The research background, way of thinking, research contents and methods of a united research project - "The Clinical Research on the Treatment of SARS with Integrated Traditional and Western Medicine" were reviewed. The latest research achievements on the treatment of SARS with integrated traditional and western medicine and the difficult points in the research were discussed. Furthermore, some tentative ideas were put forward to further the research. The conclusion was drawn that the principles of evidence-based medicine and the research scheme of multi-centered, prospective and randomized controlled trials, as well as the standard statistical and analyzing methods are the best way to assess the effectiveness and safety of treating SARS with integrated traditional and western medicine.
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.
Objective To analyze the therapeutic effect of olfactory ensheathing cells (OECs) transplantation for central nervous system diseases. Methods Between November 2001 and January 2008, 1 255 participants with central nervous system diseases were enrolled in this cl inical study for fetal OECs transplantation. There were 928 males and 327 femalesaged 1.2-87 (mean 40) years. The course of disease was (4.52 ± 4.67) years. Among them, 656 participants suffered from chronic spinal cord injury (SCI), 457 amyotrophic lateral sclerosis (ALS), 68 cerebral palsy (CP), 20 multiple sclerosis (MS), 11 the sequelae of stoke, 10 ataxia, and 33 residual diseases. The participants came from 71 countries or regions. Accidentally abortional fetal olfactory bulbs were donated voluntarily and were cultured for 2 weeks, then were transplanted. Results One thousand one hundred and twenty-eight cases were followed up for 2-8 weeks (mean 4 weeks) to obtain integrated data. Among them, the neurological functional amel ioration was noticed in 994 participants with the overall short-term improvement rate of 88.12%. Seventy-six patients experienced the various perioperative compl ications with the incidence rate of 6.74%. One hundred and twenty patients with SCI received over 1 year follow-up. And according to ASIA assessment, motor scores increased from (39.82 ± 20.25) to (44.55 ± 18.99) points, l ight touch scores from (51.56 ± 25.89) to (59.81 ± 27.72) points, pain scores from (50.36 ± 27.44) to (57.09 ± 28.51) points for foreign patients (P lt; 0.05); motor scores increased from (40.52 ± 20.80) to (46.45 ± 20.35) points, l ight touch scores from (55.64 ± 26.32) to (68.64 ± 25.89) points, pain scores from (57.05 ± 26.00) to (66.13 ± 24.29) points for good rehabil itation Chinese patients (overall P lt; 0.05); motor scores from (37.03 ± 18.52) to (38.03 ± 18.50 points (P lt;0.05), l ight touch scores from (45.88 ± 22.56) to (46.63 ± 23.09) points (P gt; 0.05), pain scores from (45.25 ± 23.68) to (45.28 ± 23.63) points (P gt; 0.05) for poor rehabil itation Chinese patients. Compared foreign patients and good rehabil itation Chinese patients with poor rehabil itation Chinese patients, difference in score change was remarkable (P lt; 0.05). One hundred and six cases of ALS, 32 CP, 8 MS, 7 ataxia, and 2 stroke sequelae were followed up for 3-48, 3-36, 2-20, 7-17, 6 and 24 months, One hundred and six cases of respectively. Majority of them (113/155, 72.9%）were benefited from OECs transplantation. Conclusion OECs transplantation into brain and spinal cord is feasible and safe . The therapeutic strategy is valuable treatment for such central nervous system diseases such as chronic SCI, ALS, CP and stroke sequelae and can improve the patients’ neurological functions and/or decrease the progressive deterioration.
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.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
As a science which focuses on evidence, the decision making process of evidence medicine encounters an opportunity for development in the big data era. The starting point is shifting forward from evidence to data. The big data technology is playing an active role in evidence's collection, process and utilization. Evidence is more objective, righteous, authentic, transparent and easier to collect. Thus, to initiate evidence-based medicine research in the big data era and to structure an evidence-based medicine intelligent service platform, a full-scaled strategy should be developed in order to improve the quality of evidence. To promote the complete publicity of clinical research data, structuralized clinical data standard should be constructed. To provide a pathway to patients' follow-up data, portable and wearable monitoring devices should be popularized. To avoid risks from utilization of clinical research big data, regulations of clinical data usage should be implemented.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.