Investigation and Analysis of Off-label Use of Estradiol Preparation in ART Patients of a Hospital / 中国药房

OBJECTIVE： To provide reference for rational use of estradiol （E2） preparation in clinic. METHODS： The medical records of outpatients receiving assisted reproductive technology （ART） and E2 preparation [Estradiol valerate tablets （EV）， Complex packing estradiol tablets/estradiol and dydrogesterone tablets （EP）， Estradiol gel （EG）] were collected from the reproductive medicine center of a hospital during Jan. 2016-Mar. 2017. Taking drug instruction as standard， the rationality of medical records was evaluated from aspects of indication， route of administration， contraindication， usage and dosage， treatment course， etc. At the same time， these patients were followed up by telephone or outpatient service， and their pregnancy outcomes and ADR were summarized. RESULTS： A total of 12 646 prescriptions were collected， and 7 222， 3 912， 181 and 1 331 prescriptions used EV， EP， EG and EV+EP， respectively. The types of off-label use included over-indication， over-route and over-contraindication， and the rates of off-label use rates were 100％， 11.73％ and 43.60％， respectively. A total of 5 868 ART patients were involved； 439 patients received fresh embryo transplantation， and 5 429 patients received frozen-thawed embryo transplantation， involving 720 and 11 926 prescriptions， respectively. The rates of off-label use of above E2 preparations were 100％ （except for fresh embryo transplantation patients using EG）. As of Feb. 2018， the infant-holding rates of ART patients using EV， EP， EG and EV+EP were 85.29％， 85.37％， 86.36％ and 85.45％， respectively. No relevant ADR and neonatal birth defect was found. CONCLUSIONS： The phenomenon of off-label use of E2 preparations is widespread in the reproductive medicine center of the hospital. Although there is no indication of related safety risks， evidence-based evaluation should be carried out by enlarging the sample size in clinical practice， and careful use.

Analysis and Suggestions on the Situation of Hepatitis C Treatment and Related Medical Insurance Compensation Mechanism in China / 中国药房

OBJECTIVE:To provide reference and suggestion for relieving the disease burden of hepatitis C (HC) in China,improving medical compensation mechanism of HC treatment and the accessibility of HC drags.METHODS:By reviewing literatures and other relevant information,the epidemic situation of HC,the situation of disease screening and diagnosis,treatment progress,the economic burden of disease,medical insurance compensation in China and international experience on improving the accessibility of HC drugs were all analyzed.RESULTS:The anti-HCV prevalence rate of 1 to 59-year-old population was 0.43％ in China,and the genotype was mainly genotype 1b(58％).Nearly 38.9％ of the patients were not treated.For patients with genotype 1b,the sustained virologic response rate of traditional PEG-interferon combined with ribavirin regimen was 62％,and the effect of new direct-acting antivimls (DAA) regimen was improved significantly;patients receiving new regimen could gain 1.29 QALYs and 0.85 life years.The costs of a single course for traditional and new regimens were 54 960 yuan and 57 810 yuan,respectively.New regimen could save 378 yuan for the cost of disease management for each patient due to evasion of end-stage liver disease.After medical insurance compensation,the cost of self payment had fallen sharply for workers and residents receiving traditional regimen,while new regimen was approved in China in 2017 and had not been covered by medical insurance yet.CONCLUSIONS:New regimen has a cost-effectiveness advantage over traditional regimen.The state should pay more attention to HC patients and take measures to reduce the economic burden of them.By improving the basic medical insurance and special medical assistance fund for HC treatment,the accessibility of the drugs in new HC treatment regimen can be improved.

Inhibitory effect of ultrasound-mediated drug loaded carboxymethyl hexanoyl chitosan nanodroplet on ovarian cancer cells / 中国医学影像技术

Objective To evaluate the inhibitory effect of phase change doxorubicin loaded carboxymethyl hexanoyl chitosan nanodroplet on ovarian cancer cells,and the effect of its ultrasound image in vitro.Methods The carboxymethyl hexanoyl chitosan synthesized through the acylationreaction with carboxymethyl chitosan and hexanoic anhydride.The drug loaded carboxymethyl hexanoyl chitosan nanodroplets were prepared by ultrasonic emulsification.The surface morphology,particle diameter and electric potential were characterized.Ultrasound imaging of the nanodroplet was evaluated in vitro.The encapsulation efficiency was determined by ultraviolet spectrophotometry.The survival rate of ovarian cancer cell was detected using CCK-8 reagent.The statistical analysis was performed.Results The drug loaded carboxymethyl hexanoyl chitosan nanodroplet was successfully prepared which showed regular morphology in microscope,the mean diameter of (458.33± 43.50)nm.The encapsulation efficiency was (52.06 ± 10.14)％.The nanodroplet could enhance ultrasonic imaging.The survival rate of ultrasound combined with drug loaded nanodroplet group ([62.54± 3.60]％) was lower than those of the free drug group ([75.55±7.21]％) and drug loaded nanodroplet group ([76.18±4.94]％),ultrasound group ([89.90±0.83]％;P＜0.05).Conclusion Ultrasound-mediated drug loaded nanodroplet can inhibit ovarian cancer cells,and has the potential for application in the clinical diagnosis and treatment.

Study on the Classification Management of Off-label Drug Use in Our Hospital / 中国药房

OBJECTIVE:To promote the normative management of clinical off-label drug use. METHODS:The degree of devi-ation from the drug instructions and the risk degree were comprehensively considered,and the off-label drug use were classified in-to three different situations for classifying approval and informed consent classifying;situation and effects after classifying were evaluated. RESULTS:The classifying included occasional or small amount off-label use on dosage and drugs solvent (the first), regular off-label use on route or administration(the second)and super-indications drug use with contraindications(the third). The approval was classified as follows as confirmed with signature by doctor,approved by medical department,approved by pharmaceu-tical committee and ethics committee accordingly;informed consent classifying were signing informed consent,informing and re-cording in medical record,informing orally. Off-label drug use approval process was officially initiated from Feb. 2014 to Jun. 2016 in our hospital,51 off-label drug use applications from 13 clinical departments were received,with 16 items belonging to the second situation,35 items belonging to the third. Finally 42 applications were approved and 9 were not. No relevant new/serious ad-verse drug reactions/ events occurred in process of the approved off-label drug use. And no off-label drug use not approved was found to continue to be used in our hospital. CONCLUSIONS:Classification management methods for off-label drug use in our hos-pital have shown high operability,improved the off-label drug use behavior of physicians.

Analysis on Distribution and Drug Resistance of Acinetobacter baumannii in Our Hospital during 2012-2015 / 中国药房

OBJECTIVE:To investigate the distribution and drug resistance of Acinetobacter baumannii in our hospital,and provide reference for rational use of antibiotics. METHODS:Clinical specimen of inpatients in our hospital from Jan. 2012 to Dec. 2015 was collected,the identification of strains and drug sensitivity test were performed by the VITEK-2 microorganism analyzer;use rate of antibiotics and detection of multidrug-resistant and pandrug-resistant A. baumannii for inpatients in our hospital were an-alyzed,and their correlation was detected by Pearson correlation analysis. RESULTS:Totally 2 468 strains of A. baumannii were isolated in our hospital during 2012-2015,mainly derived from sputum samples (88.2%),distributed in respiratory medicine de-partment(47.0%)and ICU(13.1%);A. baumannii showed totally high drug resistance to common antibiotics,and only sensitive to tigecycline. Totally 386(79.3%),434(61.6%),358(53.4%)and 291(48.0%)strains multidrug-resistant A. baumannii were detected every year in our hospital;and pandrug-resistant A. baumannii were 336(69.0%),385(54.7%),331(49.3%)and 256 (42.2%) strains,respectively. There was a positive correlation between the percentage of multidrug-resistant and pandrug-resistant A. baumannii in total strains and use rate of antibiotics (r=0.987、0.981,P<0.05). CONCLUSIONS:A. baumannii has emerged as an important pathogen in hospital acquired infections,which mainly caused respiratory system infection;the drug resistance situ-ation is not optimistic,tigecycline can be used as one of the best choice for treatment of A. baumannii infections;our hospital should continue to control the use of antibiotics to decrease the emerging of drug resistance strains.

Effect of oxidative low-density lipoprotein on the proliferation of bone marrow stem cell- derived smooth muscle cells / 南方医科大学学报

<p><b>OBJECTIVE</b>To establish the model of bone mesenchymal stem cell-derived smooth muscle cells (BMSC-SMCs) and investigate the role of BMSC-SMCs in the development and progression of artherosclerosis.</p><p><b>METHODS</b>BMSCs were isolated from the femoral bone of SD rats by adherent tissue culture method, and vascular smooth muscle cells (VSMCs) were obtained from the thoracic aorta. The differentiation of BMSCs into BMSC-SMCs was induced in the conditioned medium. The specific markers of BMSCs and BMSC-SMCs were identified by immunofluorescence (IF) staining. After treatment with 80 mg/L oxidative low-density lipoprotein (ox-LDL) for 72 h, the growth characteristics of BMSC-SMCs and VSMCs were observed. Flow cytometry was applied to analyze the cell cycle of BMSC-SMCs and VSMCs.</p><p><b>RESULTS</b>BMCS-SMCs transformed into foam cells after treatment with ox-LDL, which was more obvious in comparison with VSMCs. The growth curve of BMSC-SMCs and VSMCs presented with an S-shape pattern with the cell doubling time of 20 and 32 h, which was reduced to 15 and 28 h after treatment with 80 mg/L ox-LDL, respectively. Flow cytometry showed that exposure to 80 mg/L ox-LDL significantly increased G(0)/G(1) and decreased S and G(2)/M phase cells in both BMSC-SMCs (P<0.01, n=3) and VSMCs (P<0.05, n=3) in comparison with the control cells.</p><p><b>CONCLUSION</b>BMSC-SMC might be involved in the formation of fatty core and accelerate the development of atherosclerosis.</p>

Antibiotic Drug Use in Inpatients:Survey,Analysis and Management / 中华医院感染学杂志

OBJECTIVE To improve the management of the use of antibiotics in the hospital through investigating and analyzing the cases of inpatients.METHODS From Jan 2005 to Dec 2006,totally 810 cases of operated patients and 1220 cases of non-operated patients were investigated retrospectively,and the usage of antibiotic was analyzed.RESULTS The need of using antibiotic drugs was proven in all cases in which antibiotic drugs were used.However,only 56 cases in the total 810 operated cases used drugs were completely reasonable,which accounted for 6.91%.Unreasonableness was found in the other 754 operated cases(ccounted for 93.01%),who had used inappropriate antibiotic drugs or those drugs in an improper time during the preoperative period.The average time of using prevention drugs for Type Ⅰand Type Ⅱ incisions were 6.59 and 6.44 days after the operation,respectively.In the 1220 non-operated cases,only 730 cases used antibiotic drugs,which accounted for 59.83%.From them,432 cases(accounted for 59.18%) used the antibiotic drugs were completely reasonable and other 298 cases(accounted for 40.82%) were found have used the antibiotic drugs unreasonably.The unreasonableness mainly included in the dose and method used and a lack of examination in the pathogens in some adaptive cases.CONCLUSIONS Enhancing the training and encouraging the study of rational use of antibiotic drugs,establishing and optimizing the management system on the use of antibiotic drugs are the key tasks involved to ensure the reasonable use of the antibiotic drugs.