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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 explore the teaching model and method of pharmacy case analysis writing in standardized clinical pharmacist training. METHODS:Based on the training experience in our hospital,the purpose,contents,common problems and summary of pharmacy case analysis writing were analyzed. RESULTS:The aim of pharmacy case analysis writing was to cultivate students’pharmaceutical thinking and the ability to solve real-world pharmaceutical problems. The key was to reflect the clinical pharmacist’s role in the event. The common problems included inappropriate selection of topics,insufficient evidence in discus-sion,and unclear organization of contents,where teachers should pay more attention to. CONCLUSIONS:Improving the teaching of pharmacy case analysis writing can improve the quality of clinical pharmacy student’s case analysis and cultivate their practical skills.
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Objective To investigate the effect of Gardiner bacteria infection on preterm delivery and changes of endocrine hor-mone levels.Methods Application of Gardiner bacteria fluorescent marker detection kit in 120 cases of suspected Gardiner bacteria infection pregnant women with immunofluorescence assay,and the levels of serum follicle stimulating hormone (FSH),luteinizing hormone (LH),estradiol (E2),progesterone (P)were measured at the same time,90 cases of non maternal Gardiner bacteria infec-tion were enrolled as control.Results After the treatment,98 cases of pregnant women with Gardiner bacteria infection should ex-perienced premature delivery (24-37 week),accounted for 81.67%,compared with the normal pregnant women were statistically significant (P 0.05),E2 increased,P decreased,changed significantly (P <0.05 ).Conclusion The probability of premature delivery in women infected with Gardiner bacteria is significantly higher than that of normal pregnant women,at the same time the secretion of hormone changes,so dealing with pre pregnancy and early pregnancy should carry owt Gardiner bacteria examination.
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Objective To evaluate the effects of dexmedetomidine on the cerebral oxygen metabolism in elderly patients undergoing general anesthesia.Methods Sixty ASA physical status Ⅰ or Ⅱ patients,aged 60-87 yr,scheduled for elective abdominal surgery under general anesthesia,were randomly divided into 2 groups (n =25 each) using a random number table:control group (group C) and dexmedetomidine group (group D).Anesthesia was induced with iv injection of midazolam,fentanyl,atracurium and propofol.The patients were tracheally intubated and mechanically ventilated.In group D,dexmedetomidine 1.0μg/kg was infused intravenously over 20 min before induction of anesthesia,while the equal volume of normal saline was given in group C.Before induction of anesthesia,at 0 and 10 min after tracheal intubation and at the end of operation (T0-3),blood samples were taken from the radial artery and jugular bulb for blood gas analysis.Arteriovenous blood O2 content difference (DajvO2) and cerebral O2 extraction rate (CERO2) were calculated at the same time.The development of emergence agitation and postoperative delirium within 48 h after surgery were recorded.Resets Compared with the baseline values at T0,the Da-jvO2 and CERO2 were significantly decreased at T1-3 in the two groups (P ＜ 0.05).Compared with group C,the Da-jvO2 and CERO2 were significandy decreased at T2-3,and the incidence of emergence agitation and postoperative delirium within 48 h after surgery was decreased in group D (P ＜ 0.05).Conclusion Dexmedetomidine can improve the cerebral oxygen metabolism and reduce the development of postoperative delirium in elderly patients undergoing general anesthesia.
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Objective To investigate the effect of preoperative acute hypervolemic hemodilution with 6% hydroxyethyl starch 130/0.4(HES130/0.4)and polygeline on hemodynamic response and variance regularity of hemodynamic response in open-and close-thoracic cavity in undergoing thoracotomy patients. Methods Sixty patients undergoing thoracotomy,ASA physical status ⅠorⅡ,aged 20~65 yeansold,weighing 45~70kg,were randomly divided three group:HES130/0.4 group ( group A,n=20) ,Polygeline group ( group B,n=20) and Ringer's solution group (group C,n=20).They were respectively infused 20ml/ (kg?h) with HES130/0.4,polygeline and Ringer's solution in one hour before infuseing followed Ringer's 10ml/ (kg?h). The Blood Pressure (BP) and heart rate (HR) were recorded.RPP was calculated before induction(baseline),5min before and 10 min after open thoracic cavity,5min before and 10min after close thoracic cavity. And central venous pressure (CVP) was measured at immediately after deep venous puncture ,5min before and 10min after open thoracic cavity,5min before and 10min after close thoracic cavity. Results The changes of hemodynamics in Ringer's solution group in operation were obvious as compared with baseline before operation.HES130/0.4 and polygeline were relatively stable.Two groups had no significant difference.The CVP of HES130/0.4 and polygeline groups increased obviously before and after open thoracic cavity,but the blood pressure was relatively stable.Only systolic blood pressure increased obviously as compared with Ringer's solution group at 5min before open thoracic cavity. At 10min after open thoracic cavity,HR and CVP in three groups increased obviously as compared with 5 min before open thoracic cavity.At 5 min before close thoracic cavity,blood pressure and CVP in three groups decreased obviously as compared with 10 min after open thoracic cavity. Conclusion The preoperative acute hypervolemic hemodilution with HES 130/ 0.4 and polygeline in undergoing thoracotomy patients can keep hemodynamics more stable and improve tolerance of patients to withstand hypovolemics.
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OBJECTIVE:To analyze the situation of antiarrhythmic drugs used in40hospitals of Guangdong Province.METHODS:To investigate antiarrhythmic drugs used during the past three years in aspect to the sum of money of consumption,DDDs and daily cost.RESULTS:The increasing rate of consumption sum of antiarrhythmic drugs during the pe?riod2000～2002has been lowered year by year,while the share of market of domestic drugs showed an increasing tendency,the imported drugs decreased year by year,the drugs produced by joint ventures kept steady.Metoprolol and potassium magnesium aspartate were much more frequently used than others.Metoprolol occupied the first place in the list of sum of mon?ey.CONCLUSION:The marketing of antiarrhythmic drugs will further expand in China and the pharmaceutical factories should strengthen the development of new antiarrhythmic drugs.