Objective:To summarize the clinical characteristics of patients with coronavirus disease 2019 (COVID-19) infected with Delta variant, so as to provide further references for clinical diagnosis and treatment.Methods:A real-world study was conducted to analyze the characteristics of 166 COVID-19 patients infected with Delta variant at Guangzhou Eighth People’s Hospital, Guangzhou Medical University.Results:The study enrolled 5 asymptomatic cases, 123 non-severe cases (mild and moderate type), and 38 severe cases (severe and critical type). Among these patients, 69 (41.6%) were male and 97 (58.4%) were female, with a mean age of 47.0±23.5 years. Thirty-nine cases (23.5%) had received 1 or 2 doses of inactivated vaccine. The incidence of severe COVID-19 cases was 7.7% in 2-doses vaccinated patients, which was lower than that of 11.5% in 1-dose and 26.8% in unvaccinated patients. The proportion of severe cases in 2 dose-vaccinated patients was 7.7%, which was lower than that of 11.5% in 1-dose vaccinated patients and 26.8% in unvaccinated patients, but the difference was not significant ( P>0.05). The most common clinical symptom was fever (134 cases, 83.2%), and 39.1% of cases presented with high-grade fever (≥39 °C); other symptoms were cough, sputum, fatigue, and xerostomia. The proportion of fever in severe cases was significantly higher than that of non-severe cases (97.4% vs. 76.4%, P<0.01). Similarly, the proportion of severe cases with high peak temperature (≥39 ℃) () was also higher than that of non-severe cases (65.8% vs. 30.9%, P<0.01). The median minimal Cycle threshold (Ct) values of viral nucleic acid N gene and ORFlab gene were 20.3 and 21.5, respectively, and the minimum Ct values were 11.9 and 13.5, respectively. Within 48 h of admission, 9.0% of cases presented with decreased white blood cell counts, and 52.4% with decreased lymphocyte counts. The proportions of increased C-reactive protein, serum amyloid A, interleukin 6, and interleukin 10 were 32.5%, 57.4%, 65.3%, and 35.7%, respectively. The proportions of elevated C-reactive protein, serum amyloid A and interleukin-6 in severe cases were significantly higher than those in non-severe cases ( P<0.01). Logistic regression analysis showed that older age and higher peak temperature were associated with a higher likelihood of severe cases ( OR>3, 95% CI: 2-7, P<0.01). In terms of treatment, traditional Chinese medicine (TCM) was used in 97.6% of non-severe cases and 100% in severe cases. Other treatments included respiratory and nutritional support, immunotherapy (such as neutralizing antibodies and plasma of recovered patients). The median times from admission to progression to severe cases, of fever clearance, and of nucleic acid conversion were 5 days, 6 days and 19 days, respectively. No deaths were reported within 28 days. Conclusions:The symptoms of Delta variant infection in Guangzhou are characterized by a high proportion of fever, high peak temperature, long duration of fever, high viral load, a long time to nucleic acid conversion, and a high incidence of severe cases. The severe cases exhibit a higher percentage of elderly patients, a longer duration of fever and have a higher fever rate and a higher hyperthermia rate than non-severe cases. Age and hyperthermia are independent risk factors for progression to severe disease. The combination of TCM and Western medicine can control the progression of the disease effectively.

This paper was aimed to analyze the correlation between quality evaluation and whole complete quality assessment in traditional Chinese medicine (TCM) clinical research progress,in order to discuss key steps and strategies in the clinical research progress.In accordance with the quality control indexes,all projects of Prevention and Treatment of Chronic Disease of TCM were given a research progress evaluation and complete condition.The scores were described with radar map method.The influence of research progress to whole complete quality was analyzed with correlation methods.The results showed that there was a significant correlation between research progress (including included cases and completed cases) and the total score of quality control (P ＜ 0.05).It was concluded that research progress was a key step to influence the entire clinical research level.It is necessary to strengthen the supervision on research progress to guarantee the whole research level.

Objective To explore ways and means to improve the investigator compliance through the evaluation and analysis of the investigator compliance of TCM clinical research projects of chronic diseases. Methods Totally 28 studies from the project Chinese medicine clinical study on prevention and treatment of chronic disease started in 2010 or 2011 and ended in 2015 were collected. The investigator compliance was analyzed by the evaluation form, which were drafted by quality control core team of TCM projects of chronic diseases, as research method performance, compliance of subjects inclusion and exclusion, integrity, accuracy and normalization of case report form in final quality evaluation for TCM clinical research on chronic diseases. Results There were 19 excellent studies according to investigator compliance, accounting for 67.9%, including 3 studies with ten score, accounting for 10.7%. There were 8 good studies according to investigator compliance, accounting for 28.6%. There was 1 study up to standard, accounting for 3.6%. 11 studies included unreasonable changes in the record during the process of implementation. 12 studies included missing in the filling of research records during the process of implementation. Conclusion In general, 28 studies of TCM linical research projects for chronic diseases show high investigator compliance. The existing problems are mainly found in the integrity and normalization of research records.

ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.

According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .

Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

In our study, we adopted a schedule plan management of the Project Management Body of Knowledge(PMBOK)in the management practice of the expefimental research on "The Research in Teaching and Inheritance of Experience of Famous and Veteran Doctors of TCM "which was supposed by " tenth five years "plan of national science and technology as a key program. We tried to establish a project planning based on the special features of TCM and the characters of the project. This planning played a significant support role in the top project design and ensuring the smooth implementation of the research.

In our study,we adopted a schedule plan management of the Project Management Body of Knowledge(PMBOK)in the management practice of the experimental research on "The Research in Teaching and Inheritance of Experience of Famous and Veteran Doctors of TCM " which was supported by "tenth five years" plan of national science and technology as a key program.We tried to establish a project planning based on the special features of TCM and the characters of the project.This planning played a significant support role in the top project design and ensuring the smooth implementation of the research.

Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.

Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,(severe) adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.