The 12th Asian Conference on Pharmacoepidemiology (ACPE) has been successfully held from October 11st to 13rd, 2019 in Kyoto, Japan. More than 600 representatives from 33 countries and regions participated in the meeting. The arrangement of this conference mainly included: education session program, contributed papers report, symposium and poster presentation, which provided good opportunity for participants to communicate. Moreover, it promoted the dissemination and utilization of advanced methods and technologies of global pharmacoepidemiology, especially in Asia region, and provided technical support in order to ensure the safety and efficacy of public. Moreover, it was the first time that the symposium on herbal and Traditional Medicines has been set up in the ACPE. This paper introduced the main details of the contents
To investigate the shortsegment pedicle screw in treating degenerative L4 spondylolisthesis and the relationship of the preliminarily bending degree of the titanium rod with the lumbar lordosisangle, the slipping angle and the slipping percentage and to evaluate the clinical coincidence and curative effects of the preliminarilybent rod. MethodsFrom September 2005 to March 2007, 31 female patients (age, 40-70 years; average, 58.3 years) were admitted for surgical treatment of their L4 degenerative spondylolisthesis (MeyerdingⅠ°, Ⅱ°)． Their lumbar lordosis angle （x1）, slipping angle (x2), and slipping percentage (x3) were measured in the L4,5 segment before operation. During the operation, the titanium rod bent beforehand according to the corresponding standards was inserted. The angle of the bent rod (Y) was measured, and then the multiple linear regression equation was established. The regression equation was applied to the surgical treatment of the 30 patients.Results According to the criteria in the JOA scoring system, the 31 patients had scores of 8.300± 1.080 and 26.916±1.859 before operation and after operation, respectively. There was a significant difference between before operation and after operation（Plt;0.05）. The established multiple linear regression equation was as follows:Y=0.1390-0.327logx1+0.463x2+0.288x32．The operating time was 51.290±3.408 min in the 30 patients who underwent an insertion of the preliminarilybent rod during the operation; however, the operating time was 102.360±5.004 min in the 31 patients who underwent an insertion of the bent rod that was made based on experience during the previous operations. There was a significant difference in the operating time between the two kinds of the rods （Plt;0.05）. Estimated according to 90%, 95% and 99% of the areas under the normalcurve, the clinical coincidence rates in the preliminarily bending degrees of the titanium rod in the 30 patients were 80.00％，90.00％ and 96.67％, respectively.Conclusion The titanium rod that has been bent into a certain angle before operation according to the established criteria can definitely diminish its strain during operation and efficiently shorten the operating time．Thiskind of the titanium rod has a good coincidence in clinical application and can be effectively used in clinical practice.It is worth reference during the clinical operation.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.
ObjectiveTo systematically review the application status of Delphi method in clinical research of traditional Chinese medicine (TCM).MethodsPubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect original research and methodological research on Delphi method in TCM from inception to August 30th, 2020. Two reviewers independently screened literature, extracted data, and then, descriptive analysis was performed by using qualitative methods.ResultsA total of 612 articles involving 573 original studies and 39 methodological studies were included, which involved 167 types of diseases. The primary research purposes were disease diagnosis and treatment, syndrome research, scale development, evaluation research, index research, clinical investigation, methodology research, and other 8 categories. 487 papers reported the implementation process and results of Delphi method in varying degrees.ConclusionsDelphi method is widely used in clinical research of TCM, however, there are deficiencies in the specific implementation process.
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
ObjectiveTo use the evidence map system to search and sort out the clinical research on the prevention and treatment of hyperlipidemia with proprietary Chinese medicine, and to understand the distribution of evidence in this field. MethodsThe literature on the treatment of hyperlipidemia with proprietary Chinese medicines was retrieved from CNKI, WanFang Data, VIP, SinoMed, PubMed, Cochrane Library, Embase and Web of Science databases from inception to December 2022. The distribution characteristics of evidence were analyzed and presented by means of text and graph. ResultsA total of 865 articles were included and 79 kinds of proprietary Chinese medicines were obtained. The Xuezhikang tablets or capsules were the most frequently used. In recent years, the number of published articles showed a downward trend, and the literature quality was generally low. Most of the research intervention programs only used Chinese patent medicine, and the sample size of a single study was mostly 60-100 patients, and the study course was 4-8 weeks. Clinical studies did not highlight the characteristics of traditional Chinese medicine, and only 12.7% of the studies limited the syndrome type of traditional Chinese medicine in the study population. In terms of the selection of outcome indicators, more attention was paid to blood lipid levels and safety indicators, while less attention was paid to indicators such as traditional Chinese medicine syndrome scores. ConclusionThe results show that Chinese patent medicine has certain advantages in the prevention and treatment of hyperlipidemia, but there are some deficiencies in the reports of methodology and clinical characteristics, and the overall quality of the research is low.
A metadata standard is a high level document that establishes a common way of structuring and understanding data, and includes principles and implementation issues for utilizing the standard. It helps to record their collections and processes and to structure this information, and can be used to validate data integrity and quality. Metadata standards improve the quality and interoperability of information across information technology platforms by increasing compatibility, improving the consistency and efficiency of information collection, and reducing redundancy. This article introduced the progress and features of metadata standards of clinical research, and aimed to promote the standardization of clinical research and scientific process of therapeutic evaluation.
The research background, way of thinking, research contents and methods of a united research project - "The Clinical Research on the Treatment of SARS with Integrated Traditional and Western Medicine" were reviewed. The latest research achievements on the treatment of SARS with integrated traditional and western medicine and the difficult points in the research were discussed. Furthermore, some tentative ideas were put forward to further the research. The conclusion was drawn that the principles of evidence-based medicine and the research scheme of multi-centered, prospective and randomized controlled trials, as well as the standard statistical and analyzing methods are the best way to assess the effectiveness and safety of treating SARS with integrated traditional and western medicine.
Objective To investigate the clinical manifestations, lung function and therapy of patients with primary bronchogenic carcinoma complicated with chronic obstructive pulmonary disease ( COPD) . Methods 365 patients with primary bronchogenic carcinoma were recruited retrospectively. The patients were analyzed by COPD-complicated and COPD-free groups. The clinical manifestations, lung function ( especially FEV1 ) , pathological types and progression-free survival ( PFS) were analyzed. The use of inhaled corticosteroids for treatment of COPD was also recorded. Results There was 62.2% patients( 227 cases) complicated with COPD with an average age of ( 66.1 ±9.3) yrs, 77. 5% of male, 82. 4% of smokers, and 46. 3% of past histories of respiratory disorders. Those in COPD-free were aged ( 54.8 ±5.6) yrs, with 55.8% of male, 62.3% of smokers, and 30.4% of past histories of respiratory diseases. The COPD-complicated patients had lower lung function than that of COPD-free [ ( 68.6 ±9.7) % vs. ( 75.3 ±7.5) % in FEV1%pred and ( 65.9 ±8.5 ) % vs. ( 75.6 ±9.1 ) % in FEV1 /FVC, P lt; 0.05 ] . The COPDcomplicated patients were more likely to have squamous carcinoma ( 43.2% vs. 31.2% , P lt; 0.05) and small cell lung cancer ( 20.7% vs. 15.2% , P lt; 0.05) . Moreover, performance status ( PS) scores ( 3.3 ± 0.5 vs. 2.8 ±0.4) and PFS ( 5.9 ±1.6 vs. 7.5 ±2.1) were worse in the COPD-complicated patients than that of the COPD-free patients. Only 71 cases of the COPD-complicated patients received regularly inhaled corticosteroids for COPD treatment. These patients had better PS scores and PFS than others without corticosteroids treatment. Conclusions Primary bronchogenic carcinoma patients with COPD comorbidity are commonly encountered. Clinicians should be aware of the clinical manifestation and corticosteroids prescription should be recorded to improve the quality of life and prognosis.