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 evaluate the applicability, reliability and validity of the Rey-Osterrieth Complex Figure Test (CFT)in Chinese normal elderly. Methods: A total of 111 normal elderly were assessed by the CFT (Form A) and the mini-mental state examination (MMSE). Among these subjects, 40 were also administered the CFT (Form B), the Block Design and the Visual Reproduction tests. Results: No significant difference was found between CFT (Form A) and CFT (Form B) with respect to copy, delayed recall and recognition. Recall performance was related to copying strategy and level of organization. Details of accuracy and their respective placement were evaluated in both copy and delayed recall trials for CFT (Form A). Conclusion: As a measure for visual-spatial constructional ability and visual memory, the CFT (Form A & B) was assessed to be psychometrically reliable and valid to be used in normal Chinese elderly.

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 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 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 determine if propofol-remifentanil and isoflurane have any different effects on intrapulmonary shunt during one-lung ventilation (OLV). Methods Twenty-four ASA Ⅰ or Ⅱ patients (18 male, 6 female) aged 42-69 yr undergoing radical esophagus cancer resection via left thoracotomy were randomly divided into 2 equal groups ( n = 8 each) : propofol group (Pro) and isoflurane group (Iso) . The preoperative lung function was normal in both groups. The patients were premedicated with intramuscular diazepam 10 mg and atropine 0.5 mg. Radial artery was cannulated and S-G catheter was placed via right internal jugular vein in pulmonary artery. Anesthesia was induced with propofol 1.5-2.0 mg?kg-1, fentanyl 4 ?g?kg-1 and succinylcholine 1.5 mg?kg-1 and maintained with TCI of propofol and remifentanil (target plasma concentration was set at 3.2 ?g?ml-1 and 4.5 ng?ml-1 ) or isoflurane inhalation ( end- tidal isoflurane concentration = 1.5% -2.5 % ) and intermittent i. v. boluses of fentanyl. The patients were mechanically ventilated after endobronchial intubation with double-lumen tube (VT = 8-10 ml, RR= 10-12 bpm, I:E = 1:2) . During OLV VT was reduced to 6-8 ml and RR increased to 14-16 bpm.PaCO2 was maintained at 35-45 mm Hg. ECG, HR, MAP, SpO2, auditory-evoked potential index (AAI), cardiac index (CI), airway pressure and end-tidal isoflurane concentration were continuously monitored during operation. Blood samples were taken from radial artery and pulmonary artery at 10 min after S-G catheter placement (T0, baseline) at 10 min bilateral ventilation (in right lateral position) (T1) at 15, 30, 60, 90 min of OLV (T2-5) for measurement of blood gases and calculation of Qs/Qt.Results The two groups were comparable with respect to age, M/F ratio, body weight and preoperative lung function. AAI was below 30 during operation and PaCO2 and pH were within normal range in both groups. Qs/Qt was significantly increased while PaO2 was significantly decreased during operation (from T1 to T5 ) as compared to baseline values (T0) but Qs/Qt was gradually decreasing while PaO2 was gradually increasing from T2-5 in both groups. Qs/Qt was significantly lower in Pro group than in Iso group at each interval (T2-5) but there was no significant difference in PaO2 at T2-5 between the two groups. Conclusion There is less intrapulmonary shunt during OLV under general anesthesia with propofol-remifentanil than with isoflurane but the difference is not significant enough to affect PaO2.

Objective To investigate the effect of partial liquid ventilation(PLV) with perfluorocarbon(PFC) on pulmonary surfactant during beatment of acute lung injury(ALI) induced by oleic acid. MethodsTwenty-four male Japanese white rabbits weighing 2. 1-2.6 kg were randomly divided into three groups(n = 8 ineach group): groupl: normal animal + mechanical ventilation (MV); group 2: ALI + MV; group 3: ALI +PLV.The animals were anesthetized with intraperitoneal ketamine 100 mg/kg, trachectomized and mechanicallyventilated (FiO_2 = 1, RR = 35 bpm, I: E = 1: 2, PEEP = 5 cm H_2O, PaCO_2 was maintained at 35-45 mm Hg byadjustment of tidal volume) .In group 2 and 3 ALI was induced by infusion of oleic acid 150?g/kg via centralvenous catheter over 30 min period. ALI was considered established when PaO_2 /FiO_2 was