支气管哮喘( 简称哮喘) 是一种以多种细胞特别是肥大细胞、嗜酸粒细胞和T 淋巴细胞等炎性细胞参与的气道慢性炎性反应和以气道高反应性为特征的疾病[1] 。目前全球大约有3.0 亿哮喘患者, 占世界人口的1% ～3% , 我国大约有2 500 万哮喘患者, 哮喘的发病率和死亡率在世界范围内一直呈增高趋势[2] 。2008 年在美国估计有210 万人或1.1% 的人口在过去的12个月内寻求针刺治疗, 4% 的美国人表示在他们的生活中曾使用过针刺疗法[3] 。针刺治疗哮喘在我国已有千年历史, 且相当普遍。目前哮喘的治疗仍以现代医学为主, 但尚无根治方法, 针刺治疗哮喘主要目标是控制哮喘复发, 提高患者的生命质量。
Objective To assess the quality of randomized controlled trials (RCTs) and clinical controlled trials (CCTs) relevant to COPD besides chronic bronchitis and chronic pulmonary cor disease in strengthening immune published in Chinese medical journals to provide scientific basis of systematic review (SR) of regulating the immune function of COPD in Chinese herbs. Methods 54 articles with clinical controlled trials were obtained by electronic searching and handsearching, and the method for randomized allocation, blindness, multi-centres, sample sizes, diagnosis criteria, exclusion criteria, source of cases, immune markers (cellular immunity, humoral immunity, erythrocyte immunity, nonspecific immunity), the clinical outcome assessment, statistical management, course of treatment and the side effects or adverse drag reaction, follow-up were investigated and then methodologically evaluated. According to the investigation, literatures with the method for randomized allocation, correct controls, appropriate sample sizes (≥60), the nation-wide diagnosis criteria, the objective clinical outcome assessment distinct statistical method were stipulated as the high-quality ones relatively. Results Among the 54 trials, 70.4% had explicit diagnosis criteria, 18.5% with exclusion criteria, 20.4% with comparability of baseline, 37.0% with distinct statistical method. In the therapy, 63.0% were with Chinese herbs. Conclusion The selected 7 articles belong to the high quality and possibly are to be explored in Meta-analysis.
Medical ethics must be considered for protecting the fights and interests of patients in clinical trials. Now the fights of the subjects are more and more emphasised, but there are some problems. It is evidence-based medicine (EBM) and emphasis of evidence that need the high-quality clinical trials, yet it violates the principle of ethics in some degree. It will be helpful for the administrators to supervise the clinical trials on drugs well from the point of ethical views.
Abstract: Objective To compare the midterm patency rates of individual and sequential saphenous vein grafts (SVG) as coronary bypass conduits of offpump coronary artery bypass grafting (OPCAB) and evaluate the impact of the grafting techniques (individual or sequential grafts) on the graft patencyafter OPCAB. Methods The clinical data of 398 patients in General Hospital of the People’s Liberation Army receiving OPCAB with individual and sequential grafts from June 2005 to March 2009 were retrospectively analyzed. There were 301 males and 97 females with their age ranged from 53 to 82 years (63.6±10.3 years). A total of 714 distal coronary anastomoses on 448 SVG were assessed by using 64multislice computed tomography (64MSCTA) at an average of 19.8±23.6 months (3 months to 5 years) after OPCAB procedure. The blood flow of grafts in the proximal segment of individual and sequential SVG and the patency rates of grafts and anastomoses were compared, and the effect of different locations on the patency rate of the anastomoses was analyzed. Results The mean blood flow in double SVG (37.11±16.70 ml/min vs. 25.15±14.24 ml/min, P0.042) and in triple SVG (37.56±19.58 ml/min vs. 25.15±14.24 ml/min, P=0.048) were both significantly higher than the flow in single SVG. The anastomoses on the sequential conduits had better patency (95.1％ vs. 90.1％, P=0.013). The patency of sideto side anastomoses was better than that of endtoside anastomoses (97.0% vs. 93.1%, P=0.002) and that of the individual endtoside anastomoses (97.0% vs. 90.1%, P=0.041). There was no significant difference between distal anastomoses in sequential and those in single grafts (P=0.253). No significant difference was observed between the two methods in regard to the three major coronary systems (including the anterior descending branch, the right coronary artery, and the circumflex branch). However, anastomoses on sequential grafts had superior patency to those on individual grafts in the right coronary system (P=0.008). Conclusion The midterm patency of a sequential SVG conduit after OPCAB is excellent and generally superior to that of an individual one. The best runoff coronary artery should be placed at the distal end and the poor coronary vessels should be arranged in the middle of the grafts.
Objective To investigate the effect of various concentration of platelet-rich plasma (PRP) on osteogenic differentiation of rabbit skeletal muscle-derived stem cells (SMSCs) cultured in vitro. Methods Blood drawn from the central ear arteries of 9 one-year-old New Zealand white rabbits weighing 2.5-3.0 kg (male and female) was used to prepare PRP (Landesberg method). Full blood count and platelet count in PRP were tested. Soleus muscle of right hindl imb in rabbit was obtained and used to culture SMSCs in vitro. The cells at passage 3 were randomly divided into different groups: the experimental groups in which the cells were treated by conditioned culture media with various concentrations of autologousPRP (6.25%, 12.50%, 25.00%, 50.00%), and the control group in which the cells were treated with the media without PRP. At different time points after intervention, osteogenetic activity of the cells was detected by ALP staining observation, ALP activity detection was conducted, al izarin red staining for calcium nodules and immunofluorescence staining for osteocalcin were performed, and core binding factor α1 (Cbfα1) of osteogenic gene expression was tested by RT-PCR. Results The full blood PRP count and the platelet count in PRP was (3.06 ± 0.46) × 105/μL and (18.08 ± 2.10) × 105/μL, respectively. ALP staining: the cells in all the experimental groups were positive for the staining with many black sediment particles in cytoplasm; the cells in the control group were negative staining. ALP activity: all the experimental groups were higher than the control group (P lt; 0.05), the experimental group at 12.50% was superior to other experimental groups at each time point (P lt; 0.05). Al izarin red staining: at 14 days after culture, orange-red calcium nodules were evident in all the experimental groups; no orange-red calcium nodules were observed in the control group with a mineral ization rate of zero; there were significant difference between the experimental groups and the control group in terms of mineral ization rate (P lt; 0.05), the experimental group at 12.50% had a higher mineral ization rate than other experimental groups (P lt; 0.05). Immunofluorescence staining for osteocalcin: at 7 days after culture, the experimental groups were positive for the staining with yellow fluorescence in cytoplasm, and the result of the control group was negative. RT-PCR detection: no obvious changes of the gene expression were noted at 4, 12, and 24 hoursafter culture in the control group; the gene expression in all the experimental groups was significant superior to that of control group, especially at 12 hours, and the expression in the experimental group at 12.50% was the highest. Conclusion PRP can obviously promote the osteogenic differentiation of SMSCs cultured in vitro in a concentration-dependent manner, and the 12.50% is proved to be the ideal concentration.
Objective To study the influence of different mechanical environments on repair cartilage defect with marrow mesenchymal stem cells as seed cells. Methods The rabbit marrow mesenchymal stem cells were isolated and cultured. The cartilage defects were repaired by autologous tissue engineered cartilage with the marrow mesenchymal stem cells as seed cells. Fifteen rabbits with cartilage defect were divided into 3 groups: dislocation group with cell-free scaffold(controlgroup), dislocation group with cartilaginous construct and normal mechanical environment group with cartilaginous construct. The repaired tissue was harvested and examined 6 weeks postoperatively. Results The repair tissue in normal mechanical environment group with cartilaginous construct showed cartilage-like tissue in superficial layer and subchondral bone tissue in deep layer 6 weeks postoperatively. The defect was filled with bone tissue in dislocation group with cartilaginous construct 6 weeks postoperatively. The surrounding normal cartilage tissue showed vascular invasion from subchondral area and the concomitant thinningof the normal cartilage layer. The cartilaginous construct left in the femoral trochlea groove formed hyaline cartilage-like tissue. The defect was repaired byfibrous tissue in control group. Conclusion The repaired tissue by tissue engineered cartilage with marrow mesenchymal stem cells as seed cells showed the best result in normal mechanical environment group, which indicates that it will be essential for the formation and maintenance of tissue engineered cartilage to keep the normal mechanical stress stimulus.
Objective To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.
Assessment on adverse drug reactions (ADR) that directly affects the quality of life and mortality and an important part of the post-marketed reassessment are developing gradually in China. Many problems have been identified in clinical validity and safety for the authorized Chinese herbs. An effective and standardized system is needed in the post-marketed drug reassessment. Evidence-based drug evaluation, which mainly includes clinical epidemiology, systematic review and health technology, will be used to assess the clinical validity, safety and cost of post-marketed drug and play an important role in the process of modernization and internationalization of Chinese herbs.