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目的研究口服抗糖尿病药物不良反应特征,并提供相应临床合理用药的依据。方法通过上海市不良反应监测中心收集2006至2010年有关口服抗糖尿病药物不良反应的数据,使用描述性统计,logistie回归模型及不相称性,对不良反应发生的特征、风险因子和相关因素进行分析。结果共获得812例口服抗糖尿病药物的不良反应报告。结果显示老年人和女性占不良反应发生的多数;不良反应级别以一般为主;2009至2010年间作为药品说明书中未记载的新的不良反应有上升的趋势;双胍类及磺酰脲类(SU)不良反应最为突出;logistic回归模型显示女性、日服用药频次多、单一用药是胃肠道不良反应的危险因素。体质量是皮肤损害的危险因素,联合用药、患者年龄大是SU致低血糖的危险因素。不相称性研究同时也得到一些口服抗糖尿病药物致不良反应的信号。结论口服抗糖尿病药物不良反应累及系统器官广泛,像性别、年龄、体质量、用药频次、是否联合用药都会在一定程度上影响不良反应的发生。故口服抗糖尿病药物在临床使用时应加强不良反应监测,重视和控制其风险因子,以期更合理安全地用药。
Objective To study the characteristics of adverse reactions of oral antidiabetic drugs and provide the basis for their clinical use. Methods The ADR data were collected from 2006 to 2010 in Shanghai Adverse Reaction Monitoring Center. The descriptive statistics, logistic regression model and disparity were used to analyze the characteristics, risk factors and related factors of adverse reactions . Results A total of 812 oral antidiabetic drug adverse reactions were reported. The results showed that the elderly and women accounted for the majority of adverse reactions; Adverse reactions of the general level; Between 2009 and 2010 as a new drug unknowns there is an upward trend in adverse reactions; Biguanides and sulfonylureas (SU ) Adverse reactions the most prominent; logistic regression model showed that women, taking more frequently on a daily basis, a single drug is a gastrointestinal adverse reactions risk factors. Body mass is a risk factor for skin damage, combined with medication, patients with large age SU is a risk factor for hypoglycemia. Unparalleled research also received some oral anti-diabetic drug-induced adverse reactions signal. Conclusion Adverse reactions to oral antidiabetic drugs involve a wide range of organs and organs, such as gender, age, body weight, frequency of medication, whether combined with medication will affect the occurrence of adverse reactions to a certain extent. Therefore, oral anti-diabetic drugs in clinical use should strengthen the monitoring of adverse reactions, attention and control of risk factors, in order to more reasonable and safe medication.