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OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.
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Objective To observe and compare the clinical efficacy and safety of rifapentine and rifampicin in the treatment of tuberculosis.Methods From January 2015 to January 2018,398 tuberculosis patients admitted to Tuberculosis Clinic of the Traditional Chinese Medicine Hospital of Cixi were selected and randomly divided into observation group and control group by complete Random Distribution Method,with 199 cases in each group.The two groups were given basic treatments such as isoniazid,pyrazinamide and ethambutol.On this basis,patients in the control group were treated with rifampicin,and the observation group was treated with rifapentine.The treatment time of both two groups was 6 months.The sputum bacterial conversion rate,lesion absorption rate and cavity closure rate were observed,and the clinical treatment effect and adverse reactions were compared between the two groups.Results The sputum bacteria conversion rate (77.89％),lesion absorption rate (71.86％) and cavity closure rate (74.87％) in the control group were significantly lower than those in the the observation group(96.98％,91.96％,95.98％) (x2 =31.03,27.13,35.60,all P ＜ 0.01).The total effective rate of the observation group was 93.97％,which was higher than 75.88％ of the control group,and the difference was statistically significant (x2 =38.37,P ＜ 0.01).The incidence rate of adverse reactions in the observation group was 12.56％,which was significantly lower than 29.56％ in the control group,the difference was statistically significant (x2 =17.59,P ＜ 0.01).Conclusion Compared with rifampicin,rifapentine is effective in treating pulmonary tuberculosis patients with high safety and effective improvement of clinical symptoms,which is worthy of further application.
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Objective@#To observe and compare the clinical efficacy and safety of rifapentine and rifampicin in the treatment of tuberculosis.@*Methods@#From January 2015 to January 2018, 398 tuberculosis patients admitted to Tuberculosis Clinic of the Traditional Chinese Medicine Hospital of Cixi were selected and randomly divided into observation group and control group by complete Random Distribution Method, with 199 cases in each group.The two groups were given basic treatments such as isoniazid, pyrazinamide and ethambutol.On this basis, patients in the control group were treated with rifampicin, and the observation group was treated with rifapentine.The treatment time of both two groups was 6 months.The sputum bacterial conversion rate, lesion absorption rate and cavity closure rate were observed, and the clinical treatment effect and adverse reactions were compared between the two groups.@*Results@#The sputum bacteria conversion rate (77.89%), lesion absorption rate (71.86%) and cavity closure rate (74.87%) in the control group were significantly lower than those in the the observation group(96.98%, 91.96%, 95.98%) (χ2=31.03, 27.13, 35.60, all P<0.01). The total effective rate of the observation group was 93.97%, which was higher than 75.88% of the control group, and the difference was statistically significant (χ2=38.37, P<0.01). The incidence rate of adverse reactions in the observation group was 12.56%, which was significantly lower than 29.56% in the control group, the difference was statistically significant (χ2=17.59, P<0.01).@*Conclusion@#Compared with rifampicin, rifapentine is effective in treating pulmonary tuberculosis patients with high safety and effective improvement of clinical symptoms, which is worthy of further application.
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Objective To explore effect of increasing cerebrospinal fluid (CSF) leptin level by administration from the foramen magnum to the cerebellum medulla oblongata pool in osteoporosis in rabbit model established by ovariectomy (OVX) and methylprednisolones.Methods According to certain inclusion and exclusion criteria,30 adult rabbits which were healthy 5-month-old female New Zealand white rabbits with the same batch and weight were divided into 5 groups (n=6) with random number table,including control group,normal saline group,Low dose group,middle dose group and high dose group.The animal model of osteoporosis (OP) was established 8 weeks after ovariectomy (bilateral ovarian resection) and intramuscular injection of methylprednisolone daily for 8 consecutive weeks in all groups.The control group were only simulated puncture and didn't inject any drugs or normal saline,the normal saline group were intracerebroventricular (ICV) injection with NS and Low,Middle and High dose group injected with low,middle and high dose of leptin respectively at 0,3,7 days after OVX.Before (0 week) and 4,8 weeks after the operation,the measure of dual energy X-ray absorptiometry was done on all the rabbits femur and bone mineral density (BMD) was delivered.Before (0 week) and 4,8 weeks after the first administration,leptin in cerebrospinal fluid (CSF) and serum growth hormone (GH),insulin growth factor 1 (IGF-1) and osteocalcin (OT/BGP) were tested with Enzyme linked immunosorbent assay and serum calcium,phosphorus and alkaline phosphatase (ALP) with automatic biochemical analyzer (ACA).The rabbits were sacrificed and the thalamus and femoral neck were harvested to test the expression of leptin receptor (LEPR) in thalamus and bone morphogenetic protein-2 (BMP-2) and type Ⅰ collagen (Col Ⅰ) at 8 weeks after the first administration.Results Compared with the control group and NS group,the cerebrospinal fluid (CSF) leptin concentration of leptin administration groups kept in a higher level significantly at 4 and 8 weeks after leptin administration,it was positively correlated with the concentration of administration.After administration 4 and 8 weeks,the bone mineral density (BMD) of leptin administration groups were not significantly lower than that of non-administration groups,and the high dose group was unchanged.The serum osteocalcin/bone glad protein (OT/BGP) concentration of leptin administration groups decreased more significantly compared with the non-administration groups at 4 weeks after leptin administration;and it rebounded more significantly than the non-administration groups and low dose group rebounded more significantly than other non-administration groups at 8 weeks.The concentration of serum growth hormone (GH) of 5 groups showed a downward trend at 4 and 8 weeks,the serum GH concentration of leptin administration groups decreased more significantly than the non-administration groups.The concentration of serum insulin-like growth IGF-1 of 5 groups were decreased significantly at 4 weeks,and the serum IGF-1 concentration of control and low dose groups were significantly higher than other 3 groups at 8weeks.Compared with the non-administration groups,the concentration of serum Calcium of leptin administration groups were increased more obvious,and it was positively correlated with the concentration of administration.Serum phosphorus of 5 groups were decreased at 4 weeks and elevated at 8 weeks;there was no difference among the groups.Serum ALP showed a continuous downward trend,and the middle dose group decreased significantly compared with other groups at 4 and 8 weeks.RTPCR results showed that the BMP-2 and Col Ⅰ mRNA expression increased and positively correlated with leptin administration concentration at 8weeks.Conclusion The increase of cerebrospinal fluid leptin level can promote the bone metabolism,reduce bone loss and precaution the occurrence of osteoporosis in rabbit model caused by OVX and methylprednisolone,and it was positively correlated with the concentration of administration.That provides a new method for the prevention and treatment of osteoporosis in rabbit model.
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BACKGROUND:In recent years, the researchers have studied the adjacent segment degeneration after cervical fusion. Several studies concerned the adjacent segment degeneration after anterior cervical corpectomy and fusion. OBJECTIVE:To evaluate the correlative factors of adjacent segment degeneration after anterior cervical corpectomy and fusion. METHODS:122 patients were included in the study from 126 patients who underwent anterior cervical corpectomy and fusion that operated by the same treatment team and involved a single vertebral body and the two plates between February 2009 and February 2012. The final fol ow-up period was 3 years. According to the degeneration progress of adjacent segment degeneration, these patients were divided into non-progression group and progression group. The gender, age, preoperative adjacent segment degeneration, cervical range of motion, upper and lower vertebral range of motion, surgical segment, titanium mesh subsidence, plate-to-disc distance, and cervical curvature index were compared between two groups. Logistic regression analysis was applied to analyze the correlative factors of adjacent segment degeneration. RESULTS AND CONCLUSION:(1) There were significant differences in preoperative adjacent segment degeneration, postoperative cervical range of motion, postoperative upper and lower vertebral range of motion, and postoperative cervical curvature index (P<0.05), which were included in logistic regression analysis. (2) Logistic regression analysis regression model:adjacent segment degeneration=0.317× postoperative cervical range of motion+3.374×preoperative adjacent segment degeneration+1.862 × postoperative lower vertebral range of motion-0.795×postoperative cervical curvature index-16.481. Logistic regression analysis demonstrated that preoperative range of motion, postoperative cervical range of motion, postoperative lower vertebral range of motion and postoperative cervical curvature index were correlative factors of range of motion after adjacent segment degeneration (P<0.05). (3) These results indicated that preoperative adjacent segment degeneration, postoperative cervical range of motion, postoperative lower vertebral range of motion and postoperative cervical curvature index were correlative factors of adjacent segment degeneration. We should actively carry out effective measures to prevent the progress of the adjacent segment degeneration before, during and after anterior cervical corpectomy and fusion.
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Objective To investigate the enhanced osteogenesis during bone fracture healing after intracerebroven-tricular (ICV) leptin injection, using rabbit model with created segmental bone defect in right tibial. Method Segmental critical-sized defects were created at the right tibial bone of skeletally mature New Zealand white rabbits. In experiment group (leptin group), recombinant rabbit leptin was injected into cerebellomedullary cistern through foramen magnum. While in control group, normal saline was injected in the same way. Bone Mineral Density (BMD) was evaluated by qCT at 1st, 3rd, 7th, 14th and the 21st days. At the 21st days, all rabbits were euthanized to collect the right tibia for histomorphology, to ex-amine the BMP-2 expression in the bone callus by Fluorescence in situ hybridization (FISH). Result In the leptin group, body weight declined more obviously than control group then it start to arise at the 14th day;qCT showed significant higher BMD in leptin group than in control group at the 7th day;FISH showed a higher BMP-2 expression in leptin group than in control group. Conclusion Cerebellomedullary leptin injection through foramen magnum could accelerate limb fracture healing in rabbit model with right tibial bone defection.
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Objective To observe whether rabbit blood leptin can leak into the brain after craniocerebral trauma (CCT),and to dynamically detect serum levels of leptin,growth hormone (GH),and insulinlike growth factor-1 (IGF-1),and leptin level in cerebrospinal fluid (CSF) after CCT.Methods The FITC labeled leptin was injected into blood vessels of 15 adult male rabbits after anesthesia.Then 9 rabbits underwent unilateral fluid percussive impact,while 6 rabbits underwent sham operation.Thirty minutes postoperatively,brain tissue was taken to make frozen sections which were used to observe fluorescence labeled leptin range.Thirty three adult male rabbits were randomly divided into serum group,serum-control group,CSF group and CSF-control group.Rabbits in serum group and CSF group received fluid percussive impact,while rabbits in serum-control group and CSF-control group were drilled a 7 mm window in skull.Rabbits in serum group and serum-control group were phlebotomized 2 ml at 1 d,3 d,7 d and 14 d after operation,and rabbits in CSF group and CSF-control group were extracted CSF 0.5 ml at the same time points.Then serum levels of leptin,GH,and IGF-1,and leptin level in CSF were tested by ELISA.Results The fluorescence imaging could be seen in the injured brain tissue of rabbits with CCT,which was more than those in brain tissue of rabbits receiving sham operation.Serum leptin levels of rabbits in serum group at each time point were higher than those in serum-control group.Serum levels of GH and IGF-1 and leptin level in CSF were higher in rabbits with CCT than those in rabbits without CCT at 1 d,3 d and 7 d after operation.Conclusion The blood leptin can leak into the brain after CCT,which can cause increase of blood GH and IGF-1.And the latter may be the endocrine factors promoting fracture healing after CCT.
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Objective: To explore the effect of umbilical cord blood stem cell transplantation on axon regeneration in spinal cord injury (SCl)in rats. Methods: The umbilical cord blood was collected and prepared into suitable concentration of CD34 positive stem cells. Thirty SD rats were divided into two groups randomly. One group served as control, another one was the treatment group. The models of spinal cord contusion injury were made by Allen's weight dropping method. One week later,the treatment group was transplanted with 10x105 umbilical cord blood stem cells with Hamilton micro-syringe at the sites of rostral and caudal to the lesioned zone respectively, while control group received just the same volume of PBS injection. Five rats in each group were sacrificed at 1 w, 2 w and 6 w after this operation. Histological and immunohistochemieal examinations including GAP-43 and NF200 were used to evaluate axon regeneration. Meanwhile, BBB motion scoring and inclined plane test were performed to assess the motion function changes of hindlimbs. Results: Compared to the control group, the area of cavity in the lesioned spinal cord region decreased significantly and the expressions of GAP-43 and NF200 increased markedly in cell transplantation group. Also the motion function had better restoration in the treatment group. Conclusion: Transplantation of umbilical cord blood stem cell may achieve both morphological and behavioral improvement for the injured spinal cord.
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Objective: To explore and evaluate the biomechanic relationships between different depth of pedicle screw penetration with the sagittal plane reconstruction in thoracolumbar fracture. Methods:Six fresh cadaveric specimens of lumbar spine from L_1 to L_3 were used to make the model of thoracolumbar fracture. The system of universal spine system( USS )pedicle screw was adopted with the 6 mm diameter of screw. Each of two Schanz screws was implanted into the pedicles of L_1 and L_3 A canulated screw was fixed into the former of vertebral body in L_1 and L_3, and the distance of the two canulated screws was taken as the normal height. The axial loads were given while the pedicle screws were implanted at the depth of D1, D2 and D3, and the distance of the two canulated screw was measured as well as the distance was reduced to the normal height by axial load. The index measured included of the depth of pedicle screw penetration, the height of fractured vertebral body and afterload. Results: Along with the increasing of afterload, the height of injured vertebral body was increased accordingly, but the extent was different at three depth of pedicle screw penetration (D1, D2, and D3). While the injured vertebral body was reduced totally (reduced distance 0.00 mm), there was (2 630±13) g of afterload needed in Dl depth, and (2 339±61) g and(2 221± 164) g of afterload in D2 and D3 depth respectively. There was significant difference in distance between D1, D2 and D3 (P 0.05). Conclusion: There is a relationship in the depth of pedicle screw penetration, the capacity of reduction and sagittal plane reconstruction. The depth of pedicle screw had a significant effect on the capacity of reduction for the injured vertebral body, which would be the best option in biomechanics when the pedicle screw was implanted more than 1/2 pedicle or all of it.
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Although the development of diagnosis and treatment about degenerative scoliosis has improved significantly,it still remains controversial about how to select appropriate surgical methods.The goal of this review is to raise awareness and stimulate attention on the correlation between clinical manifestation and spinal deformity,which is one of the key factors to affect the surgical outcomes on the opinion of more and more researchers in the past 20 years.When an adult spinal deformity is not the source of symptoms and the clinical symptom is outside of curve,symptomatic relief may be provided through limited decompression.If thoroughly decompression,it will be enough to combine with short segment fixation.However,while an adult deformity is the source of symptoms and the clinical symptoms is within the curve,the options are typically limited decompression on the basis of good stability,otherwise,it will be the only consideration of decompression combined with long segment fixation.
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[Objective]To observe the characteristic ultrastructure changes of compressive spinal cord injury.[Method]Animal model of compressive spinal cord injury was made by modified Allen's method.Pathological changes of spinal cord tissues were observed with transmission electronic microscopy after 4 weeks.[Result]The characteristic ultrastructure changes of compressive spinal cord injury were observed obviously.It was necrosis without inflammatory cell reaction.The single-direction break of myelin sheath and the traumatic cell could be observed.They were all formed by the reason of biomechanics.These two characters were the characteristic ultrastructure changes of compressive spinal cord injury.[Conclusion]These new ultrastructure observations can provide certain materials for the basal explore of compressive spinal cord injury.
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OBJECTIVE: To facilitate the modernization of traditional Chinese medicine.METHODS: The connotation of good quality management norms of traditional Chinese medicine such as GAP was analyzed,and the strategies for the sound development of the modernization of traditional Chinese medicine were discussed. RESULTS & CONCLUSION: To facilitate the modernization of traditional Chinese medicine under the guidance of good quality management norms can promote the source innovation of technology of traditional Chinese medicine,speed up the internationalization of traditional Chinese medicine and promote it to a new step.
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Objectives:To study the postoperative nutritional support in patients with pancreatic disease. Methods:Based on the kind of pancreatic disease,twenty two patients were randomly divided into PN+EN group and TPN group during 20 days after operation.Body weight,the restoring time of intestinal movement,the complications,the blood amylase,the serum glutamic pyruvic transaminase,the blood urea nitrogen,the blood sugar,the serum albumin(Alb),transferritin(TFN) and prealbumin(PAB) were compared on the first,fifth,tenth and twentieth day after operation. Results:Body weight of two groups reduced lightly.The blood amylase decreased remarkably.The functions of liver and kidney were recovered gradually.The blood sugar tended to restore normal.Alb,TFN,PAB of two groups increased remarkably( P