The author discusses some problems about protocol design of clinical study of diabetes treatment by TCM.Based on the practices and lessons in many years,the design ideas and concrete ways of how to design the protocol,which offer reference and thinking on evaluation of clinical therapeutic effect and research methods of TCM are brought up.

yin asthenia. Conclusion Characteristic of syndrome about type 2 diabetes mellitus affiliated metablic syndrome show that:extreme heat with yin asthenia, deficiency of both vital energy and yin, deficiency of vital energy and blood stasis, syndrome of blood stasis run through the whole course of disease. Incorporated syndrome show characteristic of versatility and individualization.

Gouty arthritis is a clinical common joint disease caused by metabolic disorder. TCM therapy has unique advantages, such as good efficacy and few adverse reactions. Professor WEI Zi-xiao advocates differential treatment for this disease. In his opinion, acute gouty arthritis is equivalent to TCM damp-heat arthralgia, and therapy of eliminating dampness and heat should be used. During the intermission, therapy of reinforcing spleen and nourishing kidney is appropriate because of deficiency of them. Deficiency of liver and kidney and phlegm and blood stasis are basic pathogenesis in chronic phase of the disease, therefore, activating blood, reducing phlegm and nourishing liver and kidney should be adopted. In addition, Professor WEI pays attention to pharmacological research achievement of TCM, disease differentiation and life and diet regulating in treatment of the disease.

Objective To observe the efficacy and safety of Tangmoning Granule(TMG)in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrome.Methods A randomized,positive drug parallel controled,multi-center clinical trial was adopted.The tested group was treated with TMG orally and the control group received Mikebao tablet orally.Treatment course of each group was 8 weeks.Results The marked effective rate and total effective rate on electromyogram was 60.06 %and 68.47 %respectively in the tested group,and those on TCM Syndrome were 23.12 %and 90.99 %respectively.Non-inferiority test with the criterion of 15 %was conducted on the efficacy of electromyogram and TCM Syndrome,and the result showed statistical significant.Conclusion TMG has good efficacy and safety in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrom.

Objective:To explore the relationship between thyroid hormone sensitivity and obesity phenotype in people with normal thyroid function.Methods:In this retrospective study, 6155 euthyroid subjects who underwent a health check-up in the First Hospital of China Medical University between January 2017 and December 2018 were included. Participants were categorized into four obesity phenotypes according to body mass index and metabolic status. Thyroid Feedback Quantile-based Index(TFQI), Parametric TFQI, free triiodothyronine to free thyroxine ratio(FT 3/FT 4), and sum activity of peripheral deiodinases(SPINA-GD) were calculated to evaluate thyroid hormone sensitivity. Results:Compared with metabolically healthy non-obese(MHNO) phenotype, the subjects with metabolically healthy obese(MHO) or metabolically unhealthy obese(MUO) phenotype showed higher FT 3/FT 4ratio. Metabolically unhealthy non-obese(MUNO) and MUO subjects showed lower TFQI. After adjusting for confounders, FT 3/FT 4ratio was positively associated with MHO( OR 1.18, 95% CI 1.11-1.26) and MUO phenotype( OR 1.28, 95% CI 1.19-1.39). With 1 s increase of TFQI, the OR for MUNO phenotype was 0.77(95% CI 0.64-0.94). The results of Parametric TFQI and SPINA-GD were similar to TFQI and FT 3/FT 4ratio, respectively. Conclusion:In euthyroid individuals, thyroid hormone sensitivity was positively associated with increased risk for unhealthy obesity phenotypes.

Objective: To explore the patient and hospital related determinants of adherence to early antithrombotic therapy among patients with acute ischemic stroke (AIS). Methods: AIS patients aged 50 years old or above who were eligible for early antithrombotic therapy, were included from the China National Stroke Registry Ⅱ (CNSR Ⅱ) project. Characteristics related to patients and hospitals were collected. Univariate analysis method was conducted to explore the correlation between hospital or patient-related determinants and early antithrombotic therapy. A 2-level logistic regression model was set up to identify patient and hospital-related variables that were associated with the adherence to early antithrombotic therapy, with patient as level 1 and hospital as level 2. Results: A total of 16 910 patients were included in the study, with 14 332 (84.75%) of them having received early antithrombotic therapy. Results from the univariate analysis showed that the patient determinants to early antithrombotic therapy would include age, type of health insurance, average income and history of dyslipidemia. Hospital determinants would include factors as: level and region of the hospital, academic status, with/without stroke unit, quality control on single disease and the percentage of neurological beds in total beds (P<0.05). Data on multilevel model showed that the patient-related determinants on early antithrombotic therapy would include age, gender, average income, history of hypertension, National Institutes of Health Stroke Scale (NIHSS) score at admission while hospital related determinants would include percentage of neurological beds in total beds, and region of the hospital (P<0.05). Conclusions The quality of a hospital was associated with the adherence to early antithrombotic therapy. AIS patients at advanced age or with high NIHSS score at admission should be paid more attention.

With the rapid development of healthcare big data and artificial intelligence technology, how to utilize the massive medical data generated based on clinical diagnosis and treatment has become an important issue to be solved in the field of clinical research. Clinical diagnosis and treatment data is an essential part of healthcare big data, and also the main field of healthcare big data research. With the continuous deepening and extensive development of informatization, hospitals have accumulated a large number of patient-centered clinical diagnosis and treatment data. Deeply mining and analyzing these data through big data technology can provide reference for precise diagnosis and treatment, and standardized prevention and control of diseases. However, conducting relevant research still faces many difficulties and blockages, such as the increased risk of data leakage or abuse, and the difficulty in implementing informed consent. To safely, legally and efficiently utilize clinical diagnosis and treatment data to conduct clinical research and fully tap into the value of these precious medical resources, a tertiary hospital in Beijing has built a research big data platform and developed relevant systems to effectively solve the problems of blockages and difficulties in the application of rich clinical resources to clinical research, and improve the service quality of medical institutions and the conversion rate of scientific research achievements. By introducing the key points and management methods in the implementation of clinical research based on the scientific research big data platform, analyzing and exploring the existing problems and improvement measures, this paper aimed to provide theoretical basis and system reference for high-quality and efficient health and medical big data clinical research, inspire and promote the continuous improvement of medical research management, and promote the development of medical and health science and technology innovation.

With the improved understanding of driver mutations in non-small cell lung cancer (NSCLC), expanding the targeted therapeutic options improved the survival and safety. However, responses to these agents are commonly temporary and incomplete. Moreover, even patients with the same oncogenic driver gene can respond diversely to the same agent. Furthermore, the therapeutic role of immune-checkpoint inhibitors (ICIs) in oncogene-driven NSCLC remains unclear. Therefore, this review aimed to classify the management of NSCLC with driver mutations based on the gene subtype, concomitant mutation, and dynamic alternation. Then, we provide an overview of the resistant mechanism of target therapy occurring in targeted alternations ("target-dependent resistance") and in the parallel and downstream pathways ("target-independent resistance"). Thirdly, we discuss the effectiveness of ICIs for NSCLC with driver mutations and the combined therapeutic approaches that might reverse the immunosuppressive tumor immune microenvironment. Finally, we listed the emerging treatment strategies for the new oncogenic alternations, and proposed the perspective of NSCLC with driver mutations. This review will guide clinicians to design tailored treatments for NSCLC with driver mutations.
Humans ; Carcinoma, Non-Small-Cell Lung/genetics* ; Lung Neoplasms/genetics* ; Mutation ; Tumor Microenvironment/genetics*