ABSTRACT
OBJECTIVE：To initially evaluate the safety of ceritinib after it is marketed ，and to provide reference for the rational use of drug. METHODS The report odd ratio method and proportional reporting ratio method were used to mine the signals of ceritinib-related adverse events from FDA adverse event reporting system （FAERS）during the second quarter of 2014 to the third quarter of 2019. The patients ’gender，age，body weight ，daily dose and course of treatment were collected. SPSS 26.0 software was used to test the number of ADR cases of this system group and other system groups by chi square test. RESULTS ：A total of 10 318 ADR reports with ceritinib as the first suspicious drug were collected ， and 236 ADR signals of seretinib were excavated. After excluding the ineffective treatment ，187 ADR signals were obtained ，involving 16 systems. Inaddition to those mentioned in the drug instructions ，the signals also included various nervous disease ，blood and lymph system disease ，infections and infectious disease ，etc.，such as hand-foot-genital syndrome ，mutation of anaplatic lymphoma kinase gene. Among them ，the ADR reports of gastrointestinal diseases were the most （576 cases）. Compared with ADR of other systems ，gender，age，body weight，daily dose and treatment course had significant effects on ADR of gastrointestinal diseases （P＜0.05）. Most of the patient with gastrointestinal ADR after using ceritinih were female （59.9％），45 years old and above （70.3％），body weight ≤65 kg （68.1％），daily dose 451-750 mg/d（50.2％），and medication duration less than 3 months（75.7％）. CONCLUSIONS ：The risk of gastrointestinal ADR in female patients over 45 years old and with body weight less than 65 kg after using seretinib is relatively high. This kind of ADRs are also related to daily dose ，and most of which occur within 3 months. Therefore ，great importance should be attached to drug monitoring during clinical use.
ABSTRACT
OBJECTIVE:To investigate the role of compatibility on clinical efficacy action of the prescription containing Curcu-ma zedoaria,and to improve the pertinence of drug use by medical staff and clinical efficacy of C. zedoaria. METHODS:By re-viewing relevant literatures,the prescriptions containing C. zedoaria were selected to summarize the effects of compatibility on clini-cal efficacy of C. zedoaria. RESULTS:345 prescriptions containing C. zedoaria were collected,mainly including the compatibility of C. zedoaria with traditional Chinese medicine which promote the circulation of qi,activate blood and remove blood stasis,toni-fy deficiency,warm interior and clear heat. The prescriptions containing C. zedoaria with sparganii often included Rhizoma Sparga-nii and C. zedoaria,involving 219 prescriptions(13.94%). CONCLUSIONS:C. zedoaria have the effects of activating blood stag-nation,promoting the circulation of qi,removing food retention and relieving pain;different compatibility greatly influence the clinical efficacy of C. zedoaria;common couplet medicines are R. Sparganii and C. zedoaria,and it can play the role of activating blood stagnation,promoting the circulation of qi,removing food retention and relieving pain;Common Vladimiria Root combined with Rheum palmatum can promote the circulation of qi and relieve pain. Medical staff should prescribe the prescriptions and use drugs for the compatibility of C. zedoaria based on clinical demands.
ABSTRACT
OBJECTIVE:To study the effects of Heishun tablets combined with Rheum palmatum on the pharmacokinetics of hypaconitine in rats. METHODS:Rats were randomly divided into single drug group(Heishun tablets decoction)and drug combi-nation group(Heishun tablets-R. palmatum mixture decoction),with 18 rats in each group. They were given relevant drugs intragas-trically,by 10 g(medicinal materials)/kg of Heishun tablets. 0.3 ml blood samples were collected before(0 h)and 0.083,0.167, 0.333,0.5,0.75,1,1.5,2,3,4,6,8,10 h after medication with 6 rats at each time point,respectively. The blood concentra-tion of hypaconitine was determined by HPLC-MS using palmatine hydrochloride as internal standard. DAS 2.0.1 software was used to calculate pharmacokinetic parameters. RESULTS:The linear range of hypaconitine was 0.102 4-100 ng/ml (r=0.998 7),and the limit of quantification was 0.1 ng/ml. The pharmacokinetic parameters of single drug group vs. drug combination group were as follows as tmax of (0.50 ± 0.086) h vs. (0.75 ± 0.132)h;t1/2 of (9.967 ± 1.123) h vs. (3.708 ± 0.507) h;AUC0-10 h of (26.087 ± 0.672) μg·h/L vs.(6.516 ± 1.135) μg·h/L;cmax of (6.124 ± 2.312) μg/L vs. (1.592 ± 0.051) μg/L. Compared with single drug group,t1/2,AUC0-10 h and cmax of hypaconitine were decreased in drug combination group,with statistical significance (P<0.05). CONCLUSIONS:R. palmatum can inhibit the absorption of hypaconitine in rats,and speed up the elimination of it in rats.