This paper categorizes implantable medical device of collagen on Chinese market according to manufacturing technique and performance.Combining with supervision requirements from China Food and Drug Administration (CFDA), this paper discusses safety evaluation in following aspects, such as immunogenicity risk,virus and infectious pathogen risk, and product technical requirements.Finally, the paper looks into the future of collagen implants considering technology progress in biomedical engineering, tissue engineering, and genetic engineering fields.

OBJECTIVE:To discuss the importance and prospects of the reforming of the Chinese medicinal decoction pieces. METHODS: The advantages and disadvantages of all kinds of decoction pieces(categorized by particle diameter) in preparation, application and management were analyzed comprehensively. RESULTS & CONCLUSION: Comminuting and extracting are two basic approaches for the current reform of the Chinese medicinal decoction pieces, and the reform of the decoction pieces is mainly aimed at nano-Chinese medicinal decoction pieces.

OBJECTIVE:To observe the therapeutic effect of Yindanxinnaotong Soft Capsules combined with three chemicals for coronary disease angina pectoris. METHODS:91 cases which were up to the diagnosis standard were randomly divided into control group(n=44) and treatment group(n=47) . Control groups were treated with the routine isosorbide 5-mononitrate sustained release tablets(10～20 mg,bid) ,bisoprolol fumarate tablets(5～10 mg,qd) ;amlodipine besylate tablets(5 mg,qd) . Treatment group were additionally treated with 2 to 4 Yindanxinnaotong Soft Capsules,tid,p.o,with treating course of 30 days. RESULTS:The total efficacy rate of angina pectoris and the electrocardiogram were 80.85% and 74.47% for treatment group while 61.36% and 56.82% for control group. There was significant difference between two groups(P

Objective: To investigate the effects of different anaesthesia on serum catechlomine and IL-6 in surgical breast cancer patients,and evaluate the influence of anaesthesia on surgical stress.Methods: Forty breast cancer patients submitted to elective masteetomy were randomly divided into 2 groups:GEA group (general plus epidural anaesthesia,n=20),GA group (genernal anaesthesia,n=20). Blood samples were taken before operation, 30min, 120min following the incision and at the 1st and 3nd postoperative days. The concentrations of serum catechlomine and IL-6 were detected.Results: The concentrations of serum norepinephrine(NE),epinephrine(E),dopamine(DA) and catechlomine(CA) were similar in 2 groups before operation,and remarkably increased at 30min after incision and reached the peak values at 120min after incision. They were at the high level at the 1st day after operation(P

Objective To investigate the treatment of local recurrence after sphincter preserving surgery for low rectal cancer. Methods Fifty-six patients with local recurrence after sphincter preserving surgery for low rectal cancer were divided into three groups, 20 cases underwent radical resection (group A), 21 cases underwent palliative resection combined with 3 dimensional conformal radiation therapy (group B), and 15 cases only received 3 dimensional conformal radiation therapy (group C). Results All the patients were followed up from 6 months to 3 years. The 1-year,2-year and 3-year survival rates were 100.0%(20/20),80.0% (16/20),65.0% (13/20) in group A,90.5% (19/21),52.4% (11/21),33.3% (7/21) in group B and 80.0%(12/15),40.0%(6/15),20.0%(3/15) in group C respectively. Both 2-year and 3-year survival rates in group A were significantly higher than those in group B and group C (P <0.05). Conclusions The first choice of patients with local recurrence after sphincter preserving surgery for low rectal cancer is radical resection. Palliative resection combined with 3 dimensional conformal radiation therapy is the second choice.

MicroRNAs(miRNAs) are small non-coding RNAs that regulate gene expression at posttranscription. Its abnormality expression could be one of the main mechanisms on development of pancreatic neoplasm. It also offers new candidate targsts for diagnostic and therapeutic strategies of pancreatic neoplasm.

Objective To investigate the relationship between postoperative survival quality with social support and coping style of the main caregivers in the elderly patients with laryngeal carcinoma surgery.Methods A total of 60 inpatients with laryngeal carcinoma surgery and their main caregivers were investigated by the Medical University of Washington Quality of Life Scale (UW-QOL),Coping Styles Questionnaire(CSQ) and Social Support Rating Scale(SSRS).And the obtained data were statistically analyzed by adopting the statistical methods such as Pearsons correlation analysis.Results The postoperative survival quality of the elderly patients with laryngeal carcinoma surgery was generally lower.The social support was in the medium level.The main caregivers adopted more coping style of solving problem and seeking help.The patients' survival quality showed significantly positive correlation with the social support(P＜0.05),significantly positive correlation with the main caregivers' solving problems and seeking help coping style(P＜0.05),and significantly negative correlation with the main caregivers' self-accusation and withdraw and keep off coping style(P＜0.05).Conclusion Increasing the social support level and the main caregivers taking a positive the coping style to face the disease have an important significance for improving the quality of life in elderly patients with laryngeal carcinoma.

With the continuous improvement of China's drug regulatory laws and regulations, Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use. The management of post-approval changes to biological products is gradually shifting towards the risk-based model from the item-based model.In recent years, there has been a significant increase in supplementary applications for manufacturing site changes of marketed therapeutic recombinant protein drugs. However, the risks associated with manufacturing site changes vary under different circumstances. Therefore, the research that needs to be carried out is also different. This paper provides an in-depth discussion on three key aspects: risk assessment and grading, general requirements and special considerations for pharmaceutical research, and common application issues. It outlines general requirements for manufacturing site change, aiming to offer valuable insights for industry needs. Through the collaborative efforts between regulatory authorities and the industry, patient rights and interests can be effectively protected, and high-quality drugs can be made available to the public.

BACKGROUND: Tissue-engineered materials containing osteoblasts have been widely used in the treatment of orthopedic diseases. How to improve hypoxic tolerance and the biological behavior of osteoblasts under hypoxic conditions is an important goal of the research on tissue engineering.OBJECTIVE: To explore the effect of M2 macrophage supernatant and Eucommia flavonoids on the biological behaviorof osteoblasts under hypoxia to pave ways for tissue engineering. METHODS:After MC3T3E1 cells were resuscitated, and M2 macrophages were isolated, induced and cultured, all cells were divided into control, M2 macrophage, Eucommia flavonoids and combination groups. The control group received no intervention. Cells in the M2 macrophage, Eucommia flavonoids and combination groups were exposed to M2 macrophages or/and 100 mg/L Eucommia flavonoids, respectively. RESULTS AND CONCLUSION:The cell viability in the M2 macrophage, Eucommia flavonoids and combination groups was significantly higher than that in the control group. The percentage of cells in the S and G2/M phases in the combination group was significantly higher than that in the control group. The relative mRNA expression levels of Runx2, collagen type Ⅰ and alkaline phosphatase, alkaline phosphatase activity and relative concentration of calcium ions in the combination group were significantly higher than those in the other three groups. To conclude, M2 macrophage supernatant combined with Eucommia flavonoids can promote osteoblast proliferation and differentiation under hypoxic conditions, maintain normal mineralization and osteogenesis of osteoblasts, and improve the tolerance ability of osteoblasts to hypoxia.

Objective To study the effect of ganoderma lucidum polysaccharides on T cell subsets and AQP1, AQP3 expression of bladder cancer T24 cell line bearing mice.Methods 60 BALB/C nude mice were selection as experimental animals, bladder tumor bearing animal models were made by bladder cancer T24 cells subcutaneous injection, and were randomly divided into control group, cisplatin group, ganoderma lucidum polysaccharides and cisplatin group, cisplatin group given 25 mg/kgcisplatin intraperitoneal injection, cisplatin combined ganoderma lucidum polysaccharide group given 200 mg/kg ganoderma lucidum polysaccharide lavage, 25 mg/kg cisplatin intraperitoneal injection, the control group given quite a volume normal saline lavage.Then tumor volume and weight, peripheral blood T cell subsets and AQP1, AQP3, Caspase-3, Bax mRNA content in tumor tissue were determined.Results Cisplatin group, cisplatin combined ganoderma lucidum polysaccharide tumor volume and mass were significantly lower than the control group (P<0.05), cisplatin and ganoderma lucidum polysaccharide tumor volume and mass were significantly lower than that cisplatin group ( P<0.05 ); Cisplatin group, cisplatin combined ganoderma lucidum polysaccharides group CD4 + T cells, CD8 +T cells , CD4 +/CD8 + were significantly higher than that of control group (P<0.05), cisplatin combined ganoderma lucidum polysaccharide group CD4 +T cells, CD4 +/CD8 +were significantly higher than that of cisplatin group (P<0.05); Cisplatin group, cisplatin combined ganoderma lucidum polysaccharide group mices tumor tissues Bax, Caspase 3 mRNA content were significantly lower than the control group (P<0.05), cisplatin combined ganoderma lucidum polysaccharide group Bax,caspase 3 mRNA content were significantly lower than that of cisplatin group (P<0.05); Cisplatin group, cisplatin combined ganoderma lucidum polysaccharide group mice tumor tissue AQP1, AQP3 mRNA content were significantly lower than the control group (P<0.05); Cisplatin combined ganoderma lucidum polysaccharide group AQP1, AQP3 mRNA content were significantly lower than cisplatin group (P<0.05 ). Conclusion ganoderma lucidum polysaccharide can inhibit tumor growth and enhance cellular immune function of bladder cancer T24 cell line bearing mice, and adjust the expression of pro-apoptotic genes, AQP1 and AQP3.