Background AIDS (acquired immune deficiency syndrome) has become the most devastating disease which humankind has ever encountered. Human immune-deficiency virus (HIV) is transmitted through blood, sexual behavior and mother-to-baby, with more efficient transmission through blood transfusion. HIV risk among blood transfusion was severe due to lack of effective and correctly applied screening method and rigorous management, especially in some developing countries. Since the first HIV screening reagent was approved by FDA to screen the blood in 1985, the fourth generation test has been produced till now. Initially, HIV test was primarily used to screen the blood supply, it also became an important aspect of HIV prevention, especially screening among people donating blood. Today, HIV testing is seen as an integral part of both the nation’s prevention and treatment efforts. Objective To assess the effectiveness of any intervention tests for HIV screening among people donating blood, and find appropriate tests for HIV screening to decrease the risk of HIV transmission by blood transfusion. Search strategy MEDLINE, Cochrane Controlled Trials Register (CENTRAL/CCTR), AIDSLINE, EMBASE, CBM were be searched with the terms: "HIV", "AIDS", "screening", "test", "blood donor", "blood bank" and the detailed screening method. The websites of WHO, UNAIDS, CDC, FDA, and their related links were searched. Letters were mailed to various agencies and experts in this field to acquire unpublished reports. Inclusion criteria RCT and CCT for screening HIV among blood. donors will be included. Observational studies such as cohort studies, cased-control studies, and historical controlled studies will be used for sensitivity analysis. Method of the review According to the principles of Cochrane Review, selection of trials for inclusion, quality assessment of studies, data extraction and syntheses were conducted by reviewers.
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 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.
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.
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.
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.
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.
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.
As an important policy tool, real-world evidence is the basis for health insurance catalogue adjustment, and relevant policies and regulations have been issued in foreign countries to guide the use of real-world research for health insurance access, but the field of traditional Chinese medicine in China in particular is still in the exploratory stage. Since TCM protocols are widely used in clinical practice and have significant clinical value, this paper takes TCM protocols as an example and systematically constructs a technical pathway based on real-world research to support health insurance access, including clinical needs assessment, basic requirements of protocols, key points for conducting real-world research and evaluating real-world evidence, the process of access, the strategy of access, and the dynamic monitoring of access, with the aim of providing guidance for the application of real-world research in China's health insurance catalogue adjustment. Access to real-world research to provide reference for the application of real-world research in China's health insurance.
Emergency treatment of ocular trauma is a systematic and complicated work. Rapid and correct diagnosis and treatment are needed to maximize the recovery of ocular structure and function. In recent years, China has made remarkable progress in the emergency treatment of ocular trauma, including the development of Expert consensus on the norms of emergency treatment of ocular trauma in China (2019), the establishment of a national ocular trauma database, and the development of VisionGo Artificial Intelligence prediction system for ocular trauma. These measures improve the treatment level of ocular trauma and provide support for the prediction of postoperative visual acuity in severe traumatic eyes. However, with the development of economy and society, the characteristics of ocular trauma in our country have changed. For example, the majority of hospitalized patients were open ocular injuries, farmers and workers were the main occupational groups, and the proportion of eye injuries caused by traffic injuries increased year by year, and the proportion of women and minors increased. Although the annual loss of life of ocular trauma disability in China has decreased faster than the world average, the emergency treatment of ocular trauma still faces many challenges, such as regional differences, insufficient primary medical resources, lack of standardized training, and insufficient promotion of emergency treatment standards. In order to cope with these challenges, it is necessary to further strengthen the popularization of science and technology for the prevention and treatment of ocular trauma, standardize the emergency treatment process, strengthen the training of grass-roots medical personnel, strengthen the safety of emergency surgery, and pay special attention to the particularity of children's ocular trauma. In addition, relevant research has been actively carried out to establish a complete database of emergency patients with ocular trauma to promote the accurate prevention and treatment of ocular trauma.
