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| 托卡朋治疗帕金森病安全性评价 |
| Evaluation of the Security of Tolcapone in the Treatment of Parkinson''''s Disease |
| 投稿时间：2005-04-18 修订日期：2005-08-15 |
| DOI： |
| 中文关键词: 托卡朋 双盲 随机临床试验 安全性评价 药物不良反应 |
| 英文关键词:Tolcapone,Random clinical test(RCT),Security evaluation,Adverse drug reaction |
| 基金项目: |
| 王景华 宁宪嘉 程焱 张小英 黄槛政 哈志远 |
| [1]天津医科大学总医院、天津市神经病学研究所,天津300052 [2]北京天坛医院,天津300052 [3]浙江大学医学院第二附属医院,天津300052 [4]河北省人民医院,天津300052 |
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| 中文摘要: |
| 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100mg 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。 |
| 英文摘要: |
| Objective:To evaluate the security of Tolcapone 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 Tolcapone 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. |
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