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OBJECTIVE：To provide evidence-based reference for c linical drug selection and decision by rapidly evaluating the effectiveness，safety and economy of treprostinil in the treatment of pulmonary arterial hypertension （PAH）. METHODS ：Retrieved from Chinese and English database such as PubMed ，Embase，Web of Science ，the Cochrane Library ，Epistemonikos，HTA database（University of York ），CNKI and Wanfang databases ，included the health technology assessment （HTA）report，systematic/ Meta-analysis and pharmacoeconomic evaluation of treprostinil compared with placebo or other drugs in the treatment of PAH. The search time limit is from the construction of the database to May 1st，2020. HTA checklist ，AMSTA and CHEERS were applied to evaluate the quali ty of the literatures about HTA ，systematic review/Meta-analysis analysis a nd pharmacoecono mic evaluation and the inclusion studies was analyazed by descriptive summary. RESULTS：A total of 18 literatures were included ，involving 1 HTA report ，12 systematic review/Meta-analysis ，5 pharma- coeconomic studies. The analysis results of effectiven- ess mail： showed that compared with placebo ，treprostinil could signifi- cantly increase 6-MWD while decrease Borg dyspnea score of PAH p atients（P＜0.05），but had no significant effect on mortality，the rate of clinical deterioration ，WHO functional grading ，the rate of hospitalization ，mPAP，PVR，cardiac index and mRAP（P＞0.05）. In addition ，compared with placebo combined with endothelin receptor antagonist and/or phosphodiesterase inhibitors，oral administration of treprostinil combined with endothelin receptor antagonist and/or phosphodiesterase inhibitors could extend 6-MWD significantly. Compared with riociguat ，treprostinil could significantly reduce Borg dyspnea score of patients. The analysis results of safety displayed that ，although the incidence of drug withdrawal due to can ’t tolerate ADR increased in patients receiving treprostinil ，there was no significant difference in the incidence of serious adverse events compared with placebo or other treatments，and it was better tolerated when administered by inhalation or intravenous injection. The analysis results of pharmacoeconomic studies showed that ICER of treprostinil was higher than the willingness payment threshold ，although the willingness payment threshold was different in different countries and different payers. CONCLUSIONS ：Treprostinil treatment is effective for PAH. Patients may stop taking it due to can ’t tolerate ADR ，but the risk of serious adverse events are not increase. Although the price is high ，it is still an important alternative for PAH patients with clinical progress or poor prognosis.
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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.
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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.
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OBJECTIVE:To provide the new idea for clinical pharmacists providing pharmaceutical care in oncology depart-ment. METHODS:Applying the principles and methods of clinical pathway,the pharmaceutical care of anti-tumor drugs could be divided into before medication,during medication,after medication and patient education,according to the sequence of taking med-icine. On the basis of evidence-based medicine,the care contents of each unit were established,and the pharmaceutical care path-way (PCP) was formed. During chemotherapy duration for a breast cancer metastasis patient with liver function injury,clinical pharmacists conducted pharmaceutical care for drug pretreatment,ADR monitoring and disposal,patient education,as well as put forward the proposal of drug treatment as supplementing calcium,adjusting the dose of epirubicin and paclitaxel targeting on PCP of zoledronic acid,epirubicin and paclitaxel. RESULTS:Physicians adopted the pharmacist’s recommendations. The patient suf-fered from joint and muscle pain during chemotherapy,and the symptom was relieved after symptomatic treatment by celecoxib;chest and back discomfort was relieved significantly after chemotherapy,and the disease condition kept stable. The patient was dis-charged from the hospital. CONCLUSIONS:PCP focus on the time,content and countermeasures of pharmaceutical care,the pro-gram and treatment results of pharmaceutical care,and promote standardization,formalization,simplification and procedure of pharmaceutical care. Clinical pharmacists conduct individualized pharmaceutical care rapidly targeting on PCP so as to deepen the communication of clinical pharmacists with physicians,nurses and patients,and promote the development of pharmaceutical care smoothly.
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OBJECTIVE:To establish a RP-HPLC method to determine the content of Oleanolic acid in Ziyin shug-an granule. METHODS: Kromasil C18 column(250 mm?4.6 mm,5 ?m)was used as chromatographic column,and the mobile phrase consisted of methanol-0.2% phosphoric acid(80∶20) at a flow rate of 1.0 mL?min-1 and the det-ection wavelength was set at 208 nm,and the column temperature was maintained at room temperature.RESULTS:The calibration curve of Oleanolic acid was in good linearity over the range of 0.237～4.740 ?g(r=0.999 8).The average recovery of Oleanolic acid was 98.84% with RSD at 1.19%(n=6).CONCLUSION:The method is simple,feasible and reproducible, and can be used for the quality control of Ziyin shugan granule.