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.     

Safety of an injection with a mixture of extracts from Herba Artemisiae annuae, Fructus Gardeniae and Flos Lonicerae

Objective This study aimed to evaluate the safety for an injection with a mixture of extracts from Herba Artemisiae annuae, Fructus Gardeniae and Flos Lonicerae and to determine the risk factors that may affect its adverse drug reactions. Methods A drug-oriented prospective observational study was performed. Physicians filled in clinical observation forms with detailed information of the patients including general information, drug information, therapeutic effects and adverse drug events. The adverse drug reaction factors were analyzed by both mono-factor and multiple-factor logistic regression methods. Results From April to July 2007, we collected 12,427 observation forms from 46 hospitals in Jiangsu Province of China. Among the 11,707 observation forms we analyzed, 8,074 patients were children younger than 14 years old (69%). Among 51 reported adverse drug events, 45 cases were adverse drug reactions. The total adverse drug reaction incidence of the injection was 0.38%. While most adverse drug reactions were previously known (e.g., rash, pruritus, vomiting and diarrhea), we observed three new ADR symptoms: shiver, phlebitis and anhelation. All the adverse drug reactions were controlled very well through the follow-up therapy, and none of them was life threatening. The mono-factor analysis showed that adverse drug reactions of the injection were significantly correlated with total medication dose (P = 0.0049) and combination medication (P = 0.0143), especially with antimicrobial drugs (P = 0.0079) and macrolides (P = 0.0017). The multiple factor analysis confirmed these results: medication dosage and combination medication had a crucial impact on adverse drug reactions of the injection; the risk was increased by 24.8% (the estimated value of relative risk was 1.248, 95% confidence interval: 1.054–1.479) and 89% (1.890, 1.001–3.566), respectively. Conclusion The total adverse drug reaction incidence of the injection was 0.38% and lower than we expected. Moreover, we observed three new adverse drug reactions, none of which was severe.

论药品不良反应信息通报制度的目的与作用

目的:利用《药品不良反应(ADR)信息通报》,进一步发挥药物警戒与干预的作用,有效避免或减少ADR。方法:收集国家ADR监测中心自2001年11月～2009年5月发布的共22期《ADR信息通报》,运用Excel软件进行数据分类统计,探讨《ADR信息通报》制度的目的与作用。结果:《ADR信息通报》的定期公布,使ADR病例报告数量显著提高,但同时也存在政府监管部门与临床用药单位信息反馈滞缓,部分药品反复通报但ADR仍重复发生与蔓延等现象。被通报药品中,中药ADR居多,占25%以上;重复通报的14个药品中,中药高达50%。结论:需进一步采取多种形式加强ADR的宣传与培训,使医务人员有效利用《ADR信息通报》,确保公众用药安全。     

长期处方政策下慢性病患者药物警戒工作的思考

目的：目前《长期处方管理规范（试行）》正式实施,探讨长期处方政策下慢性病患者药物警戒工作的意义和做法。方法：从慢性病患者药物警戒（PV）活动和药品不良反应（ADR）监测的角度出发,分析针对慢性病患者开展PV活动和ADR监测的必要性,提出长期处方政策下慢性病患者用药安全面临的挑战,探讨加强慢性病患者PV活动和ADR监测的相关建议。结果和结论：在长期处方政策下,患者用药安全性需要医生、药师、上市许可持有人、患者及社区等相关方各司其职并相互协作,密切监测慢性病患者的ADR,在确保用药安全、合理的前提下,使长期处方方便于广大慢性病患者。     

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).     

The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance

The development of telematic exchange of information in pharmacovigilance has as a consequence the necessary development of the messages used to transmit the information. The first of these messages is the one used to transmit information on individual case reports. Common formats exist on paper, but these have not been applied to electronic transmission. A structured message for the transmission of single case information has been developed within the ENS European research programme, by three National Pharmacovigilance administrations, and reviewed by the relevant European bodies. It has been submitted to the Western European Edifact Board MD9 for admission as an EDIFACT message, so that it will be possible to exchange information concerning these single cases, using standard EDI methodology.     

Drug-induced myoclonus: a French pharmacovigilance database study

Various drugs have been reported to induce myoclonus. However, this adverse event is not well known because of the difficult diagnosis and the lack of pharmaco-epidemiological or controlled studies. As far as we know, there are only case reports. In the literature, antiparkinsonian medications, antipsychotics, antidepressants, anesthetics, opiates and anti-infectious drugs have been reported in the occurrence of myoclonus. In a French pharmacovigilance database study, only 423 reports (0.2%) involved drug-induced myoclonus. The median age of patients was 55 years and 10% of these patients had a concomitant neurological disease. Only 16% of these reports had a strong imputability score (likely). The most frequently involved drugs were anti-infectious (15%), antidepressants (15%), anxiolytics (14%), and opiates agents (12%). Fifty-six percent of these reports were classified as serious adverse event. Concerning outcome, most patients (84%) recovered without sequels.