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We have analyzed the current status of recognization and qualification of orphan drugs in China and abroad, looking at the aspects of the authority institutions, identification and qualification process, and the number of orphan drugs identified and available in the market. By comparing and analyzing horizontally the differences in orphan drugs identification between representative developed countries vs. some developing countries, we discuss the inadequacy of orphan drugs supervision in China. We introduce the advanced experience from the developed countries and some developing countries to provide suggestions for the identification and management of orphan drugs, hoping to speed up the process of development and market availability of orphan drugs and to maximize patient's accessibility to treatment in China.
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At present, the diagnosis, treatment, and social security of rare diseases have attracts social attention. As an important part of the multi-level health insurance system in China, commercial health insurance plays an increasingly important role in the supplement to basic medical insurance. Moreover, recently, the benefits of new healthcare reform policies have provided much room and great opportunities for the application of commercial health insurance for rare disease.This paper presents current medical insurance for patients with rare diseases and discuss the necessity and feasibility of bringing rare diseases into the coverage of commercial health insurance, and analyzes the current application and the potential problems of rare disease insurance in the commercial health insurance. This article also gives suggestions to the policies to make full use of the positive role of commercial insurance for the completion of multi-level health insurance system for rare disease.
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Objective:To analyze the differences in 18F-fluorodeoxyglucose (FDG) PET/CT imaging and preoperative localization between patients with temporal lobe epilepsy (TLE) and extratemporal epilepsy (ETLE) caused by focal cortical dysplasia (FCD). Methods:From April 2015 to August 2018, a total of 71 patients (45 males, 26 females, age (24.3±9.1) years) with refractory epilepsy who underwent 18F-FDG PET/CT imaging before surgery and confirmed as FCD by pathology in Xuanwu Hospital were retrospectively analyzed. Patients were divided into TLE and ETLE groups based on pathological results. 18F-FDG PET/CT images were analyzed qualitatively and compared with the operation result, then region of interest (ROI) was used to calculate the asymmetry index (AI), and evaluated the hypometabolism of every cerebral region by |AI| semi-quantitatively. Engle classification were followed-up after surgery. Independent-sample t test and χ2 test were used to analyze data. Results:Of 71 FCD patients, 35 were TLE and 36 were ETLE. The onset age of ETLE patients were younger than TLE patients ((10.1±6.5) vs (14.9±9.7) years; t=2.48, P=0.02). In TLE group, 54.29%(19/35) were completely consistent with the operation results, and 42.86%(15/35) showed hypometabolized brain regions in extratemporal lobe. In ETLE group, 27.78%(10/36) were completely consistent with the operation results, and 47.22%(17/36) showed hypometabolized brain regions in temporal lobe. There were significant differences in the lateral accuracy and positioning accuracy of 18F-FDG PET/CT between TLE and ETLE patients (97.14%(34/35) vs 75.00%(27/36), 54.29%(19/35) vs 27.78%(10/36); χ2 values: 7.19, 6.27, both P<0.05). There was no significant difference in |AI| values between the brain regions of TLE and ETLE patients ( z values: from -1.25 to -0.06, all P>0.05). Conclusion:The lateral accuracy and positioning accuracy of 18F-FDG PET/CT in TLE patients are better than that in ETLE patients.
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BACKGROUND/AIMS: Early adverse life events (EALs) are relevant to irritable bowel syndrome in adulthood. Maternal separation (MS), as one of the EALs, has proved to induce visceral hypersensitivity in adult rats. However, the effect of MS on visceral hypersensitvity from the post-weaning period to adulthood remains unknown. METHODS: One hundred and ten neonatal Sprague-Dawley rats were randomly divided into 2 groups: rats in the MS group were exposed to 3 hours daily MS on postnatal day (PND) 2–14; the normal control (NC) group remained undisturbed. Visceral sensitivity was determined by measuring the visceromotor response to colorectal distention on PND21, 35, and 56. Anxiety-like behaviors were measured by the open field test. RESULTS: Compared with NC rats, MS rats showed significant visceral hypersensitivity from the post-weaning period to adult. The proportion of visceral hypersensitive rats decreased with age from 87.5% to 70.0% in the female MS group and from 90.0% to 66.7% in the male MS group. The relative VMR ratio of MS and NC on PND21 was higher than PND35 and PND56. MS rats showed decreased ability of movement and exploration to the novel environment in the post-weaning period, obesity in the prepubertal period, and more anxiety-like behaviors in adulthood. CONCLUSIONS: MS can significantly affect visceral sensitivity and behaviors of rats in different age stages, especially in the post-weaning period. Visceral hypersensitivity of MS rats is more pronounced in the post-weaning period and slightly restored in adults. Thus, visceral hypersensitivity in the post-weaning period might play a more meaningful pathophysiologic role in the formation of adult irritable bowel syndrome.
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Adult , Animals , Female , Humans , Male , Rats , Hypersensitivity , Irritable Bowel Syndrome , Maternal Deprivation , Obesity , Rats, Sprague-DawleyABSTRACT
Objective To analyze the effect of high and low dose radiation on the expressions of Th1,Th2 and Th3 /Tr1 related-genes in mice thymocytes and investigate the possible underlying molecular mechanism.Methods ICR mice were randomly divided into low-dose group (0.075 Gy),high-dose group (2.0 Gy) and sham-control group.The mouse thymus tissue was extracted at 16 hours after irradiation and the expressions of Th1-Th2-Th3 related genes were measured by PCR array.Results Eight genes were up-regulated and five genes were down-regulated after low dose radiation (0.075 Gy);while 54 genes were up-regulated and three genes were down-regulated after high dose (2.0 Gy) radiation.These genes included Th1 cell related genes,Th2 cell related genes,Th3/Tr1 cell related genes,Th1/Th2 immune response genes and transcription factor related genes.Low dose radiation induced up-regulation of Stat4 and Socs1 of genes related to the Th1 cells,and it induced down-regulation of IL-4ra,Cebpb,Gata3 and Tgfb3 associated with Th2 and Th3 cells,which lead to Sftpd genes up-regulation of Th1 immune response eventually.The high dose radiation up-regulated all of Th1,Th2 and Th3/Tr related genes and also enhanced the expressions of Cd86,IL-18,IL-10 and Irf4 genes related to Th2 immune response,but it did not alter the gene expression of Th1 immune response.Conclusions Low-dose radiation induces Th1-type immune response,while high doses radiation triggers Th2 type immune response.
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Objective To explore the effect of miR-9 on the expression of NRP1 and its radiation effects in A549 cells.Methods Bioinformatics was used to analyze the potential binding sites of has-miR-9 and NRP1-3'UTR.The miR-9 sequence was inserted into pcDNA-DEST-47 plasmid to construct the eukaryotic expression vector (pcDNA-DEST-miR-9) and to construct the NRP1 gene 3'UTR luciferase reporter plasmid (pEZX-MT05) at the same time.They were simultaneously transferred into A549 cells for analysis of the regulatory effect of miR-9 on the expression of NRP1.Meanwhile miR-29b was used as a negative control to observe whether or not NRP1 gene was a target of miR-9.After 10 Gy irradiation,the expression of NRP1,and the inhibitory effect of miR-9 on it was confirmed by Western blot assay.The expression of miR-9 was detected by real-time PCR.Results It was found that miR-9 reduced the luciferase activity of NRP1-3'UTR wild plasmid (t =3.906,P ＜ 0.05) but not NRP1-3' UTR mutant plasmid.This luciferase activity was not inhibited by other types of miRNA (miR-29b).The expression of NRP1 protein in A549 cells was decreased after the cells were transfected with miR-9 mimic.After irradiation with dose of 10 Gy,the expression of miR-9 were decreased (t =37.319,P ＜ 0.05) and the expression of NRP1 protein were increased.Conclusions miR-9 regulates the expression of NRP1 by targeting 3'UTR site of NRP1 gene in A549 cells.
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This study was aimed to explore the effect on immunological function of T lymphocyte subpopulation and erythrocyte by the method of promoting blood flow and dissipating phlegm of rat with chronic pelvic inflammatory dis-ease (PID). A mixture of bacteria combined with mechanical injury was used in the establishment of a total of 75 Wistar chronic PID rat models. The rats were divided into the normal group, sham-operation group, model group, Gui-Zhi Fu-Ling Capsule (GZFLC) group, Shao-Fu Zhu-Y u Capsule (SFZYC) group, Jin-Gang-Teng Capsule (JGTC) group, and the control group of GZFLC, SFZYC, and JGTC. Intragastric administration of each medication was given according to different groups. The percentage of amount of CD3+, CD4+, CD8+and CD4+CD25+regulatory T cell (Treg) in the spleen of rats was observed in each group. The RBC-C3bRR and RBC-ICR in the blood serum of rats were also observed. The results showed that medications used in all treatment group significantly increased the percentage of amount of CD3+, CD4+ and CD4/CD8 ratio (P< 0.05) and reduced the percentage of amount of CD8+(P< 0.05). GZFLC has significantly decreased the abnormal increased percentage of the amount of CD4+CD25+ Treg. GZFLC and SFZYC significantly increased RBC-C3bRR (P< 0.05) and decreased RBC-ICR (P< 0.05). It was con-cluded that the prescription of promoting blood flow and dissipating phlegm can treatment chronic PID by adjusting immunity of T lymphocyte subpopulation and erythrocyte.
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Prominent problems of clinical teaching in Tibet University school of medicine were analyzed and countermeasures were proposed from aspects of management system construction, facul-ty construction, curriculum construction, base construction and quality evaluation system construction. The aim was to increase students' opportunity, enhance students' learning interest and improve stu-dents' ability of analysis and problem solving so as to improve the practical effects of clinical teaching. All countermeasures taken above laid the foundation for future clinical work and provided help for clinical medical personnel in Tibetan border areas.
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OBJECTIVE@#To investigate effect of hyperbaric oxygen (HBO) therapy on treatment of late healed wounds after pharyngeal and laryngeal carcinomas surgery.@*METHOD@#Eighty-three patients with late healed wounds after pharyngolaryngectomy were divided into two groups, which were HBO treatment group (n = 48) and control group (n = 35) by random. 48 cases were treated with the general therapeutic measure along with HBO (the pressure is 2 x 10(5) Pa, 110 minutes per day for 5 to 10 days). The other 35 cases were treated with the general therapy without HBO as control.@*RESULT@#There were fresh granulation erupted from the wound of entry after 3 or 4 days of HBO) treatment, then the granulation and the new blood capillary erupted continually to fill the wound surface, and the wound of entry was healed over finally. In the HBO and the control groups, the average healing time was 27.50 and 45.00 days (P < 0.01) in the wound by necrosectomy of the myocutaneous flap or forearm flap, 8. 50 and 14.09 days (P < 0.01) in the pharyngeal fistula, 5.93 and 8.62 days (P < 0.01) in the infected or fluid-filled wound.@*CONCLUSION@#HBO therapy is an effective and powerful treatment for late healed postoperative wounds in pharyngeal and laryngeal carcinomas surgery.
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Adult , Aged , Female , Humans , Male , Middle Aged , Hyperbaric Oxygenation , Laryngeal Neoplasms , General Surgery , Therapeutics , Otorhinolaryngologic Surgical Procedures , Postoperative Period , Treatment Outcome , Wound HealingABSTRACT
Neoadjuvant chemoradiotherapy has been used as a standard treatment for patients with locally advanced (T2 and T3 ) rectal carcinoma. Some patients who receive neoadjuvant chemoradiotherapy obtain pathological complete remission, namely, the absence of any tumor cells in the surgical specimens. The patients who obtain pathological complete remission get a better survival rate after canceling operation. Researches are still needed to investigate whether it is safe for patients in order to avoid risk and adverse reaction.
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Objective To investigate the value of macrophage activity imaging (MAI) in the diagnosis of brain and spinal cord lesions in rat model of multiple sclerosis(MS). Methods Twenty LEW rats were divided into 15 model rats and 5 control rats. MS animal model, experimental autoimmune encephalomyelitis (EAE) was induced by the injection of peptide 35-55 of myelin oligodendrocyte glycoprotein ( MOG35-55 ). MRI was performed on the third day of the acute stage of disease. The brain and spinal cord of rats were scanned by 3.0 T MR scanner( Siemens Trio Tim) with quadrature wrist joint coil.The T2W and T1 W images, Gadolinium enhanced T1 W images in 3D volume were obtained respectively. The MAI were obtained at 24 hours after intravenous injection of ultra small superparamagnetic iron oxide (USPIO) as contrast medium on T2WI. The workstation with special software was used for the reconstruction images of brain and spinal cord of rat in multiple orientations. Results Fifteen MOG35-55-EAE rats model of MS were successfully induced. The great majority lesions of central nervous system in acute stage were located in the brain( 58/63 ) and less in the spinal cord (5/63). The main manifestation of EAE lesions presented was hyperintensity on T2 WI and hypointensity on T1 WI, and some lesions had enhancement after Gd-DTPA injection. The EAE lesions presented as hypointensity on MAI images, but some of them were found to be isointensity on T2 WI. The enhancement pattern was discrepant between USPIO and Gd-DTPA.The sensitivity of depicting lesions of MOG35-55-EAE rat at acute stage were higher on T2WI ( 14/15 ) and MAI ( 13/15 ), and the detection rate was 100% ( 15/15 ) if they were combined. Gd-DTPA enhanced T1 WI had a lower sensitivity (7/15). All the MAI findings were negative in the control rats. Conclusions MAI can complement the drawback of conventional MRI techniques by continuously monitoring the inflammatory activity of EAE lesions, and it could raise the detection rate of EAE lesions by combining with T2WI. Gd-DTPA enhanced T1 WI monitors the breakdown of the blood brain barrier. MAI and Gd-DTPA enhanced MR imaging are complementary in the diagnosis and monitoring of EAE lesions.
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at model is an ideal MS model for clinical MRI study.
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OBJECTIVE@#To investigate the expression of collagen type I (Col I), collagen type IV (Col IV) and fibronectin (Fn) in laryngeal squamous cell carcinomas (LSCC) and their pathobiological relationship with invasion and metastasis of tumor.@*METHOD@#The expression of Col I, Col IV and Fn was detected by immunohistochemistry method in normal tissue of latero-carcinoma and tissue of carcinoma in 60 specimens of LSCC. Integral optical density (iOD) was detected by image analysis of computer and was analyzed by SPSS13.0.@*RESULT@#The expression of Col I was obvious and integrity. The expression of Col IV and Fn of basal membrane was like intact line-shape appearance and Fn of interstitial substance appeared like a complete network in the normal tissue of latero-carcinoma. Their expression decreased gradually and their integrity was broken and disappeared gradually from well to poorly differentiated LSCC. Their expressions also fell off with the tumor size, clinical stage and cervical lymphatic metastasis gradually and consistently in LSCC. Their variances were statistical significance separately (P<0.05 or P<0.01).@*CONCLUSION@#The expression of Col I, Col IV and Fn was closely related to tumor invasion, the regional lymph node metastasis and other some pathobiological features in LSCC. A detection of Col I, Col IV and Fn was of definite significance on a better comprehension of the possibility of metastasis, choice of surgery and prognosis.
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Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Carcinoma, Squamous Cell , Metabolism , Pathology , Collagen Type I , Metabolism , Collagen Type IV , Metabolism , Fibronectins , Metabolism , Laryngeal Neoplasms , Metabolism , Pathology , Larynx , Metabolism , Pathology , Lymphatic Metastasis , Neoplasm Staging , PrognosisABSTRACT
Objective To explore the feasibility of using clinical whole body MR scanners to investigate the intravital visibility of central nervous system (CNS) lesions in rats of multiple sclerosis (MS). Methods Ten Lewis rats were injected with the peptide 35-55 of myelin oligodendrocyte glycoprotein to make the model of MS. On a Siemens Sonata 1.5T MR scanner equipped with a flexible surface coil, rats brain and spinal cord were examined using T2-weighted and T1-weighted imaging with slice thickness of 1-2 mm. On a Siemens Trio Tim 3.0T MR-scanner equipped with a quadrature wrist coil, rats were examined using T2WI, T1WI and Gd-DTPA enhanced T1WI 3-dimensional imaging with voxel size up to 0.06-0.08 mm~3. Rat brain and spinal cord images in multiple orientations were reconstituted with special software in workstation. Results T2WI and T1WI of the lesions in MS rat brain with high spatial and contrast resolution could be obtained with clinical 3.0T MR scanner, though the image resolution of spinal cord was relatively low. The resolution of 1.5T MR was lower than that of 3.0T. Plaques in CNS of MS rats presented as hyperintense areas on T2WI and hypointense areas on T1WI. Contrast enhancement was observed as hyperintense on T1WI. Conclusion High quality images of CNS lesions canbe obtained with clinical 3.0T MR-scanner in MS rat, which offers a noninvasive access for studying CNS diseases in the rats.
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Objective:To investigate the expression of collagen typeⅠ(ColⅠ),collagen typeⅣ(ColⅣ)and fibronectin(Fn)in laryngeal squamous cell carcinomas(LSCC)and their pathobiological relationship with invasion and metastasis of tumor.Method:The expression of ColⅠ,Col Ⅳ and Fn was detected by immunohistochemistry method in normal tissue of latero-carcinoma and tissue of carcinoma in 60 specimens of LSCC.Integral optical density(iOD)was detected by image analysis of computer and was analyzed by SPSS13.O.Result:The expression of ColⅠ was obvious and integrity.The expression of Col Ⅳ and Fn of basal membrane was like intact line-shape appearance and Fn of interstitial substance appeared like a complete network in the normal tissue f latero-carcinoma.Their expression decreased gradually and their integrity was broken and disappeared gradually from well to poorly differentiated LSCC.Their expressions also fell off with the tumor size,clinical stage and cervical lymphatic etastasis gradually and consistently in LSCC.Their variances were statistical significance separately(P＜0.05 or P＜0.01).Conclusion:The expression of ColⅠ,ColⅣand Fn was closely related to tumor invasion,the regional lymph node metastasis and other some pathobiological features in LSCC.A detection of ColⅠ,ColⅣ and Fn as of definite significance on a better comprehension of the possibility of metastasis,choice of surgery and prognosis.
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<p><b>OBJECTIVE</b>To increase the reproduction efficiency of Iris plants.</p><p><b>METHOD</b>Pollen viability, stigmatic receptivity, the color of anther and stigma of 5 Iris plants were observed during blooming.</p><p><b>RESULT</b>1. The highest pollen viability was in 4 hours after blooming; 2. The stigmatic receptivities of I. sichuanensis, I. leptophylla, I. lactea and I. goniocarpa were strong in 4 hours after blooming, while that of I. lactea var. chinensis was strong in 2 hours after blooming; 3. The color of anther could reflect the pollen viability, but could not indicate the viability level; 4. The stigma color could not reflect the receptivity of stigma.</p><p><b>CONCLUSION</b>The optimum artificial pollination time of these five species were 12:00 -14:00.</p>