我院2006-2010年抗糖尿病药物应用分析

目的:分析北京医院抗糖尿病药的应用情况,为临床合理用药提供参考。方法:对卫生部北京医院2006–2010年抗糖尿病药物的种类、用量、销售金额、用药频度、日均费用等进行分析。结果:我院口服抗糖尿病药的销售金额占抗糖尿病药总金额的70%,其中,以α-葡萄糖苷酶抑制剂所占比例最高,胰岛素类约占30%;阿卡波糖、二甲双胍、诺和灵30R的DDDs较高,临床较为常用;二甲双胍、格列美脲、格列喹酮的DDC较低;噻唑烷二酮类药物的销售金额和DDDs逐年下降,其他药品的销售金额和DDDs均呈上升趋势,DDC逐年下降。瑞格列奈、那格列奈、甘精胰岛素的排序比值较低。结论:我院2006–2010年抗糖尿病药物的使用品种相对稳定,基本满足临床安全、经济、有效用药的需求。     

关于我国药品上市后评价技术工作的思考

目的探讨今后药品上市后评价工作方向。方法分析和总结以往工作体会。结果我国药品上市后评价工作已初见成效。结论应继续深入开展药品上市后评价工作。     

我院住院患者应用胺碘酮对QTc间期的影响

摘 要 目的:评估胺碘酮对住院患者QT/ QTc间期的影响及药品不良反应。方法：纳入2014年1～6月上海浦东新区公利医院心内科使用胺碘酮的住院患者共59例,记录患者一般情况和合并用药等信息,观察应用胺碘酮注射液或胺碘酮片剂后心率、QT间期、QTc间期的变化,以及在用药期间发生药品不良反应。结果：用药后患者的平均心率、QT间期和QTc间期较用药前显著减慢(P<0.01)。59例患者中,12例用药后QTc＞500 ms,5例患者用药后△QTc＞50 ms且 QTc＜500 ms。研究中,共有8例合并使用一种或多种可延长QT间期的药物,包括左氧氟沙星（4例）,阿奇霉素（3例）,氟哌噻吨美利曲辛（1例）,多潘立酮（1例）。32例应用胺碘酮注射液患者中有3例发生注射部位反应,用药中未出现与胺碘酮相关的心律失常[包括尖端扭转性室速(Tdp）]。结论：住院患者应用胺碘酮后QT间期、QTc间期均会不同程度延长,对于用药后QTc＞500 ms、△QTc＞50 ms或合并使用其他可延长QT间期药物的患者,Tdp发生风险增加,应及时调整胺碘酮用药方案并严密监测心电图,避免恶性心律失常事件的发生。     

社区卫生服务中心254份药品不良反应报告分析

目的:了解基层社区卫生服务中心药品不良反应(ADR)发生的规律及特点,为临床合理用药及药物安全性评价提供依据。方法:回顾性总结分析我中心从2010年8月-2011年7月的254例ADR报告。结果:抗高血压药的ADR发生率最高,口服用药是发生ADR的主要途径。结论:应合理使用抗高血压药;加强药品不良反应监测,保障用药安全。     

心血管疾病干细胞治疗的疗效判断方法

干细胞治疗可增加冠状动脉血液灌注,增加心肌收缩力,在严重缺血性心脏病的治疗中发挥重要作用。本文对干细胞治疗的疗效判断方法及干细胞治疗对左心室功能、心肌灌注、心肌存活等的作用作一综述。     

药品不良反应监测质量评估指标体系的建立

目的：为药品不良反应监测质量评价提供科学的参考依据。方法：采用专家法和层次分析法（AHP法）确定评估指标及权重。结果：从监测机构、监测人员、监测制度和监测报告四个维度确定各评估指标并计算出对应的权重系数,初步构建药品不良反应监测质量评估指标体系。结论：构建出药品不良反应监测质量评估指标体系。     

An open comparative study of two diuretic combinations,frusemide/amiloride (‘Frumil’) and bumetanide/potassium chloride (‘Burinex’ K), in the treatment of congestive cardiac failure in hospital out-patients

Summary

Forty elderly patients, aged 68 to 89 years, with congestive cardiac failure, who were attending a hospital out-patients department, entered an open, parallel group, comparative study of two diuretic combinations, 40 mgfrusemide plus 5?mg amiloride per tablet and 0.5?mg bumetanide plus 573?mg slow-release potassium chloride per tablet. Patients were assigned at random to receive one or other combination for 8 weeks, dosage being determined by the severity of the individual patient's condition (range 1 to 3 tablets frusemide/amiloride; 2 to 6 tablets bumetanide/potassium chloride). Clinical assessments, including visual analogue scores for dyspnoea at rest and on effort, and laboratory measurements of serum potassium and magnesium levels were carried out on entry and after 2, 4 and 8 weeks of treatment. Other variables were monitored before, during and/or after treatment. Although significant decreases were reported in dyspnoea severity scores at rest and on effort only in the bumetanide/potassium chloride group, global assessment of the patients' condition by patient and clinician at the end of the study indicated that both treatments produced improvement, and a greater proportion of patients considered treatment as satisfactory in the frusemide/amiloride group. Both drug combinations were well-tolerated and only a few minor side-effects were reported. Serum potassium levels were maintained in both treatment groups but there was a significant decrease in mean serum magnesium levels in patients on bumetanide/potassium chloride. Hyponatraemia was also detected in 2 patients on this combination. An increase in body weight was recorded in both groups, the increase being significant in patients receiving bumetanide/potassium chloride.     

三七总皂苷肠溶胶囊在比格犬体内的药代动力学

目的探讨三七总皂苷(PNS)肠溶胶囊在比格犬体内的药代动力学。方法比格犬采用随机交叉给药方案,口服PNS肠溶胶囊86.2 mg·kg-1或血栓通胶囊111.8 mg·kg-1后,用反相高效液相色谱法同时测定犬血浆中三七皂苷R1、人参皂苷Rg1和Rb1的血药浓度,采用3P97药动学软件计算药动学参数和基于曲线下面积(AUC0-∞)自定义权重系数整合血药浓度后的药动学参数。结果与参比制剂血栓通比较,受试制剂PNS R1、Rg1、Rb1的达峰时间延长:R10.18±0.09 vs(0.16±0.06)h,Rg12.03±0.76 vs(1.74±0.27)h,Rb1 0.76±0.39 vs(0.74±0.17)h;吸收延迟时间延长:R1 0.96±0.16 vs(0.50±0.11)h,Rg10.87±0.05 vs(0.02±0.01)h,Rb10.92±0.12 vs(0.44±0.07)h,3种成分及其整合后PNS的相对生物利用度分别为248.41%,107.19%,152.94%和155.31%。整合后,血栓通胶囊和PNS肠溶胶囊的主要药动学参数分别为:AUC0→t39.17±3.89 vs(46.91±3.86)mg.L-1.h,Lag时间0.45±0.18 vs(0.92±0.13)h,tmax0.74±0.17 vs(0.77±0.13)h,Cl(3.84±0.24 vs 1.84±0.97 L.kg-1.h-1)。结论本实验制备的PNS肠溶胶囊能提高PNS的口服生物利用度。     

114例神经系统不良反应报告分析

目的分析药品不良反应(ADR)发生的规律及特点,为临床合理用药及药物安全性评价提供依据。方法对我院2007年收集的114例神经系统ADR报告进行分析。结果114例神经系统不良反应涉及13类药物,52个品种,抗感染药居首位(18例,占15.78%),其次是眼用药物(16例,占14.04%)和消化系统药物(13例,占11.41%)。静脉用药引发神经系统ADR最多(93例,占81.58%)。ADR均较轻,无严重不良反应发生,临床主要表现为手脚麻木、头痛、精神异常。结论临床应重视ADR的报告和监测工作,指导临床合理用药,以减少或避免ADR的发生。     

Cell-penetrating peptide-doxorubicin conjugate loaded NGR-modified nanobubbles for ultrasound triggered drug delivery

A new drug-targeting system for CD13⁺ tumors has been developed, based on ultrasound-sensitive nanobubbles (NBs) and cell-permeable peptides (CPPs). Here, the CPP-doxorubicin conjugate (CPP-DOX) was entrapped in the asparagine–glycine–arginine (NGR) peptide modified NB (CPP-DOX/NGR-NB) and the penetration of CPP-DOX was temporally masked; local ultrasound stimulation could trigger the CPP-DOX release from NB and activate its penetration. The CPP-DOX/NGR-NBs had particle sizes of about 200?nm and drug entrapment efficiency larger than 90%. In vitro release results showed that over 85% of the encapsulated DOX or CPP-DOX would release from NBs in the presence of ultrasound, while less than 1.5% of that (30?min) without ultrasound. Cell experiments showed the higher cellular CPP-DOX uptake of CPP-DOX/NGR-NB among the various NB formulations in Human fibrosarcoma cells (HT-1080, CD13⁺). The CPP-DOX/NGR-NB with ultrasound treatment exhibited an increased cytotoxic activity than the one without ultrasound. In nude mice xenograft of HT-1080 cells, CPP-DOX/NGR-NB with ultrasound showed a higher tumor inhibition effect (3.1% of T/C%, day 24), longer median survival time (50 days) and excellent body safety compared with the normal DOX injection group. These results indicate that the constructed vesicle would be a promising drug delivery system for specific cancer treatment.