OBJECTIVE: To explore the ways to evolve the current domestic legislation on the relief of adverse drug reactions(ADR)-induced harm.METHODS: Suggestions on the improvement of the existing related legal systems were put forward by analyzing the status quo of the current legal regulations on the relief of ADR-induced harm.RESULTS & CONCLUSIONS: The relief pattern,liability principle,the scope of paying and the time limit of lawsuit etc should be given into full consideration in the legislation on the relief of ADR-induced harm.

Publishment of the draft of Chinese Medicine Act shows that the legislative work for TCM has achieved substantial progress. But after careful analysis on the legislative bills, there are some controversial questions, such as integration of traditional Chinese and western medicine, the setting of Chinese medicine clinics, Chinese medicine personnel training, the prescription-based processing Chinese medicine decoction pieces and dispensing Chinese materiamedica preparations by medical institutions. These all need to be further perfected.

OBJECTIVE:To explore the ways to consummate the current domestic legal regulations on adverse drug reactions(ADRs).METHODS:The status quo and the defects of the current legal regulations on ADRs were analyzed;and taking ADR damage relief systems adopted in some countries as reference,we put forward some suggestions on the improvement of the existing related legal regulations.RESULTS & CONCLUSIONS:The existing related legal regulations should be consummated as early as possible in respect of constitutive requirements of ADRs,legal obligation,identification system etc via suitable legislation channel so as to protect patients' rights.

OBJECTIVE:To provide the reference for the improvement of GCP(good clinical practice)regulations and protection of subject's human rights.METHODS:The status quo of the protection of subject's right of informed consent and the elements for the right of informed consent and the existing problems in its practice in China were analyzed.RESULTS & CONCLUSIONS:China should further promote the legislation of clinical trials,reinforce the legal education of researchers,and emphasize the supervision on the illegal tort act.

Objective To investigate the biomechanics of the tissue engineered tendons which use the embryonic tendon cells as the seed-cells and the silk as the scaffolds. Methods Two groups were set up with one as the group with tenocytes and the other as the group without tenocytes. Tissue engineered tendons were taken out at 2-week, 4-week, 6-week, 8-week post-operation, with 20 samples per-group each time. The values of biomechanics were measured and analyzed using the software SPSS 13.0. Results The biomechanical properties of the tissue engineered tendons in the group with tenocytes were significantly better than those in the group without tenocytes (P<0.05). In the group with tenocytes, the vitodynamics results got better with the increase of implantation time (P<0.05) except for the results of 8-week post--operation(P>0.05). But in the group without tenocytes, only the results of that from 8-week post-operation were of significant significance (P<0.05). Conclusion The results presented in the current study demonstrated that silk could stick tenocytes well, hold the characteristics of great resistance to draw after adhesion of tenocytes, and formed the tissue engineered tendon gradually in chickens, suggesting its potential application in the treatment of the defect of tendon.

[Objective]To investigate the possibility of construction of tendon defect with allogeneic embryonic tenocyte combined with silk.[Method]Roman hens were randomly divided into 2 groups: construction with allogeneic tenocyte combined with silk as cell group,construction with silk alone as non-cell group.The pathology,vitodynamics and elongation were compared between 2 groups at 2,4,6,and 8 weeks postoperatively.[Result]Collagen production and vitodynamics in cell group were better than those in non-cell group significantly(P

Adult ; Femur Head Necrosis ; chemically induced ; drug therapy ; Glucocorticoids ; therapeutic use ; Humans ; Male ; Paraquat ; poisoning

Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Paraquat ; poisoning

Objective　To study the preventive effect of hepatic metastasis from colorectal cancer and the immune function influence on postoperative patients with colorectal cancer treated by TIL, rIL-2 and cyclophosphamide by portal vein infusion. Methods　One hundred and twenty-four patients with advanced colorectal cancer (Dukes B and Dukes C stage) were randomly divided into immunotherapy group and control group. The control group were treated with 5-Fu and MMC by intravenous injection after resection of colorectal cancer. The immunotherapy group were treated with TIL, rIL-2 and cyclophosphamide by portal vein infusion after resection of the tumor, then with chemotherapy as the control group. All cases were followed-up for 3 years. Results　Eight cases (12.3%) had hepatic metastases from colorectal cancer in the immunotherapy group, but nineteen cases (33.2%) in the control group. There was significant difference between the two groups (P>0.05). The NK, IL-2 activity and CD3, CD4, CD4/CD8 levels in peripheral blood of the immunotherapy group increased significantly after treatment (P<0.05). Conclusions　The TIL, rIL-2 and cyclophosphamide treatment after resection of colorectal cancer is effective in improving antitumorgenic immune function, and preventing hepatic metastases.

OBJECTIVE:To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS:The legislation process of pediatric drug use in US,the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed,suggestions on guarantee-ing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS:The policy6-month period of pediatric exclusive protectionin Best Pharmaceuticals for Children Act has motivated the enthusiasm of phar-maceutical companies developing pediatric studies,while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments,while there is no enough force for the marketed drugs that has not been widely used for children. En-couragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifingone drug two formsin Prescription Management Regulations,accelerating approvals of related pediatric drugs on the premise that safety is guaranteed,implementing tax preference for related pharmaceutical companies that produced pediatric drugs,promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pedi-atric studies to promote the accessibility and safety of pediatric drugs.