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OBJECTIVE To establish evaluation criteria for rational drug use of atosiban in clinic， and to provide reference for rational drug use of atosiban in clinic. METHODS Based on the drug instructions of atosiban acetate injection and related guidelines， the experts of the Evaluation Group of Rational Drug Use formulated the evaluation criteria of rational drug use， including 5 primary indexes and 8 secondary indexes. The weight coefficients of secondary indexes were calculated by analytic hierarchy process （AHP）， and the use of atosiban acetate injection in 190 pregnant women from the Third Affiliated Hospital of Guangzhou Medical University （referred to as “our hospital”） was evaluated retrospectively by technique for order preference by similarity to an ideal solution （TOPSIS）. The evaluation results were divided into three levels including reasonable， basic reasonable and unreasonable application based on the relative approach degree. RESULTS Among 190 pregnant women， 49 （25.8%） were treated with atosiban reasonably， 39 （20.5%） were treated with atosiban basic reasonably， and 102 （53.7%） were treated with atosiban unreasonably. The evaluation results obtained by AHP-TOPSIS method were consistent with the actual situation in clinic. The main problems of the unreasonably use were super indications， unreasonable usage and dosage， over the course of treatment and the lack of proper economic consideration. CONCLUSIONS The rationality evaluation criteria of atosiban’s clinical application are established by AHP-TOPSIS method； the evaluation results obtained by this method are quantifiable， scientific and reliable. The unreasonable use of atosiban is common in our hospital， and the management should be strengthened in clinical application.
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OBJECTIVE： To provide reference for rational use of estradiol （E2） preparation in clinic. METHODS： The medical records of outpatients receiving assisted reproductive technology （ART） and E2 preparation [Estradiol valerate tablets （EV）， Complex packing estradiol tablets/estradiol and dydrogesterone tablets （EP）， Estradiol gel （EG）] were collected from the reproductive medicine center of a hospital during Jan. 2016-Mar. 2017. Taking drug instruction as standard， the rationality of medical records was evaluated from aspects of indication， route of administration， contraindication， usage and dosage， treatment course， etc. At the same time， these patients were followed up by telephone or outpatient service， and their pregnancy outcomes and ADR were summarized. RESULTS： A total of 12 646 prescriptions were collected， and 7 222， 3 912， 181 and 1 331 prescriptions used EV， EP， EG and EV+EP， respectively. The types of off-label use included over-indication， over-route and over-contraindication， and the rates of off-label use rates were 100％， 11.73％ and 43.60％， respectively. A total of 5 868 ART patients were involved； 439 patients received fresh embryo transplantation， and 5 429 patients received frozen-thawed embryo transplantation， involving 720 and 11 926 prescriptions， respectively. The rates of off-label use of above E2 preparations were 100％ （except for fresh embryo transplantation patients using EG）. As of Feb. 2018， the infant-holding rates of ART patients using EV， EP， EG and EV+EP were 85.29％， 85.37％， 86.36％ and 85.45％， respectively. No relevant ADR and neonatal birth defect was found. CONCLUSIONS： The phenomenon of off-label use of E2 preparations is widespread in the reproductive medicine center of the hospital. Although there is no indication of related safety risks， evidence-based evaluation should be carried out by enlarging the sample size in clinical practice， and careful use.
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OBJECTIVE:To promote the normative management of clinical off-label drug use. METHODS:The degree of devi-ation from the drug instructions and the risk degree were comprehensively considered,and the off-label drug use were classified in-to three different situations for classifying approval and informed consent classifying;situation and effects after classifying were evaluated. RESULTS:The classifying included occasional or small amount off-label use on dosage and drugs solvent (the first), regular off-label use on route or administration(the second)and super-indications drug use with contraindications(the third). The approval was classified as follows as confirmed with signature by doctor,approved by medical department,approved by pharmaceu-tical committee and ethics committee accordingly;informed consent classifying were signing informed consent,informing and re-cording in medical record,informing orally. Off-label drug use approval process was officially initiated from Feb. 2014 to Jun. 2016 in our hospital,51 off-label drug use applications from 13 clinical departments were received,with 16 items belonging to the second situation,35 items belonging to the third. Finally 42 applications were approved and 9 were not. No relevant new/serious ad-verse drug reactions/ events occurred in process of the approved off-label drug use. And no off-label drug use not approved was found to continue to be used in our hospital. CONCLUSIONS:Classification management methods for off-label drug use in our hos-pital have shown high operability,improved the off-label drug use behavior of physicians.
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Objective:To explore the content and model for clinical pharmacists to carry out pharmaceutical care on elderly pa-tients with atrial fibrillation combined with other diseases treated by warfarin. Methods:One case of an elderly atrial fibrillation patient complicated with coronary artery disease and urinary tract infection suffering elevated INR after the use of warfarin was applied as the example. The pharmaceutical care was carried out by clinical pharmacists including analyzing the causes of elevated INR and assisting the doctor to develop the individualized pharmaceutical care plan. Results: After the adjustment of warfarin dose and the other drugs combined with medical education, bleeding and thromboembolic events did not occur during the hospitalization, and finally, satisfactory effect of anticoagulation therapy was achieved. Conclusion: The implementation of pharmaceutical care on anticoagulation in atrial fi-brillation patients with various diseases is helpful to improve the compliance in patients, avoid the occurrence of adverse drug reactions and guarantee the effectiveness and safety of warfarin.
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OBJECTIVE:To investigate the efficacy and mechanism of ademetionine for treating hyper-unconjugated bilirubinemia in neonate rats.METHODS:The model of hyper-unconjugated bilirubinemia was established in 95 neonate SD rats by subcutaneously injection of phenylhydrazine hydrochloride,then the rats were randomly assigned to model control group(treated with normal saline),therapeutic control group(phenobarbital/nikethamide)and the therapeutic group(s-adenosyl-1-methionine)q.d for 7 days all by intraperitoneal injection.Blood samples were taken at different time for the analysis of the hepatic BUGT activity and serum bilirubin.RESULTS:In therapeutic control group compared with the model control group,the serum unconjugated bilirubin was lower,and the hepatic BUGT activity of therapeutic was higher(P