阿司匹林与氯吡格雷关联使用与华法林治疗发生出血的比较研究

目的：基于FDA自发呈报系统／不良反应报告系统数据库评价阿司匹林与氯吡格雷关联使用同华法林治疗发生出血不良反应的差异。方法：去掉重复报告后,依据用药情况,把不良反应报告分为阿司匹林／氯吡格雷组,华法林治疗组和对照组,依据《国际医学用语辞典》定义出血有关的不良反应。采用描述性统计、Logistic回归模型和不良反应风险比分析阿司匹林／氯吡格雷用药与华法林用药情况下患者发生出血情况之间的差异。结果：阿司匹林与氯吡格雷关联使用的出血率为20．80％,发生率最高的为胃肠系统出血（8．23%）,华法林治疗的出血率为22．30％,发生率最高的为胃肠系统出血（7．81％）。两种治疗发生的神经系统出血差异无统计学意义（P〉0．05）。两种用药情况下患者出血率随着年龄段的升高而升高。结论：依据FDA不良反应数据库分析得出,华法林治疗导致的出血率（22．30％）高于阿司匹林与氯吡格雷关联使用（20．80%）（P〈0．05）,且两种用药情况下,患者发生的出血类型存在一定差异。     

121例药品不良反应报告分析

目的 明确药品不良反应(ADR)发生特点,掌握ADR监测及评价情况,规避临床用药风险. 方法详细收集华中科技大学同济医学院附属同济医院2008年9月1日～2010年8月31日网络呈报有效的ADR报告表121份,对有关数据进行适当转换后,进行统计分析. 结果 121份ADR报告中抗微生物药所占比例最大,其次为抗肿瘤药和循环系统用药;ADR累及器官或系统主要包括全身性损害、皮肤及其附件损害、消化系统损害;其中90例(74.4%)由静脉给药所致;新的、严重的ADR报告共19例,涉及16种药品. 结论 完善ADR监测报告制度及其分析评价,开展重点监测品种的追踪和信息通报,形成有效信息流,降低临床用药风险.     

结合医院电子病历的数据采集系统在药物警戒中的应用

如何提高药品上市后监测的效率．降低研究成本．是进行药物监测研究必须考虑的问题。日本京都大学医学部附属医院开发了与医院电子病历系统相结合的数据采集系统,应用于药品上市后监测。结合医院电子病历的数据采集系统的应用．可避免传统临床研究中纸质版病例报告表的填写,有效降低药品上市后监测的成本,提高研究监测数据的质量。国内的相关研究也可考虑应用这种方法的可行性。本文对该系统进行介绍,以期为国内研究者提供参考。     

Spontaneous reporting of hepatotoxicity associated with antiandrogens: data from the Spanish pharmacovigilance system

PURPOSE: To analyse the type and main features of the hepatotoxicity induced by steroidal and non-steroidal antiandrogens spontaneously reported by physicians, pharmacists and nurses. This analysis could increase the information related to these adverse reactions mainly available from the published isolated cases. METHODS: Using the Spanish Pharmacovigilance database we searched for spontaneous reports recorded since the date of approval of each antiandrogen up to the present time. We analysed the frequency of liver disorders, the preferred terms coded, the presence of other hepatotoxic drugs, and the characteristics of cases of hepatitis. RESULTS: Liver disorders were the most common adverse reactions associated with flutamide and bicalutamide, but not with cyproterone acetate. 'Hepatitis' and 'cholestatic hepatitis' were the most frequent terms coded. In 38% of the reports related to cyproterone acetate, 18% of those related to flutamide and 33% of those related to bicalutamide the patient had simultaneously received other hepatotoxic drugs. The disproportionality analysis of hepatitis showed a strong association with flutamide and a weak association with bicalutamide and cyproterone acetate. Mean doses of flutamide and bicalutamide were very close to their defined daily dose (DDD) to treat prostate cancer, although in the case of cyproterone acetate it was slightly higher. The latency period of hepatitis was between 3 and 10 months for the three antiandrogens, and the recovery period was shorter (0.5-3 months). The majority of the reported cases of hepatitis evolved favourably. CONCLUSION: Our results highlight the hepatotoxic potential of flutamide compared to cyproterone acetate. The data related to bicalutamide should be cautiously considered due to the smaller number of reports.     

我院306例药品不良反应报告分析

摘 要 目的： 了解我院药品不良反应（ADR）发生的特点及规律。 方法: 回顾性分析我院2013年收集的306例药品不良反应报告,对患者性别、年龄、给药途径、药物类别、ADR累及系统/器官和临床表现、分类情况、因果关系评价以及报告人员构成比等进行统计分析。结果:306例ADR报告中,51～60岁患者发生ADR例数构成比最高（20.26%）;给药途径以静脉滴注引起的ADR例数构成比最高（65.58%）;药品类别以抗菌药引起的ADR例数构成比最高（20.78%）;ADR累及系统以消化系统为主,占23.91%;医师报告的数量最多,占97.71%。结论: 我院应加强对ADR的监测和报告,促进临床合理用药,降低ADR风险,保障患者用药安全。     

Plants of restricted use indicated by three cultures in Brazil (Caboclo-river dweller, Indian and Quilombola)

A detailed record of plants cited during ethnopharmacological surveys, suspected of being toxic or of triggering adverse reactions, may be an auxiliary means to pharmacovigilance of phytomedicines, in that it provides greater knowledge of a “bad side” to plant resources in the Brazilian flora. This study describes 57 plant species of restricted use (abortive, contraceptive, contraindicated for pregnancy, prescribed in lesser doses for children and the elderly, to easy delivery, in addition to poisons to humans and animals) as indicated during ethnopharmacological surveys carried out among three cultures in Brazil (Caboclos-river dwellers, inhabitants of the Amazon forest; the Quilombolas, from the pantanal wetlands; the Krahô Indians, living in the cerrado savannahs). These groups of humans possess notions, to a remarkable extent, of the toxicity, contraindications, and interaction among plants. A bibliographical survey in the Pubmed, Web of Science and Dr. Duke's Phytochemical and Ethnobotanical Databases has shown that 5 out of the 57 species have some toxic properties described up to the present time, they are: Anacardium occidentale L. (Anacardiaceae), Brosimum gaudichaudii Trécul (Moraceae), Senna alata (L.) Roxb. (Fabaceae), Senna occidentalis (L.) Link (Fabaceae), Strychnos pseudoquina A. St.-Hil. (Loganiaceae) and Vernonia brasiliana (L.) Druce (Asteraceae).