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OBJECTIVE:To observe therapeutic efficacy and safety of dexrazoxane combined with Shenmai injection in the treatment of anthracycline-induced cardiotoxicity in patients with breast cancer. METHODS:120 female breast cancer patients were randomly divided into group A,B,C and D with 30 cases in each group. Group A was given CAF chemotherapy plan(cyclophos-phamide 75 mg/m2+fluorouracil 500 mg/m2 + doxorubicin 60 mg/m2),ivgtt;group B was additionally given Shenmai injection 50 ml,qd,ivgtt,on the basis of CAF plan;group C was additionally given rapid intravenous of dexrazoxane 60 mg/m2 30 min before chemotherapy,on the basis of CAF;group D was additionally given constant dose of dexrazoxane combine with Shenmai injection on the basis of CAF plan. A treatment course lasted for 3 weeks,they were given 4 courses in total. The change of ECG,LVEF, cTnT and BNP and the incidence of bone marrow suppression were observed before and after chemotherapy. RESULTS:After treat-ment,the rate of abnormal ECG,LVEF value,cTnT value and BNP value of groups B,C and D were all decreased significant-ly,with statistical significance(P<0.05). Compared with group D,above index of groups B and C were decreased significantly, with statistical significance(P<0.05). The incidence of bone marrow suppression was in ascending order,group D
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OBJECTIVE:To carry out drug risk management so as to ensurethe safety of clinical drug use in the hospital. METHODS:The mode of drug risk management of our hospital was established,in the form of drug risk identification,risk evalu-ation,risk control and risk review,and the measures for risk management were developed and taken. The effect of drug risk man-agement was evaluated after 3 years (2012-2014) of colletion and analysis of the questionnaires given to clinical medical workers and patients and the results of evaluation by the group of pharmacy management and quality control for drug use in the hospital. RE-SULTS:Following the establishment and improvement of drug management information system,the strengthening of the manage-ment of special drugs,strict implementation of the Management System for the Return and Recall of Drugs,the establishment of specialized drug safety monitoring body,the development and implementation of the measures such as self-inspection in the hospi-tal,the problems about drug safety in our hospital had been decreasing from 2012 to 2014(88,42 and 19 cases respectively);and 96.59%,97.62% and 100% of drug safety problems were solved by the pharmacy staff to the satisfaction of the group of pharma-cy management and quality control for drug use in the hospital respectively in the three years. CONCLUSIONS:The mode of drug risk management established in our hospital has promoted the safety of drug use.
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Objective To develop a simple method of determination of sorafenib in serum by reversed-phase high performance liquid chromatography (RP-HPLC) and to explore its application in sorafenib therapeutic drug monitoring (TDM).Methods Sorafenib extracted by ethyl ether-petroleum (9∶1) with internal standard of erlotinib from serum was wiped off in 60 ℃ water bath.Sorafenib was redissolved by mobile buffer and analyzed by 40 μl.Chromatographic column was Symmetry Rp18 (5 μm,4.6 mm×250 mm,waters) column in normal temperature.The mobile buffer was 28 mmol/L acetate buffer (pH 5.8)-acetonitrile (37∶63).Sorafenib and erlotinib were detected in 249 nm and 335 nm,respectively.Results The concentration range of sorafenib was 0.50-20.00 μg/ml (r =0.9999).The within-day and between-day accuracies of sorafenib were less than 4.77 ％ and 8.79 ％,respectively.The average recovery rate was 98.48 ％.Sorafenib was stable in serum or after extraction.The concentrations of sorafenib in two patients were detected.Conclusion Detection of sorafenib in serum by RP-HPLC is simple and accurate,which is available to determine sorafenib in serum.The TDM of sorafenib has clinical significance.