OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.

BACKGROUND: Fibronectin serves not only as the supporter for cells,but also as an important intracellular linkage, possessing opsonic-like functions. It can promote the phagocytic function of mononucleophages and the repair in inflammation and trauma.OBJECTIVE: Type O plasma was freshly obtained from healthy males in search of the optimal preparation method for lower sampling, convenient and higher-yielding of fibronectin.DESIGN: Open experiment.SETTING: Institute of Traumatic Surgery, Fourth Affiliated Hospital of Guangzhou Red Cross Hospital, Jinan University.MATERIALS: This experiment was carried out in the Institute of Traumatic Surgery of Guangzhou Red Cross Hospital between July 2000 and July 2002. The major materials consisted of type O fresh plasma from healthy males, gelatin, sepharose 4B activated with cyanogen bromide,sephadex G-25, urea, and trishydroxymethylaminomethane.METHODS: Affinity column constituted by gelatin coupling with sepharose 4B activated with cyanogen bromide was used to purify fibronectin. ① Human plasma was added: 150 mL type O plasma was freshly obtained from healthy males and added into the column once by 25 mLat an interval of 20 minutes, the speed of flow was 3.5 mL/min. ② Removing mixed protein: the column was rinsed by Tris-sodium citrate equilibrium liquid (pH 7.5) until the absorbency of flow-out fluid decreased to ＜ 0.02 at 280 nm. Again lmol/L NaCl containing Tris-sodium citrate was used to wash off other mixed proteins. ③ Collecting fibronectin: the column was rinsed by urea-Trispurge Fluid (3 mol/L) to collect fibronectin.④ Removing urea from fibronectin collection: fibronectin collection liquid was filtrated by Sephade G-25 to remove urea. ⑤Disinfection: 0.22 μmgermtight filter was used for disinfection.MAIN OUTCOME MEASURES: ①Results of sodium dodecyl benzene sulfonate-polyacrylamide gel electrophoresis. ② The influence of retention time on the yield of purified fibronectin. ③ The influence of plasma quantity on the yield of purified fibronectin.RESULTS: ① Results of sodium dodecyl benzene sulfonate-polyacrylamide gel electrophoresis: The density of separation gel and condensed gel was 7% and 3%, respectively; fibronectin was electrophoresized into single protein lane. ② The influence of retention time on the yield of purified fibronectin: The yield of fibronectin was (65.24±3.45) %, (74.77±4.05) %,(86.99±4.10) %, and (80.47±3.75) %, respectively, when the loading amount of fibronectin was 150 mL with non-retention time and retention time of 10, 20 and 30 minutes. ③ The influence of plasma quantity on the yield of purified fibronectin: The yield of fibronectin was (72.56±3.63) %,(77.61±3.14) %, (86.99±4.12) %, and (74.67±3.05) % when the column retention time was controlled at minute 20 with the loading amount of 100,130, 150 and 180 mL, respectively.CONCLUSION: In a given column volume of gelatin, the quantity of purified fibronectin was closely related with the plasma retention time in column and the total loading amount of plasma. As a result, the optimal loading amount of plasma was 150 mL, and the retention time was 20 minutes.The preparation method, herein, has been proved to require small amounts of plasma and yield large amounts of fibronectin.

Objective To improve work efficiency and safety of blood transfusion in the battlefield.Methods Polyurethanes material was adopted to construct the insulation layer.Low density polyethylene,glass reinforced plastics and low-temperature bio-chemical method also got involved in.Results The blood warmer was passive,small,easy-to-carry and mobile,whose temperature regulation was realized by the input of cold or warm water.Conclusion Being advanced and easy-to-operate,the blood warmer has a brilliant future.

Objective To improve the work efficiency and safety quality of blood transfusion remedy in field battle.Methods Low density polyethylente or glass reinforced plastics was used as raw and processed materials.The polyurethane foam was used as insulation layer.U-shape Mipor bi-pass blood-transfusion tube was used in heating.Results The apparatus is small,easily-carried,flexible and free from power supply.The temperature is regulated by the infusion of cold or hot water.Conclusion Being advanced and convenient,the apparatus has good application value.

Objective To develop an one-off multifunctional instrument for blood collection and transfusion.Methods Blood collection pipe,blood sample pipe and blood transfusion pipe were united by means of three-way pipe.Different venipuncture needles could be selected by means of different connectors.Plastic clips and connectors were used to cut off and connect pipes.It was also equipped with pipe warming apparatus,manual pipe seal apparatus and newest venipuncture needles.Results The one-off multifunctional instrument for blood collection and transfusion possessed advanced technology,convenience and good application value.Conclusion The one-off multifunctional instrument for blood collection and transfusion can be applied into blood medical service,all kinds of surgical operations,emergency care,abrupt affairs,and it meets the requirements of war-readiness and medical service for troops in different periods.

Objective To standardize the procedure and ensure the safety of oral administration,and to achieve the "three-accurate",that is right medicine,right time,and right patients． Methods The concept of "Health Care Failure Mode and Effect analysis" was used to analyze the procedure of in-patients' oral administration,and adjust the system according to insecurity factors to improve the hospital oral administration system constantly． Results The systematic reconstruction of the oral administration improved nurses' and patients' satisfaction,reduced the error rate of in-patients' oral administration and improved the safety of oral administration． Conclusion The application of"Health Care Failure Mode and Effect analysis" to forward-looking analysis in-patient oral administration system,combined with the actual situation of our hospital to develop and implement plans are the guarantees of oral administration security.

Objective To discuss the application value of the APP client terminal in the improvement of the post-discharged continuing nursing of the patients with pituitary adenoma surgery.Methods One hundred and fifty-six patients with pituitary adenoma surgery who was hospitalized in the department of neurosurgery in Huashan Hospital Affiliated to Fudan University from July 2015 to June 2016 were included into the observation group. The continuing nursing in the observation group was made by APP client terminal. One hundred and sixty-seven patients with pituitary adenoma surgery who was hospitalized in the department of neurosurgery in Huashan Hospital Affiliated to Fudan University from July 2014 to June 2015 were included into the control group. The continuing nursing in the control group was conventional health education, telephone follow-up. Three months after the patients' discharge, the effects of the continuing nursing were evaluated for the patients in the two groups with the evaluation form of the continuing nursing for the patients with pituitary adenoma surgery.Results The score of the continuing nursing evaluation form for the patients with pituitary adenoma surgery in the observation group was (45.47±10.98), which was significantly higher than that in the control group (70.24±15.48) (t=16.67,P<0.05).Conclusions The APP client terminal can effectively improve the health education effects of the continuing nursing in the postoperative patients with pituitary adenoma, which is worth popularizing and referring.

To explore a simple and sensitive method to detect minimal residual disease (MRD) in Ph(+)/bcr-abl(+) ALL patients, the bone marrow samples from 84 de novo ALL patients were detected by cytogenetic analysis, nested-PCR and flow cytometry (FCM). Cytogenetic analysis method is used to detect Ph chromosome, nested-PCR and FCM are used to detect bcr/abl mRNA and an abnormal B-cell differentiation pattern in de novo and complete remission (CR) patients, respectively. The results showed that Ph chromosome has not been found in 14 cases of CR; bcr/abl fusion gene was detected in 11 of 14 CR patients by nested-PCR (78.57%) and bcr/abl fusion gene was positive in 5 of 14 in CR patients (35.71%) by FCM. The sensitivity of nested-PCR was 10(-6)-10(-7), and that of FCM was 10(-4)- 10(-5). It is concluded that the cytogenetic analysis is not sensitive for MRD detection, and the sensitivity of nested-PCR is higher than that of FCM in detecting MRD.
Adolescent ; Adult ; Female ; Flow Cytometry ; methods ; Fusion Proteins, bcr-abl ; analysis ; Humans ; Male ; Middle Aged ; Neoplasm, Residual ; Philadelphia Chromosome ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; diagnosis ; genetics ; Recurrence ; Reverse Transcriptase Polymerase Chain Reaction ; methods ; Sensitivity and Specificity

In search of the optimal preparation method for large-scale purification of human plasma fibronectin, we adopted affinity chromatography with gelatin and the Sepharose 4B activated with cyanogen bromide to purify fibronectin from type "C" plasma of healthy males, and scanned the best method under the conditions of different amount of plasma loading and different residence time in column. In a given column volume of gelatin, the absorbent was related with the plasma residence time in column and the total amount of plasma loaded. As a result, the optimal loading amount of plasma is 150 ml, and the residence time is 20 minutes. The preparation method, herein, has been proved to require small amount of plasma and yield large amount of fibronectin.
Chromatography, Affinity ; methods ; Cyanogen Bromide ; chemistry ; Fibronectins ; blood ; isolation & purification ; Gelatin ; Humans ; Male ; Sepharose ; chemistry ; Wound Healing