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OBJECTIVETo evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19). Study DESIGNSingle-center, open label, randomised controlled trial. SETTINGWuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020. PARTICIPANTS204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group. INTERVENTIONSIn treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days. MAIN OUTCOME MEASUREThe primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population. RESULTSAmong 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes. CONCLUSIONAdministration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported. TRIAL REGISTRATIONChiCTR2000030288
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In recent years, with the introduction of medical information technology from large medical institutions to communities and health management institutions and real-world data in the actual clinical diagnosis and treatment is increasingly abundant, the inherent needs of medical research methodologies are colliding with information technology, and resources are begining to transform to the application. Real-world data began to transform into clinical research evidence, providing objective conditions for the development of TCM real-world study. This paper analyzes and discusses the main characteristics of TCM real-world study, and provides reference for deepening the understanding and methodology of TCM real-world study.
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Objective: To evaluate the clinical effects of combination of traditional Chinese and Western medicine in the treatment of primary epilepsy. Methods: The China Journal Full-text Database, science and Technology Journal Full-text Database, Wanfang database, PubMed database, EMbase were searched on the treatment of primary epilepsy literature combining traditional Chinese and Western medicine, and the system evaluation and meta-analysis were performed.Results: A total of 11 studies with 951 cases of primary epilepsy were included in the randomized controlled trial. The meta-analysis showed that the clinical effects of treatment of epilepsy group with combination of TCM and Western Medicine (RR=1.18, 95％ CI: 1.07-1.29, P ＜ 0.01), incidence frequency (WMD =-0.98, 95％ CI: 1.56-0.40), electrocardiogram improvement rate (RR=1.28, 95％ CI: 1.11-1.47, P ＜ 0.01) were significantly better than western medicine treatment (control group) . Conclusion: The effects of combined traditional Chinese and Western Medicine on primary epilepsy based on the method of latent town collaterals is superior to that of pure western medicine.
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In real world clinical studies,standardized data acquisition method is a key step in the formation of reliable clinical evidence.This article described how to carry out clinical data collection and how to preprocess data in order to ensure the quality of data.The results showed that from the data sources,data collection contents,collection key points,data description and evaluation,this paper put forward the method of collecting the real world data of traditional Chinese medicine (TCM).It was concluded that the standardized methods of clinical data acquisition had laid a solid foundation for real world research.
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BACKGROUND: Stellate ganglion block has the ability to improve the imbalance of the autonomic nervous system in perimenopausal syndrome. Lumbosacral plexus is an automatic nervous block, and exerts similar effects with stellate ganglion block. OBJECTIVE: To investigate the effect of lumbosacral plexus block on the serum level of hormones and histology of the ovary in rabbits, thus providing a new treatment strategy for perimenopausal syndrome. METHODS: This was a randomized controlled animal experiment, which was finished at the Animal Center of Guiyang Medical Unversity, China. The healthy rabbits were randomly divided into experimental and control groups, and underwent lumbosacral plexus block by injecting 0.5 mg of vitamin B12, 100 mg of lidocaine and 10 mL of normal saline into the psoas compartment, and the same volume of normal saline, respectively. The effect of lumbosacral plexus block on the serum levels of hormones (estradiol, gonadotropin releasing hormone, follicle-stimulating hormone and luteinizing hormone) at rabbit proestrus, estrus and metaestrus were observed, respectively. The pathological changes of the ovary in a complete estrus cycle were observed. The relationship between the treatment time of lumbosacral plexus block and the levels of hormones was investigated after 1, 3 and 6 complete estrus cycles. The experimental followed the national guidelines for the Care and Use of Laboratory Animals, and Consensus author guidelines on animal ethics and welfare by the International Association for Veterinary Editors (IAVE), and prepared in accordance with the Animal Research: Reporting of In Vivo Experiments Guidelines (ARRIVE Guidelines). RESULTS AND CONCLUSION: Lumbosacral plexus block can increase the serum level of estrogen, reduce the serum levels of follicle-stimulating hormone and luteinizing hormone, and regulate the hypothalamic-pituitary-ovary axis function. Presumably, it may be used as a treatment method or adjuvant therapy of perimenopausal syndrome. Future experiments are needed to explore the effect of lumbosacral plexus block on the serum levels of hormones in a rabbit after oophorectomy to determine whether it exhibits the same effect on ovarian failure.
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This paper briefly introduces the research background, combined with the practical of project, analysis the feature of the construction of information collection system of TCM clinics, and puts forward how to use the method of project management in the construction of information collection system of TCM clinics. By exploring the Project Phasing, Work Breakdown Structure, Project Responsibility Matrix, and Project management standard system, it hopes to strengthen the awareness of project management in the construction of information collection system of TCM clinics, and to guide the project management and the system construction.