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。
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
Objective To investigate the clinical manifestations, lung function and therapy of patients with primary bronchogenic carcinoma complicated with chronic obstructive pulmonary disease ( COPD) . Methods 365 patients with primary bronchogenic carcinoma were recruited retrospectively. The patients were analyzed by COPD-complicated and COPD-free groups. The clinical manifestations, lung function ( especially FEV1 ) , pathological types and progression-free survival ( PFS) were analyzed. The use of inhaled corticosteroids for treatment of COPD was also recorded. Results There was 62.2% patients( 227 cases) complicated with COPD with an average age of ( 66.1 ±9.3) yrs, 77. 5% of male, 82. 4% of smokers, and 46. 3% of past histories of respiratory disorders. Those in COPD-free were aged ( 54.8 ±5.6) yrs, with 55.8% of male, 62.3% of smokers, and 30.4% of past histories of respiratory diseases. The COPD-complicated patients had lower lung function than that of COPD-free [ ( 68.6 ±9.7) % vs. ( 75.3 ±7.5) % in FEV1%pred and ( 65.9 ±8.5 ) % vs. ( 75.6 ±9.1 ) % in FEV1 /FVC, P lt; 0.05 ] . The COPDcomplicated patients were more likely to have squamous carcinoma ( 43.2% vs. 31.2% , P lt; 0.05) and small cell lung cancer ( 20.7% vs. 15.2% , P lt; 0.05) . Moreover, performance status ( PS) scores ( 3.3 ± 0.5 vs. 2.8 ±0.4) and PFS ( 5.9 ±1.6 vs. 7.5 ±2.1) were worse in the COPD-complicated patients than that of the COPD-free patients. Only 71 cases of the COPD-complicated patients received regularly inhaled corticosteroids for COPD treatment. These patients had better PS scores and PFS than others without corticosteroids treatment. Conclusions Primary bronchogenic carcinoma patients with COPD comorbidity are commonly encountered. Clinicians should be aware of the clinical manifestation and corticosteroids prescription should be recorded to improve the quality of life and prognosis.
To investigate the shortsegment pedicle screw in treating degenerative L4 spondylolisthesis and the relationship of the preliminarily bending degree of the titanium rod with the lumbar lordosisangle, the slipping angle and the slipping percentage and to evaluate the clinical coincidence and curative effects of the preliminarilybent rod. MethodsFrom September 2005 to March 2007, 31 female patients (age, 40-70 years; average, 58.3 years) were admitted for surgical treatment of their L4 degenerative spondylolisthesis (MeyerdingⅠ°, Ⅱ°)． Their lumbar lordosis angle （x1）, slipping angle (x2), and slipping percentage (x3) were measured in the L4,5 segment before operation. During the operation, the titanium rod bent beforehand according to the corresponding standards was inserted. The angle of the bent rod (Y) was measured, and then the multiple linear regression equation was established. The regression equation was applied to the surgical treatment of the 30 patients.Results According to the criteria in the JOA scoring system, the 31 patients had scores of 8.300± 1.080 and 26.916±1.859 before operation and after operation, respectively. There was a significant difference between before operation and after operation（Plt;0.05）. The established multiple linear regression equation was as follows:Y=0.1390-0.327logx1+0.463x2+0.288x32．The operating time was 51.290±3.408 min in the 30 patients who underwent an insertion of the preliminarilybent rod during the operation; however, the operating time was 102.360±5.004 min in the 31 patients who underwent an insertion of the bent rod that was made based on experience during the previous operations. There was a significant difference in the operating time between the two kinds of the rods （Plt;0.05）. Estimated according to 90%, 95% and 99% of the areas under the normalcurve, the clinical coincidence rates in the preliminarily bending degrees of the titanium rod in the 30 patients were 80.00％，90.00％ and 96.67％, respectively.Conclusion The titanium rod that has been bent into a certain angle before operation according to the established criteria can definitely diminish its strain during operation and efficiently shorten the operating time．Thiskind of the titanium rod has a good coincidence in clinical application and can be effectively used in clinical practice.It is worth reference during the clinical operation.
Rare diseases are mostly genetic disorders that often manifest in childhood, characterized by severe conditions, difficulties in diagnosis and treatment, and poor homogeneity in clinical management. Clinical research on rare diseases contributes to enhancing the diagnosis and treatment capabilities for rare diseases in China and promotes the development of rare disease medicine. Clinical research on rare diseases in China started relatively late, and there is currently no mature and comprehensive system for clinical research on rare diseases. This article analyzes the current state of clinical research on rare diseases in China, identifies existing problems and research difficulties, and proposes ideas and key measures for the construction of China’s clinical research system on rare diseases, aiming to provide opinions and suggestions for the construction of China’s clinical research system on rare diseases.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
目的:评价硫普罗宁钠治疗急慢性肝炎的有效性与安全性。方法:采用随机、双盲模拟、阳性药平行对照试验方法。硫普罗宁钠200mg静滴Qd,对照组用凯西莱(硫普罗宁)200mg静滴Qd。疗程均为4周,停药后随访4周。结果:共治疗急性肝炎患者7例,慢性肝炎患者18例。急性肝炎组:试验组与对照组4周末ALT下降率分别为69.14±39.23％及68.23±45.12％,试验组显效率33.33％,总有效率100％,对照组显效率25％,总有效率100%,两组疗效比较无显著性差异(Pgt;0.05)。慢性肝炎组:试验组与对照组4周末ALT下降率分别为44.34±53.1％及35.01±74.67％,试验组显效率22.2％,总有效率77.8％,对照组显效率11.11％,总有效率66.67％,两组疗效比较无显著性差异(Pgt;0.05)。急性肝炎组未见不良反应,慢性肝炎组中试验组及对照组不良反应发生率均为5.00%。结论: 硫普罗宁钠具有保肝降酶作用,临床上用于治疗急慢性肝炎患者安全有效。
ObjectiveBased on the requirements of the era of big medical data and discipline development, this study aimed to enhance the clinical research capabilities of medical postgraduates by exploring and evaluating some teaching innovations. MethodsA research-oriented clinical research design course was developed for postgraduate students, focusing on enhancing their clinical research abilities. Innovative teaching content and methods were implemented, and a questionnaire survey was conducted to assess the effectiveness of the teaching innovations among clinical medical master's students. ResultsA total of 699 clinical medical master's students completed the survey questionnaire. 94% of students expressed satisfaction with the course, 96% believed that the relevant knowledge covered in the course met the requirements of clinical research, 94% felt that their research capabilities had improved after completing the course, and 99% believed that the course helped them publish academic papers and complete their master's theses. ConclusionStudents recognized the teaching innovations in the course, which stimulated their initiative and enthusiasm for learning, improved the teaching quality of the course, and enhanced the research capabilities of the students.
ObjectivesTo systematically review the efficacy of absorbable barbed suture versus traditional absorbable suture in total knee arthroplasty (TKA).MethodsPubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect clinical trials of absorbable barbed suture versus traditional absorbable suture in TKA from inception to November, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 randomized controlled trials (RCTs) and 5 cohort studies were included, involving 2 008 patients. Meta-analysis showed that the joint capsule suture time of the absorbable barbed suture group [MD=–4.31, 95% CI (–4.72, –3.90), P<0.000 01], the incidence of acupuncture injury during suture [OR=0.14, 95% CI (0.03, 0.61),P=0.009], and incision complication rate [OR=0.56, 95% CI (0.36, 0.88), P=0.01] were significantly lower than the traditional absorbable suture group, but the incidence of suture fracture [OR=23.03, 95% CI (3.08, 172.09),P=0.002] was higher, yet the difference was statistically significant. There were no significant differences in the incidence of superficial infection, deep infection, aseptic redness, incision dehiscence and KSS score at 3 months after operation (P>0.05).ConclusionsAvailable evidence suggests that the use of absorbable barbed sutures to close the TKA surgical incision shortens the time to suture the joint capsule, reduces the incidence of acupuncture injury as well as the overall incidence of incision complications without increasing superficial infection, deep infection, and sterility. The incidence of redness and incision splitting has no significant effects on joint function at 3 months after surgery, however the incidence of suture fracture is higher. Due to limited quality and quantity of the included studies, the above conclusions are required to be verified by more high-quality studies.