开郁宁片人体耐受性试验  

Tolerance study of kaiyuning tablet in healthy Chinese volunteers

作　　者：王智民[1] 周蓓蕾[1] 司远萍[1] 翟屹民[1] 刘珊珊[1] 王传跃[1] 

机构地区：[1]首都医科大学附属北京安定医院临床精神药理研究室,北京100088

出　　处：《中国临床药理学与治疗学》2007年第8期943-948,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:评价健康受试者对开郁宁片的耐受性。方法:28例健康男、女受试者随机分为6组参加了单次给药耐受性试验,各组剂量分别为150、300、500、750、1000、1250mg。12例男、女健康受试者随机分为两组参加了为期7d的连续给药耐受性试验,两组日剂量分别为1000、1250mg。观察受试者的临床症状、体征和实验室检查的变化。结果:试验中未发生严重不良事件。在观察剂量范围内,与试验药物相关的不良事件包括:血压升高、血压降低、头晕、头痛、困倦思睡、面部发热、口干、手指发麻、恶心腹痛、腹泻、便秘、转氨酶升高、心电图异常。这些不良事件均为轻度,可耐受,停药后自行恢复。结论:健康受试者服用开郁宁片日剂量150～1250mg,可安全耐受。AIM： To assess tolerance of kaiyuning tablet in healthy Chinese volunteers. METHODS： 28 volunteers were enrolled in a single-dose clinical trial for tolerance study which were randomly divided into 6 groups, including 150, 300, 500, 750, 1 000, 1 250 nag dosing groups. Another 12 volunteers, randomly divided into two groups of 1 000 and 1 250 mg per day, were enrolled in the multiple-dose clinical trial for 7 consective days. Comparisons were conducted with regard to the clinical symptoms, vital signs and lab examinations acquired before and after dosing in the single-dose and multiple-dose regimens, respectively. RESULTS： No severe adverse events were found in the trial. Common ad-verse events assiociated with Kaiyuning tablet within the dose range from 150 mg to 1 250 mg including： hypertension, hypotension, dizzinese, drowsinese, headache, facial blushing, dry mouth, nausea, stomachache, constipation, diarrhea, numble in the fingers, transaminase elevation and abnomal ECG. These adverse events were slight and tolerable, which recovered spontaneously following drug discontinuation. CONCLUSION： The results suggest that kaiyuning tablet was safe and tolerable at the dose from 150 to 1 250 mg per day.

关 键 词：开郁宁 耐受性 安全性 

分 类 号：R969[医药卫生—药理学]