Methods Of Evidence-based Medicine Research Articles

Spirituality for a Community Care. The Experience of Bambino Gesù Children’s Hospital

The healthcare system becomes a field of investigation in the search for spirituality, when the human weakness encountered in illness questions nurses and doctors, children and their families about the meaning of life. The paper aims to analyse a case study of Bambino Gesù Children's Hospital. This holistic method allows to interpret statistical data, narrative methods, and participants’ perspectives. The findings underline an original interaction between evidence-based medicine methods, the humanisation of care and the role of spirituality.

Do it yourself or send for help? Considering specialty referral from a general practitioner perspective.

General practice veterinarians (GPs) are often faced with the question of which services they should provide themselves and which are more appropriately the province of board-certified specialists. The growing availability of specialty care, the expectations of many pet owners for advanced care resembling that which they receive, the expanding availability of new and more technologically sophisticated interventions, and many less easily defined shifts in the economic and cultural context of veterinary medicine all add to the pressure to limit services in general practice and refer more patients to specialists. However, the criteria for making decisions about referral are often ill-defined and controversial. Furthermore, most GPs are trained by specialists in secondary or tertiary care institutions, providing them with a perspective that may not reflect the realities of the general practice environment.While each referral decision for a specific patient must be made in the unique context of that case, reflection and discussion concerning relevant general principles can help GPs build a rational foundation for making such decisions. The principles and methods of evidence-based medicine and the expanding concept of a spectrum of care can usefully inform decision-making about referral. It is also critical that all stakeholders contribute to discussion of these questions and to the training of veterinarians so that the next generation will be prepared to shape and embody the role of GP in a manner that best meets the needs of patients, pet owners, and veterinarians themselves.

Guidelines for prevention and treatment of colorectal adenoma with integrated Chinese and western medicine

The Guidelines for prevention and treatment of colorectal adenoma with integrated Chinese and western medicine are put forward by Nanjing University of Chinese Medicine and approved by China Association of Chinese Medicine. According to the formulation processes and methods of relevant clinical practice guidelines, the experts in clinical medicine and methodology were organized to discuss the key problems to be addressed in the clinical prevention and treatment of colorectal adenoma(CRA) and provided answers following the evidence-based medicine method, so as to provide guidance for clinical decision-making. CRA is the major precancerous disease of colorectal cancer. Although the prevention and treatment with integrated Chinese and western medicine have been applied to the clinical practice of CRA, there is still a lack of high-quality guidelines. Four basic questions, 15 clinical questions, and 10 outcome indicators were determined by literature research and Delphi questionnaire. The relevant randomized controlled trial(RCT) was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries, and finally several RCTs meeting the inclusion criteria were included. The data extracted from the RCT was imported into RevMan 5.3 for evidence synthesis, and the evidence was evaluated based on the Grading of Recommendations, Assessment, Development, and Evaluations(GRADE). The final recommendations were formed by the nominal group method based on the evidence summary table. The guidelines involve the diagnosis, screening, treatment with integrated Chinese and western medicine, prevention, and follow-up of colorectal adenoma, providing options for the clinical prevention and treatment of CRA.

Insights from Evidence-Based Medicine Method for Building Security Systems Against Terrorist Attacks in Hospitals.

Hospitals have become soft targets for terrorism, with increasing terrorist attacks observed in the last two decades. Not only the counter-terrorism and law enforcement agencies but the hospitals also need to be actively involved and undertake the responsibility of safeguarding hospital security by establishing an effective security system. Evidence-based medicine emphasizes the significance of scientific evidence, and in practice, research methods for the generation, collection, and utilization of evidence may offer new insights to overcome the issue of terrorism. The present study discusses the potential application of methods in evidence-based medicine for developing security systems against terrorist attacks in hospitals. First, hospitals can use simulated scenarios of terrorist attacks to generate evidence. For example, combining virtual technology with virtual reality technology and selecting appropriate algorithms or models to generate evidence. Second, they can apply tabletop exercises to propose measures, as a means of collecting evidence. The collection of data can be obtained through questionnaires or interviews. Some biological methods, such as collecting salivary markers of acute stress (α-amylase and secretory immunoglobulin A), can also be used to assess emotional states. Third, they can use the collected evidence to practically test and refine the implemented measures. To verify the effectiveness and feasibility of the formulated solutions in real-life scenarios, simulations, models, drills, and similar methods can be used. This approach may provide new perspectives for the development of hospital security systems.

Does Vaccine-Induced Maternally-Derived Immunity Protect Swine Offspring against Influenza a Viruses? A Systematic Review and Meta-Analysis of Challenge Trials from 1990 to May 2021.

It is unclear if piglets benefit from vaccination of sows against influenza. For the first time, methods of evidence-based medicine were applied to answer the question: "Does vaccine-induced maternally-derived immunity (MDI) protect swine offspring against influenza A viruses?". Challenge trials were reviewed that were published from 1990 to April 2021 and measured at least one of six outcomes in MDI-positive versus MDI-negative offspring (hemagglutination inhibition (HI) titers, virus titers, time to begin and time to stop shedding, risk of infection, average daily gain (ADG), and coughing) (n = 15). Screening and extraction of study characteristics was conducted in duplicate by two reviewers, with data extraction and assessment for risk of bias performed by one. Homology was defined by the antigenic match of vaccine and challenge virus hemagglutinin epitopes. Results: Homologous, but not heterologous MDI, reduced virus titers in piglets. There was no difference, calculated as relative risks (RR), in infection incidence risk over the entire study period; however, infection hazard (instantaneous risk) was decreased in pigs with MDI (log HR = -0.64, 95% CI: -1.13, -0.15). Overall, pigs with MDI took about a ½ day longer to begin shedding virus post-challenge (MD = 0.51, 95% CI: 0.03, 0.99) but the hazard of infected pigs ceasing to shed was not different (log HR = 0.32, 95% CI: -0.29, 0.93). HI titers were synthesized qualitatively and although data on ADG and coughing was extracted, details were insufficient for conducting meta-analyses. Conclusion: Homology of vaccine strains with challenge viruses is an important consideration when assessing vaccine effectiveness. Herd viral dynamics are complex and may include concurrent or sequential exposures in the field. The practical significance of reduced weaned pig virus titers is, therefore, not known and evidence from challenge trials is insufficient to make inferences on the effects of MDI on incidence risk, time to begin or to cease shedding virus, coughing, and ADG. The applicability of evidence from single-strain challenge trials to field practices is limited. Despite the synthesis of six outcomes, challenge trial evidence does not support or refute vaccination of sows against influenza to protect piglets. Additional research is needed; controlled trials with multi-strain concurrent or sequential heterologous challenges have not been conducted, and sequential homologous exposure trials were rare. Consensus is also warranted on (1) the selection of core outcomes, (2) the sizing of trial populations to be reflective of field populations, (3) the reporting of antigenic characterization of vaccines, challenge viruses, and sow exposure history, and (4) on the collection of non-aggregated individual pig data.

Critical thinking in medical education

Technological advances in the modern world have led to a paradigm shift in medical education, identifying new challenges. The need to meet these challenges has required the implementation of evidence-based clinical practice, which allows the best quality evidence to be used to provide optimal patient care and improve healthcare efficiency. Obtaining evidence of the efficacy and safety of drugs and medical technologies, the diagnostic accuracy of interventions became possible due to the introduction of systematic reviews and meta-analyses. This methodology forms clinical thinking in parallel with the development of research and analytical competencies, which is one of the urgent tasks of modern medical education. The article reflects the experience of the Department of Internal Diseases of the Sechenov University in implementing a practice-oriented research module aimed at developing critical thinking using evidence-based medicine methods among students and residents. The inclusion of research competencies in the educational process will make it possible to qualitatively transform medical education and form a generation of competitive competent specialists in demand in the world of constantly developing technologies.

Aspects to consider in causality assessment of safety signals: broadening the thought process

In the field of drug safety, causality assessment aims to determine the level of plausibility of the relationship between an adverse event and exposure to a particular product. It is after the causality assessment process that we will be able to point out a product adverse reaction. While regulators often require pharmaceutical companies to use a structured approach for assessing the causality of their products, the available methods are challenged by a number of procedural differences, even when drawing from the same domain of elements. To mitigate these inconsistencies, as well as the additional challenges associated with incomplete information and differences in the application of clinical judgments at the individual case level, this paper proposes a holistic framework for causality assessment that utilizes a combination of expert judgment/global introspection, evidence-based medicine, and probabilistic method. The goal of the presented approach is to provide a guide of clues to causality reminding medical safety assessors to seek and examine all available streams of evidence in totality and to assess this evidence in a qualitative, structured way.

Developing TCM clinical practice guidelines: A comparison between traditional Chinese medicine and western medicine

Clinical practice guidelines in Traditional Chinese Medicine (CPG-TCM) is the recommendation that aims to provide the best service to users by identifying and summarizing the rules of prevention, diagnosis, treatment, rehabilitation, and regression of diseases based on systematic reviews of evidence and balancing the advantages and disadvantages of different interventions for clinical questions of Traditional Chinese Medicine. Over the past 30 years, the concept and methods of evidence-based medicine have had a significant impact on the development of clinical practice guidelines in Western Medicine (CPG-WM), and their standardized guideline development methods are being adapted and used in the development of CPG-TCM. However, the quality of CPG-TCM is far from CPG-WM, and the methodological system for developing CPG-TCM is not yet fully established. Therefore, this study aims to explore the methodological differences between CPG-TCM and CPG-WM and to inform the development of high-quality CPGTCM.

Application of evidence-based medicine methods in integrative oncology research

Application of evidence-based medicine methods in integrative oncology research

Evidence-Based Medicine and Patient-Centred Care

Proponents of Evidence-Based Medicine (EBM) argue that EBM’s approach to medicine promotes good clinical decisions while it escapes adverse issues such as implicit bias. However, EBM approaches the causation of diseases from a homogenous standpoint; that is, EBM overgeneralises evidence and the intervention measures it provides. As a result, proponents of Patient-Centred Care (PCC) allude that the strictness of EBM towards evidence impairs it from considering case-by-case treatment of patients but a generalised method of intervention. Given this problem, I argue that EBM cannot be considered a medical approach to practising medicine and conducting medical research that is in the best interest of individual patients, especially patients that prefer alternative interventions other than the methods of EBM. I conclude by drawing from the best features of EBM and PCC to create an alternative that accommodates the interests of both EBM and PCC patients.

Application of physical therapy methods for patients after stroke with spasticity in the early period

acute cerebrovascular accident is the leading cause of disability. Stroke ranks 4th among diseases that lead to death or disability. The consequences of stroke include neurological disorders, motor disorders (plegia, hemiparesis, paresis, muscle spasticity), loss of sensation, pelvic dysfunction, loss of coordination and balance, high risk of falls, and impaired ability to move independently and perform daily activities. To achieve optimal independence, stroke patients need qualified rehabilitation care as part of a multidisciplinary team. Evidence-based medicine, treatment, and rehabilitation interventions have improved significantly in the acute and early periods for stroke patients. However, in the late period, today, more than half of patients remain limited in their daily activities and have movement disorders that significantly affect their quality of life and independence. Description of the objective. To substantiate the use of evidence-based medicine methods in physical therapy to restore motor function in patients after stroke in the early period. Materials and methods. From October to December 2021, 20 patients with spasticity, aged 47-85 years, who had suffered an ischemic and hemorrhagic stroke, took part in the examination and rehabilitation activities at Kyiv City Clinical Hospital № 6, Palliative Care Department, for a period of 3 weeks to 1 month. Voluntary consent for examination, treatment, and rehabilitation was obtained from all patients and their caregivers. The diagnostic methods used were computed tomography, magnetic resonance imaging, and, if necessary, laboratory tests. Tests and scales for physical therapy were used to determine functional impairment in stroke patients with muscle spasticity: Rankin Scale, Riverbed Mobility Index, Pain Score, Modified Ashworth Scale, Degree of Arm and Hand Recovery; Degree of Leg and Foot Recovery. Results. After analyzing the methods of evidence-based medicine on the topic of the problem, we have confirmation that in the early period, recovery rates are high. However, in the late period after a stroke, the onset of muscle spasticity significantly limits the motor capabilities of patients and complicates the recovery process. In the late period, the effectiveness of methods to overcome spasticity has not been fully developed, and attention is not focused on the complications that arise and accompany them throughout the recovery period. The appearance of muscle spasticity significantly limits the motor capabilities of patients, affects the psycho-emotional state of a person, and causes pain, which prevents the full use of the affected limb. Muscle spasticity inhibits and complicates the restoration of motor function in the long term. Conclusions. The study confirms the high effectiveness of the proposed methods of evidence-based medicine in reducing pain and increasing the range of motion in the shoulder, elbow, and wrist joints in the early period in patients after stroke. As for the late period, this issue remains incomplete and requires further study. In the palliative care unit of Kyiv City Clinical Hospital № 6, an individual multidisciplinary approach to patients after stroke was used, which contributed to the achievement of the goals. It can be stated that evidence-based medicine methods for the acute and early period have a positive effect on patient independence, and improve cognitive function and motor activity of the affected limbs.

Effectiveness and safety of Inclisiran in hyperlipidemia treatment: An overview of systematic reviews.

This paper aimed to comprehensively evaluate the effectiveness and safety of Inclisiran in treating hyperlipidemia through an overview of systematic reviews (SRs). The Cochrane Library, EMBASE, PubMed, CNKI, WANGFANG database, VIP database, ClinicalTrials.gov, and ICRT were searched electronically to collect SRs and meta-analysis of Inclisiran in hyperlipidemia treatment from the establishment of the database till May 2022. Two researchers independently screened the relevant literature, then the assessment of multiple systematic reviews tool was made into assess the methodological quality of the included studies. Data extracted were used to perform the study through RevMan5.3 software. The grading of recommendations assessment, development, and evaluation tool was used to grade the quality of the evidence of the outcomes included in the SRs. Prospero ID: CRD 42022326845. A total of 10 relevant SRs were included, involving 7 randomized controlled trials. The assessment results of the assessment of multiple systematic reviews tool suggested that the quality of the SRs included needed to be improved. The reduced level of low-density lipoprotein cholesterol of the experimental group was lower than the control group, and the difference in the amount of effectiveness was statistically significant (MD = -50.13, 95%CI: -56.2 to -44.06, P < .00001). The grading of recommendations assessment, development, and evaluation results showed that out of 27 outcomes, 8 were high-quality, 3 were of medium quality, 6 were of low quality, and 10 were of the most inferior quality. 300mg Inclisiran with 2 injections a year has the best therapeutic effect, which can significantly reduce low-density lipoprotein cholesterol and total cholesterol, and increase high-density lipoprotein cholesterol levels in patients with hyperlipidemia. Inclisiran has a favorable safety profile, with no significant difference in the incidence of adverse reactions compared to a placebo. Most of the adverse effects were associated with the reaction on the injection site.

How missing evidence-based medicine indicators can inform COVID-19 vaccine distribution policies: a scoping review and calculation of indicators from data in randomised controlled trials

ObjectiveReports of efficacy, effectiveness and harms of COVID-19 vaccines have not used key indicators from evidence-based medicine (EBM) that can inform policies about vaccine distribution. This study aims to clarify...

ДИАГНОСТИКА СИНДРОМА ВЕГЕТАТИВНОЙ ДИСФУНКЦИИ У ЮНЫХ СПОРТСМЕНОВ

Purpose: A review of the most common and effective from the point of view of evidence-based medicine methods for diagnosing autonomic dysfunction syndrome in young athletes. Material and methods: The data of domestic and foreign literature on the diagnosis of autonomic dysfunction syndrome were analyzed. The search was carried out using electronic databases MEDLINE, Embase, Scopus, Web of Science, eLIBRARY and Google Academy for the period from 2017 to 2022. For the search, we used keywords and their combinations: “vegetative dysfunction syndrome”, “athletes”, “diagnostics”, “functional tests”. A total of 28 sources analyzed Results: The autonomic dysfunction syndrome (ADS) is characterized by a significant polymorphism of clinical manifestations and is characterized by functional disorders of the activity of the cardiovascular, endocrine and other systems of the body. Diagnosis of this condition is associated with great difficulties associated with the nonspecificity of symptoms, their bright emotional color and the absence of morphological changes in organs. The frequent manifestation of ADS in childhood and adolescence, the proven relationship of symptoms with exercise and mental stress, determines the importance of early and effective diagnosis of this syndrome in young athletes. The key research methods for suspected autonomic dysfunction syndrome include taking anamnesis using special questionnaires and scales and conducting functional tests with registration of the parameters of the cardiovascular system (heart rate, blood pressure, HRV). The most common and informative functional tests: deep controlled breathing test, orthostatic test (active and passive), Valsalva test. Promising methods for diagnosing ADS include accelerometric tremorography and the study of baroreflex sensitivity. Also, for a deeper examination of a young athlete, it is recommended to use laboratory diagnostic methods to identify violations of the endocrine system, detect changes in lipid and carbohydrate metabolism, etc. Conclusions: At the moment, further research is needed to study the autonomic dysfunction syndrome and methods for its diagnosis.

Comparative assessment of blood gas composition in children with cerebral ischemia during single and course application of physical factors

Introduction (relevance): Cerebral ischemia (CI) is damage to the brain tissue resulting from prolonged insufficient oxygen supply. CI occupies one of the leading places in the structure of morbidity in terms of frequency and significance, accounting for up to 60-80% of all diseases of early childhood and ranking first in the structure of childhood disability. Currently, an active search and development of new, pathogenetically substantiated, non-drug methods of treatment is underway. The purpose of the study: to study the effect of general magnetic therapy and hyperbaric oxygen therapy on the blood gas composition in children with cerebral ischemia against the background of a single and course application of physical factors. Material and methods: The results of treatment of 150 children in the first month of life with cerebral ischemia of moderate severity and intracranial hypertension syndrome, who underwent the inpatient stage, were analyzed. Depending on the treatment complex used, the children were divided into three statistically homogeneous groups of 50 people each. The patients of the main groups received physiotherapy treatment along with the standard complex. The patients of the main group I were prescribed general magnetic therapy (GMT) along with the standard complex. The patients of the main group II received basic therapy for this pathology and consecutive courses of general magnetic therapy and hyperbaric oxygen therapy (HBOT). In the course of the work, the acid-base status of capillary blood was studied. The analysis of the study results and the construction of tables and charts were carried out using the Microsoft Office 2010 office suite, the Statistica 6.0 statistical software package, and evidence-based medicine methods. Results: A comparative analysis of a single effect of various therapeutic methods on impaired acid-base balance indicators revealed a significant advantage of hyperbaric oxygen therapy in eliminating the phenomena of metabolic acidosis. The results obtained during the course administration of physical factors reliably prove the absence of a relationship between the elimination of the phenomena of metabolic acidosis, which aggravates the post-hypoxic recovery of the child's brain tissue, and the chosen therapeutic tactics for the course CI treatment, having an equivalent effect on the neurological rehabilitation of patients. Conclusion: The therapeutic effect of general magnetic therapy and its complex with hyperbaric oxygen therapy became a trigger factor for the activation of tissue respiration and cellular metabolism and led to a significant elimination of metabolic acidosis in most patients. The leading position as a catalyst for the metabolic and respiratory processes of the cell is occupied by hyperbaric oxygen therapy, which contributes to the normalization of the acid-base status of the blood in children with CI even after a single application, compared to basic therapy and general magnetic therapy.

Borders between integrative medicine and EBM: significance, potential for use and legal issues in European Union member states. Narrative review

Abstract Aim. The aim of the study is to present the meaning, potential of use and legal issues related to the use of complementary, alternative and integrative medicine in the European Union member states. Material and methods. Non-systematic review. Analysis of the literature on the subject covering the issues related to using and legal issues of complementary and alternative medicine methods in the context of the integration of Evidence Based Medicine methods into conventional medicine. Results. Despite attempts to introduce restrictions and introduce legal regulations regarding the use of unconventional medicine, it is still common to use unconfirmed methods, based on information searched on the Internet or using the services of people without any education in a given field. Lack of or insufficient regulations to manage the quality, safety and effectiveness of complementary and alternative medicine methods, and the lack of integration between the health care system and CAM pose the greatest risk. Conclusions. Due to the ever-increasing public demand for the use of complementary medicine methods, it is necessary to take steps to introduce integrative medicine that will ensure safe and effective patient-centered care, taking into account the comparability and availability of CAM practices in European Union member states.

Contrast Agent and Molecular Imaging Meta-Analysis of the Clinical Effect of Intelligent Image Sensor Combined with Visual Training in the Treatment of Children with Intermittent Exotropia in China.

At present, the main treatment for strabismus is still surgical treatment, but there is no unified standard for the evaluation of the timing of surgery. This study mainly explores the clinical effects of using meta-analysis of intelligent image sensors combined with visual training to treat children with intermittent exotropia. Cochrane systematic reviews collect, evaluate, and synthesize an increasing number of original clinical research results to obtain the comprehensive effect of relevant interventions, so as to provide real and reliable evidence for health decision-making and clinical practice. It uses scientific, clear, and reproducible research methods to reduce the influence of biased factors, so it is different from traditional reviews. Cochrane systematic reviews are especially suitable for certain interventions when the pros and cons of interventions are difficult to determine based on the results of a single clinical study or when there are large differences in the clinical application process. Poor quality systematic reviews can mislead policymakers and clinicians. In the meta-analysis, the Cochrane systematic evaluation method of evidence-based medicine was used to comprehensively search the published literature research on the treatment of intermittent exotropia with vision training. Using the Cochrane system evaluation method, computer search of CENTRAL, MEDLINE, Embase, Chinese Biomedical Literature Database, Chinese Journal Full-text Database, manual retrieval of relevant conference documents, and inclusion of all clinical trial documents of visual training in children with intermittent exotropia was conducted. Patients with intermittent exotropia were selected, simultaneous vision, fusion function, and far stereo vision with the same vision machine were measured, and near stereo vision with a stereo vision chart was measured. The number of simultaneous vision, fusion function, and distance and near stereo vision “with” and “without” cases were recorded for all patients, and the relationship with age of onset, type of strabismus, degree of strabismus, and degree of control was counted. Among them, 91 patients who underwent strabismus correction surgery were followed up for at least 6 months with correct eye position. The presence or absence of simultaneous vision, fusion function, far stereo vision, and near stereo vision were recorded and compared with preoperative. The number of recovery and nonrecovery cases was recorded, and the relationship between the age of operation, the type of strabismus, the degree of strabismus, and the degree of control was counted. It was statistically analyzed by SPSS22.0. The results of the meta-analysis showed that in terms of the effective rate of fundus lesions, the visual training group was better than the nontraining group, and the difference between the two groups was statistically significant (RR = 1.32, 95% CI: (1.25, 1.40), P < 0.0001). This study provides guidance for the early rehabilitation of children with intermittent exotropia.

Clinical Practice Guidelines of Chinese Medicine Rehabilitation for Ischemic Stroke （Cerebral Infarction）

Ischemic stroke (cerebral infarction) is a common clinical disease of ischemic necrosis or softening of localized brain tissue, which belongs to stroke disease in traditional Chinese medicine (TCM). In recent years, its incidence rate has gradually increased, the age of onset tends to be younger, and seriously affects the quality of life of patients with cerebral infarction. TCM rehabilitation is one of the effective methods to improve clinical symptoms and prevent recurrence. The clinical practice guideline of TCM rehabilitation of cerebral infarction based on the concept and method of evidence-based medicine is of great significance, which is helpful to standardize the operation technique of TCM rehabilitation of cerebral infarction and obtain better curative effect. This guideline standardizes the diagnosis and rehabilitation treatment of cerebral infarction in terms of scope, terminology, diagnosis of TCM and western medicine, rehabilitation assessment, TCM rehabilitation treatment and nursing, in order to provide guidance and reference for clinicians or rehabilitation doctors in diagnosis and treatment. ① Diagnosis: it is divided into TCM diagnosis and western medicine diagnosis, TCM diagnosis includes disease differentiation and syndrome differentiation (meridian involved style and viscera involved style), and western medicine diagnosis includes diagnosis basis, clinical stage and quantitative classification of clinical condition. ② Rehabilitation assessment: it mainly includes the assessment of neurological impairment, motor function, balance function, speech function, swallowing function, cognitive function, psychological assessment and quality of life. ③ Rehabilitation treatment of traditional Chinese medicine (TCM): it mainly stipulates the diagnosis and treatment technologies of traditional Chinese medicine treatment, acupuncture therapy, massage therapy, traditional functional methods, rehabilitation treatment and nursing in the ultra early stage, acute stage, recovery stage and sequelae stage of cerebral infarction. The guideline could provide guidance for the rehabilitation treatment of cerebral infarction in different levels and kinds of rehabilitation institutions, traditional Chinese medicine hospitals or general hospitals. It has good clinical applicability and effectiveness.

Clinical comprehensive evaluation of Danhong Injection in treatment of stroke with blood stasis syndrome

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the &quot;6+1&quot; dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).

A brief discussion on evidence-based clinical research of traditional Chinese medicine.

The evaluation of clinical efficacy of traditional Chinese medicine (TCM) is the focus of the development of Chinese medicine, but at present there is no internationally recognized clinical efficacy evaluation system, which prevents TCM going abroad. Evidence-based medicine (EBM) research methods have achieved good results in the evaluation of TCM, but there are still some problems. How to use EBM methods in accordance with China's national conditions and develop evidence-based TCM that meets its own characteristics is the key to the current discussion. Search websites such as PubMed, China National Knowledge Infrastructure, Wanfang Data and VIP by computer, and search papers related to evidence-based clinical research of TCM. A total of 15 high quality representative research papers published in internationally renowned journals were selected for example, including 4 randomized controlled trials (RCTs) related to Chinese medicine, 9 RCTs related to acupuncture, and 2 observational studies on the safety of TCM. EBM method is suitable for clinical research of TCM. There are differences between "disease" and "syndromes" in the use of TCM. Based on the further standardization of syndromes and classification of TCM, modern clinical research methods can be reasonably applied. However, the quality of clinical research related to TCM is not high, and there is a lack of research related to the safety of it, which should be paid attention to and improved in future research.