World Federation of Acupuncture-Moxibustion Societies (WFAS) standard Norms for Formulation and Evaluation of the Clinical Practice Guidelines of Acupuncture and Moxibustion (Hereinafter referred to as Norms) is the first methodological specification for the development of guidelines of acupuncture and moxibustion (Acup-Mox) issued by an international academic organization. The Norms stipulates the principles, procedures, review process and requirements of the development of WFAS guidelines of Acup-Mox. It also proposes the development method, evaluation method, and reporting standards of WFAS guidelines of Acup-Mox. This article introduces the development process of the Norms and provides an interpretation of the methodological supplementary requirements for key links such as "formulation of clinical questions", "evidence retrieval, evaluation and synthesis", and "consensus decision-making", as well as the "framework and contents of recommendation" to provide relevant references for users in learning and using the Guidelines.
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.
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.
ObjectiveTo investigate effects of vitamin K2 in combination with 5-fluorouracil (5-FU) on proliferation, migration, and invasiveness of hepatocellular carcinoma cells in vitro. MethodsHuman hepatocellular carcinoma PLC/RAF/5 cells were cultured in vitro and exposed to vitamin K2 (10 μmol/L) and 5-FU (10 μg/mL) alone or in combination for 24 h. The cell proliferation, migration, and invasiveness were measured by CCK-8 assay, wound-scratch assay, and Matrigel invasion chamber assay, respectively. ResultsThe abilities of proliferation, migration, and invasion of PLC/RAF/5 cells were significantly decreased after either alone vitamin K2 or 5-FU treatment (all P<0.05) as compared with the control cells, and above effects were further enhanced by the vitamin K2 in combination with 5-FU treatment as compared with either alone drug treatment (all P<0.05). ConclusionCombination use of vitamin K2 and 5-FU might be an effective method for inhibiting growth, migration, and invasiveness of hepatocellular carcinoma cells.
Background In the latter of 20th century, a global growth in allergic diseases has been witnessed, accompanying with spring-out of therapeutic drugs. However, trials did not clarify the comparative effectiveness and pharmaceutical economics of these agents. Severe adverse drug effects have been reported increasingly in the last few years. These made it difficult for clinical practice and selection of national essential drugs. Objective To assess astemizole, loratadine, cetirizine and tefenadine for allergic rhinitis (AR) and urticaria in terms of effectiveness, heart-related drug adverse effects and pharmaceutical economics. Search strategy Cochrane Library, Medline, Embase and Chinese Biomedical Database will be searched. Additional database should be searched for safety and economic studies. Selection Criteria The publication languages are restrained to English and Chinese. 1) Effectiveness: high-quality randomized controlled trials (RCTs) and systematic Reviews (SRs)/ meta-analysis for AR and uritcaria are included, with comparisons restrained to among these four drugs; 2) Safety: a hierarchy of evidences of these four drugs for allergic diseases are included. 3) Economical evaluation: cost-effectiveness and cost-utility assessment of these four drugs for AR and urticaria should be included. Methods of review data extraction sheet and quality appraisal table are separately designed. QUOROM STATEMENT and Jadad Scale are applied, respectively, to SRs and RCTs. Two reviewers independently select the studies, appraise the quality and extract the data. Any disagreement is solved by discussion. Data analysis Fixed effect model is first applied. Sensitivity analysis is employed to study the heterogeneity between trials. Randomized effect model is alternatively used when compromised.
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.
ObjectiveTo systematically review the effects of nursing-implemented sedation protocol on outcomes of mechanical ventilation and sedation in mechanically ventilated ICU patients. MethodsWe searched EMbase (Ovid), The Joanna Briggs Institute EBP Database (Ovid), Cochrane Central Register of Controlled Trials (CENTRAL, Ovid), MEDLINE (Ovid), Web of Knowledge, CINAHL, CBM, CNKI, WanFang Data and VIP to collect studies on nursing-implemented sedation protocol up to January 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsA total of 11 studies involving 2118 patients (1 037 were in the intervention group, and 1 081 were in the control group) were included. The results of meta-analysis showed that nursing-implemented sedation protocol could reduce the total dosage of midazolam (MD=-163.82, 95%CI -309.81 to -17.84, P=0.03), the daily dosage of midazolam (MD=-37.22, 95%CI -61.14 to -13.29, P<0.01), and the incidence rate of VAP (RR=0.53, 95%CI 0.34 to 0.81, P<0.01). However, nursing-implemented sedation protocol had no effects on the length of mechanical ventilation, the length of ICU stay, and self-extubation. ConclusionCompared with the usual sedation management, nursing-implemented sedation protocol can reduce the dosage of midazolam and the incidence rate of VAP. But no statistical significances are found in the length of mechanical ventilation, the length of ICU and the incidence rate of self-extubation.
With the widespread promotion and application of the Enhanced Recovery After Surgery (ERAS) concept in the surgical fields, the implementation of the ERAS concept in the treatment of lower extremity deep venous thrombosis (DVT) was explored in the vascular surgery. The “Six-Step” comprehensive treatment protocol and the establishment of the ERAS system for lower extremity DVT developed by the Department of Vascular Surgery at the First Affiliated Hospital of Chongqing Medical University were elaborated. The protocol includes steps such as filter placement, thrombus clearance, relief of venous outflow obstruction, dissolution of residual thrombus, filter retrieval, and standardized post-discharge anticoagulation management, along with their respective advantages. Additionally, the training and dissemination efforts undertaken to promote the “Six-Step” comprehensive treatment protocol were described. A comparison was made between ERAS and traditional recovery surgery, highlighting the comprehensive clinical benefits of the former. The aim is to promote the standardized implementation of the ERAS system in lower extremity DVT treatment and to bring greater benefits to patients.
【Abstract】Objective To study the difference of telomerase activity in the common thyroid lesions . Methods The telomerase activity was detected in 19 patients with thyroid carcinomas, 15 samples adjacent to thyroid carcinomas，21 specimens of thyromas, 17 cases of nodular goiters and 13 pieces of normal thyroid tissues by telomeric repeat amplification protocol（TRAP). Results Eighteen of 19 samples of thyroid carcinoma, 1 of 15 samples adjacent to the cancer and 1 of 21 adenoma of the thyroid specimens showed positive telomerase activity, all 17 cases of nodular goiters and 18 samples of normal thyroid tissues exhibited negative telomerase activity, and the rate of positive telomerase activity of thyroid carcinomas was significantly higher than that of the other tissues (P＜0.0001). Conclusion The telomerase is an important qualitative marker of thyroid carcinoma and a useful index in differential diagnosis of thyroid lesions.
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.