目的 比较餐后状态下两种盐酸文拉法辛缓释片在中国健康受试者体内药动学及生物等效性.方法 本试验入组26例受试者,采用随机、开放、两周期、两序列、双交叉给药设计,单次口服受试或参比制剂(75 mg)后,运用LC-MS/MS测定血浆中文拉法辛(VEN)及其活性代谢产物O-去甲基文拉法辛(ODV)浓度,经PhoenixTM WinNonlin 6.4软件计算药动学参数,以VEN的药动学参数作为评价指标,ODV作为参考,进行生物等效性分析.结果 餐后服用受试或参比制剂后,血浆VEN的Cmax分别为(58.50±19.47)和(60.14±22.18)μg·L-1,AUC0-t分别为(1074.1±526.7)和(1057.9±539.7)μg·h·L-1,AUC0-∞分别为(1084.7±536.8)和(1067.8±554.0)μg·h·L-1;ODV的Cmax分别为(101.63±29.64)和(101.45±31.62)μg·L-1,AUC0-t分别为(2694.0±834.5)和(2702.9±946.4)μg·h·L-1,AUC0-∞分别为(2753.9±885.5)和(2753.2±988.4)μg·h·L-1,VEN和ODV的Cmax,AUC0-t,AUC0-∞几何均数比值90％CI均在80.00％ ～125.00％等效区间内.结论 餐后状态下,两制剂在中国健康受试者体内具有生物等效性.

Pharmacy has been listed as one of the core courses of clinical pharmacy. The implementation of the Healthy China Strategy and the innovative development of medical education have put forward new requirements for the training of clinical pharmacy professionals. In order to improve the clinical practice and innovation ability of clinical pharmacy students, it is necessary to continuously update the pharmacy theory and practical teaching mode. Involving clinical pharmacists in pharmacy teaching can cultivate students’ clinical thinking ability and improve their ability to cope with and solve clinical problems. In this paper, combining the characteristics of the pharmacy discipline, the role of clinical pharmacists in the pharmacy teaching of clinical pharmacy specialty was analyzed from multiple perspectives, in order to provide reference for the innovation and development of clinical pharmacy education.

目的:比较单次空腹条件下口服甲苯磺酸索拉非尼片在中国健康受试者体内的药代动力学行为,评价受试试剂(T)和参比试剂(R)的生物等效性.方法:采用单中心、随机、开放、两制剂、三周期、三序列(TRR、RTR、RRT)、部分重复交叉试验设计,试验每周期空腹状态下给药一次(0.2 g),36例健康受试者随机分为3组,每组12例.结果:36例健康受试者(女性9例,平均年龄31岁)入组试验.受试制剂和参比制剂的药代动力学参数Cmax、AUC0-t和AUC0-∞经自然对数转化后的单侧95％ 置信区间上限分别为-0.0908、-0.0577、-0.0541,单侧95％ 置信区间上限均小于0;受试制剂与参比制剂的索拉非尼药代动力学参数Cmax、AUC0-t和AUC0-∞ 几何均值比值分别为101.65％、100.12％、99.24％,均在80.00％～125.00％范围内,因此受试制剂和参比制剂索拉非尼的Cmax、AUC0-t和AUC0-∞在空腹状态下生物等效性成立.结论:受试者空腹单次口服0.2 g甲苯磺酸索拉非尼片安全性和耐受性良好.受试制剂与参比制剂在空腹给药状态下生物等效.

目的:梳理药物临床试验信息化建设研究脉络,了解并掌握药物临床试验信息化建设研究热点和发展趋势.方法:本研究采用知识图谱CiteSpaceⅤ软件,在2000年至2020年中国知网数据库391条文献的基础上,从文献数量分析、研究机构分析、作者分析、研究热点主题以及研究趋势分析等角度进行了深入探讨,并绘制知识图谱,梳理药物临床试验信息化建设研究脉络.结果:分析表明近20年来药物临床信息化建设相关研究论文发表数量波动上升,主要研究机构在该领域大都有较强的研究能力,但研究机构间的联系还较为松散,学者间的学术交流还有待加强.在热点研究上的转变体现了该领域更加注重系统化和保护受试者权益.结论:药物临床试验信息化建设研究热点主要集中于临床试验、药物临床试验、质量控制等方面.通过信息化建设进一步提高试验管理效能,保证药物临床试验可靠规范,有效降低药物临床试验风险隐患是未来研究趋势.

目的 为构建住院病人自备药管理体系提供参考.方法 基于国际医疗机构联合委员会(JCI)标准对住院病人自备药管理的具体要求,构建安徽医科大学第二附属医院住院病人自备药安全管理体系,并以相关指标评判管理效果.结果 参考JCI标准具体要求,安徽医科大学第二附属医院构建的住院病人自备药管理体系包括制订制度、全方位审核和定期检查;自2016年10月构建自备药管理体系后,住院病人自备药的储存使用合格率从2016年10月63.5％提高至2017年3月的96.1％.结论 该院构建的住院病人自备药管理体系比较全面,确保了自备药的安全储存使用和管理体系的持续改进.

目的 了解2011-2014年安徽省马鞍山、池州、铜陵三个沿江地区恶性肿瘤的发病特征.方法 从安徽省肿瘤登记系统以及各级医疗报销系统收集马鞍山、池州、铜陵三地的恶性肿瘤发病数据,采用国际疾病标准编码进行分类,按照性别、年龄、年代以及肿瘤类型等计算粗发病率及年龄标化发病率.结果 2011-2014年间,安徽省沿江地区恶性肿瘤年均发病率为243.88/10万(男性为299.85/10万,女性为185.94/10万),标化率为170.81/10万(男性为201.41/10万,女性为135.82/10万).80～岁为恶性肿瘤发病最高的年龄组,90岁之后出现下降.全人群发病率前三位肿瘤分别是胃癌、肺癌和食管癌.四年间,肿瘤发病谱有轻微变化,其中脑癌、鼻咽癌发病顺位降低,甲状腺癌及膀胱癌发病顺位上升.结论 安徽省沿江地区恶性肿瘤发病率呈上升趋势,消化系统肿瘤仍然是威胁居民健康的主要疾病,是安徽省沿江地区肿瘤防治的重点.

OBJECTIVE To investigate the management effectiveness of outpatient and emergency intravenous infusion in a hospital before and after special inspection of intravenous infusion.METHODS Retrospective method was used to analyze the outpatient and emergency intravenous infusion related data in 2014 (before examination) and 2015 (after examination).RESULTS After special inspections of venous transfusion,the hospital emergency intravenous infusion rate,the hospital outpatient and emergency proportion of vein transfusion prescriptions were significantly decreased (P＜0.05).CONCLUSION Special inspection of venous transfusion is favorable to regulate and significantly improve the management quality of outpatient and emergency intravenous infusion in medical institutions.

Objective To explore the mental health status and related factors of acquired immunodeficiency syndrome (AIDS) individuals receiving antiviral therapy (ART) in Anhui Province,and to provide appropriate measures for improving their physical and mental health.Methods Quantitative questionnaire survey was conducted among AIDS patients with positive CD4 + T cell who have received treatment in 3 cities of Anhui Province to collect the general demographic characteristics and mental health status of patients from January 2013 to June 2014.Results 63 (21.1％) patients were equipped with anxiety syndrome and 126 (42.3％) with depression.Multivariate Logistic regression analysis showed that holding religious belief was related to anxiety (OR =2.221,95％ CI:1.094-4.509),good ART adherence,marital status was married or cohabitation,educational level was junior high school or college and above,area in Huaibei and knowing antiviral treatment was a lifelong process on medication were influencing factors of depression (all P ＜ 0.05).Conclusions Anxiety and depression were common syndrome among AIDS patients in 3 cities of Anhui Province and were related to multiple factors.It was important to increase ART adherence and the awareness of lifelong medication to reduce anxiety and depression incidence.

Objective To detect the expression percentages of regulatory T cell(Treg) and T helper 17 cell(Th17) in peripheral blood of living donor renal transplant recipients(RTRs) and to investigate the dynamic change pattern of Treg cell,Th17 cell and Th17/Treg ratio after living donor renal transplantation.Methods The study was prospective.The expression percentages of Treg cell and Th17 cell were determined with flow cytometry before transplantation and 1,2,3 weeks as well as 1,2,3,4,5,6 months after transplantation in living donor RTRs.Results ① The percentage of Treg cell decreased significantly in two weeks after transplantation in RTRs (P ＜ 0.05).The lowest-proportion of Treg occurred in 2nd month after transplantation,which decreased by 68.6％ compared with pretransplantation status(P ＜0.05).Proportion of Treg cell gradually gained back to baseline in 6th month post-transplantation.The percentage of Th17 cell within 3 weeks post-transplantation significantly increased compared with the pre-transplantation status(P ＜0.05),and dropped to baseline in one month post-transplantation.The significantly increased ratio of Th17/Treg observed one week post-transplantation last for nearly 3 months(P ＜ 0.05) and returned to baseline in 6th month.② The ratio of Treg in cyclosporine-a treatment RTRs demonstrated the lowest level in 2nd month post-transplantation,which decreased by 67.1％ compared with baseline(P ＜ 0.05).However,the lowest ratio of Treg in tacrolimus-treated group which decreased by 80.8％ compared with the baseline occurred in the 3 rd week (P ＜ 0.05).Both groups demonstrated a gradual recovery of Treg ratio three months post transplantation.③ The proportion of CD3 + T cell dropped to the lowest level within 1 week after transplantation (P ＜ 0.05),and rapidly rose to the baseline at the 3rd week.Conclusion Immune cell ratio is in a fluctuating status after living donor kidney transplantation.The proportion of Treg cell significantly decreases from 2nd week to 5th month after operation,with the lowest level in 2nd month.The ratio of Th17/Treg significantly increases from 1st week to 3rd month after operation.Both tacrolimus and cyclosporine have inhibitory effects on Treg cell post-transplantation.

熊果酸(ursolic acid)是广泛存在于自然界植物中的一种五环三萜类化合物,具有广泛的生物学活性,主要经肝脏代谢.传统临床治疗中熊果酸多用于抗炎、抗病毒、调节免疫功能以及保肝治疗等.近年来的研究表明,在体外和体内实验中,熊果酸能够对不同肿瘤细胞产生杀伤作用,抑制恶性肿瘤组织的生长,具有广谱的抗肿瘤活性.此外,熊果酸联合放化疗能够提高肿瘤细胞对治疗的敏感性,产生辅助增强放化疗疗效的作用,并且在放疗中可保护受照射机体的正常组织,促进免疫机能的恢复.熊果酸的抗肿瘤作用机制与下调促肿瘤生长、侵袭和转移相关基因的水平,增强凋亡基因的表达有关,并且能够通过调节多种细胞信号转导通路,杀灭肿瘤细胞,延缓肿瘤组织生长.同时,熊果酸可影响肿瘤细胞周期的分布,导致细胞的G1/S期阻滞,从而抑制肿瘤细胞的有丝分裂,诱导细胞凋亡.因此,熊果酸是一种极具潜力的天然抗肿瘤药物.本文对熊果酸在肿瘤治疗中的研究结果进行整合,阐述了熊果酸的抗肿瘤分子机制及其疗效,为熊果酸今后在临床中的进一步应用提供指导思路.

Objective To investigate the role of Kupffer cells (KC) on regulation of apoptosis of liver cell (HC) and explore the molecular mechanism of Lef on prevention and treatment of immunological liver injury.Methods Rat model of immunological liver injury was established by combining gavage administration with bacillus Calmette Guerin (BCG) and lipopolysaccharides (LPS),HC and KC were separated by the liver in situ perfusion method,and were cultured in vitro.Secretion of TRAIL and TRAIL-R of activated KC and HC were detected in each group.Results Lef reduced the cytokines TRAIL of KC secretion significantly and the expression of TRAIL-R in HC,KC on immune liver injury of rats,and liver cell apoptosis pathology changes of immunological liver injury in rats could be obviouslyimproved.Conclusion Lef can protect immune hepatic injury induced by BCG + LPS by inhibiting TRAIL's expression,and the associated mechanism may be related to the inhibition of TRAIL signal transduction pathway.

OBJECTIVE:To investigate the irrational medication orders in pharmacy intravenous admixture service ( PIVAS) of the Second Affiliated Hospital of Anhui Medical University ( hereinafter referred to as “our hospital”) from Jan.2011 to Mar.2014, so as to enhance the awareness of rational drug use and improve level of rational drug use . METHODS:Long-term medication orders of 34 wards in our hospital were checked by the pharmacists and Rational Drug Use Software .The check list mainly included improper concentration , irrational selection of solvent , drug incompatibility, excessive dosage and duplicate drug use , etc.RESULTS: There were 500 irrational medication orders, among which, 56 cases were improper concentration (1.20%), 86 cases were irrational selection of solvent (17.20%) , 36 cases were improper dosage ( 7.20%) , 223 cases were drug incompatibility ( 44.60%) , 53 cases were other causes(10.60%) ( improper administration order or no group sending ,etc.).CONCLUSIONS: Irrational drug compatibility can increase the incidence of irrational medication orders , the pharmacists should check the medication orders carefully so as to improve rational drug use in clinic .

目的：通过对某院住院患者使用奥美拉唑注射剂的情况进行分析，为其合理使用提供参考。方法通过回顾性研究分析方法，抽取某院某段时间使用奥美拉唑注射剂的住院患者病历，具体从其使用的有无适应证、预防指征、无指征使用科室分布、给药剂量和方法等方面分析。结果预防使用奥美拉唑注射剂的比例占近一半（48．41％），且有一定程度的无预防指征用药。结论奥美拉唑注射剂作为良好的质子泵抑制剂，可能有滥用现象，应得到临床重视并予以合理应用。

Objective:Some antigens of M.tb to culture with peripheral blood mononuclear cells ( PBMC) for assaying their proliferation and activation,so as to signify whether lipid antigens of M.tb have specific immune responses in host against M.tb infection or not.Methods:We treated PBMC with several lipid antigens of M.tb to explore the ability of these antigens to activate immunity in healthy individuals.We measured and analyzed cell proliferation by labeling cells with carboxyfluorescein succinimidyl amino ester (CFSE) and subjecting them to flow cytometry (FCM).The production of IFN-γ,TNF-αand IL-4 by T cell subsets (NKT,CD4+, CD8+,andγδT) from healthy donors was analyzed by FCM after stimulation with autologous immature dendritic cells pre-cultured with M.tb lipid antigens.The tested M.tb lipid antigens were the total lipid (TLIP),Acetone-Soluble Lipids (ASLIP),Purified Sulfolipid (PSLIP),Lipoarabinomannan (LAM) and Lipomannan (LM) levels.Medium free of lipid antigens(WCL,CFP,LPS,Mtb-HAg and blank) was used as a control.Results:We found the proportion of proliferative NKT and CD8+T cells significantly increased in all lipid groups (P<0.05).ASLIP,LAM and LM promoted non-proliferative CD4+T cells to secrete IL-4 and proliferative ones to secrete IFN-γ( P<0.05).All lipid antigens promoted both proliferativeγδT cells and CD8+T cells to secrete IFN-γand TNF-α,but the proportion of TNF-α-secreting cells in these populations decreased in the LM group ( P<0.05 ).Conclusion: Lipid antigens may affect the CD1-restricted T cells of the host to fight M.tb infection.

Objective To investigate the expression of T regulatory cell( CD4 +CD25 +FoxP3 + T cell or Treg cell) , T help cell 17(Th17 cell) and T cell subsets in renal transplantation recipients during 3 to 6 months after transplan-tation. To analyze the characteristic and significance of these changes. Methods 56 subjects were chosen in this study and they were divided into three groups:group of before kidney transplantation,15 cases;group of 3 to 6 month after transplantation,20 cases;and the normal group,21 cases. The expression percentages of Th17 cell, CD4 +CD25 +FoxP3 +T cell and T cell subsets in PBMC were determined with flow cytometry. Results When com-pared with the group of before kidney transplantation,the group of 3 to 6 months after transplantation had lower ex-pression percentages of CD4 +CD25 +FoxP3 +T cell(P<0. 01) and CD8 +T cell(P<0. 05). When compared with the normal group,the group of 3 to 6 months after transplantation had lower expression percentage of CD4 +CD25 +FoxP3 +T cell(P<0. 001). Conclusion In the group of 3 to 6 months after transplantation,the expression per-centages of CD4 +CD25 +FoxP3 + T cell and CD8 + T cell descend.

Objective To evaluate the utilization of antibiotics in The Second Affiliated Hospital of Anhui Medical University,so as to enhance and promote the rational drug use.Methods The relative data of antibiotics from 2012 to 2013 were statistically analyzed by the ordering of consumption sum and frequency of drug use (DDDs),and DDC.Results The portion of the consumption cost of antibi-otics in the total drug cost was declined.The second generation cephalosporin occupied the top place in terms of consumption sum and DDDs for both two years.Conclusions The utilization of antibiotics in this hospital is basically rational,but it is still necessary to focus on rational drug use.

Objective To observe the proliferation difference of human peripheral blood mononucelear cells ( PBMCs) which were stim-ulated with Mycobacterium tuberculosis ( M.tb) Whole Cell Lysate ( WCL) in human AB serum cell culture medium and fatal bovine serum ( FBS) cell culture medium.Methods PBMCs from healthy adults were stimulated by WCL or WCL with recombinant human interleukin 2 ( rhIL-2) or phytohemagglutinin ( PHA) or none as control in four groups.Each of the groups was cultured with RPMI-1640 medium containing 10%AB serum or 10%FBS for six days respectively.The proliferation of lymphocytes was carefully investiga-ted under the inverted microscope and flow cytometry.Results The proliferation of lymphocytes stimulated by WCL in medium with 10%AB serum is better than that in medium with 10%FBS (P<0.05).Similar results were obtained when PBMCs were stimulated by WCL and rhIL-2 (P<0.05) .Conclusion When human PBMCs were stimulated with M.tb WCL,the proliferation of lymphocytes was better in the culture medium supplemented with human AB serum than in that with FBS serum.

Objective To explore the regulatory effect of microRNA-1271 on the expression of its target gene CYLD in leukemia cells. Methods microRNA-1271 expression levels in normal peripheral blood mononuclear cells( PB-MC) and leukemia cells were determined by quantitative real-time PCR. microRNA-1271 targeting CYLD 3′-UTR was predicted by TargetScan. 3′-UTR of CYLD was inserted into the dual luciferase reporter vector psi-CHECK2. The reporter activity was evaluated by the dual Luciferase Reporter Assay System after the luciferase promoter vector and microRNA were co-transferred into the HEK293A cell line. K562 cell lines were transfected with microRNA-1271 inhibitors ( anti-microRNA-1271 ) or a negative control microRNA ( anti-microRNA-NC ) , the expression of CYLD protein in the above transfected K562 cells were determined by Western blot. Results microRNA-1271 was up-regulated in human leukemia cell lines and primary leukemia cells compared to normal human PBMCs. The re-sults of dual luciferase assays validate CYLD as a specific target gene of microRNA-1271 . Inhibition of microRNA-1271 resulted in the upregulation of CYLD protein expression in K562 cell line. Conclusion microRNA-1271 is overexpressed in leukemia cells, the microRNA-1271 abnormal overexpression may play a key role in leukemia due to the down-regulation of CYLD.

Objective To evaluate the application status and recent trends of antiasthmatic drugs in our hospital.Methods Data about clinical application of antiasthmatic drugs in our hospital during 2011 to 2013 were analyzed statistically in terms of drug varieties, con-sumption sum and DDDs.Results From 2011 to 2013, adrenal cortex hormone drugs ranked first based on sales amount;inhalants of asthma medication ranked first based on route of administration; budesonide suspension ranked first based on consumption sum and DDDs.Conclusions The clinical asthma medication in our hospital is basically consistent with guide specification for the prevention and treatment of bronchial asthma.

目的 了解和掌握安徽省艾滋病病毒(human immunodeficiency virus,HIV)感染未治疗者安全套的使用情况及其影响因素.方法 采用自行设计的问卷,以面对面的调查方式,对安徽省不同地区的HIV感染未治疗者进行问卷调查.结果 本研究共调查HIV感染未治疗者270人,艾滋病(acquired immunodeficiency syndrome,AIDS)相关知识知晓率较高,为92.96％.40.74％的人配偶/恋人未感染HIV,配偶/恋人已感染的调查对象比配偶/恋人未感染者更愿意告知对方自己的感染情况,差异有统计学意义(x2=13.21,P＜0.001).89.47％的人在性行为中增加了安全套的使用,48.95％的人做到在每次性行为时均使用安全套,且在近6个月性行为中是否每次使用安全套与民族、感染HIV时间以及感染HIV后是否增加安全套的使用有关.多因素分析结果表明:民族(OR=0.19,95％CI:0.04～0.97)和已感染HIV的时间(OR=3.54,95％ CI:1.56～8.04)与每次性行为都使用安全套有关.结论 HIV感染者中存在不能坚持使用安全套的问题,因此要提高人群的自我防范意识,提高安全套的使用率,更好的预防HIV通过性行为传播.