Objective To investigate the clinical manifestations, lung function and therapy of patients with primary bronchogenic carcinoma complicated with chronic obstructive pulmonary disease ( COPD) . Methods 365 patients with primary bronchogenic carcinoma were recruited retrospectively. The patients were analyzed by COPD-complicated and COPD-free groups. The clinical manifestations, lung function ( especially FEV1 ) , pathological types and progression-free survival ( PFS) were analyzed. The use of inhaled corticosteroids for treatment of COPD was also recorded. Results There was 62.2% patients( 227 cases) complicated with COPD with an average age of ( 66.1 ±9.3) yrs, 77. 5% of male, 82. 4% of smokers, and 46. 3% of past histories of respiratory disorders. Those in COPD-free were aged ( 54.8 ±5.6) yrs, with 55.8% of male, 62.3% of smokers, and 30.4% of past histories of respiratory diseases. The COPD-complicated patients had lower lung function than that of COPD-free [ ( 68.6 ±9.7) % vs. ( 75.3 ±7.5) % in FEV1%pred and ( 65.9 ±8.5 ) % vs. ( 75.6 ±9.1 ) % in FEV1 /FVC, P lt; 0.05 ] . The COPDcomplicated patients were more likely to have squamous carcinoma ( 43.2% vs. 31.2% , P lt; 0.05) and small cell lung cancer ( 20.7% vs. 15.2% , P lt; 0.05) . Moreover, performance status ( PS) scores ( 3.3 ± 0.5 vs. 2.8 ±0.4) and PFS ( 5.9 ±1.6 vs. 7.5 ±2.1) were worse in the COPD-complicated patients than that of the COPD-free patients. Only 71 cases of the COPD-complicated patients received regularly inhaled corticosteroids for COPD treatment. These patients had better PS scores and PFS than others without corticosteroids treatment. Conclusions Primary bronchogenic carcinoma patients with COPD comorbidity are commonly encountered. Clinicians should be aware of the clinical manifestation and corticosteroids prescription should be recorded to improve the quality of life and prognosis.
To investigate the shortsegment pedicle screw in treating degenerative L4 spondylolisthesis and the relationship of the preliminarily bending degree of the titanium rod with the lumbar lordosisangle, the slipping angle and the slipping percentage and to evaluate the clinical coincidence and curative effects of the preliminarilybent rod. MethodsFrom September 2005 to March 2007, 31 female patients (age, 40-70 years; average, 58.3 years) were admitted for surgical treatment of their L4 degenerative spondylolisthesis (MeyerdingⅠ°, Ⅱ°)． Their lumbar lordosis angle （x1）, slipping angle (x2), and slipping percentage (x3) were measured in the L4,5 segment before operation. During the operation, the titanium rod bent beforehand according to the corresponding standards was inserted. The angle of the bent rod (Y) was measured, and then the multiple linear regression equation was established. The regression equation was applied to the surgical treatment of the 30 patients.Results According to the criteria in the JOA scoring system, the 31 patients had scores of 8.300± 1.080 and 26.916±1.859 before operation and after operation, respectively. There was a significant difference between before operation and after operation（Plt;0.05）. The established multiple linear regression equation was as follows:Y=0.1390-0.327logx1+0.463x2+0.288x32．The operating time was 51.290±3.408 min in the 30 patients who underwent an insertion of the preliminarilybent rod during the operation; however, the operating time was 102.360±5.004 min in the 31 patients who underwent an insertion of the bent rod that was made based on experience during the previous operations. There was a significant difference in the operating time between the two kinds of the rods （Plt;0.05）. Estimated according to 90%, 95% and 99% of the areas under the normalcurve, the clinical coincidence rates in the preliminarily bending degrees of the titanium rod in the 30 patients were 80.00％，90.00％ and 96.67％, respectively.Conclusion The titanium rod that has been bent into a certain angle before operation according to the established criteria can definitely diminish its strain during operation and efficiently shorten the operating time．Thiskind of the titanium rod has a good coincidence in clinical application and can be effectively used in clinical practice.It is worth reference during the clinical operation.
The scientific research on prevention and control of coronavirus disease 2019 (COVID-19) has been a major and urgent task, of which clinical trials occupy a pivotal position in the entire prevention and control system. 204 relative clinical trials of traditional Chinese medicine (TCM) have been registered on Chinese Clinical Trial Registry. Through the analysis of all online public protocols of registered trials, it is found that the clinical studies of TCM in China showed lack of research foundation, tight time and heavy tasks, difficult clinical implementation, and disturbance by changes of the epidemic status. Based on these characteristics, this paper put forward several thoughts and suggestions on the quality management and design improvement for clinical trials of TCM preventing and treating COVID-19, in order to improve the quality of clinical trials in China, provide effective supports for the public health decision-making on the epidemic, and also give a reference for the prevention and control of epidemics in the future.
The 12th Asian Conference on Pharmacoepidemiology (ACPE) has been successfully held from October 11st to 13rd, 2019 in Kyoto, Japan. More than 600 representatives from 33 countries and regions participated in the meeting. The arrangement of this conference mainly included: education session program, contributed papers report, symposium and poster presentation, which provided good opportunity for participants to communicate. Moreover, it promoted the dissemination and utilization of advanced methods and technologies of global pharmacoepidemiology, especially in Asia region, and provided technical support in order to ensure the safety and efficacy of public. Moreover, it was the first time that the symposium on herbal and Traditional Medicines has been set up in the ACPE. This paper introduced the main details of the contents
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
In order to fully implement the ethical principles of biomedical researches and to better safeguard the legitimate rights and interests of the subjects, this paper begins from the research design and closely combines with the ethical practice of biomedical research review, seriously analyzes the key implementation points of the ethical free and compensation principles in biomedical research, including intervention study, random allocation, follow-up research and new medical techniques and so on, also will provide the beneficial reference for comprehensive formulation of enforcement regulation of ethics principle of biomedical research in the future.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
ObjectiveTo understand the genetic polymorphisms of MUC5B and TOLLIP in Chinese patients with idiopathic pulmonary fibrosis (IPF), and to explore whether gene polymorphism variation in Chinese IPF patients can be used as a genetic biomarker for accurate treatment and prognosis judgment.MethodsA total of one hundred and twenty-six patients with IPF were enrolled in this study. The baseline characteristics, total lung capacity (TLC), forced vital capacity (FVC), carbon monoxide diffusion function (DLCO), imaging changes of the patients were followed up. The levels of serum sputum glycosylated antigen-6 (Krebs Von den Lungen-6, KL-6) and B lymphocyte chemotactic factor C-X-C motif chemokine 13 (CXCL13) were detected by chemiluminescent enzyme immunoassay and enzyme-linked immunosorbent assay. The gene MUC5B rs35705950 and TOLLIP rs5743890, rs5743894 single nucleotide polymorphism (SNP) were determined by polymerase chain reaction.ResultsOne hundred and twenty-six patients with IPF were found with AA type by TOLLIP rs5743890 and rs5743894 SNP, accounting for 100.0%; MUC5B rs35705950 SNP was expressed as 116 patients (92.1%) with GG type, and 10 patients (7.9%) with GT type, no TT patients were detected. There was no significant difference in clinical characteristics between the two groups in age and non-smokers (P>0.05). Compared with group G, annual decrease of lung function (FVC, DLCO, and TLC), serum biomarkers (KL-6 and CXCL13), annual increase of reticular and honeycombing lesions, and mortality were significantly lower in group T (P<0.05). The median survival time of IPF patients carrying the MUC5B SNP rs35705950 minor allele (gene phenotype GT) heterozygous was significantly higher than that of homozygous IPF patients with a genetic phenotype of GG.ConclusionsThere are genetic polymorphisms in Chinese patients with IPF. MUC5B rs35705950 and TOLLIP rs5743890, rs5743894 gene subtypes have low mutation rates in the cohort. Compared with homozygous patients of MUC5B SNP rs35705950, heterozygous patients have smaller changes in lung function and radiological image, lower levels of serum KL-6 and CXCL13, and better prognosis.