Objective The objective of this study was to construct a new Bayesian information borrowing model based on the concept of elastic prior,evaluate the statistical properties of the method through simulation studies,and provide a new method for historical information borrowing.Methods The concept of elastic prior was introduced into the commensurate prior method to establish the elastic commensurate prior model.Simulations were conducted for clinical study outcomes as normal variables under situations where historical data was either consistent or inconsistent with the current study data.Type Ⅰ error,statistical power,and the 95％posterior highest density credible interval were used as evaluation criteria to compare the performance of the elastic commensurate prior method with non-informative prior,full-information prior,power prior,and commensurate prior methods.Results Through simulation studies in various scenarios,it was shown that the proposed elastic commensurate prior method,compared to other prior methods under similar conditions,provides better control of Type Ⅰ error,higher statistical power,and relatively narrower posterior highest density credible intervals.Conclusion The proposed elastic commensurate prior method not only better controls Type Ⅰ error but also ensures higher statistical power,improving the accuracy of estimating treatment effects.This method introduces a new approach for borrowing information from historical data in clinical trials.

Objective To investigate the occurrence and characteristics of Antineutrophil cytoplasmic antibody(ANCA)associated vasculitis induced by methimazole,and to provide references for clinical safe drug use.Methods Case reports of ANCA associated vasculitis induced by methimazole published in Wanfang,CNKI,PubMed,and Web of Science were searched from the inception to October 31 st,2023.Demographic characteristics,drug use,complications,treatment and outcome were analyzed using descriptive statistical method.Results A total of 14 patients from 14literature were included.There were 3 males and 11 females with ages ranging from 8 to 79 years,with a mean age of(47.79±23.47)years.Four patients developed symptoms within 1 year,nine patients developed symptoms from 2 to 12 years,and 1 patient developed symptoms 24 years after medication.ANCA associated vasculitis affected kidney in 5 patients,lung and skin in 5patients,vision in 2 patients and heart in 2 patients.All patients discontinued methimazole,2 patients improved spontaneously without treatment,1 patient improved after anti-infection,and all others received hormonal or immunosuppressive therapy.1 patient developed death,and all others improved or were cured after treatment.Conclusions ANCA-associated vasculitis is a rare adverse reactionof methimazole.Most patients have a long latency period before the onset of disease,mainly involving multiple organs such asskin,kidney,lung,and eyesight.Clinicians should pay attention to differentiate it from primary vasculitis and discontinue the drug as soon as possible.When serious organ damage occurs,glucocorticoids and immunosuppressants should be adminstered promptly to avoid aggravation of the disease and endangerment of life.

Objective Traditional methods for sample size estimation in clinical trial do not consider the patient size applicable to the results during the estimation process,and use point estimation for unknown true values of parameters,which has certain limitations in rare disease clinical trials.This article introduces a sample size estimation method based on Bayesian decision theory.Methods This article proposes a Tripartite Balanced Benefit Function(TBBF)and constructs a benefit function model based on the characteristics of acute and chronic diseases.The sample size in clinical trial is determined by maximizing expected benefits.Results The case analysis of hemophilia B demonstrated the application process of the model,and the sample size obtained by maximizing expected benefits is feasible in practical situations.This method has the advantage of being suitable for estimating sample sizes in small sample clinical trials.Conclusion TBBF fully utilizes prior information,incorporates patient size into the estimation process,and makes the quantitative form of different stakeholders'interests clearer,making the decision-making process more scientific and interpretable.

Objective Traditional methods for sample size estimation in clinical trial do not consider the patient size applicable to the results during the estimation process,and use point estimation for unknown true values of parameters,which has certain limitations in rare disease clinical trials.This article introduces a sample size estimation method based on Bayesian decision theory.Methods This article proposes a Tripartite Balanced Benefit Function(TBBF)and constructs a benefit function model based on the characteristics of acute and chronic diseases.The sample size in clinical trial is determined by maximizing expected benefits.Results The case analysis of hemophilia B demonstrated the application process of the model,and the sample size obtained by maximizing expected benefits is feasible in practical situations.This method has the advantage of being suitable for estimating sample sizes in small sample clinical trials.Conclusion TBBF fully utilizes prior information,incorporates patient size into the estimation process,and makes the quantitative form of different stakeholders'interests clearer,making the decision-making process more scientific and interpretable.

Objective The objective of this study was to construct a new Bayesian information borrowing model based on the concept of elastic prior,evaluate the statistical properties of the method through simulation studies,and provide a new method for historical information borrowing.Methods The concept of elastic prior was introduced into the commensurate prior method to establish the elastic commensurate prior model.Simulations were conducted for clinical study outcomes as normal variables under situations where historical data was either consistent or inconsistent with the current study data.Type Ⅰ error,statistical power,and the 95％posterior highest density credible interval were used as evaluation criteria to compare the performance of the elastic commensurate prior method with non-informative prior,full-information prior,power prior,and commensurate prior methods.Results Through simulation studies in various scenarios,it was shown that the proposed elastic commensurate prior method,compared to other prior methods under similar conditions,provides better control of Type Ⅰ error,higher statistical power,and relatively narrower posterior highest density credible intervals.Conclusion The proposed elastic commensurate prior method not only better controls Type Ⅰ error but also ensures higher statistical power,improving the accuracy of estimating treatment effects.This method introduces a new approach for borrowing information from historical data in clinical trials.

Objective To investigate the occurrence and characteristics of Antineutrophil cytoplasmic antibody(ANCA)associated vasculitis induced by methimazole,and to provide references for clinical safe drug use.Methods Case reports of ANCA associated vasculitis induced by methimazole published in Wanfang,CNKI,PubMed,and Web of Science were searched from the inception to October 31 st,2023.Demographic characteristics,drug use,complications,treatment and outcome were analyzed using descriptive statistical method.Results A total of 14 patients from 14literature were included.There were 3 males and 11 females with ages ranging from 8 to 79 years,with a mean age of(47.79±23.47)years.Four patients developed symptoms within 1 year,nine patients developed symptoms from 2 to 12 years,and 1 patient developed symptoms 24 years after medication.ANCA associated vasculitis affected kidney in 5 patients,lung and skin in 5patients,vision in 2 patients and heart in 2 patients.All patients discontinued methimazole,2 patients improved spontaneously without treatment,1 patient improved after anti-infection,and all others received hormonal or immunosuppressive therapy.1 patient developed death,and all others improved or were cured after treatment.Conclusions ANCA-associated vasculitis is a rare adverse reactionof methimazole.Most patients have a long latency period before the onset of disease,mainly involving multiple organs such asskin,kidney,lung,and eyesight.Clinicians should pay attention to differentiate it from primary vasculitis and discontinue the drug as soon as possible.When serious organ damage occurs,glucocorticoids and immunosuppressants should be adminstered promptly to avoid aggravation of the disease and endangerment of life.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

OBJECTIVE To build an “integration of drug storage and dispensing” intelligent drug validity management system in outpatient pharmacy， and to evaluate the effect of this system. METHODS The information technology was used to connect the drug information in the primary storage， the intelligent secondary storage and the rapid dispensing machine； an “integration of drug storage and dispensing” intelligent drug validity management system was constructed. At the same time， the implementation effects of drug validity management system in outpatient pharmacy of our hospital were evaluated one year before and after the construction of the system. RESULTS By using information technology， intelligent closed-loop management of batch number and expiration date information throughout the entire process of drug circulation in outpatient pharmacy of our hospital had been achieved， making it easy to track and trace drug information. After the establishment of the intelligent system， the time spent on managing drug validity every month was reduced from 103 people·h to 8 people·h； the number of near-expired drugs per month had decreased from （30.67±1.10）types to （17.67±1.17）types（P＜0.05）. CONCLUSIONS The intelligent drug validity management system in outpatient pharmacy based on the mode of “integration of drug storage and dispensing” makes the drug validity management in the outpatient pharmacy more scientific， reasonable and efficient.

OBJECTIVE: To carry out prenatal genetic testing for a fetus with de novo 46,X,der(X)t(X;Y)(q26;q11). METHODS: A pregnant woman who had visited the Birth Health Clinic of Lianyungang Maternal and Child Health Care Hospital on May 22, 2021 was selected as the study subject. Clinical data of the woman was collected. Peripheral blood samples of the woman and her husband and umbilical cord blood of the fetus were collected and subjected to conventional G-banded chromosomal karyotyping analysis. Fetal DNA was also extracted from amniotic fluid sample and subjected to chromosomal microarray analysis (CMA). RESULTS: For the pregnant women, ultrasonography at 25th gestational week had revealed permanent left superior vena cava and mild mitral and tricuspid regurgitation. G-banded karyotyping analysis showed that the pter-q11 segment of the fetal Y chromosome was connected to the Xq26 of the X chromosome, suggesting a Xq-Yq reciprocal translocation. No obvious chromosomal abnormality was found in the pregnant woman and her husband. The CMA results showed that there was approximately 21 Mb loss of heterozygosity at the end of the long arm of the fetal X chromosome [arr [hg19] Xq26.3q28(133912218_154941869)×1], and 42 Mb duplication at the end of the long arm of the Y chromosome [arr [hg19] Yq11.221qter(17405918_59032809)×1]. Combined with the search results of DGV, OMIM, DECIPHER, ClinGen and PubMed databases, and based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the deletion of arr[hg19] Xq26.3q28(133912218_154941869)×1 region was rated as pathogenic, and the duplication of arr[hg19] Yq11.221qter(17405918_59032809)×1 region was rated as variant of uncertain significance. CONCLUSION The Xq-Yq reciprocal translocation probably underlay the ultrasonographic anomalies in this fetus, and may lead to premature ovarian insufficiency and developmental delay after birth. Combined G-banded karyotyping analysis and CMA can determine the type and origin of fetal chromosomal structural abnormalities as well as distinguish balanced and unbalanced translocations, which has important reference value for the ongoing pregnancy.
Humans ; Child ; Pregnancy ; Female ; Vena Cava, Superior ; In Situ Hybridization, Fluorescence ; Chromosome Aberrations ; Karyotyping ; Translocation, Genetic ; Fetus ; Prenatal Diagnosis/methods*

Endoscopic anterior fundoplication with the MUSE is an endoscopic therapy that combines ultrasound and endoscopic anti-reflux technology for moderate to severe gastroesophageal reflux disease. Training and learning procedures are required to obtain qualifications for this endoscopic therapy before clinical operations. At present, there is limited high-quality evidence-based medical evidence on MUSE treatment, and lack of expert consensus or guidance for training and the standard of MUSE therapy procedure. This consensus is based on the published literature, and formulated by experts with MUSE clinical experience in China, to provide guidance for the training and clinical standard operation of this technique.