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Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.
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The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years， randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine （TCM）， but the quality of the implementation of blind methods is uneven， and the evaluation criteria have not yet been formed. In this paper， the data collection methods， calculation principles， advantages， and disadvantages of two quantitative quality evaluation methods of blind methods， namely James Blinding Index （JBI） and Bang Blinding Index （BBI）， were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time， a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally， the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
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Hyperglycemia, hypoglycemia, and even glucose metabolism crisis and cerebral edema are common complications in critically ill children with glucose metabolism disorders.In clinical practice, blood glucose monitoring should be strengthened.When glucose is abnormal, it should be treated in time to control it within the normal range and reduce complications.This review elucidated and discussed the diagnosis of hyperglycemia and hypoglycemia, blood glucose monitoring, glycemic target and treatment scheme for abnormal glucose metabolism in critically ill children to provide suggestions for blood glucose management in pediatric intensive care unit.
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Target trial emulation， using observational data to emulate a target trial， applies the study design principles of randomized controlled trials to observational studies that aim to estimate the effect of an intervention. The advantage of target trial emulation is that observational data is used to emulate a target trial when it is not appropriate to conduct randomized controlled trials. Target trial emulation can control bias caused by the design of observational studies， and improve the effectiveness of causal inference from observational data. This paper introduced the methodological framework and key points in terms of eligibility criteria， treatment strategies， assignment procedures， grace period， outcomes， follow-up period， effect contrasts， and statistical plan for implementing target trial emulation. This article elucidated the feasibility and necessity of applying target trail emulation in the realm of traditional Chinese medicine researches， and highlighted the challenges encountered in its implementation， such as the need for specialized personnel， data collection and integration， and the control of confounding factors.
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ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
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Vibrio splendidus is an opportunistic pathogen in aquaculture. It can infect a variety of aquaculture animals and has caused huge losses to the aquaculture industry. In this study, a novel and efficient method for detecting V. splendidus was developed by combining the exonuclease Ⅲ amplification strategy with a nucleic acid test strip developed based on gold nanoparticles-labeled DNA probe. The results could be directly visualized by naked eyes, and this system overcame the difficulty in preparation of the monoclonal antibody used in conventional immunostrip. Upon optimization of experimental conditions, the detection limit of the strip was 5 ng/mL for the synthetic oligonucleotide DNA fragment and 10 ng/mL for the actual genomic DNA sample of V. splendidus. This test strip was more sensitive compared with the PCR method and was specific for the detection of V. splendidus. The rapid preparation of nucleic acid strip and the efficient detection of V. splendidus open a new way for the prevention and control of aquatic diseases.
Subject(s)
Animals , DNA Probes , Gold , Metal Nanoparticles , Vibrio/geneticsABSTRACT
AIM:To study the effect of neuregulin-1 ( NRG-1β) or captopril alone and their combination on myocardial cell apoptosis and related gene expression in rats with chronic heart failure .METHODS:Young male Sprague-Dawley rats were randomly divided into sham-operated group, heart failure group, NRG-1βgroup, captopril group and combined treatment group .The volume overloaded heart failure model in the rats was established by aortocaval fistula .The cardiac function was evaluated by determining the changes of hemodynamics and plasma BNP level .The apoptotic index ( AI) of myocardial cells was assayed by TUNEL .The protein levels of p-Akt, Bax and Bcl-2 in left ventricular tissue were detected by Western blot .RESULTS: The LVEDP, AI and the expression of Bax were significantly lower in NRG-1βgroup, captopril group and combined treatment group than those in heart failure group ( P<0.05 ) , while the values of ±dp/dtmax and the protein levels of p-Akt and Bcl-2 were significantly higher in NRG-1βgroup, captopril group and com-bined treatment group than those in heart failure group (P<0.05).The effect of combined treatment group was more signifi-cant ( P<0.05) than that in NRG-1βgroup and captopril group .CONCLUSION: Neuregulin-1βor captopril alone and the combination of them effectively improve the cardiac function and inhibit myocardial cell apoptosis in chronic heart failure rats.The therapeutic effect of combination of NRG-1βand captopril is better than that of NRG-1βor captopril alone .
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OBJECTIVE:To observe clinical efficacy and safety of torasemide in the treatment of chronic heart failure(CHF). METHODS:94 patients with CHF were selected and randomly divided into control group and observation group,with 47 cases in each group. Control group were treated with routine treatment,such as bed rest,oxygen inhalation,control of total body fluid in-take,routine anti-heart failure therapy and use of diuretic in 24 h. Based on the above treatment,observation group were treated with Torasemide injection with initial dose of 5-10 mg,qd,gradually increasing to 20 mg/d,maximal does of 40 mg/d. Both group re-ceived 7 days of continuous treatment. Clinical efficacies were observed in 2 groups as well as serum potassium and sodium,Scr,24 h urine volume and the rate ofⅠ-Ⅱgrade cardiac function before and after treatment. The occurrence of ADR was compared between 2 groups. RESULTS:The total effective rate of observation group was 61.70%,which was significantly higher than that of control group (46.81%),with statistical significance (P0.05). There was no statistical significance in 24 h urine volume and the rate ofⅠ-Ⅱgrade cardiac function between 2 groups before and after treatment(P>0.05);after treatment,24 h urine volume and the rate ofⅠ-Ⅱgrade cardiac function of 2 groups were increased significantly,the observation group was higher than the control group, with statistical significance (P0.05). CONCLUSIONS:Torasemide is effective for CHF,and can promote diuresis and the recovery of cardiac function with good safety.
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Objective We performed experiments using Neuregulin-1β (NRG-1β) treatment to determine a mechanism for the protective role derived from its beneficial effects by remodeling gap junctions (GJs) during heart failure (HF). Methods Rat models of HF were established by aortocaval fistula. Forty-eight rats were divided randomly into the HF (HF, n = 16), NRG-1β treatment (NRG, n = 16), and sham operation (S, n = 16) group. The rats in the NRG group were administered NRG-1β (10 μg/kg per day) for 7 days via the tail vein, whereas the other groups were injected with the same doses of saline. Twelve weeks after operation, Connexin 43 (Cx43) expression in single myocytes obtained from the left ventricle was determined by immunocytochemistry. Total protein was extracted from frozen left ventricular tissues for immunoblotting assay, and the ultrastructure of myocytes was observed by transmission electron microscopy. Results Compared with the HF group, the cardiac function of rats in the NRG group was markedly improved, irregular distribution and deceased Cx43 expression were relieved. The ultrastructure of myocytes was seriously damaged in HF rats, and NRG-1β reduced these pathological damages. Conclusions Short-term NRG-1β treatment can rescue pump failure in experimental models of volume overload-induced HF, which is related to the recovery of GJs structure and the improvement of Cx43 expression.
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OBJECTIVE To control the quality of cleaning and sterilization of rent instruments and to secure medical safety of patients undergoing operations.METHODS We randomly chose 60 pieces of rent instruments and divided them into two groups,machinery wash group and hand wash group.Occult blood test was performed before and after washing and rinsing.RESULTS Positive rate of occult blood tests was 86.67% before either machinery or hand wash.While after machinery wash and hand wash it was 0% and 6.67%,respectively.Both wash methods had significant effect on depleting occult blood(P0.05).CONCLUSIONS Hospitals must enhance the management of rent instruments cleaning which is of poor quality at present by regulating the procedure and monitoring methods so as to ensure the quality of rent instruments cleaning and secure patients safety.
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Objective To identify the application of puncture biopsy under ultrasound guidance in diagnosis of bone tumor.Methods The results of ultrasonic puncture biopsy were comparatively analysed with that of imaging diagnosis and postoperative-pathological diagnosis in 17 patients with bone tumors.Results The giant cell tumor of bone were diagnosed by puncture biopsy in 8 cases,by imaging in 12 cases and by pathology,postoperation in 9 cases,the corresponding rate was 66.7% and 88.9% respectively.Bone cyst in 2 cases,fibrous dysplasia in 2 cases,metastasis from lung carcinoma in one case,osteosarcoma in 2 cases were confirmed by both pathology and puncture biopsy.The aneurysmal bone cyst in one case was diagnosed by imaging,but no blood-like fluid was harvested in puncture,one case of metastasis in proximal femur,one case of fibrous dysplasia and one case of osteosarcoma were diagnosed by imaging,while one case,2 cases and one case diagnosed by puncture respectively.One case of bone cyst was confirmed by imaging,puncture biopsy and pathology.Conclusion The puncture biopsy under ultrasound guidance is of high diagnostic rate in bone tumors,it is a good choice for the diagnosis of bone tumor.