OBJECTIVE:To provide references and suggestions for building and improving the R&D incentive policies for or-phan drugs in China. METHODS:The R&D incentive policies for orphan drugs in USA and the EU were compared in aspects of its legislative history,incentive measures and effects. And suggestions for improving related policies in China were put forward. RE-SULTS & CONCLUSIONS:The R&D incentive policies for orphan drugs in USA and the EU respectively started from Orphan Drug Act in USA(1983)and Orphan Drug Management Specification in the EU(1999),then formed relatively complete system by continuous improvement. The USA and the EU showed differences in its certification standard,procedure and specific incentives [R&D funding,tax deduction,fee reduction,additional incentives for micro and small and medium enterprises (SMEs),market exclusivity and special approval procedure],etc. In terms of fee reduction,for example,prescription application fee,production cost and drug confirmation fee were exempted in USA,while arrangement assist fee,initial and follow-up fee,checking fee before approval,initial listing type were reduced to a certain percentage in the EU. After developing incentive policies for orphan drugs, there is great increase in numbers of recognized qualifications and listing,SMEs have become new force in orphan drug R&D, R&D investment covers all types of diseases,orphan drug R&D are becoming the main direction of drug innovation and biotechnol-ogy development. China should determine the relevant legislation of R&D incentives for orphan drugs as soon as possible,set certi-fication and improve specific measures of R&D incentives for orphan drugs from multiple aspects,while strengthen the cooperation with other countries in qualification and R&D incentives.

Objective To investigate the potential factors which have impact on the working space for surgeons in gasless laparoscopic cholecystectomy and to probe into the specifications of gasless surgeries.Methods Clinical data of 49 cases of gasless laparoscopic cholecystectomy between March 2007 and July 2010 were summarized.The impacts of body mass index,bowel preparation and means of anesthesia on operation time and conversion to laparotomy were analyzed.Results For patients with body mass index ≤25and ＞ 25,operation times were (43.0 ± 5.4) min,and (52.8 ± 7.4 ) min,respectively,and rates of conversion to laparotomy were 0/34 and 4/15,respectively.Both indices in the first group were higher.For patients with and without bowel preparation,operation times were (44.5 ± 5.4) min and (46.1 ± 8.0)min,respectively,and rates of conversion to laparotomy were 2/26 and 2/23,respectively.For patients with epidural anesthesia and lumbar/epidural anesthesia,operation times were (46.5 ± 7.9) min and (44.1 ±6.8) min,respectively,and rates of conversion to laparotomy were 2/24 and 2/25,respectively.Conclusions The operation time of gasless laparoscopic cholecystectomy could be affected by many factors,such as body mass index.Gasless operations can be improved by evaluating the conditions of patients correctly and by selecting suitable operation methods,anesthesia means and bowel preparation.

Objective To investigate the systemic stress responses after laparoscopic resection in colorectal cancer patients.Methods Sixty patients were randomized into the laparoscopic resection group (30 cases) and open resection group (30 cases) from October 2001 to September 2002 in our hospital.Analgesic dosages, recovery time of intestinal peristalsis, postoperative temperatures, C reactive protein(CRP), IL 6 and white blood cell (WBC) counts were recorded after operation. Results The changes of postoperative temperatures and WBC counts showed no significant difference between two groups.But in the laparoscopic resection group, the recovery time of intestinal peristalsis, postoperative analgesic dosages, CRP and IL 6 significantly decreased ( P

Objective This study was carried out to reveal the photocatalytic degradation characteristics of Bisphenol A,a representative endocrine disruptor,with immobilized nanometer TiO2 catalyst supported on fiberglass net.Methods The effects of photolysis under black light lamp and cold cathode low-pressure mercury lamp,and initial concentration(0.98-6.23 mg/L) on the degradation of bisphenol A(BPA) was explored by photoreactor in laboratory.Photocatalytic mineralization and intermediates under different irradiations was also investigated.Results It was found that the reaction kinetics was first order with respect to BPA concentration,and the apparent kinetic constants decreased with the increase of initial concentration.Photodecomposition of BPA under black light lamp irradiation was caused by not photolysis but photocatalysis,while that under cold cathode low-pressure mercury lamp was caused by the synergistic effect of photolysis as well as photocatalysis.Further studies showed that photocatalytic mineralization of BPA differed greatly under those different irradiations.1,4-benzoquinone,p-dihydroxybenzene,methyl p-hydroxybenzoate,D-hydroxyacetophehone,1-(4-hydroxyphenyl)-1-propanone,1-(4-hydroxyphenyl)-vinyl alcohol were identified as intermediates under black light lamp,and 3-hydroxyl-3-crotonic acid,4-hydroxybenzaldehyde,D-hydroxyacetophehone,2-acetyl-3-methoxyl-5,8-dihydroxy-1,4-naphthoquinone,3,4-di-(4-hydroxyphenyl)hexane were found under cold cathode low-pressure mercury lamp.Conclusion The differences of photocatalytic mineralization under different illumination are attributed to the molecule structure with two benzene-rings.

50% luminal narrowing) by rest first-pass MR imaging was 70.4%,94.2% and 78.7%,respectively.Conclusion Multimodality MR imaging in detecting the myocardial viability is superior to echocardiography,and has high coincidence with coronary angiography.

Objective To evaluate the application effects of mind map in community health education of rheumatoid arthritis patients. Methods 65 rheumatoid arthritis patients from Shunqing district of Nanchong City, Sichuan Province were randomly divided into an observation group (n=33) and a control group(n=32). Both groups received six-month health education. Health educators utilized mind map for the observation group and traditional health education for the control group. Before and after implementation, the two groups' mastery of disease knowledge was compared. During the period of 1, 3, 6 months, two groups received compliance evaluation respectively. During the study period, a questionnaire was given to the observation group to collect their attitude towards the mind map health education and their evaluation about it. Measurement data was represented by x ± s, using group t-test design information and single-sample t-test. χ2test was used in the count data for compar-ison between groups with test levelα=0.05. Results The scores of disease knowledge were as follows. Before implementation there was no statistically significant difference between two groups (P=0.921);After implementation, the score of observation group was(19.97±3.03), while the score of control group was(17.59±3.11), the difference was statistically significant(t=3.122,P=0.003). The difference of 1,3,6-month compliance scores was statistically significant(t=2.173,P=0.034;t=2.371,P=0.021;t=2.615,P=0.011) with the observation group's scores(18.24±3.44),(18.94±3.25),(19.64±3.06) respectively,and the control group's scores(16.47±3.13),(16.97±3.45),(17.44±3.70). Observation group's attitude questionnaire scores of each project are > 3, and there was significant difference be-tween two groups (P=0.000). Conclusion Mind mapping method can be used in community health education for rheumatoid arthritis patients to help patients master the knowledge of the disease and improve the compliance. Its effect is better than traditional methods.

Objective To evaluate the antitumor effect of corosolic acid and its impact on CAM and YSM angiogenesis.Methods The effects of CRA on A549 proliferation was studied by MTT method in vitro.Tumor-bruden nude mice model were established by injecting A549 lung cancer cell marked with bioluminescent to nude mice,and the growth of tumor in mice were detected by IVIS small animal in vivo imaging system.Experiment of chicken embryos eggs are used to observe the role of drugs on CAMand YSMblood vessels. Results The value of IC50 of CRA for A549 in vitro was 26.8μg/mL.A tumor-burdened animal experiment results showed that the CRA to A549 solid tumor has a certain therapeutic effect.CAM and YSM blood vessels of chicken embryos eggs treated with CRA were decreased significantly than negative control group.Conclusion CRA has certain therapeutic effect for A549,which may be related to the inhibition of angiogenesis in tumor tissues.

Objective To assess risk factors in NSCLC with N2 metastasis.Methods A total of 177 NSCLC patients (109 males,68 females; age:(60.1 ± 10.6) years) who underwent both 18F-FDG PET/CT scan and surgery were enrolled.They were divided into two groups.One was with N2 metastasis (N2+) and the other was without (non-N2+).The gender,age,location,size,primary tumor SUVmax,histopathologic type and differentiation grade between N2+ group and non-N2+ group were compared with x2 test and two-sample t test.After assignment of significant factors and groups,correlations between each factor and group were analyzed with uni-and multivariate analyses,and then the risk factors were identified finally with logistic regression analysis.Results Significant difference among factors of tumor size ((36.1±19.7) mm vs (49.3±24.4) mm),SUVmax(8.81±6.23 vs 11.21±4.43) and differentiation grades (high:3 vs 0; moderate:74 vs 11; poor:65 vs 24) were observed between non-N2+ group and N2+ group (t =-2.969,-2.633,x2 =6.143,all P＜0.05).Besides,the univariate analysis showed significant correlations between tumor size,SUVmax,differentiation grade and N2 status (r=0.201,0.245,0.185,all P＜0.05).However,multivariate logistic regression revealed that only SUVmax had a predictive value (β=0.546,P＜0.01).The incidence of N2 metastasis went up along with the increase of SUVmax.There was no N2 metastasis in the patients with SUVmax ≤2.5,and the incidence rate of metastasis increased to 0.29 in those with SUVmax＞7.5.Conclusion SUVmax may be an independent risk factor to predict N2 metastasis in NSCLC patients.

Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Capsules ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Integrative Medicine ; Lung Neoplasms ; drug therapy ; Phytotherapy ; Small Cell Lung Carcinoma ; drug therapy

Objective To investigate the correlation between the red blood cell distribution width (RDW) with risk and and severity of noncardiac ischemic stroke.Methods The patients with acute noncardiac ischemic stroke were enrolled retrospetively and were used as a case group,and the non-stroke patients admitted to the Department of Neurology at the same period were served as a control group.The National Institutes of Health Stroke Scale (NIHSS) was used to assess the baseline neurological deficits.The NIHSS score ＜ 8 was defined as mild stroke and ≥ 8 was defined as moderate to severe stroke.The demographics,clinical data,and RDW were collected and compared.Multivariate logistic regression analysis was used to identify the independent risk factors for the risk of disease and severity of stroke in noncardiac ischemic stroke.Receiver operator characteristic (ROC) curve was used to analyze the predictive value of RDW for acute noncardiac ischemic stroke and its severity.Results A total of 1 173 patients with acute noncardiac ischemic stroke were enrolled.Over the same period,996 non-stroke patients were hospitalized in the Department of Neurology.The RDW in the case group was significantly higher than that in the control group (13.1％ ± 1.0％ vs.12.7％ ±0.7％;t=9.545,t ＜0.001).Multivariatelogistic regression analysis showed that RDW (odds ratio [OR] 9.920,95％ confidence interval [CI] 6.286-15.655,P＜ 0.001) was an independent risk factor for acute noncardiac ischemic stroke.ROC curve analysis showed that the RDW cutoff value for predicting acute noncardiac ischemic stroke was 12.55％,the area under the ROC curve was 0.611 (95％ CI 0.588-0.635),the sensitivity was 73.3％,the specificity was 43.7％,the positive predictive value was 60.5％,the negative predictive value was 58.2％,and the accuracy was 59.7％.RDW in the moderate to severe stroke subgroup was significantly higher than that in the mild stroke subgroup (13.7％ ± 1.6％ vs.12.9％ ± 0.6％,t =-13.794,P＜ 0.001).Multivariate logistic regression analysis showed that RDW (OR 3.835,95％ CI 3.002-4.899,P ＜ 0.001) was an independent risk factor for the severity of acute non-cardiac ischemic stroke.ROC curve analysis showed that the RDW cutoff value for predicting moderate to severe non-cardiac ischemic stroke was 13.45％,the area under the ROC curve was 0.713 (95％ CI 0.674-0.752),the sensitivity was 47.7％,the specificity was 86.1％,the positive predictive value was 49.8％,the negative predictive value was 85.1％,and the accuracy was 77.6％.Conclusions RDW is an independent risk factor for acute non-cardiac ischemic stroke.Increased RDW is associated with the severity of acute non-cardiac ischemic stroke.