健康志愿者单次口服盐酸丙哌维林耐受性研究  

SINGLE ORAL DOSE STUDY ON THE SAFETY AND TOLERATION OF PROPIVERINE HYDROCHLORIDE IN CHINESE HEALTHY VOLUNTEERS

作　　者：王睿[1] 方翼[1] 薛俊峰[1] 王雅芹[1] 梅开城[1] 赵学兰[1] 刘庆锋[1] 王中孝[1] 赵继红[1] 

机构地区：[1]中国人民解放军总医院,北京100853

出　　处：《解放军药学学报》1999年第6期14-19,28,共7页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的 :在健康志愿者中评价单次口服国产新药盐酸丙哌维林的安全性和耐受性。方法 :选择 3 7名 18岁～ 5 0岁健康受试者 ,随机分配至A( 10mg)、B( 2 0mg)、C( 3 0mg)、D( 4 0mg)剂量组 ,并设E( 3 0mg安慰剂 )和F( 4 0mg安慰剂 )对照组。观察临床症状体征及实验室检查变化。结果 :各组入选受试者耐受性较好 ,但有 7例女性于给药后体温一过性轻度升高 ,可能与该药的抗胆碱作用有关。另有 4 0mg组 2例女性瞳孔轻度散大 ,2例女性出现头痛、头晕、乏力 ,4 0mg组 1例男性出现一过性窦性心动过缓等轻微不良反应。结论 :3 7名健康受试者单次口服盐酸丙哌维林最大剂量至 4 0mg比较安全。AIM Single oral dose study was performed to assess the safety and toleration of domestic propiverine hydrochloride in chinese healthy volunteers.METHODS The healthy subjects aged 18-50 years were screened to ensure that 37 subjects completed the study and were allocated to group A(10mg)、groupB(20mg)、group C(30mg)、group D(30mg placebo)、groupE(40mg) and groupF(40mg placebo), then the clinical symptoms、vital sign and laboratory tests were observed pre-dose and post-dose.RESULTS The safety and toleration of all subjects were good, but we found the body temperature transient slightly increased in 7 female, it might be related with anticholinergic activity. In addition, we observed some slightly ADRs ,eg pupil slightly dilated in 2 female administered 40mg, headache and tiredness in 2 female administered 40mg, sinus bradycardia in 1 male administered 40mg.CONCLUSION It was safe and tolerable that 37 subjects were administered single dose up to 40mg.

关 键 词：口服药 盐酸丙哌维林 耐受性 药物试验 解痉作用 

分 类 号：R969.4[医药卫生—药理学]