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目的 为了考察国产万拉法新胶囊在健康人体的耐受性和不良反应。方法征集28名健康志愿受试者,随机分7组,接受万拉法新单剂量空腹顿服。结果 发现万拉法新主要不良反应为恶心、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 健康受试者对国产万拉法新胶囊耐受性较高,短期用药对人体正常生理代谢无明显影响。
Objective To investigate the tolerance and adverse reactions of domestic venlafaxine capsules in healthy volunteers. Methods A total of 28 healthy volunteers were enrolled and randomly divided into 7 groups and received a single dose of venlafaxine fasting Dayton clothing. The results showed that Venlafaxine main adverse reactions were nausea, dizziness, sweating, anorexia, dry mouth, fatigue, vomiting, insomnia, mostly mild reaction, untreated disappear on their own. There were no serious adverse reactions such as delirium, disturbance of consciousness, abnormal thinking and disintegration of personality in the experiment. Compared with those before taking medicine, the subjects took vital signs such as body temperature, heart rate and blood pressure, blood, urine, stool routine, liver and kidney function And ECG fluctuations in the normal range. Conclusion Healthy volunteers are relatively tolerant to domestic venlafaxine capsules. Short-term medication has no significant effect on the normal physiological metabolism of the human body.