Multi-center Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection / 中国药房

OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.

Multi-center Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection / 中国药房

OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.

Experimental study on percutaneous selective isolated hepatic perfusion chemotherapy / 中国普通外科杂志

ObjectiveTo investigate the feasibility and isolation efficiency of percutaneous selective isolated hepatic perfusion chemotherapy(PSIHP). MethodsSix pigs underwent the procedure of routine transhepatic arterial infusion(HAI) and 6 underwent PSIHP.5-FU was used in this study. The drug(5-FU) (concentration) of blood from hepatic and systemic veins of both groups was observed. Liver tissue was (investigated) for pathologic changes. ResultsThe peak level of 5-FU concentration in blood from right (hepatic) vein and systemic vein in HAI group was(4082.530415.213)mg/L and (1682.230216.834)mg/L respectively.In PSIHP group, the peak level(5-FU) was(5321.711517.318)mg/L and(510.83452.518)mg/L, respectively.There was a statistically significant difference between HAI group an PSIHP group(P

Quality Investigation of Compound Danshen Injection from Different Manufactures / 中国药房

OBEJECTIVE:To study quality differences of compound danshen injections of different batch numbers from different manufactures.METHODS:The fingerprints of compound danshen injections were obtained through gradient elution by HPLC;The contents of danshensu,protocatechualdehyde and savianolic acid B in samples of different batch numbers and different manufactures were determined,and the insoluble fine particle,protein,tannin,resin etc.in samples were studied ac-cording to the specification of China Pharmacopoeia2005.RESULTS:The fingerprints of compound danshen injections were specific;Great differences were found in the contents of danshensu,protocatechualdehyde and salvianolic acid B of the samples from different manufactures,quality discrepancies were found between some of the related substances in some of the prepara-tions and the specifications.CONCLUSION:Quality differences were found in compound danshen injections from different manufactures,therefore,the quality control standards of compound danshen injections should be enhanced and unified,and with regard to the controlling of the insoluble fine particles,the technics and techniques of which should be improved and given a further study.

Study on the Adsorption of Disposable Transfusion Connective Tube and Infusion Needle for Single Use only to Nitroglycerin / 中国药房

OBJECTIVE:To study the adsorption of disposable transfusion connective tube and infusion needle for single use only to nitroglycerin in intravenous injection via minipump.METHODS:The intravenous injection via minipump was im-itated;the concentration change of nitroglycerin during the injection process was determined by the high performance liquid chromatography(HPLC)and ultraviolet spectrophotometry.RESULTS:Disposable transfusion connective tube and infusion needle for single use only had significant adsorption to nitroglycerin with an mean adsorption rate at(73.88?2.05)%within8hours.CONCLUSION:It is unsuitable to use those disposable transfusion connective tubes and infusion needles for single use only that have strong adsorption to nitroglycerin in the intravenous injection of nitroglycerin via minipump.

Detection of Serum Benzodiazepines Concentrations in 149 Cases of Unconfirmed Drug Overdose / 中国药房

OBJECTIVE:To find the quick detection method for serum benzodiazepines concentrations.METHODS:Using flurosence polarization immunoassay method to detect the serum concentration of benzodiazepines(BZDs)in149patients who were suspicious of receiving drug overdose in emergency unit.RESULTS:We got positive results in104samples from149pa?tients,but the levels of BZDs concentration were not coincident with the state of drug overdose.CONCLUSION:The method used in our report is a quick and useful assay for patients with unconfirmed drug overdose in emergency unit,but caution should be taken in the result interpretation to doctors.

Monitoring of Serum Phenytoin Concentration in 130 Cases and Analysis of the Cases of Intoxication / 中国药房

OBJECTIVE: To study the relationship among the dosage, serum concentration and clinical effect of phenytoin(PHT) in treating epileptic patients .METHODS: 130 steady -- state serum concentrations of PHT were determined by fluores-cence polarization immunoassay(FPIA) in 70 patients with or without other drugs used in combination .RESULTS: The indi-vidual difference among the patients who received routine dosage of PHT was very significant. Intoxication occurred ex-tremely often in patients whose PHT serum concentrations were over 30?g/ml .CONCLUSION: It is necessary to perform TDM(Therapeutic Drug Monitoring) and individualize the use of PHT,so that the safe and effective use of drug can be ensured.

Quality Evaluation of Levofloxacin Tablets Produced by Six Different Pharmaceutical Factories / 中国药房

OBJECTIVE:To evaluate the quality of levofloxacin tablets produced by 6 different factories.METHODS:To investigate the quality of 17 batches of levofloxacin tablets produced by 6 factories according to related standards and to evaluate the drug dissolubilities using paddle method.RESULTS:17 products from six factories were all proved qualified.Significant differences of dissolution parameters and treatment costs were found among the different products.CONCLUSION:There are difference in quality of levofloxacin tablets.The tablets produced by the factory holding the patent right are more expensive,however the qualiity is more stable.