目的 分析药品零售企业网售处方药风险,为网售处方药的风险防控提供对策建议.方法 采用层次分析法构建药品零售企业网售处方药风险层次结构模型,再进行风险判断矩阵的归一 化权重计算和一 致性检验;采用德尔菲专家调查法对123对评价指标进行多轮风险研判,开展模糊定量研究.结果 药品零售企业网售处方药风险中的处方调剂及审核风险(6.48%)、先药后方风险(5.48%)、合理用药指导风险(4.99%)、非正常用途购买药品风险(4.97%)、"首诊、非慢性病、非常见病"风险(4.43%)、退货药品质量安全风险(4.34%)、监管技术应用风险(4.06%)为高风险点;药品零售企业(连锁)网售处方药的总体风险为38.67%,药品零售企业(单体)网售处方药的总体风险为61.33%,两者之间相差22.66%.结论 药品零售企业网售处方药高风险指标有7个,其中处方调剂及审核风险、先药后方风险、合理用药指导风险为排名前3位的高风险点;药品零售企业(单体)网售处方药的风险要高于药品零售企业(连锁).建议监管部门重点关注并规范药品零售企业(单体)的网售处方药行为,鼓励药品零售企业(连锁)建立系统的处方药网售流程;对于网售处方药的高风险点,建议监管部门和药品零售企业重点关注并采取有效风险防控措施,以保障老百姓网购处方药的安全用药权益.
目的:研究灵芝多糖粗提物对雌二醇诱导小鼠胸腺萎缩的改善作用.方法:将60只雌性ICR小鼠随机分为正常对照组(生理盐水)、模型组(生理盐水)和灵芝多糖粗提物高、低剂量组(400、100 mg/kg,以生药量计),每组15只.除正常对照组外,其余各组小鼠均隔天腹腔注射雌二醇(0.1 mg/只,共6次)建立胸腺萎缩模型.造模结束后次日,小鼠灌胃给药,每天1次,连续给药14d.末次给药24 h后,测定小鼠脏器(胸腺、脾)指数以及血浆中丙二醛(MDA)含量和谷胱甘肽S-转移酶(GST)活性,采用苏木精-伊红染色法观察小鼠胸腺、脾组织的病理学变化,采用原位末端标记法检测小鼠胸腺细胞凋亡情况,并采用流式细胞术检测其外周血中T细胞亚群分类.结果:与正常对照组比较,模型组小鼠胸腺指数和外周血中CD3+CD4+T细胞比例、CD4+/CD8+T比值均显著降低(P<0.01),脾指数、血浆中MDA含量、胸腺细胞凋亡水平以及外周血中CD3+CD8+T细胞比例均显著升高(P<0.05或P<0.01);小鼠胸腺皮质和髓质分界模糊、细胞间隙增大、皮质出现部分细胞损伤凋亡,脾组织未见明显病理学变化.与模型组比较,灵芝多糖粗提物高剂量组小鼠胸腺指数、血浆中GST活性以及外周血中CD3+CD4+T细胞比例、CD4+/CD8+比值均显著升高(P<0.05或P<0.01),血浆中MDA含量、胸腺细胞凋亡水平显著降低(P<0.05或P<0.01),且胸腺组织病理学变化明显改善;灵芝多糖粗提物低剂量组小鼠仅血浆中MDA含量显著降低(P<0.01),其余指标/病理学变化均不明显.结论:高剂量(400mg/kg)灵芝多糖粗提物对雌二醇诱导的小鼠胸腺萎缩具有一定的改善作用.
OBJECTIVE To study the features of adverse drug reaction in cardiovascular system induced by immune checkpoint inhibitors through literature analysis and provide reference for clinical rational use of immune checkpoint inhibitors. METHODS Literature about marketed immune checkpoint inhibitors-induced cardiac ADRs were collected from Pubmed database before September 2017 with "Ipilimumab", "Nivolumab", "Pembrolizumab", "Atezolizumab", "Avelumab" and "Durvalumab" as key words, and analyzed statistically in respect of patients' gender, age, primary disease, drug use and clinical manifestations of cardiac ADRs. RESULTS A total of 17 cases of immune checkpoint inhibitors-induced cardiac ADRs were collected. Ipilimumab was most frequently reported. Nivolumab and Pembrolizumab were the second. Myocarditis was the most common diagnosis of cardiac toxicity(58.8%), followed by arrhythmia and heart failure. The fastest ADRs occurred at 1 week after the first dose, the slowest occurred at 31 weeks, the median was 9 weeks. Of the 17 patients, 9 died. CONCLUSION It should be payed more attention to the ADR of immune checkpoint inhibitors in cardiovascular system.
Objective:To evaluate the clinical application of human serum albumin in the inpatients in our hospital to promote its rational use. Methods:Totally 1 183 cases were selected from the inpatients treated with human serum albumin from January to De-cember in 2014, the clinical department, classification of diseases, age distribution and relevant concentration checks of serum albumin in the inpatients were analytically reviewed. Results: Totally 26 clinical departments were involved in the use of human serum albu-min,mainly in the digestive departments and ICU. The elderly patients aged above 65 years accounted for great proportion (47. 68%). In addition, all patients had relevant concentration checks of serum albumin. Conclusion:The patients with digestive diseases tend to have the largest consumption proportion of human serum albumin in our hospital. It is important for physicians to strictly follow the indi-cations of medication in using human serum albumin.
Objective To evaluate the clinical effect and safety of val-sartan on patients with hypertension and paroxysmal atrial fibrillation (PAF).Methods One hundred and twenty -one patients with hyper-tension and PAF were randomly divided into control group (n =63) and treatment group(n =58).Patients in the control group were given amiod-arone and nifedipine orally, and patients in the treatment group were given valsartan on the basic medicine of control group.After 12 -month follow -up, the recurrence of PAF, the blood pressure and serum AngⅡ were recorded and compared between the two groups.Results The recurrence rates of PAF were 22.6% and 55.4% in treatment group and control group respectively, which showed that the risk to develop PAF was much higher in control group (P <0.05).The blood pressure were significantly decreased in both groups after administration (P <0.05), but without statistical differences between the two groups (P >0.05). The serum level of Ang Ⅱ was much lower in the treatment group than the control group after treatment (P <0.05).There was no statistical difference in side effects between the two groups (P >0.05).Conclusion On the basis of blood pressure control , valsartan can significantly reduce the risk to develop atrial fibrillation (AF) and decrease the level of serum Ang Ⅱ.
目的:有效控制医院药房的药品质量风险,为药品质量风险管理在医院药房的应用提供思路。方法:采用风险识别、风险评估、风险控制、风险审核的方法,运用事先危害分析(Preliminary Hazard Analysis)工具,结合杭州市第一人民医院药房药品养护环节的实例对药品质量风险实施管理。结果:医院药房的药品质量风险经过科学管理,处于可控范围之内。结论:医院药房作为目前我国药品流通的主要环节,应尽快建立药品质量风险管理体系,应用合理的药品质量风险管理方法和工具,以有效控制药品质量风险,保证人民用药安全。
OBJECTIVE To study the effect of Xueshuantong injection on plasm biomarker including NSE, S100B, MBP and GFAP concentrations in patients with traumatic cerebral infarction, and thus to investigate its effect of promoting the recovery of neural function. METHODS Eighty patients with traumatic cerebral infarction were randomly divided into control group(n=40) and treatment group(n=40). Control group obtained ordinary therapy, and treatment group obtained additional Xueshuantong injection. Pre-treatment and after 1, 3, 7, and 14 d treatment, NSE, S100B, MBP and GFAP concentraions in plasma were determined. The effects of Xueshuantong injection on these plasma biomarker were investigated. RESULTS Pre-treatment, there were no statistically significant differences of NSE, S100B, MBP and GFAP concentraions in the plasma between treatment group and control groups(all P>0.05). After treatment, compared with control group, Xueshuantong injection could markedly diminish NSE, S100B, MBP and GFAP concentraions in plasma of patients with traumatic cerebral infarction (all P<0.01). CONCLUSION Xueshuantong injection can markedly inhibit the enhancement of NSE, S100B, MBP and GFAP concentraions in plasma after traumatic cerebral infarction, and possesses obvious cerebral protective effect.
OBJECTIVE To investigate the effect of oxymatrine on neuronal cell apoptosis,oxidative injury and inflammatory reaction and furthermore discuss possible mechanism of oxymatrine suppressing neuronal cell apoptosis.METHODS All of 140 male Wistar rats were randomly divided into sham operation group,brain trauma group,as well as oxymatrine of 60 mg·kg 1 and 120 mg·kg 1 treatment group.The rat model of traumatic brain injury was induced by a modi?cation of Feeney's weight-drop model.Oxymatrine was given to rats in the oxymatrine of 60 mg kg 1 and 120 mg kg 1 treatment groups via intraperitoneal injection(60 and 120 mg·kg 1) after trauma,and then once a day till day 5.The rats in the brain trauma and sham operation groups received an intraperitoneal administration of 1 mL of saline after trauma or procedures.Animals were sacrificed by decapitation at hour 2,6 and 12,as well as day 1,2,3,and 5 after trauma.Brains were removed and blood was collected.Neuronal cell apoptosis was measured using terminal deoxynucleotidyl transferase biotin-dUTP nick end labeling;superoxide dismutase activity in serum,was determined by xanthine oxidase method;serum malondialdehyde level,was analyzed by thiobarbituric acid reactive substance assay;interleukin-1beta,tumor necrosis factor-beta,and interleukin-6 levels in serum,were measured by enzyme linked immunosorbent assay.Statistical analysis was performed.RESULTS At hour 2,6 and 12,as well as day 1,2,3,and 5 after trauma,the differences between the number of apoptotic neuronal cell,superoxide dismutase activity in serum,as well as serum malondialdehyde,interleukin-1beta,tumor necrosis factor-beta and interleukin-6 levels in the oxymatrine of 60 mg·kg 1 treatment group and brain trauma group were not significant statistically(P>0.05).At hour 12,as well as day 1,2,3,and 5 after trauma,the number of apoptotic neuronal cell,superoxide dismutase activity in serum,as well as serum malondialdehyde,interleukin-1beta,tumor necrosis factor-beta and interleukin-6 levels in the oxymatrine of 120 mg·kg 1 treatment group were significantly lower than those in the brain trauma group(P<0.05),but at hour 2 and 6,these differences were not significant(P>0.05).CONLCUSION Oxymatrine may suppress neuronal cell apoptosis via inhibition of free radical and inflammatory reactions after traumatic brain injury.
目的 分析高血压前期合并糖代谢异常(IGT)老年患者的颈动脉内膜中膜厚度(IMT)改变.方法 按照高血压前期和IGT的诊断标准,将研究对象分为:高血压前期组(仅高血压前期,无IGT)72例;IGT组(仅IGT,无高血压前期);高血压前期合并IGT组108例;对照组(无高血压前期和IGT) 100例.均测量血压、体重指数(BMI),空腹静脉采血,进行血脂、血糖、肾功能和高敏C反应蛋白(hs-CRP)的测定并进行IMT测量.结果 高血压前期组和高血压前期合并IGT组的收缩压和舒张压显著高于IGT组和对照组(P<0.05),IGT组和高血压前期合并IGT组的2h PG显著高于高血压前期组和对照组(P<0.05),高血压前期合并IGT组的hs-CRP和IMT显著高于其余三组(P<0.05).同时,高血压前期组和IGT组的hs-CRP和IMT均高于对照组(P<0.05).析因设计的方差分析显示只有hs-CRP和IMT受到血压和血糖交互作用的影响(均P<0.05).收缩压、舒张压、2 hPG和hs-CRP对IMT有显著影响,回归分析得到方程:IMT=-0.732 +0.328(hs-CRP) +0.052(2 h PG) +0.004(收缩压)+0.004(舒张压).结论 IGT会显著促进老年高血压前期患者的血管损害,老年高血压前期合并IGT患者不但需要控制血压,还需要及时检测自身的血糖变化,并加强早期干预.
OBJECTIVE To investigate the effects of antiangiogenesis of DL111-IT in vivo and in vitro.METHODS To detect the inhibition ratio of DL111-IT on endothelial cells with the method of MTT.The different concentrations of DL111-IT were injected onto the 6th day chick embryo chorioallantoic membrane(CAM),and antiangiogensis activities were assayed 72h later.Use suturation on cornea to induce the vascularization.On the third day after suturation,the rabbits were divided into four groups and gave drugs of different concentrations.The growth of neogenetic vessels of each eye was carefully observed daily during the following 21 days after suturation. RESULTS DL111-IT could inhibit the growth of neogenetic vessels effectively,IC50 of endothelial cells were ranged from 9 μg·mL-1 to 15 μg·mL-1 according to different time of drug action.The number of neogenetic vessels on the CAM were declined and it also showed the same inhibition effect on the rabbit cornea.CONCLUSION DL111-IT could inhibit angiogenesis.
目的观察奥扎格雷钠治疗急性脑梗死的临床疗效与安全性。方法将129例急性脑梗死患者随机分为治疗组64例和对照组65例。两组均给予常规治疗,即给予丹参注射液20 mL+0.9%氯化钠注射液250 mL静脉滴注,qd;胞二磷胆碱0.5 g+0.9%氯化钠注射液100 mL静脉滴注,qd;阿司匹林100 mg口服,qd;根据病情使用降血压药、降血糖药和脱水药,维持水和电解质平衡。治疗组加用奥扎格雷钠80 mg+0.9%氯化钠注射液250 mL静脉滴注,qd;对照组加用0.9%氯化钠注射液250 mL静脉滴注,qd。两组均连续治疗14 d。结果治疗组神经功能缺损评分改善较对照组明显,差异有极显著性(P<0.01);治疗组和对照组显效率分别为46.9%和27.7%,总有效率分别为85.9%和70.8%,均差异有显著性(均P<0.05)。治疗组日常生活活动能力评分改善较对照组明显(均P<0.05)。两组梗死后出血无明显差异。结论奥扎格雷钠治疗急性脑梗死安全有效,值得临床推广。
AIM To evaluate the effect of omeprazole in preventing upper gastrointestinal hemorrhage after hypertensive cerebral hemorrhage.METHODS A total of 252 patients with hypertensive cerebral hemorrhage were treated with conventional therapy including dehydration,antihypertensive and supporting treatment.The patients were randomly divided into omeprazole group and control group.The control group received conventional therapy only,while the omeprazole group received additional omeprazole 40 mg,iv,qd,for 14 d.RESULTS The incidences of upper gastrointestinal hemorrhage were 4.0% in the omeprazole group and 15.7% in the control group and the difference had significant meaning(P< 0.01).The mortalities of cerbral hemorrhage were 6.4% in the omeprazole group and 11.8% in the control group and the difference had no significant meaning(P>0.05).CONCLUSION Omeprazole has significant beneficial effect in preventing upper gastrointestinal hemorrhage after hypertensive cerebral hemorrhage.
Objective:To evaluate the efficacy of lamivudine for patients with chronic hepatitis B (CHB).Methods:96 patients with CHB were orally taken with lamivudine 100mg once per day for 18 months.The serum samples were collected to measure concentrations of ALT,AST and BIL as well as the HBV mark,HBV DNA load,HBV YMDD motif mutations and the HBV genotype.Results:At the end of the 18-month therapy,the lamvudine-treated patients with CHB showed an overall efficacy rate of 71.9%,eAg negative of 16.7%,eAb of 14.6% and HBV DNA load negative of 53.1%.36.9% of pa- tients reduced the HBV DNA load by 10~2copy·mL~(-1).The YMDD motif mutations rate was 31.3% at the end of the 18-month therapy.The overall efficacy rate for the CHB patients with genotype B and C was 84.7% and 32.3%,respectively.No adverse events were reported during the study.Conclusion: Lamivudine provided a superior therapy of HBV genotype B over genotype C.
随着计算机的普及推广,实现科学化管理是医药领域发展的必然趋势.为实现信息资源的共享,各单位都纷纷运用计算机管理,以提高工作效率及药剂科管理工作水平.本院是浙江省三级甲等医院,日门诊量近4 000人次,所以早在二年前本科室就运用计算机管理.在这二年的运用中,已摸索出一整套适合于医院药剂科的管理系统.