【摘要】 目的 探討糖尿病管理的有效模式，提高糖尿病患者的治療達標率，減少低血糖發生。 方法 研究對象為2008年5月-2009年5月就診的2型糖尿病患者356例。測量所有研究對象的空腹血糖、餐后2 h血糖、糖化血紅蛋白。觀察糖尿病管理后及常規治療后血糖的變化。 結果 應用糖尿病達標管理軟件管理糖尿病患者，血糖達標率明顯升高，差異有統計學意義（Plt;0.05）；低血糖的發生率下降，差異有統計學意義（Plt;0.05）。 結論 大多數糖尿病患者的病情控制未達到理想的目標，應用科學的糖尿病達標管理軟件進行管理是改善現狀的有效方法。【Abstract】 Objective To study the effective management model for diabetes mellitus, promote the treatment results of patients with disease, and reduce the occurrence of hypoglycemia. Methods A total of 356 patients with type 2 diabetes mellitus (T2DM) treated from May 2008 to May 2009 were chosen in this study. Fasting bloods glucose, 2-hour postprandial blood glucose and hemoglobin A1c were detected in all the subjects. Then, the change of glucose level for the management group and the common treatment group was observed. Results The glucose-target-rate of patients managed by diabetes management software was significantly higher than patients in the common treatment group (Plt;0.05), and the occurrence rate of hypoglycemia was also significantly lower (Plt;0.05). Conclusions The control of T2DM for most patients is far from satisfaction. The application of scientific disease care software is effective for improving disease control.
ObjectiveTo study the relationship among cholecystectomy/gallbladder disease and bile reflux gastritis.MethodsA retrospective collection of 123 patients with bile reflux gastritis who were diagnosed as outpatients and hospitalized from January 2014 to February 2019 in Shengjing Hospital Affiliated to China Medical University, and 221 patients with non-biliary reflux gastritis at the same period were collected. According to the gallbladder status, the patients were divided into three groups: gallbladder disease, cholecystectomy, and gallbladder disease-free group. The relationship between gallbladder status and bile reflux gastritis was analyzed.ResultsAmong 123 patients with bile reflux gastritis, there were 22 cases (17.89%) with cholecystectomy and 26 cases (21.14%) with gallbladder disease; 221 cases of non-biliary reflux gastritis with cholecystectomy in 7 cases (3.17%) and gallbladder disease in 30 cases (13.57%). Univariate analysis showed that the gallbladder status was different between the bile reflux gastritis group and the non-biliary reflux gastritis group (χ2=21.089, P<0.001). The study showed that the gallbladder status was related to the occurrence of bile reflux gastritis. In contrast, patients with cholecystectomy and gallbladder disease had a higher risk of occurrence than those with no gallbladder disease (OR>1, P<0.012 5). Independent risk factors were considered by logistic multivariate regression analysis, including cholecystectomy, gallbladder disease, and age (P<0.05).ConclusionsThere is a correlation between cholecystectomy/gallbladder disease and bile reflux gastritis. Cholecystectomy and gallbladder disease may be the independent risk factors for bile reflux gastritis.
摘要:目的:分析本院住院城鎮及農村患者的乙型肝炎病毒感染及免疫情況,推測不同區域發病及免疫狀況,為免疫預防及臨床提供參考。方法:收集我科2000年度,2004年度,2008年度住院患者的乙肝五項檢測報告,按患者長期居住地分為農村組及城鎮組,對比分析兩組患者乙型肝炎病毒感染、具有免疫力及無免疫力年度變化情況及不同組別的差異。結果:同農村組相比,城鎮組乙型肝炎病毒感染率、無免疫率低于農村組,免疫率高于農村組。年度對比乙型肝炎病毒感染率及免疫率呈上升趨勢,無免疫率呈下降趨勢。結論:近年來乙型病毒性肝炎發病有上升趨勢,農村地區免疫普及率相對較低,仍為發病及預防免疫的重點區域,應給予足夠重視。Abstract: Objective: To observe the disposition of infection and immunifaction on type B hepatitis in patients from hospital, suppose the disposition of infection and immunifaction in differently region, and provide information for immunifaction and clinical treatment. Methods: Reports of type B hepatitis from patients in hospital were collected, and were divided into town group and country group according to the habitation of patients. The difference of infection, immunifaction and no immunifaction were compared between two groups. Results: In comparison with the country group, the percentage of infection and no immunifaction was lower in town, and immunifaction was higher, attack rate of type B hepatitis had a tendency to increasing and no immunifaction was decreased by contrasting with annum. Conclusion: Recent years, attack rate of type B hepatitis has a tendency to increasing, and the popular rate of immunifaction is lower in country, so country is still the focal point of immunifaction and infection, and sufficient attention must be paid.
Objective?To analyse the procedure and effectiveness of internal fixation in treatment of displaced radial head fractures.?Methods?Between August 2005 and May 2009, 35 patients with displaced radial head fractures underwent open reduction and internal fixation with SmartNail? and/or AO mini-plates. There were 28 males and 7 females with an average age of 28.4 years (range, 17-48 years). The injury mechanism included traffic accident in 16 patients, falling in 13, and falling from height in 6. According to Mason classification, 21 fractures were rated as type II, 9 as type III, and 5 as type IV. All fracturs were closed fractures. Six cases complicated by radial neck fractures, 1 case by olecranon fracture, 3 by posterior dislocations of the elbow, 1 by posterior dislocation of the elbow and coronoid process fracture, and 3 by medial collateral ligament injuries. The time from injury to operation was 3 to 7 days.?Results?Except 1 patient whose incision healed by second intention, healing of incision by first intention was achieved in the other patients. All patients were followed up 12-25 months with an average of 17 months. The average fracture healing time was 10.2 weeks (range, 8-16 weeks). At last follow-up, the average flexion and extension of the elbow was 119° (range, 95-145°). The average arc of forearm rotation was 126° (range, 90-175°). According to elbow functional evaluation criteria by Broberg and Morrey, the results were excellent in 18 cases, good in 13, and fair in 4; the excellent and good rate was 88.6%.?Conclusion?In treatment of displaced radial head fractures, open reduction and internal fixation can be performed with SmartNail? and/or AO mini-plates based on different fracture types and the short-term effectiveness is satisfactory.
Statistical analysis of clinical trials has traditionally relied on frequentist methods, but Bayesian statistics has attracted considerable attention from regulators and researchers in recent years due to its unique advantages, and its use in clinical trials is increasing. Despite the obvious advantages of Bayesian statistics, the complexity of its design, implementation and analysis poses a number of challenges to its practical application, which may lead to an increased risk of unregulated use. This study aims to comprehensively sort out the application scenarios, common methods, special considerations and key elements of reporting of Bayesian statistical methods in clinical trials, with the aim of providing researchers with references for conducting Bayesian clinical trials, and promoting the scientific and rational application of Bayesian statistical methods in clinical trials.
With the increasing improvement of real-world evidence as a research system and guideline specification for pre-market registration and post-market regulatory decision support of clinically urgent drug and mechanical products, identifying an approach to ensure the high quality and standards of real-world data and establishing a basis for the generation of real-world evidence is receiving increasing attention and concern from regulatory authorities. Based on the experience of Boao hope city real-world data research pattern and ophthalmic data platform construction, this paper discussed the "source data-database-evidence chain" generation process, data management, and data governance in real-world study from the special features and necessity of multiple sources and heterogeneity of data, multiple research designs, and standardized regulatory requirements, and provided references for further construction of comprehensive research data platforms in the future.
Retrospective database study is an important type of real world study that employ observational designs, which has received wide attention. However, misunderstandings and inappropriate conduct of retrospective database studies are very common. We systematically introduced the concept, features and applications of retrospective database study, as well as discussed the methods to plan a retrospective database study and how to develop a research database. This article is expected to offer guidance for the quality production and appropriate use of retrospective database study.
ObjectiveTo investigate the effects of single-disease quota payment in Chengdu.MethodsThe data of medical insurance in Chengdu from 2009 to 2013 were used to compare changes of average hospitalization expenses, hospitalization days, re-admission rate and so on by establishing a difference-in-difference (DID) model.ResultsThe quota payment policy effectively controlled the overall medical expenses. Drug fee and examination fee were significantly affected (P<0.01). However, the re-admission rate was significantly improved (P<0.10).ConclusionThe implementation of single-disease quota payment in Chengdu controlled the medical expanses growth effectively, but it is necessary to prevent its side effects.
Real world data (RWD) and real world evidence (RWE) have increasingly received wide attention. Patient registry study is an important part of real-world studies using observational design. In this paper, we introduce the concept, classification and application of patient registries, and discuss the planning for a patient registry study and development of registry database, and provide methodological guidance for developing high-quality patient registry studies.
In 2019, the national government issued the document "Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area", which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng. These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas. Through the use of these medical products, real-world data were generated in the routine clinical practice, based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods. In March 2020, the first medical device product using domestic real-world data was approved, suggesting that the real-world data initiative in Boao Lecheng achieved initial success. This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China. Here, we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.