Data Mining of Azathioprine Related Death Events Based on FDA Adverse Event Report System / 中国药房

OBJECTIVE： To mine the data of azathioprine related death events based on FDA Adverse Event Report System （FAERS）， and to provide reference safe use of azathioprine in clinic. METHODS： Totally 60 quarters of FARES data were downloaded from 2004Q1 to 2018Q4. After drug names standardized by Medex_UIMA_1.3.7 and adverse events classified by MedDRA， death events related to azathioprine were extracted. The safety signals were detected by using ROR and PRR methods. The death events related to azathioprine were analyzed in respects of patient’s general information， reporter’s information， time and country distribution of reports， signal detection results， dose and drug combination of direct and indirect death， reported frequency of indirect deaths. RESULTS： A total of 39 695 azathioprine related death events were gathered， including 707 direct death reports and 3 219 indirect death reports. The media age was 55 years in dead. Physicians and other health professionals reports took up 77.38％. Azathioprine administered orally took up 90.40％ （647/715） in reported cases of known route of adiministration. “Fetal death” （ROR＝4.16， PRR＝4.16） and “neonatal death” （ROR＝4.99， PRR＝4.99） were detected as signal. About 30 percent of the death reports were the old patients. There were cases using azathioprine beyond contraindications or maximum dosage. Among drug combination， immunosuppressive drugs were used most frequently. Infection events were reported most frequently in indirect deaths （3 122 reports）. CONCLUSIONS： The potential death risk of azathioprine should be paid attention to， and the contraindications and dosage of azathioprine should be strictly controlled. Great importance should be paid attention to medication for special population of the elderly and children. It is suggested that genetic testing and precise drug use should be perfected before using azathioprine.

Cost-effectiveness Analysis of SOX Regimen versus CapeOX Regimen for Metastatic Colorectal Cancer / 中国药房

OBJECTIVE:To evaluate the cost-effectiveness of SOX regimen(tegafur+oxaliplatin)vs. CapeOX regimen (capecitabine+oxaliplatin)in the treatment of metastatic colorectal cancer,and to provide reference for exploring more economical first-line regimen of metastatic colorectal cancer. METHODS:Based on published high-quality Ⅲ-phase randomized controlled trial,Markov model was established according to the process of disease development in patients with metastatic colorectal cancer. The model was divided into progression-free survival state,progressive disease state and death state. Combined with relevant data of our hospital,pharmacoeconomic cost-effectiveness analysis was conducted for SOX regimen and CapeOX regimen. Sensitivity analysis validation model was used to analyze the stability of the model. RESULTS:According to the results of Markov model operation,compared to standard CapeOX regimen,SOX regimen could increase 0.14 QALYs,and cost increased by 35 493.45 yuan;incremental cost-effectiveness ratio was 253 524.64 yuan/QALYs,which was higher than willingness-to-pay(WTP) threshold(168 201.201 yuan/QALYs). Single factor sensitivity analysis showed that cost of oxaliplatin had the most important impact on the result of cost-effectiveness analysis. Probabilistic sensitivity analysis depicted that with the increase of GDP per capita,the probability of SOX regimen with cost-effectiveness would increase. CONCLUSIONS:At present,compared with standard CapeOX regimen,SOX regimen has no cost-effectiveness for metastatic colorectal cancer,which is not recommended as the first choice for first-line treatment of metastatic colorectal cancer.