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 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.
Spine is a common site of metastasis in patients with malignant tumors, and tumor metastasis to the spine can lead to pain, pathological fractures, and nerve compression. In order to optimize the diagnosis and management of patients with spinal metastases and metastatic spinal cord compression (MSCC), the National Institute for Health and Care Excellence (NICE) in the UK proposed the first diagnostic and treatment guidelines for patients with MSCC (or at risk of MSCC) in 2008. In recent years, with the rapid advancement of spinal surgery and radiotherapy technology, the standardized process of MSCC diagnosis and treatment urgently needs to be updated. In 2023, NICE launched new guidelines for spinal metastases and MSCC. Based on a thorough study of the guidelines, this article discusses and interprets pain management, corticosteroid treatment, application of bisphosphonates and denosumab, tools for assessing spinal stability and prognosis, radiation therapy, surgical timing and approach, etc., providing reference for clinical diagnosis and treatment in China.
Objective
To understand research progress on peritoneal metastasis from gastric cancer at present stage briefly.
Methods
The literatures about mechanism, diagnosis, prevention and treatment of the peritoneal metastasis from gastric cancer at home and aboard were collected to make a review.
Results
The peritoneal metastasis is the common site of the distant metastasis in the advanced gastric cancer. It’s occurrence mechanism is complex, the diagnostic measure is varied, the prevention way is difficulty, and it give priority to with the comprehensive treatment and the transformed therapy.
Conclusion
It has a certain necessity to study occurrence mechanism, prevention methods and treatment measures so that improve survival rate and prognosis for patients with peritoneal metastasis from advanced gastric cancer.
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.
