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目的:考察抗抑郁药国产万拉法新胶囊在健康人体的药物不良反应。方法:28名健康志愿受试者,随机分为7组,分别接受万拉法新单剂量25,75,100,125,150,175,200mg/次空腹顿服。结果:万拉法新主要药物不良反应为恶心、头昏、出汗、厌食、口干、疲乏、呕吐、失眠等,大部分为轻度反应,未经处理,自行消失。试验中未出现谵妄、意识障碍、思维异常、人格解体等严重药物不良反应。与服药前相比,受试者服药后的体温、心率、血压等生命体征和血、小便、大便常规,肝肾功能及心电图等均在正常范围内波动。结论:国产万拉法新胶囊对健康人体耐受性较高,短期用药对人体正常生理代谢无明显影响
OBJECTIVE: To investigate the drug adverse reactions of homemade venlafaxine capsules in healthy volunteers. Methods: Twenty-eight healthy volunteers were randomly divided into 7 groups, receiving single dose of venlafaxine 25,75,100,125,150,175,200mg / time fasting Dayton clothing. Results: The main adverse drug reactions to venlafaxine were nausea, dizziness, sweating, anorexia, dry mouth, fatigue, vomiting and insomnia. Most of them were mild reactions and disappeared without treatment. No delirium, disturbance of consciousness, abnormal thinking, personality breakdown and other serious adverse drug reactions occurred in the trial. Compared with before taking medicine, subjects’ body temperature, heart rate, blood pressure and other blood and urine, urine, stool routine, liver and kidney function and electrocardiogram fluctuated within the normal range after taking medicine. CONCLUSION: Domestic venlafaxine capsules have higher tolerance to healthy human body, and short-term administration has no significant effect on the normal physiological metabolism of human body