冰栀伤痛气雾剂Ⅰ期临床耐受性研究  

Phase-Ⅰ Clinical Study on the Tolerance of Ice Gardenia Pain Aerosol in Healthy Chinese Volunteers

作　　者：罗柱[1] 李梅[1] 王颖[1] 舒世清[1] 梁茂植[1] 苗佳[1] 

机构地区：[1]四川大学华西医院国家药物临床试验机构/GCP中心,成都610041

出　　处：《华西医学》2016年第10期1701-1704,共4页West China Medical Journal

摘　　要：目的观察冰栀伤痛气雾剂在中国健康受试者的单次和连续用药的安全性和耐受性,评估其安全剂量范围,确定人体最大耐受量,为Ⅱ期临床试验剂量提供依据。方法选择2014年5月-9月在某国家药物临床试验机构Ⅰ病房登记的40例受试者。单次给药耐受性试验分为5个剂量组,共纳入28例受试者,每组分别为4、6、6、6、6例,男女各半;给药剂量分别为2、6、10、14、18喷/次。连续给药耐受性试验分为2个剂量组共纳入12例受试者,每组各6例,男女各半;给药剂量为6、10喷/次,1次/d,连续给药14 d。安全性评价指标包括受试者症状、生命体征、体格检查、心电图和实验室检查。结果共纳入40例健康受试者,均按方案完成研究。单次给药各剂量组给药后1、2、4、8、12、24 h受试者均无具有临床意义的异常检查指标及不良反应;连续给药各剂量组给药期间受试者也无具有临床意义的异常检查指标及不良反应。单次给药最大耐受剂量为18喷/次,单次给药在2-18喷/次范围内均安全、可耐受;多次给药6、10喷/次,1次/d,连续给药14 d,安全且耐受性良好。结论单次和连续给药耐受性试验均提示冰栀伤痛气雾剂具有良好的安全性。单次给药最大耐受剂量18喷/次;多次给药6、10喷/次,1次/d,连续给药14 d,安全性好。建议Ⅱ期临床试验可在此范围内选取给药剂量。Objective To study the tolerance of Ice Gardenia Pain Aerosol with single and multiple dosing in healthy Chinese volunteers,evaluate the safe dosing range and the highest tolerance dose of human body,and supply proof for the dose amount in Phase- Ⅱ study.Methods Forty subjects enrolled in Ward I of a national medicine clinical experiment institute between May and September 2014 were included in this study.For single dosing experiment,28 eligible subjects were enrolled and assigned into 5 groups to receive a single dose of 2,6,10,14 and 18 puffs per time,respectively.The patient number for each group was 4,6,6,6 and 6,respectively with equal number of male and female patients in each group.For the multiple dosing treatment,12 eligible subjects were enrolled and assigned into 2 groups to receive multiple dosing of 6 and 10 puffs per time per day,respectively,for 14 days.Both the two groups had 6 male and female patients.Tolerability was evaluated by monitoring adverse events,physical examinations,laboratory tests and electrocardiogram.Results Totally,40 subjects were enrolled and all of them completed the study.No adverse events or severe adverse events were observed or reported.No abnormal laboratory test was reported 1 hour,2,4,8,12 and 24 hours after the treatment of single dosing,and multiple dosing group had no abnormal indexes or adverse events,either.The maximum single tolerance dose was 18 puffs per time,and a single dose of 2-18 puffs per time was well tolerated;Multiple dosing of 6 and 10 puffs per day,once a day for 14 days was well tolerated.Conclusions Single and multiple dosing of Ice Gardenia Pain Aerosol are considered to be well tolerated by healthy Chinese volunteers.The maximum single tolerance dose is 18 puffs per time;multiple dosing of 6 and 10 puffs per day,once a day for 14 days is well tolerated.We suggest that the above dosing range can be chosen in the following Phase- Ⅱ study.

关 键 词：冰栀伤痛气雾剂 番木鳖碱 Ⅰ期临床试验 人体耐受性 

分 类 号：R285.6[医药卫生—中药学]