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OBJECTIVE:To provide suggestions for standardizing and protecting the off-label drug use. METHODS:Accord-ing to the field interviews with pharmacists and lawyers,the present situation of off-label drug use in judicial practice at home and abroad,and relevant countermeasures were put forward. RESULTS & CONCLUSIONS:At present,there was no mechanism for off-label drug use in the laws and regulations in China;there was only"special circumstances"statement in sporadic terms,while lacking explanation. In judicial practice of medical disputes,judges had different identifications in various references,such as the le-gality of routine and guidelines,teaching medical materials,clinical pathways,and internal regulations of medical institutions pre-pared by authoritative departments. Meanwhile,the judicial environment of hearing cases by identification made the off-label drug use had impartial adjudication. Legislation in 6 countries,including America,allows reasonable off-label drug use;FDA required off-label drug use must be for the benefit of patients rather than clinical trials,and it also should protect the patient's right to know. China should establish the authority specification of off-label drug use,providing scientific identification procedures,protect the patient 's informed consent by law. Medical institutions should develop relevant management system and processes to regulate medical prac-tices and ensure off-label drug use in line with the interests of doctors and patients.
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OBJECTIVE:To provide suggestions for standardizing and protecting the off-label drug use. METHODS:Accord-ing to the field interviews with pharmacists and lawyers,the present situation of off-label drug use in judicial practice at home and abroad,and relevant countermeasures were put forward. RESULTS & CONCLUSIONS:At present,there was no mechanism for off-label drug use in the laws and regulations in China;there was only"special circumstances"statement in sporadic terms,while lacking explanation. In judicial practice of medical disputes,judges had different identifications in various references,such as the le-gality of routine and guidelines,teaching medical materials,clinical pathways,and internal regulations of medical institutions pre-pared by authoritative departments. Meanwhile,the judicial environment of hearing cases by identification made the off-label drug use had impartial adjudication. Legislation in 6 countries,including America,allows reasonable off-label drug use;FDA required off-label drug use must be for the benefit of patients rather than clinical trials,and it also should protect the patient's right to know. China should establish the authority specification of off-label drug use,providing scientific identification procedures,protect the patient 's informed consent by law. Medical institutions should develop relevant management system and processes to regulate medical prac-tices and ensure off-label drug use in line with the interests of doctors and patients.
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[Objective]To investigate the effect of Luteolin on mRNA expression ,protein expression and enzyme activity of 11β-Hydroxysteroid Dehydrogenase (11β-HSD) in rats.[Methods]Twenty-four rats were randomly divided into 4 groups and orally administrated with vehicle(1 % CMC-Na solution)or Luteolin(5,10 or 20 mg/kg daily)for 14 days. Gene expression of 11β-HSD I and 11β-HSD II in liver and kidney was determined with quantitative RT-PCR method. Protein expression was deter-mined with quantitative Western Blot method. The enzyme activity was expressed as the production rate of metabolites of prednisone and prednisolone.[Results]Luteolin significantly induced gene expression of 11β-HSD I and inhibited gene expression of 11β-HSD II in liver tissues ,significantly inhibited gene expression of 11β-HSD I and induced gene expression of 11β-HSD II in kid-ney tissues. Luteolin obviously up-regulated protein expression of 11β-HSD I and down-regulated protein expression of 11β-HSD II in liver tissues ,down-regulated protein expression of 11β-HSD I and up-regulated protein expression of 11β-HSD II in kidney tissues. Luteolin significantly induced activity of 11β-HSD I in liver and11β-HSD II in kidney.[Conclusions]Luteolin could change the activity of corresponding enzyme through affecting gene expression ,protein expression and enzyme activity of 11β-HSD I and 11β-HSD II in liver and kidney tissues in rat ,and affect in vivo activation of glucocorticoids and hormone level in liver and kidney.
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OBJECTIVE:To shorten time consuming for dispensing mode of automatic medicine packaging machine(ATC), and improve the efficiency of ATC. METHODS:In the inpatient pharmacy of our hospital,previous dispensing mode that two ATC matched with one tablet case separately was replaced by new mode,i.e. one ATC(another ATC was on standby)matched with two tablet cases(one of them added medicine beforehand),and the information of drug-position coordinate was equipped. The time con-sumed,average daily number of packages,financial expenses and labor costs were recorded and analyzed to evaluated the effect of new mode. RESULTS & CONCLUSIONS:Compared with previous mode,new dispensing mode improve the efficiency of ATC greatly. In previous mode,two ATCs and four pharmacists work simultaneously and spend 4.5 hours for 3 850 bags of medicine, which cost 4 400 000 yuan;in new mode,only one ATC and three pharmacists work simultaneously,and spend 3.0 hours for 4 015 bags of medicine,which cost 2 350 000 yuan. Therefore,double-universal tablet cases greatly improves the efficiency of ATC and reduce the financial expenses as machine maintenance and labor cost.
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Objective To analyze the method of self-management education on the health status of patients with gastric carcinoma during chemotherapy. Methods Patients with gastric carcinoma (60 cases) were divided into the test group and the control group with 30 cases in each group. The two groups both received chemotherapy of complete cycle and general health education. The test group adopted self-management education based upon the above treatment, including collective education, group discussion and individual instruction. The treatment effect was appraised and compared by senior primary nurses. Results The recent total effective rate of chemotherapy in the test group was 76.7%, which was higher than that of the control group (50.0%). The level of life quality of the test group was also better than that of the control group (P<0.05). Conclusion Patients-centered self-management education could improve the health status of patients with gastric carcinoma during chemotherapy.
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OBJECTIVE: To establish a SPE-HPLC method to determine the whole blood concentration of sirolimus.METHODS: The blood sample was treated on Waters OASIS SPE column in which a Supelcosil LC-18DB chromatographic column(250 mm?4.6 mm,5 ?m) was adopted and the temperature was set at 50 ℃.The mobile phase was a mixture of methanol and water(75∶25) at a flow rate of 1.5 mL?min-1.The UV detector was operated at 276 nm.RESULTS: The assay procedure was shown to produce linear calibration curves over the range 1.25～70 ng?mL-1 of sirolimus in blood(r=0.999 7).The limit of detection was 0.5 ng?mL-1.Within the range,the average recovery rate was(101.7?2.7)% and the extraction recovery rate was≥82.8%.The coefficients of variation within a day and between days did not exceed 4.0% and 5.4%,respectively.CONCLUSION: This method is found to be easy,convenient and precise for fast monitoring of plasma concentration of sirolimus.
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OBJECTIVE:To evaluate the situation and the tendency of antihypertensive use in guangdong province.METHODS:The sales volume,defined daily use(DDDs)and daily expense of antihypertensive from2002to2004in guangdong province were investigated and analyzed.RESULTS:The sales volume of antihypertensive from2002to2004had been in?creasing.Calcium antagonist dominated over all other antihypertensives in respect of sales volume and DDDs.CONCLUSION:Calcium antagonist dominate in the antihypertensive market in guangdong province.
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OBJECTIVE:To eualuate the situation and the tondency of antihyperlipidemics used in Guangdong Province.METHODS:The sales volume,DDDs and daily expense of antihyperlipidemics in Guangdong Province from2000to2003were investigated and analyzed.RESULTS:The sales volumes of cardiovascular agents from2000to2003had been increasing.The proportion of antihyperlipidemics to cardiovascular agents in respect of sales volume assumed a decreasing tendency from2001.Simvastatin dominated over all other drugs in respect of sales volume and DDDs.CONCLUSION:HMG-CoA reductase in-hibitor and natural drugs dominate in the antihyperlipidemics market of Guangdong Province.
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OBJECTIVE:To investigate the relationship between Tacrolimus blood concentration and effectiveness after renal transplantation and to find factors affecting Tacrolimus blood concentration METHODS:Steady-state trough concentrations of Tacrolimus were collected from 80 renal transplantation patients RESULTS:The effective blood concentration of Tacrolimus was associated with course of treatment CONCLUSIONS:The therapeutic concentration of Tacrolimus was between 12ng/ml and 15ng/ml during the first 2 weeks after renal transplantation,then should be 8ng/ml～15ng/ml
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OBJECTIVE:To establish a HPLC method for the determination of 5-fluorouracil in human plasma METHODS:The plasma samples were extracted with ethyl acetate-isopropanol(85∶15,V/V)following precipitation of plasma proteins with ammonium sulfate The solvent was evaporated to dryness under a stream of nitrogen The dry extract was dissolved in mobile phase and then injected into the Diamonsil C18 column(150mm?4 6mm,5?m)and 0 01mol/L KH2 PO4(pH5 5) was taken as mobile phase The flow rate was 1 5ml/min,UV detection wavelength was 267nm The internal standard was 5-bromouracil RESULTS:The minimal detectable drug concentration in plasma was 0 025?g/ml The calibration curve was linear over a range from 0 3?g/ml to 10?g/ml The intra-day RSD≤5 0%(n=5) and the inter-day RSD≤11 5%(n=5) CONCLUSION:The method can be used for studying the pharmacokinetics and bioavailability of 5-fluorouracil