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 establish HPLC-ELSD method for content determination of astragaloside Ⅳ in Qizhi jiangtang granules. METHODS:The separation was performed on Hypersil ODS2(250 mm?4.6 mm,5 ?m)column with acetonitrile-water(32 ∶ 68)as mobile phase. The flow rate was 1.0 mL?min-1. Injection volume was 10 ?L. The column temperature was 25 ℃. The temperature of drift tube for measurement was 110 ℃ and flow rate of N2 was 3.12 SLPM. RESULTS:Regression equation was A=1.699 C+6.181. The linear range of astragaloside Ⅳ was 0.259～1.295 mg?mL-1(r=0.999 6,n=5) with lowest detectable limit of 5.18 ?g?mL-1. An average recovery rate were 97.75%(RSD=2.17%). CONCLUSION:The method is simple,rapid and reliable for quality control of Qizhi jiangtang granules.

Objective To explore the risk factors of collapse of osteonecro si s of the femoral head (ONFH) with a retrospective study, and put forward a treat ment protocol according to this study results. Methods From October 1993 to Apri l 2000, 40 cases (56 hips) were followed-up. The term of follow-up ranged from 1 2 to 68 months (average 29.2 months). The age of patients was from 16 to 60 year s old (average 36.8 years old). Preoperatively, the AP and frog view X-ray film, coronal and sagittal MRI were taken. The staging of ONFH proposed by ARCO was a dopted. Clinically the Harris score was used to assess the clinical outcome. The patients were divided into three groups: 1) Non-operative: 10 cases (14 hips), stage Ⅰin 7 hips(ⅠA 4,ⅠC 3),stageⅡin 7 hips (ⅡA 1,ⅡB 3,ⅡC 3); 2) Core dec ompression with vascularized iliac bone graft (VICBG): 18 cases (24 hips ), stag eⅠin 6 hips (ⅠB 4,ⅠC 2), stageⅡin 16 hips (ⅡA 4,ⅡB 8,ⅡC 4), stageⅢ in 2 hips (ⅢA); 3) Transtrochanteric rotational osteotomy(TRO): 12 cases (18 hips), stageⅡin 1 hip (ⅡC), stageⅢ in 17 hips (ⅢA 8, ⅢB 7,ⅢC 2). Harris score was 46 to 82 (mean 62.9). Results Collapse of the femoral head occurred in 9 hips a mong the 14 hips in the nonoperative group, in 10 hips among the 24 hips in the VICBG group. In TRO group, further deterioration was prevented in all but one hi p. Whether theres surgical intervention or not, no collapse occurred in both s tageⅠA and ⅡA, collapse occurred in both stage ⅠB and ⅡB was 7 hips among 15 hips (46.7%), 13 hips progressed into collapse of the femoral head with ⅠC and ⅡC (100%). The Harris score was 47 to 93(mean 77.4) postoperatively. Conclusio n With MR imaging, it is possible to predict the possibility of collapse of ONFH . The lower risk is below 30 percent of necrotic area, the higher risk is 30 to 60 percent of necrotic area, and the higherest risk is beyond 60 percent of necr otic area. The best results can be obtained if selection of treatment individual ly according to ARCO stage, patient age and necrotic extent.

Objective To explore the concentration of required residual available chlorine dioxide(ClO 2 )and optimun contact time for ClO 2 disinfection in order to ensure the microbiological indexes of waste water of hospital disinfected by ClO 2 qualified.Meth ods The waste water samples collected from hospital,to which were aritificially added with predetermined con-centrations of bacteria,were disinfected by various concentrations of ClO 2 (2?4?6?8?10?12mg /L)with various contact time (5?10?30?60?90min).After disinfection,the concentration of residual ClO 2 and the contents of microorganism in waste water samples were determined.Re sults After30-min disinfection by10.0mg /L ClO 2 ,the waste water sample originally containing1.52?10 2 /L E.coli showed a bactericidal rate of99.99%and a concentration of residual ClO 2 at2.5mg /L.After10-min disin-fection by10.0mg /L ClO 2 ,the waste water samples originally containing1.12?10 10 /L Salmonella showed a bactericidal rate of100%and a concentration of residual ClO 2 at2mg /L.After5-min disinfection by10.0mg /L ClO 2 ,the waste water samples o-riginally containing M.tu berculosis at concentration of++++showed a negative result and a concentration of residual ClO 2 at3.5mg/L.Conclusion After the primary treatment,ClO 2 disinfection with contact time of30minutes and a residual concentration of ClO 2 at2.5mg /L could ensure the germicidal effect for E.coli,Salmonella and M.tu berculosis in waste water of hospital qualified.

28 patients with acute respiratory distress syndrome caused by 2009 H1N1 influenza were mechanically ventilated for 1 hour in the supine, lateral, semi-supine, lateral prone, and prone position respectively. Changes of heart rate, respiratory parameters and arterial partial pressure of oxygen ( PaO2 )were measured. There were no significant differences ( P ＞ 0. 05 ) of heart rate and mean arterial pressure among these postures. Lateral prone ( P ＜ 0. 05 ) and prone posture ( P ＜ 0. 01 ) , however, can both significantly improve tidal volume, mean airway pressure, PaO2, static lung compliance and oxygenation index. We concluded that mechanical ventilation delivered in the prone position can remarkably improve oxygenation in patients with H1N1 influenza-associated acute lung injury.

This study aimed to study the criteria of two-way referral between tertiary-care hospital and communityhealth-care service center for patients with cerebralhemorrhage and a protocol of implementation to promote its treatment and rehabilitation.The criteria of two-way referral between tertiarycare hospital and community health-care service center for patients with cerebral hemorrhage after surgical operation were formulated on a trial basis with mutual consultation by the department of neurosurgery,Shenzhou hospital affiliated to Shenyang Medical College and Hunhewan Community Health-Care Service Center,Heping district,Shenyang. Totally,91 patients of cerebral hemorrhage admitted to the hospital during October 2007 to September 2010 were recruited for the study,46 in the intervention group with two-way referral and 45 in the control group by self-referral determined by their family members.All the patients of the two groups were followed-up for three years.During the follow-up in the intervention group,40 of 46 (95％) patients could comply with taking medication ordered by physicians,ability of daily living remarkably improved by Barthel index in 21 (50％),physical function recovered well in 33 (79％),34 (81％) could insist in self-monitoring and 32 (76％) could visit physicians for regular consultation,all these being significantly better than those in the control group (64％,31％,28％,25％ and 25％,respectively) (P ＜0.01 ).Medical and rehabilitative cost for patients with cerebral hemorrhage accounted for 575 RMB yuan per month in intervention group,as compared to 2246 RMB yuan for those in control group.Two-way referral for patients with cerebral hemorrhage can reduce their medical cost and promote their better rehabilitation.

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 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.