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??OBJECTIVE To study the hepatotoxicity of Polygonum multiflorum on the basic of the bilirubin metabolism mediated by glucuronidation of UGT1A1 enzyme. METHODS Inspected the enzyme kinetic parameters after giving the rats Polygonum multiflorum extract orally(in vivo), and added the Polygonum multiflorum extract into the human liver microsome(rat liver microsome; human recombinant UGT1A1 enzyme) to test the hepatotoxicity using the bilirubin as UGT1A1 enzyme substrate, investigating the inhibition of the UGT1A1 enzyme(in vitro). Apparent inhibition constant K_i and enzyme kinetic parameters were used to evaluate the hepatotoxicity. RESULTS Polygonum multiflorum extract has a strong inhibiton to the UGT1A1 enzyme in all the three systems in vitro. All the type of inhibition is the competitive inhibition. While Polygonum multiflorum extract has a strong inhibiton to the UGT1A1 enzyme in vivo, but the type of inhibition is the uncompetitive inhibition.CONCLUSION The method we had established in our study provides a new idea and a new method to evaluate the hepatotoxicity and the safety of Chinese herbs.     

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??OBJECTIVE To provide the reference for clinical rational safe drug use by the signal mining of adverse drug reactions caused by rituximab. METHODS Reporting odds ratio and Bayesian confidence propagation neural network METHODS were used to make a signal mining of suspected ADRs caused by rituximab from FDA Adverse Event Reporting System,where the reports collected from the first quarter in 2014 to the fourth quarter in 2015 can be used in this study. RESULTS 657 and 43 warning signals were obtained by ROR method and BCPNN method,including 68 new suspected ADR signals by ROR(limited with 95%CI value ranked top 300 ADR signals and ROR value greater than 2.5) and 10 new ADR signals by BCPNN,which are not mentioned in instructions. CONCLUSION Mining the signals of the adverse drug reactions of rituximab can provide reference for domestic clinical rational safe drug use.     

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??OBJECTIVE To investigate the varieties and use of oral proprietary Chinese medicines in our hospital, analyze the problems existing in their labelings, and put forward suggestions to provide reference for clinical rational drug use. METHODS The properties of the 101 kinds of oral proprietary Chinese medicines in regard to the category, dosage form, essential drug, health care, OTC, and so on were summarized. Their labelings were collected to analyze the specification, usage and dosage, adverse reactions, contraindications and precautions, etc. RESULTS Among the 101 traditional Chinese medicines, 44.6% were developed specially for children. When counted by categories and dosage forms, the medicines for regulating spleen and stomach and granules accounted for the majority, respectively. Essential drugs, drugs belonging to the directory of insured drugs, and OTC drugs accounted for 19.8%, 70.4%, and 26.7%, respectively. It was found that 51.5% of the labelings included dosage information for different ages in detail, 59.4% did not state adverse reactions and contraindications clearly, and the smallest dosage suggested by 14.9% of the labelings were less than the smallest packaging dose. CONCLUSION Chinese patent medicines are widely used in pediatrics, but the information for children is still incomplete. The problems in the prescribing mainly include inappropriate selection of drugs and combination of medications. It was recommended that the relevant authorities carry out pediatric drug reevaluation and improve the labelings of pediatric drugs.     

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??OBJECTIVE To investigate the clinical use of ornidazole injection in a wide patient population by the post-marketing hospital centralized monitoring method in order to regulate and guide its rational use, improve the drug specification, and provide a basis for the drug therapy. METHODS A prospective, multi-center, large sample hospital centralized monitoring method was adopted. Five sentinel hospitals in Hubei Province were selected, and hospitalized patients who received ornidazole injection treatment from July 1, 2015 to October 31, 2015 were observed. The basic information of the patients was recorded, as well as the drug use and adverse events, and then statistical analysis was made. RESULTS A total of 4396 cases were enrolled in this study, most of them were middle-aged female patients. Ornidazole injection was mainly used before surgeries to prevent infections and after surgeries for treatment of anaerobic infections, abdominal infections and pelvic infections. Irrational drug use existed in clinic, mainly concentrating at unreasonable dosing frequency, excessive dripping speed, and long duration of use. Eleven cases of adverse reactions were collected during the monitoring, indicating an incidence of adverse drug reactions of 2.5??, and most of the adverse drug reactions occurred within 30 min post drug administration. CONCLUSION The manufacturers should make further investigation on the dripping speed and quality standard of ornidazole injection to further improve the information in the package insert and regulate the clinical use.     

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??OBJECTIVE To choose a PPK model of vancomycin most suitable for Chinese pediatric patients, in order to guide the dosage adjustment.METHODS Based on the database of PubMed and CNKI, all studies regarding vancomycin population pharmacokinetics were investigated and their basic information including PPK models was extracted. The data of Chinese pediatric patients who were administered vancomycin and received therapeutic drug monitoring(TDM) were introduced into the reported final PPK models, and the fitting was conducted by model fitting graphics. RESULTS Twelve vancomycin PPK studies during 1986-2014 were included. As judged by the correlation coefficient (R) and R-square(R2) between predicted concentration and measured concentration, the models 4 and 9 presented a relatively better fitting with the data of Chinese pediatric patients we collected. The VPC fitting demonstrated that number 1 model achieved the best fitting. However, because the limited data used in this study was based on irregular sampling time, so the VPC test results were difficult to be distinguished and could only be used as a secondary reference. On the other hand, NPDE has corresponding statistical test, and its evaluation ability for the model is not affected by the factors of the experimental design. NPDE analysis showed that one-compartment model was better than two-compartment model, and model 4 and model 9 achieved better fitting to the collected data than others.CONCLUSION The fitting effects of most reported vancomycin PPK models, except individual models, were poor for the TDM data of Chinese pediatric patients, therefore it is necessary to establish a vancomycin population pharmacokinetic model particularlly for Chinese pediatric patients, in order to guide dosage adjustment more accurately.     

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??OBJECTIVE To evaluate the quality of now available clinical guidelines and consensus statements on type 2 diabetes. Based on this assessment, the comparison of guidelines and consensuses is made to give some suggestions on the METHODS of making these documents. METHODS PubMed, Embase, CNKI, Wanfang, SinoMed and guideline websites were systematically searched. Literatures were screened according to defined criteria for including. AGREE ?? was used to instrument assess the quality of the guidelines and consensuses. RESULTS The result showed that the quality of included guidelines is various, but the overall quality of guidelines is still higher than consensuses. Guidelines got high scores in scope and purpose domain and clarity of presentation domain, but low scores in rigor of development domain and applicability domain. Consensus statements got low scores in all 6 domains. CONCLUSION The main reason for the difference is consensuses have poor methodology. Rapid advice guidelines were suggested as an alternative for consensus statements.     

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??OBJECTIVE To establish an interferon-resistant hepatitis B virus cell model and provide experimental basis for further investigating the mechanism of HBV resistance to interferon. METHODS HepG2.2.15 was continuously grown in the presence of 10,30,50 and 70 u??mL^-1 of interferon ??-2b for up to 48 weeks. The HepG2.2.15/IFN??-2b cell model was constructed after 48 weeks of induction. The cells were treated with the best-effect concentration. Then, the levels of HBsAg, HBeAg, and HBV DNA in the supernatant of cell culture medium before and after the treatment were compared. RESULTS After stimulation with low concentrations of IFN??-2b for 12 weeks, the 50 u??mL^-1 group showed significant resistance to the best-effect concentration of IFN??-2b. Compared with the levels before stimulation, the inhibition rate on HBsAg, HBeAg, and HBV DNA decreased by 25.48%, 8.40%, and 15.43%, respectively, suggesting that 50 u??mL^-1 was the best-stimulation concentration. After stimulated with 50 u??mL^-1 IFN??-2b for 12-48 weeks, the results showed that the inhibition rate on HBsAg, HBeAg, and HBV DNA after 36 weeks was the most significant. CONCLUSION Continuous induction with 50 u??mL^-1 IFN??-2b for 36 weeks could most easily induce drug resistance in HepG2.2.15 cells.     

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??OBJECTIVE To provide basis for rational use of biapenem in elderly patients through Monte Carlo simulation. METHODS A total of 294 strains from five species of Enterobacteriaceae were collected. The MICs of biapenem against the bacteria were measured by double broth dilution method. Six therapeutic regimens (300 mg q24h; 300 mg q12h; 300 mg q8h; 300 mg q6h; 600 mg q24h; 600 mg q12h) were simulated by using Monte Carlo simulation, then the probability of target attainment (PTA) and cumulative fraction of response (CFR) were calculated. RESULTS In patients at 65-74 years old, only the CFR of 300 mg q24h regimen was ??90% (73.69%) for E. coli; only the CFRs of 300 mg and 600 mg q24h treatment regimens were ??90% (64.98%,82.51%;63.83%,79.82%;63.11%,78.7%, respectively) for K. pneumonia, E. aerogenes and E. cloacae; in patients ??75 years old, all of the regimens had PTAs ??90% for E. coli and E. aerogenes; only the 300 mg q24h regimen had CFRs??90% (89.39% and 88.98%) for K. pneumonia and E. cloacae; for E. aerogenes, all the regimens had CFRs ??90%. CONCLUSION It is suggested that different regimens can be used for target therapy of biapenem on the basis of MICs, while frequency of q12h or higher can be used for experiential therapy of enterobacteriaceae infection in old people in our hospital. Other antimicrobial agents should be chosen for treatment of E. aerogenes.     

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??OBJECTIVE To prepare nano-micelles with amphiphilic self-assembly poly (ethylene glycol)-co-poly (propylene sulfide) (PEG-PPS) copolymer as carrier to study the release characteristics of tilianin and investigate its activity to against H9c2 cell apoptosis in vitro. METHODS An amphiphilic diblock PEG-PPS polymer was used as a carrier material to prepare the tilianin-containing nano-micelles by solvent evaporation. The morphology, particle size and distribution, drug loading and encapsulation rate and in vitro drug release behavior were characterized, H9c2 rat myocardial cell injury model was established by hypoxia/reoxygenation process. Using propranolol (Pro) as a positive control, the morphology of injured cardiomyocytes was observed by microscope. Cell proliferation and cell apoptosis was detected to evaluate the protective effect of blank micelles, tilianin and tilianin loaded nano-micelles on H9c2 cells induced by hypoxia/reoxygenation. RESULTS Tilianin-loaded nano-micelles was spherical with uniform particle size distribution. The drug loading was 3.82%. The average particle diameter of tilianin-loaded nano-micelles was 137 nm, polydispersity coefficient was 0.162 and the encapsulation efficiency was 91.45%. In vitro drug release studies showed that there was no drug-induced burst release of tilianin-containing nano-micelles and sustained release characteristics, and the presence of hydrogen peroxide significantly promoted the release of tilianin from the nano-micelles. In vitro cytotoxicity experiments showed that when the concentration of tilianin 5 ??g??mL^-1, the cell viability of tilianin-loaded nano-micelles was significantly higher than the corresponding concentration of tilianin and PEG-PPS polymer nano-micelles. In vitro anti-apoptotic activity experiments show that tilianin-loaded nano-micelles on H9c2 cell apoptosis induced by hypoxia-reoxygenation have a significant inhibitory effect and was provided inhibition of apoptosis with propranolol. CONCLUSION Tilianin-loaded nano-micelles have uniform particle size and distribution, sustained release and oxidation characteristics, has a significant protective and apoptosis-inhibiting effect on H9c2 cell injury induced by hypoxia-reoxygenation, which can be used as a promising drug delivery system for the treatment of myocardial ischemia-reperfusion injury.     

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??Topical ocular medication is commonly used for eye diseases treatment.In view of low bioavailability and poor efficacy of traditional ocular preparations,the development of novel ocular drug delivery systems has become a great challenge in pharmaceutics.In recent years, nano preparations have been widely used for ocular drug delivery systems. At present, several nanocarriers, such as polymeric micelles, nanoparticles, nanosuspension, liposomes, emulsion, and dendritic polymers have been developed for ocular drug delivery.There are some other new dosage forms, such as in-situ gelling systems, implants, contact lenses, and microneedles are also under continuous research. The aim of development of these new dosage forms is to improve the drugs' ocular bioavailability and therapeutic effects.In this paper,the development in these areas in recent years are reviewed in order to provide reference for the development of new ocular drug delivery systems.     

江苏省昆山市第一人民医院2007-2009年中成药用药分析

目的：了解我院中成药的应用情况,为临床合理用药提供科学依据。方法：调取我院2007-2009年中成药的年消耗金额和用量数据,对年消耗金额、用药频度（DDDs）、日均费用（DDC）等进行回顾性统计分析。结果：我院2007-2009年中成药消耗金额呈上升趋势,其中妇科用药、感冒类常用药在消耗金额上居于前列;清热凉血、补血类药日均费用较高,消耗金额排前10位的药物过于集中,对于中成药总消耗状况有重要影响,日均费用较高的品种的消耗金额和DDDs的排序比值有不少小于1。结论：中成药的监管应重视DDDs的排序,加强上市后的再评价。     

中药房质量管理的探讨

中药房的质量管理包括对中药饮片质量、中药配方质量和人员的管理等,提高中药房的全面质量管理,目的是为提高药学服务质量,使医院获得更好的社会效益与经济效益。     

我院3158张门诊中药处方分析

目的通过对我院中药处方进行分析,了解我院中药处方和中药临床使用存在的问题。方法随机抽取我院2010年第一季度门诊中药处方3158张,进行统计分析。结果我院门诊中药处方在临床诊断、重复用药、给药途径、用药剂量,处方脚注、配伍禁忌、处方用药天数和单张处方药数等方面存在一些问题。结论要加强和重视对中药处方的管理,制定切实可行的适应于中医中药的处方管理办法,以促进中药的临床合理应用。     

2008-2010年我院药品不良反应情况分析

目的：了解我院2008～2010年药品不良反应（ADR）的发生和分布情况,为临床用药提供参考。方法：将我院2008～2010年临床科室上报的558份《药品不良反应/事件报告表》,按患者的性别、年龄、药品种类、不良反应主要临床表现等进行分类统计和分析。结果：抗感染药物的ADRs报告例数位居第1位,为308例,占55.20%,其中以头孢菌素类引起的ADRs最高（122/308,39.61%）;皮肤及其附件ADR发生频率最高,为198例,占31.88%。结论：应提高临床医护人员的安全用药意识,从而减少、避免ADR的发生,保障公众用药安全。     

我院2015年度中药饮片超剂量使用分析

目的:通过分析我院中药饮片超剂量使用情况,提出解决办法。方法:抽取2015全年度每月16日处方,统计超剂量中药饮片数量,得出规律,分析原因,提出建议。结果:抽取的8038张中药饮片处方中,超剂量使用1617张,占比20.12%,其中有毒中药处方322张,超剂量使用127张,涉及毒性中药7种。结论:中药饮片超剂量使用普遍存在,需要相关法律法规的细化、医院职能部分加大考核力度和药学工作者严格处方审核以求共同改善。     

绵阳市中医院门诊病人抗高血压药使用分析

目的:了解绵阳市中医院门诊抗高血压药的使用情况。方法:对治疗高血压的3 886张处方进行调查,统计分析患者的年龄、性别、抗高血压药的用药频度(DDDs)及药物的联合使用情况。结果:中老年患者是高血压的高发阶段,该样本所分析的患者中男性多于女性。用药频度前3位是钙通道阻滞剂、血管紧张素转化酶抑制剂和β受体阻滞剂。单品种用药频度靠前的是苯磺酸氨氯地平片、依那普利、赖诺普利、美托洛尔片。单一用药比例为49.69%。联合用药达50.31%。结论:该院门诊抗高血压药在品种选择、联用方案选择上基本合理。     

我院2015年门诊中药处方分析

目的了解我院中药的使用情况、用药趋势和存在的问题。方法采用回顾性分析方法对处方进行统计分析。结果收集得到门诊处方共2 034张,男性占1 030张,女性占1 004张。处方中患者平均年龄约为57岁,以61~70岁的居多,占28.76%;平均药味约15味,以16~20味居多,占31.71%。处方涉及中药品种有363种,使用频率和使用量排名前20的中药以利水渗湿药、补虚药、理气药、清热药、止咳平喘药为主。处方合格率为83.38%,不合格原因中临床诊断不合理占0.44%,特殊煎法未脚注占15.49%,重复给药占0.79%,修改处未签名盖章占0.34%,超剂量用药占1.82%。结论我院门诊中药处方总体用药情况较合理,但仍存在一些问题,医疗工作者应加强中医药专业知识的学习,促进中药饮片的合理应用。     

我院2016年毒性中药应用分析

目的分析并研究东南大学医学院附属南京胸科医院毒性中药的使用情况,探讨其临床用药特点。方法采用医院THIS系统对处方中涉及的毒性中药进行统计分析。结果收集得到有毒性中药的处方共674张。处方中涉及毒性中药品种有21种。在剂量使用方面,有15种中药饮片出现超剂量使用的情况。结论该院有毒中药饮片总体用药情况较合理,但仍存在一些问题。     

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??OBJECTIVE To investigate and study the 2012 edition of National Essential Medicine List chemical medicines and biological products off-label drug use in pediatrics, analyze the causes of off-label use of medications, provide the suggestion for off-label drug use in pediatrics. METHODS To adopt questionnaire survey in different regions of the 10 third-grade class-A children??s hospital off-label use of medications in 2012 edition of National Essential Medicine List chemical medicines and biological products of 309 types which excluded obstetrics and gynecology medication, family planning administration and national immunization programs with vaccine from 317 types. Excel 2007 software is used for data calculation and statistical analysis. RESULTS ??20 categories, 22 dosage forms, which accounted for 80% of all drug categories are involved in off-label use of medications in 2012 edition of National Essential Medicine List. ?? Lack of children??s dosage (62.95%) is mainly responsible for off-label of drugs. Off-label use of medications mainly manifest in off-labeling with pediatric indications (85.94%), of which labeling with pharmacological action without indication (45.63%) is the main type, and off-labeling with route of medication (66.96%).?? 2013 edition of Chinese National Formulary(Chemical and Biological Products for Children)and 2010 edition of Chinese Pharmacopoeia of Clinical Medication Information are the main evidence for off-label drug use, account for 34.60% of the total number of cases. ?? 147 types of medicines which involved in off-label use are searched in a database named Micromedex. Indications have been approved by the the US Food and Drug Administration (FDA) or not which labeling with children??s dosage account for 27.10% of the total number of indications. CONCLUSION Off-label drug use in the 2012 edition of National Essential Medicine List is an important public health issue for children. It reflects the lack of labeling with pediatric information. It is suggested that joint efforts should be paid by departments concerned and more support be provided to further improve the policy for children??s medication.
     

新疆医科大学第二附属医院2009—2011年活血化瘀类中成药应用分析

目的:分析新疆医科大学第二附属医院活血化瘀类中成药(BCCPM)的应用现状及趋势,为临床上的合理用药提供参考.方法:对我院2009-2011年BCCPM的销售金额、用药频度(DDDs)及日均费用(DDC)等进行统计、分析.结果:3年来,我院BCCPM的销售金额、用药频度逐年增长,尤其是口服的复方丹参滴丸、血塞通软胶囊和注射剂疏血通注射液、丹参川芎嗪注射液在销售金额上每年位居前列,用药频度排序靠前的是复方丹参滴丸和疏血通注射液.结论:我院活血化瘀类中成药应用结构基本符合我国当前的药品总体消耗趋势,价廉、效果明显,不良反应少,具有重要的临床意义.