Building on the backbone of CD47-based therapy in cancer: Combination strategies, mechanisms, and future perspectives

Described as a "don't eat me" signal, CD47 becomes a vital immune checkpoint in cancer. Its interaction with signal regulatory protein alpha (SIRPα) prevents macrophage phagocytosis. In recent years, a growing body of evidences have unveiled that CD47-based combination therapy exhibits a superior anti-cancer effect. Latest clinical trials about CD47 have adopted the regimen of collaborating with other therapies or developing CD47-directed bispecific antibodies, indicating the combination strategy as a general trend of the future. In this review, clinical and preclinical cases about the current combination strategies targeting CD47 are collected, their underlying mechanisms of action are discussed, and ideas from future perspectives are shared.

Modification effects of temperature on outpatient visits caused by ozone in Linzhi / 公共卫生与预防医学

Objective To investigate the modification effect of atmospheric temperature on outpatient visits caused by O3 in Linzhi City. Methods The daily outpatient data, the daily O3 concentration and daily meteorological data (including daily average temperature, average relative humidity, etc.) in Linzhi City from 2018 to 2019 were collected. The distributed lag non-liner-model (DLNM) was used to quantitatively evaluate the impact of O3 in different temperature layers on the risk of outpatient visits. Results At low temperature layers, the cumulative relative risk (CRR) of total outpatient visits and non-injury outpatient visits increased by 53.8%（4.2% -126.9%) and 59.1%（5.8% -139.2%）for every 10 μg/m3 increase of O3 concentration, respectively. The subgroup analysis showed that for every 10 μg/m3 increase of O3 concentration at low temperature, the CRR of patients with circulatory diseases, men, women, and people being 3 in Linzhi City. In general, the cumulative risk increases as the temperature decreases.

Congenital factor X deficiency: a retrospective analysis of 11 cases / 中华血液学杂志

Objective: To analyze the clinical characteristics, laboratory examination, diagnosis, treatment, and outcome of hereditary factor Ⅹ (FⅩ) deficiency. Methods: Clinical data of 11 patients with congenital FⅩ deficiency were retrospectively analyzed from July 2009 to February 2021. Results: There were 3 males and 8 females. Median age was 39 (5-55) years. The media duration of follow-up was 81.67 (1.87-142.73) months. Of the 11 patients, 10 had bleeding symptoms, 7 had ecchymosis or hemorrhage after skin bump, 7 had nosebleed, 6 had gingival hemorrhage, and 1 had muscle hematoma. Among the female patients, 6 had menorrhagia and 1 experienced bleeding after vaginal delivery. Family history of FⅩ deficiency was found in one case. Eight patients had a history of surgery, and four had postoperative bleeding. Laboratory findings were characterized by significantly prolonged activated partial thromboplastin time, prothrombin time, and decreased FⅩ activity (FⅩ∶C) . Four cases underwent gene mutation analysis and five new mutations were found. Four cases were treated with prothrombin complex concentrates (PCC) and seven cases with fresh frozen plasma (FFP) . One female patient had significantly reduced menstrual volume after PCC prophylactic therapy. One patient received FFP for prophylactic infusion with no bleeding during and after the operation. Conclusion: Most patients with congenital FⅩ deficiency had bleeding symptoms and there was no significant correlation between severity of bleeding symptoms and FⅩ∶C. Prophylaxis should be applied in patients with severe bleeding tendencies. Gene mutation test is significant for screening, diagnosis, and prognosis prediction of congenital FX deficiency.

Design of case report form for oncology clinical trials based on CDASH / 中国临床药理学与治疗学

AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.

General considerations for clinical data management of antineoplastic drugs / 中国临床药理学与治疗学

With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.

Standard operation procedure of real-world data management: syphilis data as an example / 中华医院管理杂志

Clinical data is one of the key sources of real-world data, while the reliability of such data is often hindered by unscientific and irregular data management. Based on various problems found in the application of clinical data to scientific research, this study formulated a standard operation procedure(SOP) for real-world data management, and organized the data in terms of content and logic consistency, completeness and standardization. The clinical data of syphilis at a tertiary hospital were used as an example for verification. The clinical data of syphilis patients in the dermatology department from January 1, 2008 to January 1, 2018 were derived from the basic information database, diagnosis database, laboratory information database, and treatment information database of its hospital information system, and a total of 71 705 pieces of relevant information were extracted. SOP analysis showed that 6 816 articles were completely repeated. There were content or logical inconsistencies in name, medical identification number, resident ID number, age and gender, being 152, 360, 88, 107 and 457 respectively. There were many missing entries for marital status, ethnicity, gender, birthday, and ID number, being 1 711, 1 077, 457, 496 and 355 respectively. The standardization situation was generally good, and the number of irregularities in filling out occupational items was 1 884. The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment, indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.

Application of ADaM in safety analysis of bioequivalence trail of generic drugs / 中国临床药理学与治疗学

AIM: To promote the Clinical Data Inter-change Standards Consortium (CDISC) standard in clinical trials and promote the standardization of clinical trial data. METHODS: To combine the implementation guide of Analysis Data Model (ADaM) and common problems of actual data, and to introduce the application of analytical data model ADaM in the safety of bioequivalence trails of generic drugs. RESULTS: For different types of clinical trial data, according to various situations that may occur, a safety analysis data set that meets the standards was generated. CONCLUSION: Under the background of the continuous development of generic drugs in China and the low degree of standardization of clinical trial data, the use of CDISC standards in clinical research can promote the standardization of clinical trial data, and can also shorten the time of statistical analysis and accelerate the process of drug development.

Clinical characteristics and disease outcomes of 493 cases of hydatid disease / 实用医学杂志

Objective To investigate the demographical data,clinical data and outcomes of patients with Hydatid disease. Methods The data of 493 Hydatid disease patients collected from January 2013 to June 2017 in Qinghai Province were treated with the Epi Data 3.02 to record the data in duplicate and establish Hydatid disease database,which was then analyzed with SPSS 17.0 for statistical analysis.Results There were 409 cases of Cystic Echinococcosis and 84 cases of Bursal Echinococcosis. The male patients accounted for 42%,and the female for 58%.The curative rate of CE2 and CE4 patients was higher than that of patients with CE1,CE3 and CE5,with sig-nificant differences(χ2=3.502,Р=0.835).The cure rate of patients with cystic echinococcosis was significantly higher than that of Bursa edulis(χ2=30.275,Р=<0.01).The difference was statistically significant in view of the affected position(χ2= 17.521,Р = 0.020). In view of Child-Pugh classification and immunological examination on the outcome of the disease,the difference was statistically significant(χ2= 17.521,Р = 0.020;χ2= 15.731,Р < 0.022). In view of the operation method,the different was statistically significant(χ2= 57.389,Р < 0.01). Conclusion The data of Hydatid disease patients in Qinghai province were establisheded,which provides scientif-ic and detailed and clinical data on Hydatid disease.

Development of Clinical Data Mart of HMG-CoA Reductase Inhibitor for Varied Clinical Research

BACKGROUND: The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMR data being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first time was developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers. METHODS: Seoul St. Mary's Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescription events, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basis of a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December 31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted. RESULTS: We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refined through a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins were first prescribed by the endocrinology department in most cases (69%, 14,865/21,368). CONCLUSION: Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness of treatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a short period.

Design and Application of Multidisciplinary Consultation System Based on the Clinical Data Center / 医学信息学杂志

The paper introduces the background of establishing the multidisciplinary consultation system,designs the architecture of the multidisciplinary consultation system including the links of consultation application,prompt,acceptance,recording,evaluation,etc.,and collects all diagnosis and treatment information of patients based on the clinical data center.The application of the multidisciplinary consultation system is able to optimize the process,improve the efficiency and quality,and achieve closed-loop management.

Application of Clinical Data Interchange Standards Consortium (CDISC) Standards to Electronic Data Capture System / 世界科学技术-中医药现代化

Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.

Analysis of mutations detection in 23S rRNA gene locus of Mycoplasma pneumoniae among children / 国际检验医学杂志

Objective To understand the mutations of macrolide resistance gene locus (23S rRNA) of Mycoplasma pneumoniae (MP) and its correlation with clinical features .Methods A total of 354 respiratory tract samples were collected from children pa-tients with pneumonia .MP and its mutations in 23S rRNA gene locus were detected by real-time PCR .The children cases of MP positive were divided into the mutation group and non-mutation group .Then the clinical data were compared between the two groups .Results Among 354 respiratory tract samples ,166 cases(46 .9% ) were MP positive ,moreover the mutation of 23S rRNA gene locus existed in 135 MP positive samples with the positive detection rate of 81 .3% ,while no 23S rRNA gene locus mutations were detected in 31 samples .Analyzing the clinical data of the mutation group and non-mutation group found that there was no sta-tistical difference in the aspects of age and gender between the two groups .The occurrence rates of severe pneumonia and extrapul-monary complications in the mutation group were higher than those in the non-mutation group (P<0 .05) ,moreover the average hospitalization time and fever duration in the mutation group were longer than those in the non-mutation group (P<0 .05) .Conclu-sion 23S rRNA gene locus mutation has higher detection rate ,prompting that MP shows high resistant rate to macrolides ,which could provide a certain basis for treatment of M P infections .

Construction of Hospital Knowledge Service System Based on Clinical Data Center / 医学信息学杂志

Based on the new trend of transition from information service to knowledge service currently emerging in the field of information service,the paper presents the construction of a knowledge service system based on clinical data center.It introduces the architecture of the system,analyzes its features,describes its application effect and discusses the issues to be concerned for the further development of the knowledge service system in the future.

A Study on the Named Entity Recognition Method on Symptom Names in the History of Present Illness in Traditional Chinese Medical (TCM) Clinic / 世界科学技术-中医药现代化

Clinical cases of TCM are used as important clinical data to record the whole process of the interaction between doctors and patients in the form of text.However,in the context of big data,there is a lack of research on the use of information covered in clinical cases.Therefore,we studied the method of extracting the symptom term from the history of present illness in TCM clinic in this paper,in order to lay the foundation for the further use of clinical cases.First,twelve thousand,three hundred and sixty-seven history data of present illness were obtained by random selection and expert review.According to the different disease types,they were divided into the two groups of the experiments:4,838 data in the diabetes group,7,529 data in the spleen and stomach disease group and 12,367 data in the mixed or combined group.A glossary of symptom terms covering 22,996 words were compiled.Then,five feature templates,such as sliding window feature,prefix and suffix character and lexical features,were selected.CRFs model was adopted to carry out named entity extraction experiment.As a result,in the open test,the performance of diabetes,spleen and stomach disease and mixed group were (0.83,0.8,0.82),(0.9,0.9,0.89) and (0.88,0.87,0.87),respectively,while the results were (0.83,0.82,0.83),(0.95,0.95,0.95) and (0.93,0.92,0.92) in the ten-fold cross validation.In conclusion,the results showed that the CRFs algorithm was an excellent sequence labeling algorithm and applied to the named entity extraction task of symptom history.

Development and application of venous thromboembolism intelligent evaluation and automatic warning system / 医疗卫生装备

Objective To develop an intelligent evaluation and automatic warning system to improve the diagnosis rate of venous thrombo embolism (VTE) and strengthen its standardized treatment.Methods A clinical data center was constructed by using data extraction,conversion and loading,which involved in military medical system,clinical laboratory system,electronic medical record system and surgical anesthesia system.The warning model was established with international standards,clinician experiences,warning parameters selection by statistical method and weighted assignment.Results The system could predict the risk of the hospitalized patient for VTE rapidly and inform the doctor in time.Conclusion The system facilitates the doctor to prevent and control VTE,and thus is worthy promoting practically.

Clinical analysis of 23 patients with Brucellar epididymo-orchitis / 中华地方病学杂志

Objective Study the epidemiological and clinical findings of patients with Brucellar epididymo-orchitis (BEO),to provide a theoretical basis for clinical diagnosis.Methods A study was carried out to analyze the patients' files of epidemiological,outcome,clinical and laboratory features of 23 cases of BEO and 185 in patients with brucellosis in Hulunbuir People's Hospital during 2011-2013.Results The age of patients with BEO and without epididymo-orchitis (EO) were (34.48 ± 10.32) years old and (42.07 ± 12.19) years old,the difference was statistically significant (t =-2.842,P ＜ 0.05).Patients with BEO and without EO of brucellosis patients with hypogastralgia ratio was 78.3％ (18/23) and 8.6％ (14/162),the difference was statistically significant (x2 =68.238,P ＜ 0.05).The proportion of BEO cases with abnormal White Blood of Cell (WBC) and C-reactive protein (CRP) levels were 34.8％ (8/23) and 91.3％ (21/23),which was significantly higher than those in without EO group [9.9％ (16/162),63.0％ (102/162),x2 =11.066,7.260,all P ＜ 0.05].After 2 to 7 days,BEO patients with scrotal swelling and pain and/or tenderness relieved.After two weeks treatment,11 patients of the urinary system showed normal by ultrasound,and no patients underwent testicular resection.Conclusions Young male patients with Brucellar are prone to BEO.Laboratory abnormalities are mainly leukocytosis and high CRP level.

A Preliminary Discussion of Application of CDISC Standards in Clinical Research Data Management of New Traditional Chinese Medicine / 中国中医药信息杂志

In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.

Analysis of clinical characteristics and etiology of inpatients with neonatal hyperbilirubinemia in Chenzhou area / 国际检验医学杂志

Objective To analyse clinical characteristics and etiology of inpatients with neonatal hyperbilirubinemia in Chenzhou area.Methods A total of 534 cases of inpatients with neonatal hyperbilirubinemia in Children′s Hospital,First People′s Hospital of Chenzhou City were selected from January to December 2012 and their clinical data were collected.The levels of total bilirubin,hu-man cytomegalovirus (HCMV)gene,and enzymatic activity of glucose-6-phos-phate dehydrogenase (G-6PD)were detected.And screening of hemolytic disease of newborn was carried out as well.Data were statistically analysed.Results Among these patients with neonatal hyperbilirubinemia,43 cases of neonatal patients were diagnosed with G-6PD deficiency(accounted for 8.0%),98 ca-ses of neonatal patients were diagnosed with ABO hemolytic disease(accounted for 18.4%),1 53 cases of neonatal patients were di-agnosed with HCMV infection(accounted for 28.6%)and 149 cases of neonatal patients were diagnosed with bacterial infections (accounted for 27.9%).Conclusion The main etiology of patients with neonatal hyperbilirubinemia in this area is infectious factor. Strengthening monitoring bilirubin in neonatal patients,and analysing test results and etiology could effectively reduce damages in-duced by neonatal hyperbilirubinemia.

Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

Construction and Standardization Research on Hospital Medical Imaging Data Center Based on Clinical Data Repository / 中国医学影像学杂志

Hospital image information system is evolving from department-oriented to patient-oriented. This paper introduces the implementation of Beijing University People's Hospital image data center. The ideas, approaches and the technological standards for image data center's system integration are proposed. Additionally, the problems in practical application and the outlook for this system are discussed.