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 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.
ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Objective To explore the technique of arthroscopic treatment of local ized pigmented villonodular synovitis of the knee and to evaluate its cl inical results. Methods From February to December 2006, 22 cases of local ized pigmented villonodular synovitis of the knee were treated by arthroscopic excision of the focus and partial synovectomy. There were 8 males and 14 females, with an average age of 24 years old (16 to 35 years old). Eight patients had a trauma history, the others had no obvious inducement. The disease course was from 1 month to 30 months with an average of 10 months. The Lysholm score was 68.5 ± 8.2, and the International Knee Documentation Committee (IKDC) score was 72.7 ± 5.2 before operation. MRI showed that 20 knees had definite focuses and 2 had no ones. In all the cases, routine arthroscopic approach combined with assistant approach adjacent to the focus was used. Results All the patients were diagnosed as having local ized pigmented villonodular synovitis of the knee by pathological examination. The incisions healed at stage I. No compl ications occurred after operation. All patients were followed up 18-28 months (average 22 months). The angle of genuflex was less than 90° in 2 cases after 6 weeks, and the range of motion of the knee was recovery after manipulation release. At last followup, MRI showed no recurrence was found in 19 patients. The IKDC score was 92.8 ± 2.4, and the Lysholm score was 94.5 ± 3.5, respectively, indicating significant differences when compered with before operation (P lt; 0.01). Conclusion Local ized pigmented villonodular synovitis of the knee can be effectively treated by arthroscopic excision of the focus along with a rim of surrounding healthy synovium with most minimal invasive and best knee function.
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.
Objective To evaluate the primary cl inical results of double-bundle anterior cruciate l igament reconstruction (ACLR) with semitendinosus allografts. Methods From March 2006 to October 2006, 33 patients underwent double-bundle ACLR with semitendinosus allografts. The complete followed-up data of 31 patients was analyzed retrospectively. There were 24 males and 7 females aged 18-35 years old (average 25 years old). The injury was caused by sports accidents in 23cases and traffic accidents in 8 cases, involving the left knee in 18 cases and the right knee in 13 cases. Anterior cruciate l igament rupture were confirmed by MRI and arthroscopy in all the patients, without lateral collateral l igaments injuries and posterior cruciate l igament injuries. The time from injury to operation was 1-43 months (average 11 months). The knee was fixed at 0° position after operation for 2 weeks and got knee joint rehabil itation exercises gradually. Results The incision of 2 patients showed effusion 4 and 7 days after operation, respectively, and healed after symptomatic treatment. The incision of 29 patients healed by first intention. There were no compl ications such as stiffness of knee joint, neurovascular injuries and joint infections. All the patients were followed up for 24-29 months (average 26 months). MRI displayed the anterior cruciate l igament grafts presented with good connection and signal similar to the normal 2 years after operation. There was significant difference between the preoperational value and the final follow-up value in terms of bilateral knee joint difference of prior laxity, Lachman test, and pivot shift test (P lt; 0.05 ). The circumference difference between the injured and the normal was (11.6 ± 7.9) mm before operation and (5.0 ± 3.1) mm at the final follow-up (P lt; 0.05). The Tegner score, Lysholm score, and International Knee Documentation Committee score was 3.83 ± 1.15, 64.38 ± 6.81, and 41.42 ± 6.30, respectively, before operation, and 6.29 ± 0.64, 94.45 ± 3.03, and 95.72 ± 3.10, respectively, at the final follow-up. There was a significant difference between before and after operation (P lt; 0.05). Conclusion The primary cl inical results of double-bundle ACLR with semitendinosus allografts are satisfactory and the allogeneic semitendinosus are good grafts for double-bundle ACLR.
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.
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.