中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
Objective To summarize the basic research and the cl inical appl ication of biodegradable interbody fusion Cage. Methods Recent l iterature concerning biodegradable interbody fusion Cage at home and abroad was extensively reviewed, and current developments of the basic research and the cl inical appl ication of biodegradable interbody fusion Cage were investigated. Results Basic research showes that the stiffness of biodegradable interbody fusion Cage is lower than that of metall ic Cage, so it can enhance interbody fusion. As interbody fusion proceeded, biodegradable interbody fusion Cage degrades constantly, but the speed of degradation can not keep in parallel with that of fusion. In addition, the tissue response to degradation products is controversy. Cl inical appl ication showes that the biodegradable interbody fusion Cage can enhance interbody fusion and maintain disc space height. The short term results are good, however, the long term results need further observation. Conclusion Biodegradable interbody fusion Cage can effectively enhance interbody fusion.
An in vitro experiment showed that the skin expanders were permeable to metronidazole and procaine. Twenty kidney shaped skin expanders were divided into four groups. Group 1. 100ml 0.2% metronidazole solution was injected into the expanders and the expenders were immersed in a flask filled with 100ml saline solution, and then were placed in a hermetically sealed glass chamber; Group 2.the whole procedure was the same as that of Group 1 except the expander was previously boiled in water for 30 minutes; Group 3. 100 ml 2% procaine was injected instead of metronidazole, other step was the same as that ofgroup I; and Group 4. the whole procedure was the same as that of Group 2 except the solutioninjected was 2% procaine. The concentration of metronidazole and procaine in the surrounding saline was measured at 1st, 2nd, 4th, 16th, 24th, 48th, 72nd 120th hours. The rate of diffusion of a drug was highest at 2 and 4 hous. The rate of diffusion was inversely proportional to its molecular weight, i.e., the smaller the molecular weight the greater the permeability. In view of this, during the process of expansion, metronidazole and procaine would diffuse out of the expander which might be beneficial for preventing infection and controlling pain.
Objective To review the lately new progress of fish collagen as biomedical materials, and then analyze feasibility and risk management of its application as a substitute of collagen originated from mammals in clinical practice. Methods Based on extensive research on new application and investigation of fish collagen, the paper was prepared to bring comprehensive analysis of its research and application status, and then several key points were focused on. Results Fish collagen has been proved to be a novel collagen of rich source, low risk of virus transmission, low biological risk, less religious barrier, and high biocompatibility. Fish collagen has promising prospect when applied in clinical practice as novel collagen especially as a substitute of collagen derived from mammals. However, very few related translational medicine research of fish collagen has been reported up to now in China. Conclusion As a novel potential substitute of collagen source derived from mammals, fish collagen is concerned to be clinical feasible and necessary in translational medicine. However, massive applied basic researches should be focused on in the further investigations.
Abstract An animal experiment had been conducted for the purpose to find out the possibility of application of instantaneous sustained limited expansion (ISLE). A total of 54 skin defects in 9 pigs were obtained and were divided into two groups. One group of the pigs were subjected to instantaneous sustained limited expansion, the others, as the control group, just received the tension suture. At the same time the blood supply of the skin was measured by laser doppler flowmeter (LDF). It was showed that microcirculatory perfusion of the ISLE group was considerably better than that of the control. Inaddition, the correlation between the blood flow of the skin and the expanding pressure, as well as the pathologic changes of the skin were discussed.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
ObjectiveTo summarize the relationship between lateral femoral notch sign (LFNS) and anterior cruciate ligament (ACL) rupture. MethodsThe relevant literature of LFNS at home and abroad in recent years was retrospectively reviewed, and its mechanism, diagnostic criteria and influencing factors in diagnosis of ACL rupture were summarized and analyzed.ResultsThe LFNS is associated with rotational stability of the knee. As an indirect sign of ACL rupture, the LFNS has high clinical diagnostic value, especially the diagnosis of ACL rupture with lateral meniscus injury.ConclusionThe diagnostic criteria and influencing factors of LFNS in diagnosis of ACL rupture are still unclear and controversial, which needs further study.
ObjectiveTo summarize the clinical progress of minimally invasive techniques in treatment of pilonidal disease.MethodThe relevant literatures about minimally invasive techniques in the treatment of pilonidal disease in recent years were reviewed.ResultsAbout hair removal and carbolic acid injection, they had less damage, fewer complications, higher recurrence rate compared to other surgery, and did not affect the second treatment. The fibrin injection could not clarify its role in the treatment of pilonidal disease due to some defects in the clinical design. Bascom Ⅰhad the advantages of fast recovery and no need for hospitalization, with a recurrence rate of 8%–16%. According to the results of some current clinical researches, it was a promising operation. Sinus resection required further clinical evaluation due to the limited results of current researches. A clinical study of more than 1 000 cases over 10 years showed that the recurrence rate in 10 years was 16%. Compared with frequently used pilonidal operations, the trephine technique was associated with a lower recurrence rate and a lower incidence of postoperative complication. Some short-term clinical researches showed that endoscopic pilonidal sinus treatment was a safe, minimally invasive, and less complication treatment.ConclusionsCompared with frequently used pilonidal operations, minimally invasive technique has the advantages of shortening the hospital stay, shortening the healing time, and reducing complications. It is worth of application.
ObjectiveTo investigate the changes of fibrinogen and classical markers of collagen metabolism [carboxy-terminal propeptide of type Ⅰ procollagen (PICP) and carboxy-terminal cross-linked peptide of type Ⅰ collagen (ICTP)] in peripheral blood and pericardial drainage after coronary artery bypass grafting (CABG) and/or heart valve replacement (VR), and to evaluate their relationship with postoperative atrial fibrillation (POAF) after cardiac surgery. MethodsPatients who underwent CABG and/or VR in the Heart Center of Beijing Chao-Yang Hospital from March to June 2021 were included. Peripheral blood and pericardial drainage fluid samples were collected before surgery and at 0 h, 6 h, 24 h and 48 h after surgery to detect PICP, ICTP and fibrinogen levels, and preoperative, intraoperative and postoperative confounding factors were also collected. PICP, ICTP and fibrinogen levels were measured by enzyme-linked immunosorbent assay (ELISA). ResultsA total of 26 patients with 125 blood samples and 78 drainage samples were collected. There were 18 males and 8 females with an average age of 64.04±7.27 years. The incidence rate of POAF was 34.6%. Among the factors, the fibrinogen level in pericardial drainage showed two peaks within 48 h after operation (0 hand 24 h after operation) in the POAF group, while it showed a continuous downward trend in the sinus rhythm (SR) group, and the change trend of fibrinogen in pericardial drainage was significantly different over time between the two groups (P=0.022). Fibrinogen in blood, PICP and ICTP in blood and drainage showed an overall decreasing trend, and their trends over time were not significantly different between the two groups of patients (P>0.05). Univariate analysis showed that fibrinogen at 24 h and 48 h after pericardial drainage, fibrinogen in preoperative blood, PICP immediately after surgery and right atrial long axis diameter were significantly higher or longer in the POAF group than those in the SR group. Multiple regression showed that fibrinogen≥11.47 ng/mL in pericardial drainage 24 h after surgery (OR=14.911, 95%CI 1.371-162.122, P=0.026), right atrial long axis diameter≥46 mm (OR=10.801, 95%CI 1.011-115.391, P=0.049) were independent predictors of POAF. ConclusionThis study finds the regularity of changes in fibrinogen and collagen metabolic markers after CABG and/or VR surgery, and to find that fibrinogen in pericardial drainage 24 h after surgery is a potential novel and predictive factor for POAF. The results provide a new idea for exploring the mechanism of POAF, and provide a research basis for the accurate prediction and prevention of clinical POAF.
This experiment was to study the blood supply of diffcrent types of skin flaps and the revascularization of the host region. The types of skin flaps used in this cxpcriment were the axial pattern flap and the random pattern flap on the back of rabbite. Forty New Zealand rabbits were divided into 5 groups at random. In gathering the data For assessment, besides the local changes such as color, swelling of the flaps, the area of survival of flaps after division of the pedicles, the tests used to observe the postoperative changes included the isotope (99mTc) clearance test, intravenous orescein test, tissue transparent method by perfusion of the flap vessels with Chengdu ink and histologie study. The following conclusions cule be drawn: The complete revaseularization of random pattern flap occurred at 10 days after operation and that of xaial pattern flap was 14 days, the random pattern flaps had a quicker rate of revascularization. It was suggested that the flap ischemia was a factor which enhanced revascularization.