OBJECTIVE:To investigate off-indication use of oral chemical drugs medical orders by the standards of CFDA and FDA,and to compare the differences between the two standards,analyze reasons and rationality of drug use,so as to pro-vide reference for establishing off-indications use management system. METHODS:The oral chemical drugs medical orders of inpatients were analyzed statistically during Jan.-Jun. 2016. Off-label uses was judged according to the standards of CFDA and FDA. RESULTS:Totally 507 oral chemical drugs medical orders were collected,the percentage of off-indications use were in high level,being 58.58% and 55.82% respectively by the standards of CFDA and FDA. The incidence of off-indication use of quetiapine and aripiprazole by the CFDA standards were significantly higher than the results of FDA standards,with statistical significance(P<0.05). Magnesium valproate(54.03%),escitalopram oxalate(10.45%)and quetiapine(10.15%)occupied the top 3 places in the list of constituent ratio. Among off-indication medical orders,7 orders had no evidence-based medicine,ac-counting for 2.36% of total. CONCLUSIONS:Most off-indication medical orders of our hospital could provide the basis and lit-erature support,while there are still a few off-indication use with insufficient evidence. The corresponding management system of the hospital should be formulated to guarantee the medication safety of the patients and legitimate rights and interests of the doctors.

Objective:To investigate the proliferation of rat glomerular mesangial cells (GMC) influenced by different ethanol extracts of Tripterygium wilfordii HooK F.(TWHF).Methods:An HPLC method was used to establish the fingerprints of 5 different ethanol extracts of TWHF,and GMC was chosen to study the effects of different ethanol extracts of TWHF on cell proliferation.After statistical analysis,the spectrum-activity relationship was analyzed by using partial least squares regression(PLSR).Results:The HPLC fingerprints of the 5 different ethanol extracts of TWHF were established,and 32 characteristic peaks were characterized by the HPLC fingerprints.60%,70% and 95% ethanol extracts and glycosides tablets showed dose-effect relationship,and with the increase of dose,the more significant inhibition of cell proliferation was exhibited.The absorbance values of the 60% ethanol extracts at medium and high doses were lower than those of the other extracts at the same dose.The proliferation inhibition rate of GMC was used as the potency index and analyzed by PLSR,and 20 peaks were potency peaks at high dose(40 μg·L-1),17 ones were potency peaks at medium dose(20 μg·L-1) and 15 ones were potency peaks at low dose(10 μg·L-1).Conclusion:Part of the potency peaks has regular dose-effect relationship with the changes of dose.