RESUMEN
OBJECTIVE:To systematically review the efficacy and safety of nedaplatin or cisplatin combined with paclitaxel in the treatment of advanced non-small cell lung cancer(NSCLC)and esophageal cancer. METHOD:Retrieved from PubMed,CJFD and Wanfang Database,randomized controlled trials(RCT)about nedaplatin combined with paclitaxel(TN)or cisplatin combined with paclitaxel (TP) in the treatment of advanced NSCLC and esophageal cancer were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extract and quality evaluation. RESULTS:Totally 7 RCTs were included,involving 505 pa-tients. Results of Meta-analysis showed,there were no significant differences in the short-term efficacy [NSCLC:OR=1.08,95%CI (0.66,1.75),P=0.76;esophageal cancer:OR=1.44,95%CI(0.68,3.06),P=0.34],1-year survival rate [NSCLC:OR=1.21, 95%CI(0.60,2.44),P=0.59],2-year survival rate [NSCLC:OR=1.01,95%CI(0.38,2.68),P=0.99],the incidence ofⅢ/Ⅳleuko-penia [esophageal cancer:OR=1.36,95%CI(0.62,2.96),P=0.44],incidence ofⅢ/Ⅳthrombocytopenia [NSCLC:OR=1.37,95%CI(0.64,2.92),P=0.42;esophageal cancer:OR=0.97,95%CI(0.30,3.18),P=0.96] and incidence of Ⅲ/Ⅳ neutropenia [NSCLC:OR=1.38,95%CI(0.70,2.74),P=0.35]. Compared with TP,TN can significantly reduce the incidences of nausea and vomiting [NSCLC:OR=0.34,95%CI(0.20,0.60),P<0.001;esophageal cancer:OR=0.16,95%CI(0.07,0.35),P<0.001] and nephrotox-icity [esophageal cancer:OR=0.10,95%CI(0.02,0.55),P=0.009]. CONCLUSIONS:Both TN and TP show good efficacy in the treatment of NSCLC,but TN has lower incidences of astrointestinal reactions and nephrotoxicity.
RESUMEN
OBJECTIVE:To provide reference for formulating related provisions,guidelines and regulations for off-label drug use,standardizing medical behavior in medical health institutions. METHODS:According to the connotation of off-label drug use,Questionnaire for off-label drug use was developed for medical institutions,in which drug name,treatment disease,the type and use evidence ofoff-label drug usewere included. The questionnaires were delivered to pharmacists who participatedClinical phar-macist practice skills training in Sichuan province to collect the related information of off-label drug use for statistical analysis, and suggestions were put forward. RESULTS:Totally 150 questionnaires were sent out,124 were effectively received with effec-tively recovery of 82.7%;the surveyed pharmacists came from 22 medical institutions,including 18 tertiary hospitals and 4 second-ary hospitals;there were 128 information about off-label drug use,including 14 (10.9%) with incomplete reporting information. The another 114 information were major in“super indication”(61) and“super administration”(43),accounting for 53.5% and 37.7%,respectively,and there are 8 other drug overdose(7.0%),2 super object(1.8%). The relevant off-label drug use mainly included anti-infection drugs (34 information,29.8%),anti-tumor drugs (16 information,14.0%),TCM injections (8 informa-tion,7.0%),and etc.;the relative concentration of varieties were metronidazole,dexamethasone,gentamicin,methotrexate, azithromycin,irinotecan,vancomycin,nystatin,etc.. Some medical institutions were absence of effective regulatory measures. CONCLUSIONS:Off-label drug use is quite common in medical institutions of Sichuan province,some of them exist obvious med-ication risk. It is suggested that the state should be as soon as possible to develop related provisions,guidelines and regulations for off-label drug use,endowing legal force for off-label drug use;medical staff should avoid no evidence-based drug use,unreason-able or even unnecessary off-label drug use;pharmaceutical production enterprises should strengthen communication with medical institutions and pay attention to collect information related to the clinical medication,timely update the drug instructions to ensure the legitimate rights for patients and the interests for medical staff.
RESUMEN
Objective To explore the feasibility of anti-85B and ESAT-6 monoclonal antibodies targeted contrast agent of CT by the murine acute tuberculosis animal model.Methods Preparation the targeted contrast agent of computed tomography by iodine atoms coupled with anti-85B and ESAT-6 murine monoclonal antibodies after purified.Calculate the label rate and the quality of 127Ⅰ of the targeted contrast agent solution,and dilute the contrast agent solution to the required concentration (5μg I/ml) to spare.There were twenty mice of acute tuberculosis animal model,which were divided into four groups by completely randomized digital table and each group was five animals.According to the different antibody named as 85B group and ESAT-6 group of targeted contrast agent,common contrast agent and blank control separately.The common contrast agent group was injected with diluents of iohexol,which was diluted into the same concentration with the targeted contrast agent.The control group was injected with antibody diluents pH 7.4 Phosphate Buffered Saline (PBS).All the animals were scanned before and after injection the contrast agent in different time,such as immediate,6 hours,12 hours and 24 hours.Observe the display and changes of the murine tuberculosis lesions,and measurement the CT value,which was regarded as evaluating mark.Enhancement ratio was also calculated.Two sample mean differences with t test and the multiple sample mean differences with ANOVA.Results The volume of anti-85B contrast agent solution was 2.52 ml,and the quality of antibody and 127Ⅰ were range from 210 to 255 μg and 10.5 to 16.6 μg respectively.The volume of anti-ESAT-6 contrast agent solution was 2.93 ml,and the quality of antibody and 127Ⅰ were 147 μg and 20.58 μg respectively.The lesions of the control group showed no visible density changes before and after injection of PBS.The CT value of the lung lesions in the targeted contrast agent group were gradually increased with time,and the lesion showed visible enhancement after the contrast injection twelve hours(t12),and also remained visible enhancement after injection twenty-four hours(t24)[85B group t12 =(-125.04 ± 13.58) HU,t24 =(-117.37 ± 12.28) HU and ESAT-6 group t12 =(-122.14 ± 19.01) HU,t24 =(-114.23 ± 17.08) HU],which is significant difference compared to the common contrast agent [t (85B-24 h) =4.05,t (ESAT-6-24 h) =6.39,P ＜ 0.05].Conclusions The targeted property of anti-85B and ESAT-6 murine monoclonal antibody contrast agent of CT had been partly proved by the acute tuberculosis animal model.Also provided an experimental basis for further study of tuberculosis targeted contrast agent.