口服抗糖尿病药物不良反应信号及其相关因素分析(英文)

Analysis on the adverse drug reaction signal and its impact factors induced by oral hypoglycemic agents

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。

MM To study the feature and regularity of adverse drug reaction （ADR） induced by oral hypoglycemic agents （OHAs） and provide reasonable advice for clinical use. METHODS By collecting ADR reports of O- HAs from database of Shanghai ADR spontaneous reporting system from 2006 to 2010, we made through analysis on the character and risk factors of ADR induced by OHAs using descriptive statistics and logistic regression model, and also applied disproportional measures on data mining of ADR signal and its relevant factors. RESULTS A total of 812 ADR reports induced by OHAs were included in this study. The results indicated that the senior and female patients were mostly concerned, and mainly marked as moderately injured, but new ADR reports marked as moderate and severe which were not recorded in drug instructions and references increased significantly during the period of 2009 to 2010, and the most frequently involved agents were biguanides and sulfonylureas （SU）. The logistic regression analysis of ADR and its influence factors showed female, the high frequency of taking drug and single medication were risk factors of gastrointestinal damage, weight was the risk factor of skin damage, and combined medication and patients＇ age were the risk factors of hypoglycemia caused by SU. The results of measures of disproportionality found some ADR signals induced by OHAs. CONCLUSION The ADR of oral hypoglycemic agents could involve multiple systems and organs. Risk factors such as gender, age, weight, frequency of taking drug and drug combination had effects on the occurrence of ADR in differentdegree, so in order to take OHAs safely and reasonably, we should strengthen the ADR monitoring and put emphasis on controlling the risk factors of ADR in clinical practice.