Comprehensive Clinical Evaluation of Xueshuantong for Injection（Lyophilized） in Treatment of Acute Cerebral Infarction / 中国实验方剂学杂志

ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.

Expert Consensus on the Application of Multiple criteria Decision Analysis in Comprehensive Clinical Evaluation of Orphan Drugs(2022) / 罕见病研究

@#Comprehensive clinical drug evaluation is an important technical tool for decision-making on drug supply. Traditional evaluation on health technology provides methodological references for comprehensive clinical evalu-ation of drugs. However, data from clinical trials for orphan drugs are often insufficient. It is difficult to evaluate the clinical and economic value of orphan drugs by using the criteria of ordinary drugs. Particularity of orphan drugs makes it difficult to use the traditional evaluation methods for health technology. Multiple criteria decision analysis explores the comprehensive value of drugs from different angles. It promotes the transparency and scientific thinking on the basis of evidence-based medicine, improves the quality of decision-making, and thus provides a possible solution to the comprehensive clinical evaluation of orphan drugs. However, its application in the comprehensive evaluation of orphan drugs in China is still in its infancy and trial stage, and no methodological guidelines is available. In order to optimize the construction of a diversified system for comprehensive clinical evaluation of orphan drugs in China, the Multi-disciplinary Team for Rare Diseases of Peking Union Medical College Hospital and China Alliance for Rare Disease organized experts in related fields to formulate this consensus, aiming to provide standardized methodological guideline to the comprehensive clinical evaluation of orphan drugs.

An Introduction of EVIDEM Framework and Its Application in Healthcare Decision Making / 中国实验方剂学杂志

Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.

Feasibility Analysis of EVIDEM Framework in Health Technology Assessment of Traditional Chinese Medicine / 中国实验方剂学杂志

Traditional Chinese medicine （TCM） health technology assessment （HTA） provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However， it is still in its infancy. In the future， it is necessary to strengthen top-level design， improve cognition and attention， enhance talent training and cooperation， and speed up the development of evaluation criteria in line with the characteristics of TCM， so as to promote the development of HTA in TCM. Therefore， it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking （EVIDEM） framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system， which can provide methodological support for medical insurance reimbursement， clinical practice decision-making， drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability， but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research， pilot studies are carried out with Chinese patent medicine as the breakthrough point， forming a preliminary framework and implementation path for the research of TCM HTA， in order to promote healthcare decision-making and achievement transformation.

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.

Clinical comprehensive evaluation of Huangkui Capsules in treatment of chronic kidney diseases / 中国中药杂志

Based on Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), this study aims to sort out the clinical evidence of Huangkui Capsules(HC) in the treatment of chronic kidney diseases in aspects of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) from real-world data, secondary literature evaluations, questionnaires, and public data, with the methods in evidence-based medicine, epidemiology, pharmacoeconomics, and health technology. Furthermore, with multi-criteria decision analysis(MCDA) model and CSC v2.0, the clinical value of the medicine is comprehensively assessed. All the above are to highlight the advantages and characteristics of HC and lay a basis for scientific decision-making by the medical management department. The dimensions are graded A, B, C, or D. According to the conclusions from phase Ⅳ clinical trial, spontaneous reporting system(SRS), systematic review and Meta-analysis, acute toxicity and long-term toxicity tests, it mainly results in the adverse reactions of nausea, abdominal distension, vomiting, pruritus, rash, and good prognosis in patients. According to the available research, the safety evidence is sufficient and the risk is controllable, so the safety of this medicine is grade B. According to Meta-analysis, HC in combination with conventional drugs in the treatment of chronic kidney disease is superior to conventional drugs alone in reducing urinary protein, serum creatinine concentration, and blood urea nitrogen. In addition, HC combined angiotensin receptor blocker(ARB) or angiotensin converting enzyme inhibitor(ACEI) is outstanding in improving total clinical effective rate, reducing 24 h urinary protein quantity, urinary albumin excretion rate, serum creatinine concentration, triglyceride, and total cholesterol in the treatment of diabetic nephropathy as compared with ARB or ACEI alone. As for chronic nephritis, the application together with ARB or ACEI can raise the total effective rate, reduce 24 h urinary protein content, serum creatinine concentration, and blood urea nitrogen, and delay the progress of the disease. HC boasts high-quality evidence in treating chronic kidney disease, diabetic nephropathy, and chronic nephritis. It has obvious clinical significance in treating chronic kidney disease and thus its efficacy in this aspect is grade B. It has outstanding clinical significance for diabetic nephropathy and chronic nephritis and corresponding and the effectiveness is grade A. As for the pharmacoeconomic value, HC combined with ARB or ACEI is more economical in the treatment of chronic kidney disease than Bailing Capsules combined with ARB or ACEI, with high-quality evidence, and thus the economy of the formula is grade B. HC is a key solution to the high urinary protein in patients with hypotension and chronic kidney disease. The innovation is evidenced by the methods to ensuring drug supply, community-level supply, drug safety, effectiveness, and reasonable price, as wells as the aspects of enterprise philosophy, equipment management, research and development in process and technology, enterprise management and marketing. Thus, the prescription is grade A in innovation. The suitability, as evidenced in drug administration, technical management, drug storage, information service, and medication, is grade B. The course of the medicine is affordable, and it is accessible in a wide range of areas and hospitals. Thus, the accessibility is grade A. HC was developed from an in-hospital preparation, with application in numerous patients and thus large-scale real-world data. As a result, HC is grade B in terms of characteristics of traditional Chinese medicine. After comprehensive evaluation, the clinical value of HC in treating chronic kidney disease is class B, and that for diabetic nephropathy and chronic nephritis is class A. The result is of great reference value for the basic clinical medication management.

Clinical comprehensive evaluation of Reyanning Mixture in treatment of acute upper respiratory tract infection (heat-toxin attacking lung syndrome) / 中国中药杂志

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from "pneumonia Ⅲ", has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.

Clinical comprehensive evaluation of Guanxin Shutong Capsules in treatment of coronary heart disease angina pectoris with heart blood stasis syndrome / 中国中药杂志

This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in "6+1" dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.

Clinical comprehensive evaluation of Qilong Capsules in treatment of ischemic stroke with Qi deficiency and blood stasis syndrome / 中国中药杂志

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of "6+1" dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.

Performance Appraisal of Select Nations in Mitigation of COVID-19 Pandemic using Entropy based TOPSIS Method / Avaliação de desempenho de nações selecionadas na mitigação de pandemia de COVID-19 usando método TOPSIS baseado em entropia

Abstract The present study was an effort to assess the mitigation interventions carried out, so far, by the nations to fight the pandemic COVID-19. The novelty of the study was that it had considered the issue of pandemic mitigation strategy as a decision making problem. The performances of the twenty nations were to be ranked. The problem considered in the study was essentially a Multi-Criteria Decision Analysis (MCDA) problem. The available alternatives were the 20 countries and the 8 traits were the criteria. The Technique of Order Preference Similarity to the Ideal Solution (TOPSIS) was used in the present study. The study used Entropy method for assignment of weights to all the criteria. The performance score obtained in respect of the countries considered in the study and the corresponding ranks indicated the relative performances of the countries in their efforts to mitigate the COVID-19 pandemic. The results show that New Zealand is the best performing country and India is the worst one. Brazil ranked 17th, while the rank of UK was 15. The performance of the USA stood at 18th position.

Resumo O presente estudo foi um esforço para avaliar as intervenções de mitigação realizadas, até o momento, pelas nações para combater a pandemia COVID-19. A novidade do estudo é que considerou a questão da estratégia de mitigação da pandemia como um problema de tomada de decisão. As performances das vinte nações deveriam ser classificadas. O problema considerado no estudo era essencialmente um problema de Análise de Decisão Multi-Critério (MCDA). As alternativas disponíveis eram os 20 países e as 8 características eram os critérios. A Técnica de Similaridade de Preferência de Pedido com a Solução Ideal (TOPSIS) foi utilizada no presente estudo. O estudo utilizou o método da Entropia para atribuição de pesos a todos os critérios. A pontuação de desempenho obtida em relação aos países considerados no estudo e as classificações correspondentes indicaram os desempenhos relativos dos países em seus esforços para mitigar a pandemia COVID-19. Os resultados mostram que a Nova Zelândia é o país com melhor desempenho e a Índia o pior. O Brasil ficou em 17º, enquanto o Reino Unido ficou em 15. O desempenho dos EUA ficou na 18ª posição.

Multi-criteria decision analysis was used to construct the intervention strategy and nursing practice of early removal of catheters in severe neurological patients / 中国实用护理杂志

Objective:To explore the establishment of a cluster intervention strategy by multi-criteria decision analysis (MCDA) to provide a basis for the early removal of indwelling catheters in severe neurological patients.Methods:Through literature retrieval and MCDA, the catheter cluster intervention strategy was constructed, and the expert consultation was adopted to finally form 7 item cluster intervention strategies. The convenience sampling method was used to select 122 patients with severe neurological diseases as the research objects. A total of 61 patients with indwelling catheters from November 2018 to April 2019 were selected as the control group, and routine nursing care was performed according to indwelling catheters. A total of 61 patients with indwelling catheters from May 2019 to October 2019 were selected as the intervention group to compare the success rate of removing catheters, the number of days of indent catheters and the incidence of catheter-associated urinary tract infection ( CAUTI) in the two groups, as well as to analyze the indicators related to indent catheters in the intervention group with different diagnoses. Results:CAUTI incidence, successful catheter removal rate, indwelling days of catheter in the intervention group were 39.3% (24/61), 32.79% (20/61), 17 (14,22) days, which were significantly higher than 59.0% (36/61), 8.19% (5/61), 21 (15, 27) days in the control group, and the difference was statistically significant (χ 2 values were 4.723, 11.775, Z value was -9.211, P<0.05 or 0.01); In the intervention group, stroke patients′ indwelling time of catheter were 7-20 days, and the highest success rate of removing urinary catheters 36.6% (15/41), compared with other diseases, the difference was statistically significant ( Z values were -2.448, -2.109, P<0.05). Conclusion:MCDA construction of early catheter removal strategy can significantly shorten the indwelling time of the catheter in patients with severe neurological diseases, improve the success rate of early catheter extubation, reduce the CAUTI rate, to provide evidence-based basis for clinical nursing.

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.

Clinical comprehensive evaluation of Wenxin Granules in treatment of arrhythmia with deficiency of Qi and Yin / 中国中药杂志

This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.

Selección de proveedores de insumos críticos en términos de sostenibilidad, a través de la metodología multicriterio, en una empresa del sector azucarero / Suppliers' selection of critical supplies in terms of sustainability, through the use of multi-criteria methodology, in sugar sector Company / Selecção de fornecedores de inputs críticos em termos de sustentabilidade, através da metodologia multicritério, numa empresa do sector do açúcar

RESUMEN Se presentan aquí, los resultados de una investigación teórico-práctica, en la cual se abarcó el eslabón de suministro, en una cadena de abastecimiento, en una empresa del sector azucarero en el Valle del Cauca. Para la selección de proveedores de insumos críticos, se aplicó la metodología multicriterio, considerando criterios que iban más allá del costo, tomando como referencia una clasificación de insumos de acuerdo a su criticidad en términos de sostenibilidad, para el proceso productivo. Inicialmente, se hizo una caracterización y una selección de los insumos críticos, en términos de sostenibilidad. Igualmente, se identificaron los proveedores para los insumos seleccionados. Luego, y en consenso con un comité escogido al interior de la empresa, se seleccionó y aplicó el método de jerarquía analítica AHP (Analytic Hierarcgy Process). Finalmente, se tomó la decisión más acorde a los requerimientos reales de la organización, los cuales consideraban como criterio principal la sostenibilidad, para alcanzar la competitividad y el desarrollo sostenible. Esto contribuirá con el tiempo, a que la organización sea económicamente viable, ambientalmente soportable y socialmente equitativa. CLASIFICACIÓN JEL 181

ABSTRACT We undertake a theoretical-practical investigation in which we study the supply function carried out by a company in the sugar sector at the Valle del Cauca. For the selection of critical input suppliers, we apply a multi-criteria methodology in which we take into account other criteria besides cost by considering a supplies' classification based on how critical these supplies are for the production process in terms of sustainability Initially we classify and select supplies that are more critical in regards to sustainability. Likewise, the suppliers for the selected inputs were identified. Then, in agreement with a committee chosen within the company we select and apply the analytical hierarchy method AHP (Analytic Hierarchy Process). Finally according to the real requirements of the organization, the most appropriate decision is made, which considers sustainability as the main criterion to achieve competitiveness and sustainable development. This will contribute to an economically feasible, environmentally bearable, and socially equitable company JEL CLASSIFICATION 181

RESUMO São aqui apresentados os resultados de uma investigação teórico-prática, que abrangeu o elo de abastecimento de uma cadeia de abastecimento de uma empresa do sector do açúcar no Valle del Cauca. Para a selecção de fornecedores de inputs críticos foi aplicada a metodologia multicritérios, considerando critérios que iam além do custo, tomando como referência uma classificação dos inputs de acordo com a sua criticidade em termos de sustentabilidade, para o processo produtivo. Inicialmente, foi feita uma caracterização e selecção de inputs críticos em termos de sustentabilidade. Do mesmo modo, foram identificados os fornecedores dos factores de produção seleccionados. Em seguida, e em consenso com um comité escolhido na empresa, foi seleccionado e aplicado o método AHP (Analytic Hierarchy Process). Finalmente, foi tomada a decisão mais consentânea com os requisitos reais da organização, que considerou a sustentabilidade como o principal critério para alcançar a competitividade e o desenvolvimento sustentável. Isto contribuirá, com o tempo, para tornar a organização economicamente viável, ambientalmente sustentável e socialmente equitativa. CLASSIFICAÇÃO JEL 181

Reflections on the Establishment of Clinical Comprehensive Evaluation Mechanism for Drugs in China / 中国药房

OBJECTIVE：To prom ote the implementation of clinical comprehensive evaluation of drugs in China ，promote the return of drugs to clinical value ，improve the utilization efficiency of limited resources ，and provide reference for decision makers of health departments. METHODS ：By combing the relevant policy documents and literatures of clinical comprehensive evaluation of drugs，the evolution and research progress of relevant policies in China were introduced ；the advanced experiences （including evaluation subjects ，evaluation value dimensions ，evaluation methods ，evaluation procedures and results applications ）of Canada ，the United States ，the United Kingdom ，Australia，Europe，International Society for Pharmacoeconomics and Outcomes Research and other countries （regions/organizations）were analyzed and summarized ；relevant suggestions on the construction of China ’s clinical comprehensive evaluation mechanism for drugs were put forward. RESULTS & CONCLUSIONS ：It is suggested that the following measures should be taken to construct the clinical comprehensive evaluation mechanism of drugs in China including that the development goal and orientation of clinical comprehensive evaluation of drugs should be further clarified with the guidance of decision-making needs ；the government should play a leading role and strengthen inter departmental cooperation and policy coordination；the traceability quality control system of internal and external standards should be established ，adhere to openness ， fairness and fair ；at the same time ，it is suggested to give full play to the role of informatization and big data ，strengthen the exploration of evaluation methodology and standards ，strengthen the transformation and application of evaluation results ，and promote the service of evaluation results to policy decision-making.

Study on establishing a methodology of comprehensive clinical evaluation for Chinese patent medicine based on health technology assessment / 中国中药杂志

At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.

Aconitum in treatment of rheumatoid arthritis: benefit-risk assessment / 中国中药杂志

Rheumatoid arthritis (RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events (ADR/ADE) due to the long-time medication. Thus, it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum, a kind of toxic traditional Chinese herbs, is an important complement therapy for RA, with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines (TCM) and Western medicines (WM), this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not, which was carried out by the method of multi-criteria decision analysis model. RevMan 5.2 software was used to separately analyze the results of every index of 21 random clinical trials (RCTs) of Aconitum exclusive use in the treatment of RA, and 49 RCTs of Aconitum combined use with WM. The merged results indicated that as compared with the conventional therapy of WM, no matter the exclusive use or the combined use of Aconitum could improve the efficacy and decrease the incidence of ADR/ADEs. Based on the benefit-risk assessment decision tree of RA treatment, Hiview 3 software and Crystal Ball Monte Carlo simulation were used to calculate the benefit value, risk value and benefit-risk value of Aconitum exclusive use and the combined use of Aconitum with WM. The results showed that the combination therapy had significantly better benefits than Aconitum exclusive using, difference value was 15, (95%CI[9.72, 20.25]), but the risk of combined use was higher difference value=23, （95%CI[15.57, 30.55]）. In comprehensive consideration of the benefit and risk, the total benefit-risk value of using Aconitum alone was 58, while that of the combination therapy was 55, and the probability of the former superior to the latter was 81.07%. The study showed that Aconitum was the important therapy to supply RA treatment. In clinical application, the patient's acceptability of benefit and risk need to be considered; if patients cannot bear the risk, the combination use of Aconitum and WM is not recommended.

Multi-criteria decision analysis and spatial statistic: an approach to determining human vulnerability to vector transmission of Trypanosoma cruzi

BACKGROUND Chagas disease (CD), caused by the protozoan Trypanosoma cruzi, is a neglected human disease. It is endemic to the Americas and is estimated to have an economic impact, including lost productivity and disability, of 7 billion dollars per year on average. OBJECTIVES To assess vulnerability to vector-borne transmission of T. cruzi in domiciliary environments within an area undergoing domiciliary vector interruption of T. cruzi in Colombia. METHODS Multi-criteria decision analysis [preference ranking method for enrichment evaluation (PROMETHEE) and geometrical analysis for interactive assistance (GAIA) methods] and spatial statistics were performed on data from a socio-environmental questionnaire and an entomological survey. In the construction of multi-criteria descriptors, decision-making processes and indicators of five determinants of the CD vector pathway were summarily defined, including: (1) house indicator (HI); (2) triatominae indicator (TI); (3) host/reservoir indicator (Ho/RoI); (4) ecotope indicator (EI); and (5) socio-cultural indicator (S-CI). FINDINGS Determination of vulnerability to CD is mostly influenced by TI, with 44.96% of the total weight in the model, while the lowest contribution was from S-CI, with 7.15%. The five indicators comprise 17 indices, and include 78 of the original 104 priority criteria and variables. The PROMETHEE and GAIA methods proved very efficient for prioritisation and quantitative categorisation of socio-environmental determinants and for better determining which criteria should be considered for interrupting the man-T. cruzi-vector relationship in endemic areas of the Americas. Through the analysis of spatial autocorrelation it is clear that there is a spatial dependence in establishing categories of vulnerability, therefore, the effect of neighbors' setting (border areas) on local values should be incorporated into disease management for establishing programs of surveillance and control of CD via vector. CONCLUSIONS The study model proposed here is flexible and can be adapted to various eco-epidemiological profiles and is suitable for focusing anti-T. cruzi serological surveillance programs in vulnerable human populations.

Uso de adhesivos tisulares para el cierre de heridas en la práctica médica / Use of tissue adhesives for the wound closure in medical practice

Introducción: los adhesivos tisulares generan una película impermeable que una vez aplicados sobre la herida quirúrgica mantienen los bordes juntos hasta que se produce la cicatrización, lo que ayuda a disminuir el riesgo de infección de las heridas tratadas. Su empleo en la medicina permite simplificar procedimientos quirúrgicos complejos y brinda mayor comodidad al paciente. Objetivo: identificar los ámbitos de la práctica médica donde el cierre quirúrgico de heridas con el uso de adhesivos tisulares ofrece mejores resultados. Métodos: estudio descriptivo con un diseño de análisis de decisión, se confeccionó un árbol de decisión que comparó dos posibles alternativas: uso de adhesivos tisulares en adultos y en pediatría. La información se obtuvo de la literatura mediante la revisión de bases de datos médicas en el periodo de enero/2002 a diciembre/2012. Se identificaron 25 estudios (15,4 por ciento) que fueron válidos para estimar las probabilidades de complicaciones y éxito en el cierre de heridas. Resultados: el uso de adhesivos titulares en adultos mostró los mejores resultados con una alta probabilidad de éxito (0,99) para el cierre de heridas en piel y mucosas y especialmente en la cirugía de cabeza y cuello. En pediatría la probabilidad de éxito fue de 0,96 y su mejor uso se decidió en la cirugía de tórax y abdomen. Conclusiones: el uso de adhesivos titulares en adultos y niños ofrece una alta perspectiva de éxito para el cierre de heridas en piel y mucosas, si bien su uso en adultos es su mejor opción(AU)

Introduction: tissue adhesives generate, based on its characteristics, a water-proof film that once spread over the surgical wound, can keep wound edges together until cicatrization, all of which helps to decrease the infection risk. The use of tissue adhesives in medicine allows making complex surgical procedures simpler in addition to making the patient feel more comfortable. Objective: to identify the areas of medical practice where the surgical wound closure with adhesives exhibits better results. Methods: descriptive study with analysis decision design; a decision tree was created to compare two possible alternatives: use of tissue adhesives in adults and in pediatrics. Information was taken from literature through revision of medical database in the period of January 2002 to December 2012. Twenty five studies (15.4 percent), which were valid for estimating the odds of complications and successes of each wound closure option. Results: the use of tissue adhesives in adults showed the best results with high probabilities of being successful (0.99) in closing skin and mucosa wounds, mainly in the head and the neck. The probabilities for success in pediatrics were 0.96 and it is better used in thorax and abdomen surgery. Conclusions: use of tissue adhesives in adults and children provide high success probabilities for the closure of wounds in the skin and in the mucosa, although their use in adult people is the best choice(AU)

The significance of multi-criteria decision analysis for the bundle treatment of severe pneumonia / 中华危重病急救医学

ObjectiveTo determine the effect of multi-criteria decision analysis (MCDA) on the effect of bundle treatment for severe pneumonia.Methods A prospective historical control observation was conducted. Seventy-five patients with severe pneumonia having received MCDA (from January 2013 to August 2014) were assigned as intervention group. MCDA group was set up by the medical staff. Bundled treatment plan was composed of the MCDA evaluation results, anti-infection, phlegm and other conventional treatment measures which was adjust on time until the patient was transferred out of the respiratory intensive care unit (RICU) or died. Seventy patients with severe pneumonia before receiving MCDA (from August 2010 to December 2012) were set as historical control group. Comparison of general condition before treatment and the incidence of hospital infection, average hospitalization cost, duration of RICU stay and mortality between these two groups were performed.Results There were no statistically significant differences in gender, age, past history, and acute physiology and chronic health evaluationⅡ (APACHEⅡ) score at admission between two groups. Compared with control group, the incidence of hospital infection [1.33% (1/75) vs. 11.43% (8/70),χ2 = 4.723,P = 0.030], mean hospitalization cost in RICU (10 thousand Yuan: 3.44±0.79 vs. 3.76±0.91,t = 2.265, P = 0.025), length of RICU stay (days: 15.01±4.22 vs. 16.92±4.79,t = 2.552,P = 0.012) and mortality in RICU [8.0% (6/75) vs. 21.4% (15/70),χ2 = 5.272,P = 0.032] in intervention group was significantly decreased. Conclusions Application of MCDA in the bundle treatment of severe pneumonia could elevate the scientificalness of decision, and reduce the medical cost. Additionally, MCDA is worth to be generalized because the implementation of guidelines can improve the clinical outcome and prognosis of the patients.