苯乙基异硫氰酸酯胶囊多次给药人体耐受性及膀胱毒性观察研究

Tolerance and Urinary Bladder Toxicity Study of Phenethyl Isothiocyanate Capsules at Multiple Doses in Human Body

目的评价健康人体对多次给药苯乙基异硫氰酸酯胶囊的耐受性与安全性。方法采用单中心、双盲、随机、安慰剂对照试验。12名健康受试者参与为期28天的连续给药耐受性试验,给药组与安慰剂组各6人。口服苯乙基异硫氰酸酯胶囊30 mg/次,每天3次,连续给药28天。观察用药期间受试者临床症状、生命体征,血常规、尿常规、血生化、心电图、膀胱B超等的变化,并记录受试者每日出入量,观察和记录不良事件。结果 12名健康男性受试者接受耐受性及膀胱毒性观察,用药期间无脱落。本试验未发现药物对男性健康受试者的膀胱有明显影响。不良反应共12件,试验用药组7件,安慰剂组5件,给药组中3人诉口干。结论药物的主要不良反应是口干,考虑环境、连续用药以及受试者本身生理变化等各种因素,认为30 mg/次、每天3次用药是基本安全的。

Objective To evaluate the safety,tolerance and make sure the safe dose range of single dose andcontinuous Phenethyl Isothiocyanate capsules in Chinese healthy volunteers.Methods A single-center,double-blind,randomized,placebo-controlled trial was used.12healthy subjects were enrolled in a28days continuous drug-tolerancetrial,with6subjects in the study and6in the placebo group.Oral Phenylethyl Isothiocyanate capsules,30mg/time,three times a day,continuous administration of28days.The clinical symptoms,vital signs,blood routine,urineroutine,blood biochemistry,electrocardiogram and bladder ultrasonography were observed during the course ofadministration.The daily intake and withdrawal of the subjects were recorded and adverse events were observed andrecorded.Results This study did not find drugs on male healthy subjects have a significant impact on the bladder.Therewere12adverse reactions,test drug group were7,placebo group were5.3subjects of the test drug group complained ofdry mouth,while not in the placebo group.Conclusions The main adverse drug reaction is dry mouth.Taking intoaccount the environment,continuous medication and the subjects themselves physiological changes and other factors,that30mg/time,TID is basically safe.