ObjectiveTo explore the method for establishing a pig left lung orthotopic transplantation model. MethodsDetailed surgical procedures, including animal anesthesia, tracheal intubation, donor lung retrieval, and recipient transplantation, were thoroughly reported. By examining the histological morphology and blood gas analysis of the transplanted lung 2 hours after reperfusion, the histological changes and function of the transplanted lung were assessed. ResultsThis method was applied to four male Yorkshire pigs with an average weight of (40.0 ±2.5) kg for left lung in situ transplantation, effectively simulating conditions relevant to human lung transplantation. Two hours after the transplantation, arterial blood gas analysis showed PaO2 was 155.4-178.6 mm Hg, PaCO2 was 53.1-62.4 mm Hg, and the oxygenation index was 310.8-357.2 mm Hg. Hematoxylin and eosin staining indicated a low degree of pulmonary edema and minimal cellular infiltration. ConclusionThe pig left lung orthotopic transplantation model possesses strong operability and stability. Researchers can replicate this model according to the described methods and further conduct basic research and explore clinical translational applications.
Real-time free breathing cardiac cine imaging is a reproducible method with shorter acquisition time and without breath-hold for cardiac magnetic resonance imaging. However, the detection of end-diastole and end-systole frames of real-time free breathing cardiac cine imaging for left ventricle function analysis is commonly completed by visual identification, which is time-consuming and laborious. In order to save processing time, we propose a method for semi-automatic identification of end-diastole and end-systole frames. The method fits respiratory motion signal and acquires the expiration phase, end-diastole and end-systole frames by cross correlation coefficient. The procedure successfully worked on ten healthy volunteers and validated by the analysis of left ventricle function compared to the standard breath-hold steady-state free precession cardiac cine imaging without any significant statistical differences. The results demonstrated that the present method could correctly detect end-diastole and end-systole frames. In the future, this technique may be used for rapid left ventricle function analysis in clinic.
Backgroud Chronic hepatitis is the major infectious disease of liver. There is no effective drug for it up to now. Clinical trials have showed that glycyrrhizin have potentional effective for chronic hepatitis. Objective To evaluate the effectiveness, safety and economics of glycyrrhizin for chronic hepatitis B and C. Search strategy The search terms include glycyrrhizin and its products’ name, chronic hepatitis and chronic carrier status. The thais registers of the Cochrane Hepato-Biliary Group, the Cochrane Complementary Medicine Field, and the central database of The Cochrane Library as well as MEDLINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. And the free Internet search was operated to find ongoing and unpublished researches. Twenty Chinese medical journals and relevant academic conference proceedings have been searched by manual method. The reference lists of identified documents were checked as the complementary search. Inclusion criteria All randomized trials that tested glycryyhizin for chronic hepatitis B virus or hepatitis C virus infection were included in this review. Method of the review According to the principle of Cochrane systematic review, selection of thai for inclusion, assessment of methodological quality, data extraction and data syntheses were conducted by two reviewers.
Precision medicine is an individualized clinical research model established according to gene, environment, lifestyle and other information. As an innovative method of clinical trials, the main scheme design breaks the barriers of traditional randomized controlled trials to the evaluation of targeted therapies in precision medicine and improves the efficiency of clinical research. This paper will systematically introduce the types, concepts and principles of the main scheme design of the new method of precision medicine clinical trial design, and summarize the advantages and limitations of the main scheme design combined with classic cases, aiming at providing scientific and rigorous methodological guidance and clinical practice experience for precision medicine scientific research design.
The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs.
Background Mortality and morbidity of acute myocardial infarction remains high. Intravenous magnesium started early after the onset of myocardial infarction is a promising adjunctive treatment that may limit infarct size, prevent serious arrhythmias, and reduce mortality. Several earlier trials and meta-analyses demonstrated a mortality rate reduction with magnesium treatment, but one mega trial found no benefit. Objective To examine the effect of intravenous magnesium versus control on early mortality and morbidity, stratified by time since onset of symptoms (lt;6 hours, 6+ hours), use of thrombolysis (used, not used), dose of magnesium used (lt;75 mmol, 75+ mmol). Search strategy We search the Cochrane controlled trial register (CCTR) of Cochrane Library, Medline and Embase. We also search Chinese Biomedical Disk (CBM disk) to identify the Chinese trials. Each database will be searched from its starting date to the first-half year of 2002. Selection criteria All randomized controlled trials that compared intravenous magnesium with placebo in the presence or absence of fibrolytic therapy in addition to routine treatment are eligible if they reported mortality and clinical events within 35 days of onset, regardless of language. Methods of review A data abstraction form will be specifically developed to extract information from the eligible articles. The quality assessment of RCT will be focused on method of treatment assignment, blinding of participants and investigators, control of selection bias after treatment assignment. The selection of studies, data extraction and assessment of methodological quality will be performed independently by two reviewers. Disagreements will be resolved through discussion, when necessary, in consultation with a third reviewer. Publication bias, heterogeneity and sensitivity analysis will be performed. The odds ratio (OR) will be used to pooling the effect if appropriate.
In order to standardize and improve the level of TCM diagnosis and treatment of uterine prolapse, the Gynecology Branch of China Association of Traditional Chinese Medicine and the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine took the lead in initiating the revision of the "Guidelines for the TCM diagnosis and treatment of uterine prolapse". Based on the existing relevant literature, the guideline revision working group strictly abides by the principles and steps of evidence-based guideline revision, and establishes a multi-disciplinary and multi-field expert team to standardize the guideline revision work. This plan focuses on the necessity of guideline revision, the establishment and division of labor of the guideline project team, the determination of clinical problems, the screening and evaluation of evidence, and the formation of recommendations.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
Objective To investigate the consistency of regions of interest (ROI) volume among different radiological treatment planning systems (TPS) for the same group of patient data, and analyze the tendency and degree of differences caused by data transfer. Methods Between October 2010 and December 2013, the data of 10 nasopharyngeal carcinoma patients treated in West China Hospital were transferred from Monaco TPS into various other treatment planning systems. Based on different ROI volumes, they were divided into 8 groups. We counted the volume differences between these TPS and Monaco TPS, and carried out the statistical analysis. Results For small ROI volume, the calculated difference reached up to 65% in our study. As a general trend, differences became less and less with the increasing of volumes. But for single ROI, the volume difference was likely to vary randomly. The percentage of ROI volumes which were smaller than that of Monaco TPS was 70% for Raystation TPS, 38.75% for Pinnacle TPS, 88.75% for Eclipse TPS, 97.5% for Masterplan TPS, and 83.13% for iPlan TPS. Conclusions ROI volume differences exist generally among different treatment planning systems when ROIs are transferred among them by DICOM protocol. The volume variations may be affected by multiple factors. The volume consistency should be evaluated before any direct comparison of dose volu me histogram parameters which are done between different systems.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.