Clinical trial, an important research method, plays a crucial role in the development of medicine. It provides important decision support for medical workers. Medical research proposal should be posted at clinical trial registries. Researchers should update original data and research results, which contributes to data sharing. Clinical trial registration can avoid repetitive research and make clinical trials more transparent and standardized. This paper briefly introduces the clinical trial registration, including the definition, the significance, the history, the scope of registration, the organization of registration, and some common problems in the process of registration. Taking the application of clinical trial registration in the field of neurological research as an example, the article describes the current application status of clinical trial registration and explores it’s value and deficiency in specific clinical research, to provoke the awareness on trial registration, which can help to improve the quality of clinical trials.
Objective To sum up the research advances of the seed cell and the culture system using in tissue engineering cartilage. Methods The recent original articles about the seed cell and the culture system in tissue engineering cartilage were extensively reviewed. Results At present, autologous or homologous cells is still major seed cell and the three dimensional culture system is also major system for tissue engineering cartilage. Conclusion The source of seed cell for tissue engineering cartilage. Conclusion The source of seed cell for tissue engineering cartilage should be further explored, and the culture system need to be improved and developed.
OBJECTIVE To investigate the feasibility of repairing the whole layer defects of tibial plateau by implanting tissue-engineering cartilage. METHODS: The chondrocytes of 2-week-old rabbits were cultured and transferred to the 3rd generation, and mixed with human placenta collagen-sponge. The whole layer defects of tibial plateau in adult rabbits were repaired by the tissue-engineering cartilage in the experimental group; the defects were left un-repaired in control group. The repair results of defects were observed after 4, 12 and 24 weeks. RESULTS: In experimental group, no obvious new cartilage formation was seen 4 weeks after operation; some new cartilage formation was found after 12 weeks. Histological observation showed that chondrocytes had irregular edge, honeycombing structure and that cartilage cavities formed around the chondrocytes. After 24 weeks, obvious new cartilage formation was found with smooth surface, and linked with the tissues around it, but the defect was not repaired completely; histological results showed that cartilage cavities formed and that cartilage matrix was stained positively for toluidine blue. In control group, the defect was not repaired. CONCLUSION: The tissue-engineering cartilage can repair the defects of the whole layer cartilage of tibial plateau in rabbits, it is feasible to repair the whole layer cartilage defects of tibial plateau by this method.
In the new era of development, countries in the world have realized the importance of cultivating interdisciplinary and innovative talents, and China is also paying more and more attention to the cultivation of medicine-engineering talents. Compared with the cultivation of single discipline postgraduates, the cultivation of medicine-engineering postgraduates involves effective integration of multiple disciplines, and its cultivation difficulty is greater. At present, China is still in the exploration stage of the medicine-engineering postgraduates training model. Therefore, this article intends to summarize the relatively mature and advanced medicine-engineering postgraduates training models at home and abroad, and extract experiences that are in line with China’s actual development, providing some suggestions for the establishment of postgraduates training systems of medicine-engineering interdisciplinary in China.
Objective To systematically review the health state utility values in patients with schizophrenia, and to provide references for subsequent studies on the health economics of schizophrenia. Methods The PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data, and VIP databases were searched from inception to December 1st, 2021 to collect studies on health state utility values in patients with schizophrenia. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed by Stata 15.0 software. Results A total of 19 studies were included. Patients’ utility values were 0.68 (95%CI 0.59 to 0.77) for direct measures, and 0.77 (95%CI 0.75 to 0.80) and 0.66 (95%CI 0.61 to 0.70) for indirect measures with the EQ-5D-5L and EQ-5D-3L as the primary scales. Utility values varied with measures, tariffs, regions, and populations. Conclusion Studies on health state utility value in schizophrenia are diversified in measurement methods, showing high inter-study heterogeneity. Therefore, it is necessary to promote the study on utility value measurement in schizophrenia in China.
Objective To investigate the diagnosis and effectiveness of improved percutaneous kyphoplasty (PKP) for patients with thoracolumbar metastatic tumors, who could not tolerate anesthesia and open operation. Methods Between September 2009 and September 2010, 16 patients with thoracolumbar metastatic tumors underwent improved PKP. Of 16 patients, 7 were male and 9 were female with an average age of 64.5 years (range, 60-73 years). All patients had vertebralmetastasis tumor. The disease duration was 3-6 months with an average of 4 months. The visual analogue scale (VAS) score was 8.9 ± 0.8. No spinal cord compression and nerve root compression was observed. The involved vertebrae included T7 in 1 case, T8 in 1, T12 in 1, L2 in 2, L3 in 2, L4 in 3, T1, 2 in 1, T3, 4 in 1, T7, 8 in 1, T11, 12 in 1, T7-L1 in 1, and T12-L4 in 1. Nine patients had vertebral compression fracture with a vertebral compression rate below 75%. Results All patients were successfully performed PKP. There was no serious adverse reactions in cardiopulmonary and brain vascular systems and no perioperative death. The biopsy results showed that all were metastatic adenocarcinoma. All patients were followed up 9-18 months mean, 14 months). Complete pain rel ief was achieved in 14 cases and partial rel ief in 2 cases 6 months after operation according to World Health Organization criterion, with a pain-rel ief rate of 87.5%. The VAS score was 1.8 ± 0.6 at 6 months postoperatively, showing significant difference when compared with the preoperative score (P lt; 0.05). Two patients had cement leakages in 3 vertebrae with no symptoms at 6 months postoperatively. During follow-up, 12 patients died and the others survived with tumor. Conclusion For patients with thoracolumbar metastatic tumors who can not tolerate anesthesia and open operation, improved PKP has the advantages such as minimal invasion, high diagnostic rate, and early improvement of pain in the biopsy and treatment. It can improve patient’s qual ity of l ife in the combination of radiotherapy or chemotherapy.
Objective To summarize the methods and experience of animal experiment ethics training at home and abroad, analyze the opportunities and problems, and explore the ethics training methods suitable for the current situation of animal experiments in China. Methods Documents relating to animal experiment ethics training from January 2012 to February 2022 were searched in PubMed, Embase, China National Knowledge Infrastructure and Wanfang Data databases. After literature screening and data extraction by 2 researchers independently, descriptive analysis was performed. Results A total of 44 documents were selected, including 19 in Chinese and 25 in English, involving 44 institutions. According to the literature analysis, in the United States, Britain and other developed countries, the welfare and ethical laws for laboratory animals were relatively perfect, such as the Animal Welfare Act of the United States, the Animals (Scientific Procedures) Act of Britain, the Animal Welfare Act of German, and the Act on Welfare and Management of Animals of Japan, while in China administrative regulations were the main ones, and most of the institutions were restricted by management regulations; the ethics of personnel involved in animal experiments were uneven; the training time of some domestic institutions was less than that of institutions abroad; domestic training methods and contents needed to be improved. Basing on the comparative results at home and abroad and combining the training experience, West China Hospital of Sichuan University improved the animal experiment ethics training system. Conclusion It is suggested that the animal experimental institutions in China should improve the training methods, to enhance the awareness and cognition of people involved in animal experiments more systematically and scientifically, and strengthen the ethical review.
Objective To investigate time differences in directional differentiation of bone marrow mesenchymal stem cells (BMSCs) into nucleus pulposus-like cells (NPCs) in a non contact co-culture system so as to search for the best time for transplantation in vivo. Methods Six New Zealand white rabbits (aged 6 weeks, weighing 1.5-2.0 kg) were selected. BMSCs were collected and cultured for immunocytochemistry identification of CD34, CD44, CD45, and CD90; NPCs were isolated and identified immunocytochemically by RT-PCR. The 2nd passage BMSCs and the primary NPCs were co-cultured in a non contact co-culture system. The cell morphological changes were observed and the cell growth curves were made at 1, 3, and 5 passages after co-culture. The expressions of the aggrecan and collagen type II genes were detected by RT-PCR in BMSCs at 5, 10, and 15 days after co-culture; the expressions of the aggrecan and collagen type II proteins were detected by Western blot at 5, 10, 15, 20, 25, and 30 days after co-culture. Results The expressions of CD44 and CD90 were positive, CD34 and CD45 were negative in BMSCs. The expressions of the collagen type II and aggrecan were positive in NPCs. At 2 weeks after co-culture, the morphology of BMSCs changed obviously, the cells were polygonal and irregular shape. The cell growth rate showed no difference within 3 passages, but decreased obviously after 3 passages. RT-PCR showed that the expressions of collagen type II and aggrecan genes at 10 and 15 days were significantly higher than those at 5 days (P lt; 0.05), no significant difference was found between at 10 days and at 15 days (P gt; 0.05). Western blot showed that the expressions of collagen type II and aggrecan proteins gradually increased with time, and there was significant difference within 5, 10, and 15 days (P lt; 0.05), but no significant difference was found after 15 days of co-culture (P gt; 0.05). Conclusion In a non contact co-culture system, BMSCs can differentiate into the NPCs. The expression of collagen type II and aggrecan can reach a stable level at 15 days after co-culture, and it is the suitable time for transplantation in vivo.
The management of malignant pleural effusion remains a clinical challenge. In November 2018, American Thoracic Society, Society of Thoracic Surgeons, and Society of Thoracic Radiology summarized the recent advances and provided 7 recommendations for clinical problems of the management of malignant pleural effusion. This paper interprets these recommendations to provide references for management and research on malignant pleural effusion.
Objective To explore the condition and quality of domestic clinical therapeutic studies on integrated traditional Chinese and western medicine for posthepatitic cirrhosis in recent 30 years. Methods Jadad scale was used to score 121 literatures selected from January 1980 to January 2010 in periodicals of domestic authoritative resources databases, such as CNKI, VIP, WanFang Data, and CBM. Systematic reviews were conducted to 39 randomized controlled trials (RCTs) literatures of treating posthepatitic cirrhosis with integrated traditional Chinese medicine and western medicine scored two or more points. Results In 30 years, the main problems existing in domestic posthepatitic cirrhosis clinical research of integrated traditional Chinese and western medicine were as follows: the design of clinical RCTs was not strict enough; there was deficiency in the use of blind method; the standardized and uniformed research standard were insufficiency; the sample content was low without specific estimation methods; there was lack of analyses in compliance with cases falling off or without follow-up; and the report of adverse reaction and the quality of life research was neglected. Conclusion Posthepatitic cirrhosis therapy of integrated traditional Chinese and western medical is of “personalized” and “diversified” characteristics. Its therapeutic effects are significantly better than those of pure western medicine and worthy to be popularized in the clinic. However, the quality and level of its clinical scientific research methods still need further improvement.