仲香胶囊Ⅰ期临床耐受性研究  

Phase Ⅰ clinical trail for tolerance of Zhongxiang capsule in healthy volunteers

作　　者：张锡玮[1] 李国信[1] 卢春玲[1] 吴萍[1] 李晓[1] 

机构地区：[1]辽宁中医药大学附属医院,沈阳110032

出　　处：《中国新药杂志》2009年第5期424-426,共3页Chinese Journal of New Drugs

摘　　要：目的:评价中国健康志愿者单次及连续口服仲香胶囊的耐受性。方法:研究分为单次和连续给药两部分。单次给药分为4组,分别给予仲香胶囊2(n=2),4(n=6),6(n=6),9粒(n=4)。连续给药组分为2组,分别给予仲香胶囊6(n=6)和9粒(n=6),qd,用药7 d。观察各组用药后的临床症状和生命体征,并检查心电图、血尿常规、肝肾功能、凝血功能、腹部彩超等。结果:单次给药理化检查有12项指标出现异常,均无临床意义。连续给药有1例受试者检测结果出现异常,但无临床意义,发生1例轻度不良事件,表现为一侧耳鸣(左),与药物无关。结论:建议本品进行II期临床试验的安全剂量范围在9粒以内,进行II期临床试验时注意观察该药物有可能引起的毒性反应,特别是神经系统的症状。Objective： To assess the tolerance of single-dose and continuous oral administration of Zhongxiang capsule in Chinese volunteers.Methods：Thirty healthy volunteers were randomly divided into 4 single-dose groups（2,4,6 and 9 pills respectively） and two multiple-dose groups（6 and 9 pills respectively,qd for 7d）.Subjective symptoms,objective signs,and vital signs（blood pressure,heart rate and respiration） were observed;routine blood and urine tests,hepatic function,renal function,clotting function,electrocardiogram,and abdominal CDFI were monitored during medication.Results： In the single-dose groups,12 indicators of physical and chemical inspection were abnormal,but they had no clinical signification.In the multiple-dose groups,one-sided tinnitus（left） occurred without association with Zhongxiang capsule.Conclusions： For phase Ⅱ clinical trial,the safe dose of Zhongxiang capsule is recommended within 9 pills;during the trial,the possible toxic reactions may occur,especially those in the nervous systems.

关 键 词：仲香胶囊 Ⅰ期临床试验 耐受性 

分 类 号：R28[医药卫生—中药学] R969.4[医药卫生—中医学]