摘要
目的:采用安慰剂作对照,评价托卡朋治疗帕金森病安全性。方法:托卡朋组给药剂量每次100 mg po,tid;安慰剂组每次1片,tid,po,疗程6个月。分别于服药前后,对患者的症状、体征、血尿常规、肝肾功能及心电图、B超进行检查。结果:入组患者240例,安全性数据集240例,试验组与对照组各120例;两组分别有27例 (22．5％)和20例(16．67％)发生不良反应,经比较差异不明显,P>0．05。结论:托卡朋治疗帕金森病是安全的。
Objective： To evaluate the security of Toleapone in the treatment Parkinson＇s Disease by placebo control. Method： The dosage of the Tolcapone group was 100 mg per time, three times a day and that of the placebo group was one table per time, three times a day. The period of one treatment was six months. The symptom and clinical features, the general test in blood and urine, the hepatic and nephritic function test, electrocardiogram, B ultrasonic were measured before and after taking medicine. Result： There were 240 cases in this study, safety data group being 240 cases. There were 120 cases in the Tolcapone group and control group respectively. 27 cases （22.5%） showed some adverse drug reactions in the Toleapone group and 20 cases （16.67%）, in the control group. There was no significant statistical difference between the two group, （P 〉 0.05）. Conclusion： Tolcapone was the secure drug to treat Parkinson＇s disease.
出处
《药物流行病学杂志》
CAS
2005年第6期349-351,共3页
Chinese Journal of Pharmacoepidemiology
