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目的:了解2012~2014年驻陕西省药品生产企业产品的药品不良反应发生情况与变化趋势,为药品生产、监督和临床合理用药提供依据。方法:对2012~2014年收集到的81 585份驻陕药品生产企业的药品不良反应报告从基本情况、严重程度、报告来源、性别年龄、累及系统等方面进行回顾性研究。结果:共涉及214家药品生产企业,约1 500种药品。(1)合并用药导致的不良反应报告数量增长明显。(2)新的和严重的不良反应报告数量快速增长。(3)不良反应报告中女性多于男性,且呈上升趋势;0~6岁患者报告数量略有增长,50岁以上患者报告数量快速增长;(4)不良反应主要累及胃肠系统、皮肤及其附件、中枢及外周神经系统等。(5)不良反应报告涉及80%以上化学药品,17%以上中成药。化学药品中抗感染药占比逐年下降;药品剂型以片剂、注射剂、胶囊为主,给药途径以口服给药、注射给药、皮肤给药为主。结论:驻陕西省药品生产企业药品不良反应报告数量不断增加,“新的”和“严重的”报告数量上升趋势明显,不良反应报表的上报总体情况较好,但“新的”和“严重的”药品不良反应报告仍未达到世界卫生组织要求;我国不良反应报告的来源构成中,由企业上报所占的比例明显偏低;报告患者性别比例相近,老龄化加剧;少数大中型企业不良反应报告比例较高;药品不良反应集中发生于口服和注射给药,而注射给药可能与抗菌药使用相关。
OBJECTIVE: To understand the occurrence and trend of adverse drug reactions in the pharmaceutical manufacturing enterprises in Shaanxi Province from 2012 to 2014, and provide the basis for drug production, supervision and clinical rational drug use. Methods: The adverse drug reaction reports of 81 585 drug-producing enterprises in Shaanxi collected from 2012 to 2014 were retrospectively studied in terms of basic information, severity, source of report, sex and age, and system of involvement. Results: A total of 214 pharmaceutical manufacturing enterprises were involved, with about 1,500 medicines. (1) the number of adverse reactions caused by the combination of drugs increased significantly. (2) The number of new and serious adverse reactions increased rapidly. (3) There were more female than male in the report of adverse reactions, and there was an upward trend. The number of patients aged 0 ~ 6 years increased slightly while the number of patients over 50 years increased rapidly. (4) Adverse reactions mainly involved gastrointestinal system, skin and Its annexes, central and peripheral nervous system and so on. (5) Adverse reactions report involving more than 80% of chemicals, more than 17% of proprietary Chinese medicines. The proportion of anti-infectives in chemical drugs decreased year by year. The dosage forms of drugs are mainly tablets, injections and capsules. The routes of administration are oral administration, injection and dermal administration. Conclusions: The number of ADRs reported by drug manufacturers in Shaanxi Province has been continuously increasing, the number of “new” and “serious” reports has been on the rise, and the reporting of ADRs has generally been better. However, “new ”And “ serious ”reports of adverse drug reactions have not yet reached the requirements of the World Health Organization; China’s sources of adverse reactions reported by the proportion of enterprises reported significantly lower; the proportion of reported patients with similar sex, increased aging ; A small number of large and medium-sized enterprises reported a higher proportion of adverse reactions; adverse drug reactions occur centrally and injections, and injection may be related to the use of antibacterials.