OBJECTIVE:To probe into the quality of the package inserts of oral chemical drugs to lay a foundation for the further standardization of drug package inserts.METHODS:180 package inserts of oral chemical drugs current on market were selected and subjected to inspection in accordance with the Regulatory Guidelines for the Package Inserts of Drugs announced by SFDA as well as other related references to find out the problems existing in the package inserts,and a statistical analysis was conducted on the typical problems.RESULTS:Among the 180 package inserts,109(60.56%)had problems(totaled 167 defects)predominantly in drug name,storage,usage and dosage.CONCLUSION:It is urgent to improve the quality of the package inserts.

The prognosis of patients with pancreatic cancer is dismal, especially at the advanced stage of the disease. Surgery is considered as the only curative treatment modality for pancreatic cancer;however, less than 20% of patients are candidates for curative surgical resection. Multidisciplinary management, including radiation therapy with concurrent chemotherapy, followed by systemic chemotherapy, is the treatment of choice for locally advanced pancreatic cancer. An early phase Ⅲ clinical trial conducted by GITSG (GI Tumor Study Group) has demonstrated a survival benefit for concurrent chemoradiation as compared to radiation alone in locally advanced disease. 5-FU,capacitabine and gemcitabine are the most investigated chemotherapy agents used with radiation. Currently thecombined use of gemcitabine and radiation therapy is under active investigation, and may provide substantial clinical advantage over other regimens. Multi-agent chemotherapy regimen used in concurrence with radiation has not demonstrated any significant effect but with severe toxicities. Conformal radiotherapy should be routinely used to treat locally advanced pancreatic cancer with doses of 45-50.4 Gy. The target of locally advanced pancreatic cancer is focussed on the gross tumor with safe margins. The use of IMRT is highly recommended for unresectable tumor, and makes further dose escalation possible.

OBJECTIVE: To assess the influence of Qingdu (QD) capsule on the pharmacokinetic of HAART. METHODS: The 36 SD rats were divided into 3 groups. Rats in Group HAART were given, using an intragastric gavage needle, highly active antiretroviral therapy (HAART) containing zidovudine (AZT), 2',3'-dideoxy-3'-thiacytidine (3TC) and efavirenz (EFV). Group HAART+QD were given HAART and QD capsule simultaneously. Group HAART+QD (2 h interval) were given HAART and then given QD capsule 2 h later. Blood samples were collected at 0, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 h. AZT, 3TC, and EFV concentrations were tested with high performapce liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were compared among different groups. RESULTS: The t1/2 of AZT were statistically different among the three groups (P<0.05), Group HAART+QD (2 h interval) had the lease t1/2 of AZT than the other two groups. There were no statistical differences among groups for the AUC0-12, tmax, ρmax and CL of AZT, and all five parameters of 3TC and EFV. CONCLUSION: QU doesn't show influence on pharmacokinetic parameters of AZT+3TC+EFV regimen, but intention should be paid to individual differences.

Objective To investigate the association of platelet-derived growth factor(PDGF)-B gene single nucleotide polymorphism(SNP) and plasma PDGF-BB level with in-stent restenosis(ISR) in elderly patients.Methods 157 patients who had undergone coronary artery stenting for more than half year were divided into ISR group(n=74) and NISR group(non-ISR,n=83) according to the angiographic diagnosis of in-stent restenosis (ISR).Plasma level of PDGF-BB was measured by enzyme-linked immunosorbent assay(ELISA).DNA was isolated from leukocytes.Two SNPs of the PDGF-B gene(rs1800818 and rs1800817) were determined by Taqman Quantitative Real-Time PCR with TaqMan-MGB probe.Results There were no significant differences in genotype frequency of rs1800818 AA,AG,GG between ISR group and NISR group(x2 =4.48,P＞0.05).The frequency of rs1800818A allele was much higher in ISR group than in NISR group(x2 =5.33,P＜0.05).There were no significant differences in genotype frequency of SNP rs1800817 AA and AC(x2 =0.06,P＞ 0.05) and allele frequency of SNP rs1800817 A and C(x2 =0.06,P＞0.05) between ISR group and NISR group,while genotype CC was not found.The plasma level of PDGF-BB was higher in ISR group than in NISR group [(6.53±3.65) ng/L vs.(5.07±2.45) ng/L,t=2.92,P＜0.01].Plasma level of PDGF-BB in patients with rs1800818 AA genotype was significantly higher in ISR group than in NISR group [(9.94 ± 4.60) ng/L vs.(5.90 ± 2.98) ng/L,t =2.69,P＜0.05].Multivariable logistic regression analysis showed that plasma PDGF-BB level was the risk factor for ISR (OR =1.187,95.0％ CI:1.054 1.337,P＜0.01).Conclusions High plasma PDGF-BB level is the risk factor for ISR,but PDGF-B gene SNPs rs1800818 and rs1800817 are not associated with the occurrence of ISR.

Objective: To analyze neuropsychological test identification of neurodegenerative (NMCI) and vascular (VMCI) subtypes of mild cognitive impairment. Methods: 94 normal elderly, 107 NMCI and 32 VMCI were evaluated by neuropsychological tests, such as mini mental state examination(MMSE), auditory verbal memory test (AVMT), Rey-Osterrich complex figure test (CFT), trailmaking test (TMT), Stroop Color Words Test (CWT), Verbal fluency test (VFT) and Clock Drawing Test (CDT). MMSE total score of 3 groups were 28.1?1.6, 26.9?1.8 and 26.2?1.7 , respectively. Results: There are similar global severity between NMCI and VMCI groups. VMCI group performed better than NMCI group in verbal delay memory rather than verbal short memory, or figure memory. Stroop interference effect and TMT interference effect of VMCI group were more powerful significantly than that of NMCI. VMCI group also generated fewer figure copy score on CFT. But there wasn't difference on VFT and CDT. Conclusion: These results suggest that decline in executive function is associated with cerebral vascular factors, and decline in episodic memory (such as verbal delay memory) is associated with neurodegenerative factors.

Objective To assess the efficacy of interventional bronchoscopic techniques used to treat stenosis of bronchial anastomosis after lung transplantation.Methods A retrospective study of 24 cases who underwent lung transplantation from September 2003 to August 2005 in our Unit was done. All recipients were subjected to surveillance bronchoscopy with biopsy at predetermined intervals and when clinically indicated. Endobronchial electrocauterization with microwave therapy apparatus and endobronchial electrocoagulation with high-frequency electrotome were performed for the management of bronchial stenosis or granuloma formation.Results There were 2 of 24 recipients (2/24,8.3 %) with stenosis of bronchial anastomosis. Airway stenosis appeared in 3 of 28 anastomoses (3/28,10.7 %): 2 on the left and 1 on the right. These patients with airway stenosis responded to interventional bronchoscopy,and their respiratory function was improved significantly.Conclusions Despite the improvements in surgical technique and immunosuppression strategies,a small number of patients still had airway complications after lung transplantation. Interventional bronchoscopic techniques,i.e. endobronchial electrocauterization with microwave therapy apparatus and endobronchial electrocoagulation with high-frequency electrotome will be effective in the treatment of airway complications after lung transplantation and with good response in respiratory function.

[Objective]To explore the vascularization within spherical porous ?-TCP scaffolds in vivo.[Method]Thirty adult rabbits were selected and divided into 5 groups randomly.Spherical porous ?-TCP scaffolds(the diameter was 2 cm,the pore size was 500～600?m,the interconnection size was 110～120 ?m) were harvested at 1,2,4,8 and 12 weeks after embedded into muscle-fascia lumbodorsalis pouches in each rabbit separately,in order to observe the vascularization by means of morphological and quantificational analysis.[Result]No vessel was detected at one week after surgery,and only a few immature vascular buds could be seen at the 2nd week.The first vascularization peak could be observed at 4 weeks,characterized by the growth of quantity of new blood vessels(P0.05).[Conclusion]The process of vascularization comprises two phases,the quantity increasing in the early stage and the quality enhancing in the later stage.The special architecture and biodegradation characters of scaffolds could influence the vascularization.

Objective To test the efficacy and safety of nicergoline in treatment of vascular dementia patients with mild or moderate cognitive impairment. Methods A multicenter,double blind,randomized,efficient drug controlled clinical trial was carried out All the subjects met the DSM-Ⅲ criteria for vascular dementia We used MMSE and WMS as main assessing items and ADL,CGI as secondary assessing items. Results 103 subjects were assessed MMSE were raised in both groups after the treatment and more obvious in nicergoline group than in anecetan group (1 62?2 33 and 2 88?2 85 respectively) WMS raised in nicergoline group (5 04?10 61),but not in anecetan group (1 98?9 49) ADL and CGI (SI) showed decreased scores in both groups Total efficiency of nicergoline was 80 0% and of anecetan was 56 6%. Conclusions Nicergoline was an effective drug in treatment of vascular dementia and more effective than anecetan Using nicergoline 60 mg per day was safe

Objective: To develop Auditory Verbal Memory Test (AVMT) suitable for Chinese elderly. Method:100 normal elderly and 22 patients with mild to moderate Alz heimer' s disease were evaluated by AVMT, mini mental state examination. 40 person randomly selected from the 100 sample were assessed in follow up by AVMT, Wechsler Memory Scale ( Chinese Revised Version), information and similaritias subtests of Wechsler Adult Intelligence Scale - Chinese Revised Version (WAIS- RC) . Results: The correlation between inter- raters was 0.99, test- retest reliability at 3 months interval were 0.87～0.94. Education was a prominent influence factor of memory and recognition of AVMT. There were significant correlation between third recall, short delayed recall and total scores of VMS- RC, between long delayed recall and verbal sceres of WAIS - RC. Semantic clustering strategy showed gradual strongly correlation with measures of recall ability in higher education group. Performance of Alzheimer group was poorer than that of matched normal control. Scores of long delayed re call differed most obviously in group comparison. Conclusion: AVMT had good reliability and validity

Methamphetamine is a powerful stimulant of amphetamine type in the central nervous system (CNS),and recently it has become the major drugs of abuse.A lot of research results show that MA may induce dopaminergic neurotoxicity in the animal and human striatum.The mechanisms include effects on dopaminergic signaling and dopamine oxidation,glutamate induced excitotoxicity,oxidative stress and inflammatory cytokines,disruption of mitochondfia,apoptosis,activation of glial cells and hyperthermia.However the mechanisms by the MA-induced dopaminergic neurotoxicity are not completely understood.The paper reviewed recent progress of study on them to provide reference materials for related research.