吗氯贝胺治疗抑郁症药物不良反应监测  

Monitoring of Adverse Drug Reaction on Moclobemide in the Treatment of Depression

作　　者：王济中[1] 

机构地区：[1]安徽省芜湖市皖南医学院弋矶山医院心理科,241001

出　　处：《药物流行病学杂志》2001年第3期128-130,共3页Chinese Journal of Pharmacoepidemiology

摘　　要：目的 :了解吗氯贝胺治疗抑郁症时药物不良反应发生情况 ,以提高该药在临床应用中的有效性与安全性。方法 :按年龄、性别、剂量分组观察 ,按持续用药的不同时间对发生的不良反应逐例逐次统计 ,共 8周。结果 :治疗观察 198例抑郁症患者 ,8周内出现药物不良反应 (ADRs) 97例 ,发生率为 48.99% ;共计 2 74例次 ,发生频度为 178.38% ;轻度反应占 42 .2 7% ,中度反应为 32 .99% ,重度反应为 2 5 .77% ;重度反应中男女各占42 .2 8%和 45 .36 % ,两者无显著差异 (P >0 .0 5 ) ;6 0岁以下各年龄段ADRs发生率无显著差异 ,大于 6 0岁者ADRs发生率及其严重程度均有明显上升趋势 ;30 0mg/d、45 0mg/d和 6 0 0mg/d三个剂量组ADRs发生率及重度ADRs表现发生率依次为 41.76 %、0 % ;43 .0 %、18.9%和 6 7.3 %、48.6 %。多数ADRs在持续用药 1～ 2周内出现 ,主要表现为抗胆碱能作用 ,实验室检查改变多在持续用药 5～ 6周后出现。结论 :吗氯贝胺治疗抑郁症具有一定的不良反应 ,多数较轻 ,其发生率及严重程度与剂量、持续用药时间及年龄有一定的正相关系 ,与性别无明显关系 。To get data on the adverse drug reaction(ADRs) of moclobemide in the treatment of depression, patients were divided different groups in terms of age, sex and dosage and observed of adverse drug reactions for 8 weeks. Our results showed that among the 198 patients, 97 patients developed adversed durg reaction, with an incidence of 49.0%(total:274 case times)and a frequency of 138.4%, 42.3% of the ADRs were mild, 33.0% were moderate and 25.8% were serious. In cases of serious ADRs, the rates for males and females were 42.3% and 45.4% and there was no significant difference in the ADR incidence between the two groups ( P>0.05 ). There was no significant difference in ADR incidence among the groups over 60, while there was a tendency of increase in incidence and severity of ADRs in the patients over 60. The incidences of ADRs and serious ADRs in the three dosage gropus(300 mg/d, 450 mg/d and 600 mg/d) were 41.7%, 0%, 43.0% and 18.9%, 67.3%, 48.6%. Most ADRs developed within 1 2 weeks after continuous use of the drug. The main reaction was of anticholinergic effect and the changes in laboratory tests occurred mostly 5 6 weeks after the continuous use of the drug. It is concluded that moclobemide causes some ADRs in the treatment of depression, most of which are mild and the incidence and severity of the ADRs are positively related to the dosage, time of medication and age and have no relation with sex. The changes in results of laboratory tests occurred relatively late.

关 键 词：吗氯贝胺 抑郁症 药物不良反应 发生频度 治疗 

分 类 号：R749.405[医药卫生—神经病学与精神病学]