通栓救心片Ⅰ期临床人体耐受性试验  

Phase Ⅰ Clinical Tolerance Study of Tongshuanjiuxin Tablet in Healthy Volunteers

作　　者：陈光宇[1] 刘松山[1] 刘卫昌[1] 

机构地区：[1]成都中医药大学附属医院心血管科,成都610072

出　　处：《华西医学》2013年第9期1376-1379,共4页West China Medical Journal

摘　　要：目的评价健康志愿受试者对通栓救心片的耐受性和安全性,为Ⅱ期临床试验给药方案提供依据。方法 2009年1月-4月,选择健康受试者38例,随机进入5个单次给药组和2个连续给药组。单次给药组分别口服通栓救心片3、6、8、10、15片;连续给药组口服通栓救心片2片/次和3片/次,3次/d,服药7 d。观察生命体征、实验室检查指标、临床症状和不良反应。结果单次给药8片和15片组各有1例有轻微头痛、头昏;连续给药组有轻微头昏或恶心的不良反应,均未经处理自动消失。结论健康人体对通栓救心片耐受性较好,临床应用较安全,仅见轻微头昏、头痛或恶心。推荐Ⅱ期临床试验给药剂量范围是(2～3)片/次,3次/d。Objective To evaluate the tolerance and safety oi Tongshuanjluxm tablet in healthy volunteers, and assess the safety range of its clinical use in phase II clinical trial. Methods Between January and April 2009, 38 healthy volunteers were randomly divided into five single-dose groups （3, 6, 8, 10, and 15 tablets respectively） and a continuous- dose group （2 or 3 tablets per time, three times a day, for seven days）. The safety profile and tolerance were evaluated by observing vital signs, laboratory test results, clinical symptoms and adverse reactions. Results Mild adverse reactions such as slight headache, dizziness or nausea, appeared in continuous-dose group and single-dose group （8, 15 tablets, each group had one case of mild adverse reaction）. All these reactions were relieved automatically. Conclusions Healthy body has a good tolerance for Tongshuanjiuxin tablet, and it is safe to use this drug except slight headache or nausea. The recommended dose is 2 tablets or 3 tablets per time, three times a day in phase lI clinical trial.

关 键 词：通栓救心片 临床试验 Ⅰ期 耐受性 安全性 

分 类 号：R96[医药卫生—药理学]