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Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment ， Development，and Evaluation （GRADE）approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ，this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ，involving evaluation prior to administration （liver and renal function ，pleural effusion and ascites ， comedication，genetic testing ），pre-treatment and routine dosing regimen （pretreatment of hydration and alkalization ，urine alkalization，routine dosing regimen ），therapeutic drug monitoring （necessity，method，timing，target concentration ），leucovorin rescue（rescue timing ，rescue regimen ，rescue dose optimization ），and management of toxicities （liver and kidney function monitoring，supportive treatment ，blood purification treatment ）. This article aims to summarize and interpret the recommendations of this guideline ，so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.
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@#Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.
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@#Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
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Key healthcare resources are doubtlessly critical in emergency management. How to balance the supply and demand, use limited resources scientifically and rationally, and maintain a healthy public service system, have emerged an important challenge in emergency command. Based on the theory of supply-demand balance of public goods, the article took Wuhan as an example to analyze and establish a model on key healthcare resources allocation, in order to provide reference and evidence for global health governance and other similar public health emergencies.
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This study introduces 5 methods of causality assessment of adverse drug reactions (ADRs) domestic and overseas. According to the assessment of ministry of public health of China, the key points about the relevance analysis have been illuminated for the post-evaluation of Chinese patent medicine. Under the guidance of the causality assessment, we should describe the ADR reports in detail and further detect the accurate ADR warning signals. In order to supplement the ADR information, more researches concerning the ADR mechanism should be fully explored.
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In clinical practice, the application of Traditional Chinese Medicine injections (TCMIs) has several problems, for example, at some time, the components are complicated, the ingredients and pyrogen are uncontrollable, the usage, the dosage, and the drug interactions are unclear and the method of application is also ambiguous and non-standard. The factors have restricted the development of TCMIs. Based on the policies of the TCMI package inserts since 2006, this paper takes consideration of the problems and gives suggestions of making strict, normal and evidence-based TCMI package inserts.
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Retinitis pigmentosa (RP) is a group of inherited disorders which involve photoreceptors of the retina and can lead to visual loss. The genetic and clinical phenotypes of RP feature high heterogeneity. RP can be divided into nonsyndromic and syndromic types, both may feature autosomal dominant, autosomal reccesive and X-linked inheritance. So far, many genes have been identified, most of which are expressed in the photoreceptors or retinal pigment epithelium. Sixty-three genes have been identified in nonsyndromic RP. This paper reviews recent progress in the research of the genetics of RP.
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Humans , Genes, X-Linked , Proteins , Genetics , Retinitis Pigmentosa , GeneticsABSTRACT
Objective To investigate the incidence and risk factors of acute kidney injury (AKI) after craniocerebral injury.Methods A single cohort of 791 patients who suffered from craniocerebral injury from January 2008 to January 2010 in the Second Hospital of Lanzhou University were prospectively analyzed.Craniocerebral injury was defined according to definite medical history of craniocerebral injury,the verification of CT and Glasgow coma scale (GCS) score.AKI was defined as a relative 50％ increase or an absolute increment of 26.4 μmol/L in Scr within 48 hours and/or urine volume ＜0.5 ml·kg-1·h-1 up to 6 h.Multivariate Logistic regression analysis was used to evaluate possible risk factors associated with post-craniocerebral injury AKI.Results Of the 791 patients,the incidence of AKI was 39.4％.In hospital mortality of AKI patients was 27.9％,which was 5.065 times of non-AKI patients (P＜0.01).The incidence of AKI in patients with lower GCS score (≤8 score,heavy group)was 69.7％,which was significantly higher as compared to moderate and mild groups (P＜0.01).Unconditional multivariate Logistic regression analysis revealed that lower GCS score (≤ 8 score),hypotension (systolic pressure＜90 mm Hg),elderly and male were the independent predictors of AKI episodes,the corresponding OR values were 2.932,2.176,1.789,1.544 respectively.Conclusions AKI is a common complication after craniocerebral injury.Lower GCS score,hypotension,elderly and male are the independent risk factors of AKI in patients after craniocerebral injury.
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Objective To investigate the characteristics and risk factors of anemia in renal transplant recipients over 60 years old.Methods Clinical data of one hundred and sixty-eight renal transplant recipients over 60 years old were retrospectively analyzed.Logistic regression analysis was used to determine the risk factors of anemia.Results In 168 cases of renal transplant recipients,the incidence of anemia was 45.2％(76/168).Forty cases were normocyte and normochromic,26 cases were microcytic hypochromic,10 cases were hemolytic anemia.In these anemic recipients,51 cases were short of erythropoietin (EPO),25 were EPO resistance.The incidence of malnutrition and cardia-cerebrovascular complication was higher in recipients with anemia than those without anemia (P＜0.01).The incidence of anemia in CsA+Aza+Pred treatment was 57.1％,which was significantly higher as compared to other three treatments (P＜0.01).Unconditional multivariate Logistic regression analysis revealed that male,creatinine level,acute reject reaction,delayed graft function (DGF) were the independent predictors of anemia,the corresponding OR values were 1.089,5.156,6.345,1.876.Conclusions Anemia is a common and serious complication in renal transplant recipients over 60 years old.Male,creatinine level,acute reject reaction,DGF are the independent risk factors of anemia in renal transplant recipients over 60 years old.
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Comparison of the institutional setup, policies and adverse event report mechanism for medical risk control in the countries of UK, USA, Canada, and Australia by means of browsing information on their official websites. It is found that these countries maintain a national patient safety authority, coupled with a tiered management at national, local, medical institutions and NGOs level; the USA pattern features laws and regulations, that of UK and Australia features guidelines as policy guarantee for medical safety; these countries regulate adverse event reporting by either government leadership or cooperation with trade associations. Inspirations from this study suggest China to enhance institutional construction, complete regulations, and advocate the culture for medical safety, and to build the national-level reporting and study system for medical safety events, and improve medical risk management.
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Objective To explore whether anoxia can induce expression changes in connective tissue growth factor(CTGF)in renal tubular epithelial cells(TECs)and epithelial-mesenchymal transition of TECs.Methods Rat renal TECs(NRK-52E)anoxia models were established.NRK-52E cells were exposed to anoxia for 4 h.The real-time RT-PCR,Western blotting,immunohistochemical staining were used to detect the expression of CTGF at 6,12,24,48,and 72 h in NRK-52E cells.Morphological changes and cytoskeleton remodeling in NRK-52E cells under anoxia were examined by a laser confocal microscope and BODIPYFL staining respectively.Results Under anoxia,NRK-52E cells became round,enlarged and cytoskeleton was remodeled.The expression levels of CTGF mRNA and protein were up-regulated at 6 h,reached their peak at 48 h:the expression of CTGF mRNA protein was 29.33±0.21 and 1.30±0.02 respectively.Under anoxia,NRK-52E cells underwent an epithelial-mesenchymal transition process,including cytoskeleton remodeling,and morphological changes.Conclusion Anoxia can change the expression of CTGF and other fibrosis-associated genes in NRK-52E cells,and CTGF played an important role in fibrosis process and epithelial-mesenchymal transition development in NRK-52E cells.
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Objective To investigate the effects of different immunosuppressive agents on mesangial cell proliferation through a mesangial cell injury model in vitro. Methods Mesangial cell line (HBZY-1) in period of proliferation was cultured in vitro with cytochalasin B for 2 h, then HBZY-1 cells were divided into 5 groups: blank (control) group, cyclosporine A (CsA) group, Tacrolimus (Tac) group, mycophelonate mofetil (MMF) group and rapamycin (RAPA) group. Subsequently,the number of HBZY-1 cells at different time points was measured by using the professional image analysis software after treatment for 6, 12 and 24 h, respectively. Results Damaged HBZY-1 cells recovered in all groups. At 6 h, the number of HBZY-1 cells in Tac group was significantly more than that in control group (P＜0.05), but the difference had no significance between the other treatment groups and control group (P＞0. 05). At 12 h, there was no significant difference in of the number of HBZY-1 cells among the all groups (P＞0. 05). At 24 h, there was no significant difference in the cell number between MMF and control groups (P＞0. 05). CsA, Tac and RAPA resulted in HBZY-1 cell proliferation, and the cell number in CsA and Tac groups was significantly more than that in the other groups (P＜0. 05). As compared with the control group, the cell number in RAPA group was significantly increased (P＜0. 05). Conclusion CsA, Tac, MMF and RAPA contribute to recovery of damaged HBZY-1 cells, but CsA and Tac result in over-proliferation of HBZY-1 cells. RAPA and MMF can prevent HBZY-1 cells against over-proliferation, and MMF scarcely results in HBZY-1 cell proliferation.
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Unclear clinical orientation in practice has become one of the common problems with the effective application of famous and excellent Chinese herbal drugs, consequently restricting their development. The authors suggest that there are three aspects to be considered in dealing with this problem. Clinical evaluation and orientation of the famous and excellent Chinese herbal drugs is an important task, and it is also a requirement for the internationalization of traditional Chinese medicine. Literature evaluation-pharmacology research-clinical expertise analysis method will establish a theoretical basis and method for post-marketing development of famous and excellent Chinese patent drugs.
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Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.
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Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.
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The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.
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Abstract: Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.
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In the 21st century, one of the focuses in the field of organ transplantation is the prevention of chronic kidney graft dysfunction (CKGD) and the furtherance of the long-term survival rate. Researches on the mechanism and prevention of CKGD have made progress in the important immune and nonimmune factors of CKGD. Researchers' endeavors to establish the model of CKGD in the animals such as inbreeding pigs; to develop new drugs which are characterized by high efficacy, low toxicity, low cost, and synergy when used together with immune depressants available from natural medicine; and to probe deeply into the mechanism and prevention of CKGD, will be the important aspects in the field of organ transplantation in the 21st century.