OBJECTIVE:To excavate and evaluate the security alert signals of linezolid after marketing,and to provide refer-ence for rational drug use in clinic. METHODS:The reporting odds ratio(ROR)method was used to excavate the security alert signals from the adverse drug events(ADE)data in the OpenFDA platform of FDA during second quarter of 2004-2016. The low-er limit of 95%CI >1 was regarded as suggestive of ADE alert signal. RESULTS:A total of 6828534 reports were extracted, among which there were 7224 reports mainly induced by linezolid. Top 10 ADE reports were thrombocytopenia,drug interac-tion,thrombocytopenia,nausea,anaemia,serotonin syndrome,diarrhoea,pyrexia,drug ineffective,vomiting. After the detec-tion of top 200 ADE reports by ROR method,120 signals related to 18 system organ class(SOC)were identified. Top 5 ADE sig-nals in turn by SOC were medical examination,nervous system disorders,blood and lymphatic system disorders,metabolism and nutrition disorders,cardiac disorders. The high risk signals with clinical reference value included 42 cases of optic neuropathy (ROR=56.33),350 cases of serotonin syndrome(ROR=52.86),162 cases of lactic acidosis(ROR=18.30),31 cases of endo-carditis (ROR=15.38),566 cases of thrombocytopenia (ROR=14.29),122 cases of bone marrow failure (ROR=14.20),261 cases of panhematopenia (ROR=11.92),86 cases of disseminated intravascular coagulation (ROR=10.91),58 cases of toxic epidermal necrolysis(ROR=9.06),etc. As for ADE reports,male was slightly higher than female,and the patients in age group of ≥45 reported evidently more compared to younger age group. CONCLUSIONS:By detecting and evaluating alert signals of li-nezolid through OpenFDA platform,we could effectively lay the foundation for further research of pharmacovigilance.

We studied the correlation of sustained-release tablet of naftopidil between the in vitro release and the in vivo absorption in the dog. The release rate (X) of naftopidil sustained-release tablet in artificial gastric fluid was determined and the naftopidil concentration in plasma was determined after a single oral dose of 100 mg naftopidil (tablet or sustained-release tablet) in the dog. The absorbed fraction(F) and in vivo absorption rate (A) of the NAF sustained-release tablet in the dog at different time were calculated by W-N method and deconvolution method, respectively. Then the regression equations between F or A and X of the corresponding time point were obtained: F=2. 1533X - 27. 636(r = 0.9927) and A=2.3452X - 25.474(r= 0.9938). W-N method and deconvolution method both indicated that the correlation between the in vitro release and the in vivo absorption in the dog of the NAF sustained-release tablet was good.
Animals ; Biological Availability ; Delayed-Action Preparations ; Dogs ; Naphthalenes ; chemistry ; pharmacokinetics ; Piperazines ; chemistry ; pharmacokinetics ; Solubility ; Tablets

OBJECTIVE:To explore the role of clinical pharmacists participating in anti-infective treatment for a child with complex infection. METHODS:Clinical pharmacists participated in treatment process of one child with pulmonary infection and brain abscess after a near-drowning incident,assisted physicians to adjust antibiotics therapy plan,and put several suggestions as the adjustment of anti-gram-positive and anti-gram-negtive bacterium drugs,the dosage adjustment of vancomycin,vancomycin-induced ADR and disposal,the selection of anti-Pasteurella pneumotropica drugs,the enhancement of anti-fungal infection therapy,accord-ing to pathogen characteristics,treatment effect and ADR. RESULTS:Physicians partly adopted the advice of clinical pharmacists, the child’s pulmonary and brain infection were controlled effectively and ADR disappeared after 5 times of adjusting anti-infective the rapy plan. CONCLUSIONS:Clinical pharmacists participate in the treatment process of one child with complex infection,and assist physicians to formulate safe and effective anti-infective plan according to the results of etiological examination;dispose ADR timely and carry out efficacy evaluation of antibiotics and pharmaceutical care,that can give positive effects on patient treatment.

OBJECTIVE:To systematically review the efficacy of agomelatine in the treatment of depression in acute phase, and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from Cochrane Library,Medline,EMBase, CJFD,VIP,CBM,Wanfang Database,WHO Clinical Trials Registry Platform and American Clinical Trials Registry Platform, the randomized controlled trials (RCT) about agomelatine versus placebo in the depression patients in acute phase. After quality evaluation and data extraction,Meta-analysis was conducted by using Rev Man 5.2 statistics software. RESULTS:A total of 7 RCT were included,involving 2 378 patients. Results of Meta-analysis showed the effective rate in agomelatine group was obviously bet-ter than placebo group [RR=1.43 ,95%CI(1.29 ,1.59),P<0.001] ,remission rate was obviously better than placebo group [RR=1.27 ,95%CI(1.03 ,1.57),P=0.02] ,and the endpoint score of depression scales was obviously lower than placebo group [MD=-2.92,95%CI(-3.65,-2.20),P<0.001],there was statistically significance. CONCLUSIONS:Agomelatine is effective in the treatment of depression patients in acute phase. However,due to the limit of methodological quality and sample size,it remains to be further verified with more rigorously designed and long-term follow-up of large-scale RCT.

OBJECTIVE:To provide reference for vancomycin-induced neutropenia adverse reactions/adverse events in clinical diagnosis. METHODS:With a case of children with neutropenia treated by long-course and large-dose vancomycin,PubMed and CNKI were retrieved to collect related literature and the literature was analyzed. RESULTS:Neutropenia may be associated with vancomycin,based on causality criterion of adverse reaction in China. CONCLUSIONS:Vancomycin-induced neutropenia in chil-dren is most likely associated with prolonged exposure induced by infusion,vancomycin dosage should be reduced or stopped,and routine blood and plasma concentration should be closely monitored.

Objective To explore the factors influencing serum trough concentration of vancomycin in pediatric patients with severe gram-positive cocci pneumonia. Methods The general information, the biochemical test results, and plasma concentration of vancomycin were collected from 93 pediatric patients with severe gram-positive cocci pneumonia. The relative factors influencing trough concentration of vancomycin were analyzed retrospectively. Results With the dosage of 40-60 mg/(kg·d), serum trough concentration of vancomycin were between 10-20 mg/L in 26 patients, <10 mg/L in 54 cases, ≥20 mg/L in 13 cases. The ALT, AST, GFR, and γ-GT were significantly different among three groups (P<0.05); the 10-20 mg/L group had the highest levels of AST and γ-GT, the ≥20 mg/L group had the highest level of ALT and the lowest level of GFR. Multiple linear regression analysis showed that GFR was negatively linearly correlated with the serum trough concentration of vancomycin (R2=0.039, P<0.05). The median serum trough concentration of vancomycin in pediatric patients with GFR≥90, 60–90, 30–60 mL/(min·1.73m2) were 8.66, 18.21, 8.45 mg/L respectively, and the difference is statistically significant (P<0.05). Conclusions The serum trough concentration of vancomycin is negatively linearly correlated with GFR in pediatric patients with severe gram-positive cocci pneumonia. The patients with impaired renal function are easier to reach the target serum trough concentration of vancomycin. Clinical use of vancomycin should follow the low doses in the range the guideline recommended, and the serum trough concentration should be closely monitored.

In order to cultivate clinical pharmacy undergraduates to have better quality, Chongqing Medical University collaborated with The University of Chicago and University of Cincinnati in the reform of the course of pharmacotherapeutics. We build pharmacotherapeutics series curriculum with the center of disease, construct department of clinical pharmacy for transnational departments, build course leader and teaching team of pharmacotherapeutics series curriculum , compile teaching program and its material of pharmacotherapeutics series curriculum, build pharmacotherapeutics series curriculum and teaching model in line with the current direction of China's education system of clinical pharmacy training, reform teaching methods, and strengthen clinical pharmacy practice and community clinical pharmacy education.

OBJECTIVE:To investigate the general regularity and characteristics of propylthiouracil (PTU)-associated small vasculitis (ASV),and to provide reference for rational drug use in the clinic. METHODS:ADR/ADE case reports of PTU-ASV published during 1990-2016 were retrieved. The data of 118 ADR cases were analyzed statistically. RESULTS:The incidence of PTU-ASV was higher in female and was highest in 18-59 age group. Drug dose of 87 patients were within 600 mg/d,and the inci-dence of PTU-ASV was the highest within 1-5 years after medication. Main clinical manifestations were renal and lung function in-jury. After drug withdrawal,59 patients received hormone therapy,and 30 patients received hormone combined immunosuppressive agent. Finally,115 patients were recovered and 3 patients died. CONCLUSIONS:In older to reduce or avoid the occurrence of ADR,it is necessary to regularly check antineutrophil cytoplasmic antibody related indexes and evaluate the symptoms of ADR.

Objective To analyze the characteristics of serum vancomycin concentrations and its clinical therapeutic effects. Methods Serum vancomycin concentrations of 59 children diagnosed with severe Gram positive cocci pneumonia and treated with vancomycin were retrospectively analyzed. Vancomycin concentrations, biochemical values and disease status of patients were analyzed. Results The serum vancomycin concentrations of severe Gram positive cocci pneumonia children accompanied by acyanotic congenital heart disease was significantly higher than those without congenital heart disease, ( 12 . 12 mg/L vs 7 . 76 mg/L, P=0 . 008 ). The therapeutic effect of 40-60 mg/(kg·d) dosage group was signiifcantly higher than that of?60 mg/(kg·d) dosage group. Acute liver function damage and moderate/severe anemia may be risk factors for poor therapeutic effects to severe Gram positive cocci pneumonia children (P?

Glioblastoma (GBM), characterized by rapid progression, easy recurrence and treatment resistance, is the most aggressive and lethal tumor of the central nervous system. Adenovirus E1A binding protein p300 (p300) serves rich functions as transcriptional coactivator and lysine acetyltransferase. Studies have shown that p300 plays an important role in the occurrence, proliferation, invasion and resistance to chemoradiotherapy of GBM. This paper reviews the structure and function of p300, and systematically expounds its various ways participating in GBM development and its translational perspectives, so as to provide references for GBM study.