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 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.

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 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

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.

Coronary heart disease has become a major threat of human health, and its incidence rate remains surprisingly high.In recent years, technology on its diagnosis and treatment has developed greatly.The present article made a review on related new diagnosis and treatment so as to provide reference for clinical diagnosis and treatment of coronary heart disease.

Objective To study the curative effect of traditional chinese medicine combined with noninvasive ventilation on respiratory failure in patients with acute exacerbation of chronic obstructive pulmonary disease.MethodsThe patients were divided into experimental group (n=37) and control group (n=37).The experimental group was treated with traditional chinese medicine combined with noninvasive ventilation.The control group was treated with noninvasive ventilation method.The heart rate, blood gas analysis index, ventilation index and complication were compared between the two groups before and after treatment.ResultsAfter treatment, the levels of PaO2 in the two groups were not significantly different.The heart rate and PaCO2 of the experimental group were significantly lower than those of the control group, while the pH value and SaO2 were significantly higher than those in the control group (P< 0.05), and the total incidence of complications was 21.62%, which was significantly lower than that of the control group (64.86%, P<0.05).The time of infection control window, the highest PEEP and the time of mechanical ventilation were significantly shorter than those of the control group (P< 0.05).ConclusionThe treatment of patients with acute exacerbation of chronic obstructive pulmonary disease(COPD) combined with noninvasive ventilation therapy can significantly improve the heart rate and blood gas analysis indexes, and optimize the noninvasive ventilation efficiency, control lung infection as soon as possible, shorten the time of noninvasive ventilation and reduce the side effects that noninvasive ventilation brought about.