OBJECTIVE:To discuss how to solve patents problems in the registration and approval of drugs.METHODS:Regulations and problems in the registration and approval of drugs in China were analyzed and which were compared with that of the American and Europe.RESULTS&CONCLUSIONS:The registration and approval of drugs and their patents right protection were legally independent of each other,to which the drug administration law and patent law respectively are appli-cable.There is no necessary association between the registration and approval of drugs and the infringement of patents right.Patent dispute should be solved in accordance with the patent related regulations,the registration and approval of drugs should not involve the solving of patent disputes of drugs.

Objective To explore the chest features of patients with the novel influenza type A H1N1 on HRCT. Methods One hundred and seventy-two chest HRCT examinations on 163 cases with Influenza type A H1N1 (9 cases were reexamed) were retrospectively analyzed using standard pulmonary window and mediastinal window, respectively. HRCT imaging appearances were summarized. Results Ninety-seven cases showed normal on chest HRCT, while the others showed abnormalities of parenchymal and interstitial. Among them, HRCT identified ground-glass opacity in 35 cases (53.0%), centrilobular nodules in 30 cases (45.5%), thickening of intralobular septa in 31 cases (47.0%), intralobular thin reticulation and micro-nodule in 8 cases (12.1%), single-lobular inflammation in 19 cases (28.8%), consolidation of lung(the large consolidation and multiple small consolidations)in 15 cases (22.7%), pulmonary atelectasis in 3 cases (4.5%), and irregular lines in 2 cases (3.0%). Pleurisy was also revealed including 8 cases with right pleurisy, 5 cases with left pleurisy, and 19 cases with bilateral pleurisy. Mediastinal and axillary lymphadenopathy were found in 7 cases, who were spared of pleural effusion. All above abnormalities resolved quickly after anti- virus treatment. Conclusion Parenchymal and interstitial abnormalities, mediastinum and axillary fossa lymphadenopathy, and pleural effusion were the common findings on HRCT in patients with Influenza type A H1N1, which were similar to those of other viral pneumonia.

Objective:To study the effects of glutamine on the rehabilitation and the immune function in patients with acute stroke. Methods: The study included 57 patients with cerebral ischemia and 29 patients with brain hemorrhage.Nutritional and immune function parameters were evaluated at admission and after 2 weeks following stroke respectively.Neurological deficit was also evaluated by the Chinese Stroke Scale at admission and after 28 days following stroke.The infective complications were investigated. Results:At the same duration after acute stroke,the extent of neurological deficit recovery was significantly lower in the control group than the glutamine group.The rate of the infective complications was significantly higher and it's duration was significantly longer in the control group than the glutamine group.The degree of nutriture and immune function deteriorating was significantly severer in the control group than the glutamine peptide group. Conclusion:Parenteral glutamine supplements is helpful for the rehabilitation and in preventing deterioration of nutrition status and immune function following acute stroke.

Objective To evaluate the effects of total glucosides of paeony (TCP) on cell proliferation of and expression of VECF and IL-23 in human HaCaT keratinocytes and their potential mechanisms. Methods MTT assay was performed to detect the cell proliferation of HaCaT cells incubated with various concentrations (0.5 to 312.5 mg/L) of TGP. HaCaT cells were classified into 8 groups, control group without any treatment, TGP groups treated with 6 different concentrations of TGP, SB203580 group treated with TGP of 125 mg/L after 2-hour pretreatment with SB203580 of 10 μmol/L After additional culture, reverse transcription (RT)- PCR and enzyme linked immunosorbent assay (ELISA) were conducted to determine the expression levels of VEGF and IL-23 mRNA and protein, Western blot to test the phosphorylation of p38 mitogen-activated protein kinase (MAPK) in these cells. Results The proliferation of HaCaT cells was promoted by TGP of low concentrations (0.5 and 2.5 mg/L), but inhibited by TGP of equal to or more than 12.5 mg/L, and peaked at the concentration of 125 mg/L. TGP of 0.5 and 2.5 mg/L enhanced the mRNA and protein expressions of VEGF and IL-23, while TGP of 12.5 to 125 mg/L suppressed the expression of VEGF mRNA and protein, and TGP of 62.5 to 125 mg/L downregulated the expression of IL-23 mRNA and protein. The phosphorylation of p38 protein kinase in HaCaT cells was induced by TGP of 125 mg/L in a time-dependant manner. Concretely, the level of phosphorylated p38 kinase in HaCaT cells was 0.3314 ± 0.0245 (peak) at 5 minutes, decreased to 0.2173 ± 0.0189 at 10 minutes (still statistically higher than untreated HaCaT cells) and 0.1664 ± 0.0201 at 30 minutes after treatment with TGP of 125 mg/L. SB203580 attenuated the effect of TGP on p38 phosphorylation, and the level of phosphorylated p38 kinase was 0.1529 ±0.0147 in HaCaT cells pretreated with SB203580 prior to the treatment with TGP. Conclusion TGP can inhibit the cell proliferation of and expressions of VEGF and IL-23 mRNA and protein in HaCaT cells, likely mediated by the p38 MAPK signaling pathway.

Objective To investigate the clinical characteristics of gliomas in children,and assess the value of CT and MRI for diagnosing glioma.Methods Fifty-three children under 14 years old who were admitted into department of neurosurgery of Henan Provincial People's Hospital from Jan.2001 to Dec.2006 were diagnosed as glioma.Their age and sex distribution,clinical symptoms and signs,imaging examinations and pathological examinations were retrospectively analyzed.Results 1.There were 35 males and 18 females.2.The common symptoms and signs were headache and dizziness(32 cases,60.4%),nausea and vomiting(32 cases,60.4%),balance function disorder(31cases,58.5%),episodic convulsion(6 cases,11.3%) and fundus changes(33 cases,62.3%).3.There were 24 gliomas located at supratentorial and 29 gliomas located at infertentorial in this group.4.Thirty-three cases had a CT examination(1 case was wrongly diagnosed) and 28 cases had a MRI examination(all cases were positive);The positive rate of CT for displaying these tumors was 97%,MRI was 100%.5.Pathological examination revealed gliomas in 42 cases after operation.The most common histologically confirmed tumor type reported was astrocytoma,which accounted for 40.5%(17 cases),and the second was medulloblastoma,which accounted for 31.0%(13 cases).Conclusions 1.Glioma are more frequently affected in males than females in children.2.It often occurs in cranial posterior fossa and midline,which causes the symptoms of intracranial hypertension including headache,dizziness,nausea,vomiting,fundus changes,and so on.3.It often occurs in infertentorial,which causes the symptoms of balance function disorder,since it can invade cerebellum directly or indirectly.4.CT and MRI play an important role in the diagnosis of glioma in children.MRI is more valuable than CT in glioma diagnosis.5.Histological types of glioma in children are significantly different from adults.The most common histological types are astrocytoma and medulloblastoma.

Objective To detect the protein expression of gonadotropin-releasing hormone (GnRH) and its receptor (GnRH-R) in various endometrial tissues, and to investigate its significance. Methods Immunohistochemistry was employed to analyse the protein expression and localization of GnRH and GnRH-R from endometriosis(EMS), endometrial hyperplasia, endometrial carcinoma and control group. Results GnRH and GnRH-R are expressed at the protein level in all eutopic endometrium, in 50% ectopic endometrium and 92.3% endometrial hyperplasia, while the expressional rate in endometrial carcinoma are 58.8% and 82.4%, respectively. The majority of GnRH and GnRH-R existed in the plasma of glandular epithelium cells and some stroma cells. Conclusions There exists GnRH and its receptor proteins in endometrial tissues, and their abundant expression in endometriosis, endometrial hyperplasia and in endometrial carcinoma may imply that they could be used in clinical diagnosis and treatment.

Objective To investigate the relationship between the expression of Fas, FasL, Bcl-2 and Bax in transitional cell carcinoma of bladder and its clinical significance. Methods Immunohistochemistry method was used to detect the expression of Fas, FasL, Bcl-2 and Bax in 40 specimens of transitional cell carcinoma of bladder and 24 specimens of normal bladder mucosa tissue. Results The positive expression of Fas was detected both in transitional cell carcinonma of bladder and in normal bladder mucosa tissue, while FasL, Bcl-2 and Bax only in transitional cell carcinonma of bladder. The expression of Fas was significantly lower in careinoma of high-grade malignancy than in carcinoma of low-grade malignancy (P

Objective Pulmonary benign metastasizing leiomyoma (PBML) is a rare entity that leiomyoma of uterus metastasized to the lung.The clinical characteristics of this rare disease were analyzed in this article.Methods The detailed clinical records of 7 patients diagnosed as PBML at Peking Union Medical College Hospital between January 2001 and June 2015 were reviewed.Results All patients were women with median age of 44 years (range 28-62).Symptoms included dyspnea (2/7),chest pain (1/7),cyanosis (1/7),cough (1/7) and bloody sputum (1/7),while 4/7 cases were asymptomatic.Six patients had the past-history of leiomyoma of uterus 20 months to 14 years ago among whom 5 patients received hysterectomy.Chest CT showed bilateral,random-distributed multiple round solid nodules,or diffuse-distributed miliary nodules,or single solid nodule,even some small cavities.Extra-pulmonary metastasis was found in left superclavicular lymph node (1 case) and right heart (1 case).Histological tissues were obtained by video-assisted thoracic surgery lung biopsy (4/7),mass resection on tricuspid valve (1/7),transbronchil lung biopsy (1/7),and CT-guided percutaneous lung biopsy (1/7).Pathology showed an interlacing pattern by spindle cells having elongated nuclei without cellular atypia.Ki-67 index was less than 1％.Molecules such as smooth muscle antibody,estrogen receptor (ER) and progestrone receptor (PR) were positive in immunohistochemistry staining.Neither letrozole nor zoladex was effective.Two patients responded to bilateral adnexectomy,presenting as shrunk nodules.No relapsed disease was seen in one patient with single nodule after resection.There was only one patient with disease-related mortality,whose chest CT showed milliary nodules.Conclusion Although CT findings of PBML are similar to malignancies,the clinical outcome is good.Despite the positive expression of ER and PR,the effectiveness of hormone related treatment is limited.And periodical follow up is suggested even to those uneventful patients.

Objective To investigate the changes of ultrastructure and Bax,Bcl-2 expression of cerebral cortex in lymphostatic encephalopathy(LE).Methods LE models were established by occluding and removing both the shallow and deep cervical lymph nodes in rats.Ultrastructural changes of the cerebral cortex were observed at 1 d,2 d,3 d,5 d,7 d and 14 d after operation.Expression of Bax and Bcl-2 were examined by Western blot.Results Brain edema appeared under electron microscope in LE model group.The perivascular spaces in the cortex were enlarged and full of fluid,the dropsical nerve fibers had swelling and fragmented myelin sheath.Some neurons showed apoptotic conformation and some had characters of necrosis.The changes mentioned above were the most serious at day 5.The protein expression of Bax,Bcl-2 and the ratios of Bax/Bcl-2 in LE 3 d,5 d,7 d groups were significantly higher than those in normal control group(all P

Objective To analyze rick factors for postoperative recurrence of spontaneous pneumothorax surgery. Methods The clinic characteristics of 1128 patients who received spontaneous pneumothorax surgery in Tianjin Chest Hospital were collected from January 2009 to March 2015. The relationship between clinic characteristics and the pulmonary bullae was analyzed. Logistic regression analysis was used to assess factors affecting the postoperative relapse of spontaneous pneumothorax. Results The pulmonary bullae were found in 877 patients of 1128 during the operation. The incidence of pulmonary bullae was significantly high in patients with age below 25 years compared with patients over 25 years (P<0.05). The duration of surgery was significantly longer in patients with pulmonary bullae compared with that of patients without pulmonary bullae (P<0.05). Postoperative recurrence occurred in 21 cases, with a recurrence rate of 1.86%. Logistic regression analysis showed that pulmonary bullae, pleurodesis without pleura friction, delayed drainage duration (> 3 d) were independent risk factors of postoperative recurrence for spontaneous pneumothorax (P<0.05). Conclusion Pulmonary bullae, pleurodesis without pleura friction and delayed drainage duration are risk factors of postoperative recurrence for spontaneous pneumothorax, which should be paid more attention in clinic.