盐酸苯环壬酯预防晕动病临床试验研究  

CLINICAL STUDY OF PHENCYNONATE HYDROCHLORIDE IN THE PREVENTION OF MOTION SICKNESS

作　　者：徐国柱[1] 蔡志基[1] 董良[2] 黄翠玉[2] 刘薇薇[3] 赵如冰[3] 安定一[4] 徐先荣[4] 王淑范[5] 王汉斌[5] 

机构地区：[1]北京医科大学中国药物依赖性研究所,北京100083 [2]海军422医院 [3]北京医科大学校医院 [4]空军总医院 [5]解放军307医院

出　　处：《中国临床药理学杂志》1993年第2期65-74,共10页The Chinese Journal of Clinical Pharmacology

摘　　要：盐酸苯环壬酯是中国人民解放军军事医学科学院毒物药物研究所研制的抗胆碱I类新药。本项多中心临床试验研究由中国药物依赖性研究所负责组织,对盐酸苯环壬酯预防晕动病进行乘车、乘船试验和试验室内运动试验。对照药为眩晕停和安慰剂。乘车、乘船试验301例,包括双盲对照试验104例与开放试验197例。总有效率81.40%,显效率60.80%,有效率20.60%,部分有效率11.96%,无效率6.64%。总有效率与安慰剂比较,差异极为显著(p<0.01),与眩晕停比较也有显著性差异(p<0.05)。试验室内运动试验60例,包括双盲对照和开放试验各30例。旋转性眼球震颤记录显示,服药后旋转中眼震和旋转后眼震速度均明显低于服药前,具有显著性差异(p<0.01);科里奥力加速度刺激胃电记录显示,服药后胃体和胃窦胃电振幅均明显低于服药前,差异非常显著(p<0.01)。组间对照表明:本药与安慰剂组比较有显著性差异,与眩晕停组比较无显著性差异。苯环壬酯副作用主要是口干,发生率9.7%,无其他严重不良反应。以上结果表明,盐酸苯环壬酯是预防晕动病的安全有效药物之一。Phencynonate hydrochloride is a Class 1 new anticholinergic drug developed bythe Institute of Pharmacology and Toxicology, Chinese Academy of Military Medical Sciences. The multi-centre clinical trials of phencynonate in the prevention of motion sickness were or-ganized by the National Institute on Drug Dependence.The trials were divided into 3 test groups (boat.car and laboratory) Diphenidol and placebo were used as control. A total of 301 cases (104 in double-blind controlled trial, 197 in open trial) were included in boatand car test groups. The total effective, excellent, effective. partial effective and noneffectiverates of phencynonate were 81.40%, 60.80%, 20.60%, 11.96% and 6.64%, respectively. Thetotal effective rate of phencynonate was significantly higher than those of placebo (p<0.01) anddiphenidol (p<0.05). Laboratory motion tests were carried out in 60 cases (double-blind controlled and open trials30 cases each). Results showed that the speed of nystagmus during and after rotation was sig-nificantly lower after drug administration (p<0.01). Records from Coriolis acceleration test showedthat the amplitude of electrrogastrogram was significantly lower after drug administration (p<0.01).There was significant difference between phencynonate and placebo groups, but there was no sig-nificant difference between phencynonate and diphenidol groups. The major adverse drug reaction caused by phyencynonate was dry mouth (9.7%). There wasno other severe adverse drug reactions observed. It is concluded that phencynonate hyrochloride is an effective and safe drug in the prevention ofmotion sickness.

关 键 词：盐酸 苯环壬酯 晕动病 预防 

分 类 号：R594.601[医药卫生—内科学]