributions in the battle against COVID-19. In this review, updated clinical effects and potential mechanisms of TCM, presented in newly recognized three distinct phases of the disease, are summarized and discussed. By integrating the available clinical and preclinical evidence, the efficacies and underlying mechanisms of TCM on COVID-19, including the highly recommended three Chinese patent medicines and three Chinese medicine formulas, are described in a panorama. We hope that this comprehensive review not only provides a reference for health care professionals and the public to recognize the significant contributions of TCM for COVID-19, but also serves as an evidence-based in-depth summary and analysis to facilitate understanding the true scientific value of TCM.

Clinical comprehensive evaluation of Diemailing~® Kudiezi Injection in treatment of cerebral infarction / 中国中药杂志

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.

Report standards for clinical comprehensive evaluation of Chinese patent medicine / 中国中药杂志

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.

The Role of Kampo Medicines in the Pandemic of Viral Infections : Learning from the Spanish Flu / 日本東洋医学雑誌

Various measures are being undertaken all over the world to control the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Artificial respirators and extracorporeal membrane oxygenators (ECMO) have been introduced for severely ill patients, and antiviral pharmacotherapy has been attempted. However, in the current situation, it is not feasible to wait for evidence-based effective treatments, and it is imperative to deal with daily situations. It would be very helpful to retrospectively evaluate the doctors who worked during the Spanish flu pandemic without access to medical devices such as ventilators, or drugs including antibacterial and antiviral agents. Based on the fact that Kampo medicine was used to treat patients with the Spanish flu, this article demonstrates the high pathogenicity of the Spanish flu virus, the mechanism of action of antiviral drugs, and clinical evidence. As one of the measures against the COVID-19 pandemic, we propose the role of Kampo medicine, which has relative clinical safety with few side effects, and can be expected to induce antiviral action by autoimmune activation.

Construction of the integrative evidence chain in clinical trial of acupuncture and moxibustion / 中国针灸

The research aims to propose the approaches to the clinical trial of acupuncture and moxibustion and provide the methodological guide for the research in this field in terms of the inadequate systematic collection, lack of the specific characteristics of acupuncture-moxibustion treatment and insufficient persuasion in clinical evidences of acupuncture-moxibustion research. Through a systematic review of the registration of acupuncture-moxibustion clinical trials at home and abroad, the distribution of diseases with the recommendation of acupuncture and moxibustion in Cochrane Library database, combined with the evidence grade of the evidence-based medicine and the individual characteristics of clinical practice with acupuncture and moxibustion, some research ideas and framework are proposed for the clinical trial of acupuncture and moxibustion. To take the curative effect as the forerumer, the dominant disease and therapeutic methods of acupuncture and moxibustion should be initially generalized by the case experiences and clinical observation at the first. In view of the potential function of acupuncture and moxibustion in treatment, the rigorous and standardized clinical trial should be carried out to verify their therapeutic effect. Finally, the experimental research is adopted to explore the mechanism of acupuncture and moxibustion. Through the combination of quantitative and qualitative methods, all of the evidences are integrated to form an integrative evidence chain. It is anticipated that the construction of the integrative evidence chain in clinical trial of acupuncture and moxibustion may enhance the promotion of clinical practice with acupuncture and moxibustion and increase the influence of acupuncture-moxibusiton discipline.

Clinical Evidence and Effect Mechanism of Yiqi Fumai (Freeze-dried) for Treatment of Coronary Heart Disease with Heart Failure / 世界科学技术-中医药现代化

In review of recent literature on the treatment of heart failure with coronary heart disease by injection of Yiqi Fumai (freeze-dried), clinical evidence for the treatment of coronary heart disease with heart failure was reviewed from relevant systematic reviews, clinical randomized controlled trials, and safety evaluation, from the experiments in vivo and in vitro on its working mechanism of the treatment of coronary heart disease, heart failure, for more in-depth research on clinical and basic research in the future to lay the foundation.

Clinical Evidence Evaluation and Effect Characteristics of Shuxuening Injection / 世界科学技术-中医药现代化

Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles and conference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane with thematic word"Shuxuening"in Chinese and English, then all forms of clinical studies were screened and the disease types and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore, RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and its effectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treat disease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed by endocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researches appeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris and coronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of which were of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than that of the control group, with a total efficiency of 84.48％. There were 21.96％ references to adverse reactions, but all of them were minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseases of cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the quality of evidence is generally poor, which needs further study.

Clinical Evidence Evaluation and Mechanism Exploration of Xinxuening in Cardiovascular Disease Treatment / 世界科学技术-中医药现代化

Objective: To refine and evaluate the clinical evidence, and provide proof and reference for Xinxuening's clinical program establishment from the perspective of evidence-based medicine through screening the clinical studies of cardiovascular disease by Xinxuening.s treatment. Method: The included and excluded criteria was established before the setting of search terms, eligible databases (PubMed, Web of Science, Ovid, Embase, Cochrane, CNKI, CBM, Wanfang and Vip) were searched and the quality evaluation and evidence classification was conducted for eligible documents. The software RevMan was used to evaluate the clinical evidence of Xinxuening in the treatment of cardiovascular disease (primary hypertension, coronary heart disease, heart failure and hyperlipidemia) and to explore the specific mechanism.Results: A total of 16 suitable studies were included, of which 15 were RCTs and 1 was observation study. 9 of the 16 studies were the C level evidence and 7 were the D level. The included studies were all low quality. The outcome indicators of clinical treatment for cardiovascular disease were: the efficacy of hypertension therapy, the level of systolic and diastolic blood pressure after therapy, the efficacy of angina pectoris and hyperlipidemia treatment, and the total cholesterol and triglyceride levels after treatment. The results showed that Xinxuening could significantly reduce the level of blood pressure for patients with hypertension, improve the symptoms of angina pectoris in patients with coronary heart disease, and reduce the levels of blood lipids (triglycerides and total cholesterol) . The results have statistical differences (P ＜ 0.05) . However, it the specific mechanism of Xinxuening in the treatment of cardiovascular disease was not found.Conclusion: Xinxuening has higher clinical effect on the treatment of some cardiovascular diseases compared with some western drugs and other proprietary Chinese medicine. However, it still needs further exploration of the specific clinical mechanism and to conduct high-quality clinical research.

Development Status and Enlightenment of Foreign Clinical Knowledge Base / 医学信息学杂志

The paper investigates 31 foreign representative clinical knowledge base,analyzes development status including the establishment and maintenance institutions,user version control,localization application,clinical evidence resources,clinical specific content representation,evidence quality evaluation criteria and so on,summarizes revelation for domestic clinical knowledge base construction.

A summary and evaluation of current evidence for myocardial infarction with Chinese medicine / 中国结合医学杂志

<p><b>OBJECTIVE</b>To provide evidence-based recommendations for clinical application and provoke thoughts for future researchers by conducting a comprehensive summary and evaluation of the current evidence profile for the role of Chinese medicine (CM) in treating myocardial infarction (MI).</p><p><b>METHODS</b>Online databases including PubMed, EMBase, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Medicine (CBM), VIP Journal Integration Platform, and Wanfang database were systematically searched for literatures on CM in treating MI. After screening, studies were categorized into 5 types, i.e. systematic review (SR), randomized controlled trial (RCT), observational study, case report and basic research. General information was abstracted, and the quality levels of these studies and their conclusions were summarized and assessed.</p><p><b>RESULTS</b>A total of 452 studies including 10 SRs, 123 RCTs, 47 observational studies, 28 case reports, and 244 basic researches were selected. Clinical studies centered primarily on herbal decoction and mostly were not rigorously performed. High-quality studies were predominantly on Chinese patent medicines (CPMs) such as Danshen Injection (), Shenmai Injection (), Shengmai Injection () and Qishen Yiqi Dripping Pills (). The most frequently observed pattern of drug combination was decoction plus injection. Results of SRs and clinical studies showed that CM may reduce mortality, decrease risk of complication, reduce myocardial injury, improve cardiac function and inhibit ventricular remodeling. Findings from basic researches also supported the positive role of CM in reducing infarct size and myocardial injury, promoting angiogenesis, preventing ventricular remodeling and improving cardiac function. According to the current evidence body, CM has proven effects in the prevention and treatment of MI. It is also found that the effects of CPMs vary with indications. For instance, Shenmai Injection has been found to be especially effective for reducing the incidence of acute clinical events, while CPMs with qi-nourishing and bloodcirculating properties have been proven to be effective in inhibiting ventricular remodeling. High quality evidence supports the use of CM injection for acute MI and CPM for secondary prevention. Reports on adverse events and other safety outcomes associated with CM for MI are scarce.</p><p><b>CONCLUSIONS</b>Sufficient evidence supported the use of CM as an adjuvant to Western medicine for preventing and treating MI. The choice of drug use varies with disease stage and treatment objective. However, the quality of the evidence body remains to be enhanced.</p>

Clinical evaluation research of medical device registration / 中国医学装备

Objective: To help medical device registration applicant understand the content of clinical evaluation, guided on the clinical evaluation method, and also putted forward several suggestions of the improvement scheme for our country registered clinical assessment and review of the work. Methods:Described the Global Harmonization Task Force (GHTF) medical device registration guidance for clinical evaluation, combined with the status quo of supervision in China, and made some specific scheme on China's medical device of clinical evaluation work. Results: Introduced the contents of the clinical evaluation and the relationships between the factors, in order to help the medical device registration applicant and Chinese regulators to do clinical evaluation work of scientific and reasonable. Conclusion:The definition of medical device registration clinical evaluation should clear the clinical evaluation, and to develop guidance for clinical evaluation of the corresponding.

Rehabilitation of occlusion---Science or art? / 实用口腔医学杂志

The procedure of occlusal treatment involves improving the morphology and the stomatognathic function.Several practical methods and morphological endpoints have been described in occlusal rehabilitation.We made a selection of these (mandibular position,oc-clusal plane,occlusal guidance,occlusal contact,face-bow transfer,use of an adjustable articulator and occlusal support)and performed a literature review to verify the existence of compelling scientific evidence for each of these.A literature search was conducted using Medline /PubMed in March 2011.Over 400 abstracts were reviewed,and more than 50 manuscripts selected.An additional hand search was also con-ducted.Of the many studies investigating stomatognathic function in relation to specific occlusal schemes,most studies were poorly designed and of low quality,thus yielding ambiguous results.Overall,there is no scientific evidence that supports any specific occlusal scheme being superior to others in terms of improving stomatognathic function,nor that sophisticated methods are superior to simpler ones in terms of clini-cal outcomes.However,it is obvious that the art of occlusal rehabilitation requires accurate,reproducible,easy and quick procedures to re-duce unnecessary technical failures and /or the requirement for compensatory adjustments.Therefore,despite the lack of scientific evidence for specific treatments,the acquisition of these general skills by dentists and attaining profound knowledge and skills in postgraduate training will be necessary for specialists in charge of complicated cases.

Interacción warfarina y acetaminofén Evaluación para establecer su relevancia clínica / Warfarin and acetaminophen interaction Assessment to establish its clinical relevance

Objetivo: realizar una revisión estructurada de la interacción warfarina y acetaminofén, buscando establecer su relevancia clínica y profundizar en el mecanismo de dicha interacción. Método: revisión estructurada en PubMed/Medline, de artículos en inglés y español, buscando los términos warfarin AND (acetaminophen OR paracetamol) en el título o resumen. La búsqueda se complementó con las referencias de artículos valorados como importantes. Los trabajos se agruparon en: relacionados con el aumento de sangrado por la interacción warfarina-acetaminofén, o relacionados con el mecanismo de la interacción. Resultados: se identificaron 45 artículos, de los cuales se incluyeron 15 en la revisión: 11 relacionados con el aumento del riesgo de sangrado por la interacción y cuatro con el mecanismo de la interacción. La gravedad del efecto (aumento de la probabilidad de sangrado) se consideró moderada; mientras que la probabilidad de aparición fue valorada como definida. Además, se identificó una relación entre la dosis de acetaminofén y el riesgo de sangrado. Por su parte, el N-acetil-para-benzoquinona-imina (metabolito del acetaminofén) inhibe enzimas del ciclo de la vitamina K y tiene un efecto sinérgico con el efecto anticoagulante de la warfarina. Conclusiones: la relevancia clínica de la interacción warfarina - acetaminofén es de riesgo alto, debido a que la gravedad del efecto (aumento del riesgo de sangrado) es moderada y su probabilidad de presentación es definida. Por tanto, estos dos medicamentos pueden ser utilizados conjuntamente, pero se debe realizar una estricta monitorización. El metabolito N-acetil-para-benzoquinona-imina es el responsable del aumento del efecto anticoagulante de la warfarina. (Acta Med Colomb 2013; 38: 22-27).

Objective: to make a structured review of the interaction between warfarin and acetaminophen, seeking to establish its clinical relevance and deepen in the mechanism of this interaction. Method: structured review of PubMed/Medline of articles in English and Spanish, looking warfarin and acetaminophen or paracetamol in the title or abstract. The search was complemented with references of articles rated as important. The papers were grouped in: related to increased bleeding due to warfarin-acetaminophen interaction, or related to the mechanism of the interaction. Results: we identified 45 articles, of which 15 were included in the review: 11 related to increased risk of bleeding due to the interaction and 4 with the mechanism of the interaction. The severity of the effect (increased likelihood of bleeding) was considered moderate, whereas the probability of appearance was rated as definite. In addition, we identified a relationship between the dose of acetaminophen and the risk of bleeding. In turn, the N-acetyl-para-benzoquinone-imine (metabolite of acetaminophen) inhibits enzymes of the vitamin K cycle and has a synergistic effect with the anticoagulant effect of warfarin. Conclusions: the clinical relevance of the interaction warfarin-acetaminophen is of high risk due to the fact that the severity of the effect (increased risk of bleeding) is moderate and the probability of its presentation is definite. Therefore, these two drugs can be used together, but a strict monitoring should be conducted. The metabolite N-acetyl-para-benzoquinone-imine is responsible for the increase in the anticoagulant effect of warfarin. (Acta Med Colomb 2013; 38: 22-27).

Cochrane systematic reviews on childhood neurological diseases / 临床儿科杂志

Cochrane systematic review is the highest grade of evidence in evidence-based medicine, and the best source of effective evaluation on health care intervention. This paper studies the Cochrane systematic reviews on childhood neurological diseases, with examples interpreted, aiming to help readers to understand the high grade of clinical evidence for neurological diseases in children, and to provide a perspective for pediatrician’s clinical practice and research.