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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 an anticholinergic Class I drug developed by the Institute of Toxicants and Pharmaceuticals, Chinese Academy of Military Medical Sciences, People’s Liberation Army. This multicentre clinical trial was organized by the China Institute of Drug Dependence and conducted rides, boat trials and laboratory exercise tests on prevention of motion sickness by phencynonate hydrochloride. Control drugs for dizzy stop and placebo. 301 car and boat trials, including 104 double-blind controlled trials and 197 open trials. The total effective rate was 81.40%, the effective rate was 60.80%, the effective rate was 20.60%, the partial effective rate was 11.96% and the inefficiency rate was 6.64%. The total effective rate compared with placebo, the difference was extremely significant (p <0.01), compared with the vertigo stopped there were significant differences (p <0.05). 60 cases of laboratory exercise test, including double-blind control and open trial of 30 cases. Rotational nystagmus records showed that nystagmus velocity in nystagmus and rotation after taking medicine were significantly lower than that before taking medicine (p <0.01); Coriolis acceleration stimulated electrogastrogram showed that after administration of stomach Body and gastric antrum amplitude was significantly lower than before medication, the difference was significant (p <0.01). Group control showed that: the drug compared with the placebo group were significantly different, and dizziness stop group no significant difference. Phencynonate side effects are mainly dry mouth, the incidence of 9.7%, no other serious adverse reactions. The above results show that phenylcyclohexyl hydrochloride is one of the safe and effective drugs to prevent motion sickness.