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.
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.
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.
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.
ObjectiveTo compare the clinical efficacy and complications of intra-arterial chemotherapy (IAC) and intravenous chemotherapy (IVC) for unilateral advanced retinoblastoma (RB). MethodsA retrospective clinical study. From January 2020 to January 2021, 40 patients (40 eyes) unilateral group cT2 RB patients diagnosed at Baoding Children’s Hospital and Beijing Children’s Hospital were recruited in this study. There were 22 males (22 eyes) and 18 females (18 eyes). All were monocular. All the patients were assigned to two groups according to different treatment modalities they received: IVC group and IAC group. There were 26 eyes and 14 eyes, respectively. When the tumor invades the optic nerve, choroid, sclera, anterior chamber and iris, enucleation was performed. The globe salvage rate, tumor extraocular metastasis rate, solid tumor control rate, treatment-related complications and pathological high-risk factors after enucleation were observed. The globe salvage rate and solid tumor control rate were compared between the groups by chi square test. ResultsThe globe salvage rate of IAC group and IVC group were 88.5% (23/26) and 50.0% (7/14), respectively. Solid tumor control of IAC group and IVC group were 84.6% (22/26) and 42.9% (6/14), respectively. There were statistically significant differences in globe salvage rate and solid tumor control between the two groups (χ2=7.18, 7.56; P＜0.05). Compared with IVC group, IAC group had less systemic complications, mild ocular and periocular side effects. Among 26 cases in IAC group and 14 cases in IVC group, 3 and 7 cases underwent enucleation respectively. The results of pathological examination showed that there were 2 cases and 3 cases with pathological high-risk factors in the two groups, respectively. During the follow-up period, 2 cases in IAC group had extraocular metastasis, there was no extraocular metastasis in IVC group. ConclusionCompared with IVC, IAC has the advantages of high tumor control rate, high globe salvage rate, less and mild complications, however, there is still tumor recurrence.
Ciliary body tumor is a rare intraocular tumor. Due to its unique anatomical location, its correct diagnosis and reasonable treatment are very difficult problems. In terms of diagnosis and differential diagnosis, ophthalmologists need to fully utilize the role of slit lamp microscope and transillumination experiment to capture secondary changes in the anterior segment caused by hidden ciliary body tumors, such as monocular localized cataract, lens indentation, and pigment dissemination, etc. Ophthalmological imaging methods, especially ultrasound biomicroscopy, can achieve the purpose of early detection and early diagnosis. According to the size, location and morphological characteristics of the tumor, a reasonable treatment plan is formulated. Since ciliary body tumors are mostly benign, the recurrence rate of local resection is low, which can satisfy the pathological diagnosis and preserve part of the patient's vision. Therefore, eye-preserving treatment should be advocated. However, enucleation remains the treatment of choice for tumors that are too large to be treated with local excision or radiation, eyes with refractory glaucoma, and tumors that do not respond to radiation therapy.
ObjectiveTo observe and analyze the clinical characteristics of children who died of intraocular retinoblastoma (RB). MethodsA retrospective clinical study. Fourteen children (23 eyes) with intraocular RB who died after receiving treatment in Beijing Children's Hospital from 2009 to 2017 were included in the study. Among the children, there were 7 males (10 eyes) and 7 females (13 eyes); 5 had unilateral and 9 had bilateral tumor. Age were 17.2±15.5 months. All children underwent RetCam examination. RB was staged according to the international intraocular RB classify. Among the 23 eyes, 1 eye was in stage B, 2 eyes were in stage C, 12 eyes in stage D, and 8 eyes in stage E. Treatment methods included a systemic (vincristine, etoposide and carboplatin) chemotherapy (VEC chemotherapy), enucleation surgery, and vitrectomy. The basic conditions including age, time of diagnosis, pathological diagnosis, treatment and main causes of death were retrospectively analyzed. ResultsAmong the 14 cases, the first symptom was leukemia in 12 cases, red eye in 1 case, and squintin in 1 case. Systemic VEC chemotherapy was used for 1-6 courses of treatment; 5 cases were enucleated, 3 cases underwent histopathological examination; 3 cases were treated with vitrectomy. Among the 3 cases who underwent histopathological examination, the sclera and optic nerve, optic nerve and optic disc were invasted respectively. Seven patients died of tumor metastasis and/or intracranial lesions (50.0%, 7/14); the median survival time was 19 months. Four patients died of treatment (28.6%, 4/14), including 3 patients died of chemotherapy-related side effects, and 1 died of organ failure after enucleation surgery (7.1%); the median survival time was 3.5 months. Early abandonment of treatment died in 3 cases (21.4%, 3/14); the median survival time was 15 months. ConclusionIntracranial metastasis is the main cause of death in children with intraocular RB.
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.