摘要
目的:研究延参口服液的耐受性以确定其安全剂量。方法:共有38名健康受试者(年龄18～32岁)纳入耐受性研究,接受单剂量方案或多剂量方案的临床试验。单剂量方案为开放性研究,26名受试者分为5组:5ml组(4人)、10ml组(4人)、20ml组(6人)、30ml组(6人)和40ml组(6人)。多剂量方案为随机、双盲、安慰剂对照研究,12名受试者分为2组:延参组(6人)和安慰剂组(6人)。各组内男女之比均为1:1。试验期间观察记录受试者的生命体征和出现的不良事件,做血、尿、粪常规试验、血生化试验(包括血钾、血钠、血钙、血氯、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、碱性磷酸酶、尿素氮、肌酐等)和心电图检测,并对其结果进行统计学分析。结果:单剂量方案4个剂量组(40ml组因不能耐受被取消)和多剂量方案2组患者之间年龄、性别、体重和身高差异均无统计学意义。单剂量方案最高耐受剂量为30ml,共有20名受试者完成试验。多剂量方案中选择剂量为20ml/次,3次/d口服,连续给药7d。单剂量或多剂量方案给药后受试者生命体征,血、尿、粪常规和血生化试验结果未发生有统计学意义的改变。单剂量方案中,20ml组和30ml组各1名受试者用药后出现窦性心动过缓;多剂量方案受试者用药后心电图检查均正常。用药后主要不良反应为轻度恶心和呕吐。单剂量方案5ml和20ml组各出现恶心1例和3例,呕吐各1例和2例,30ml组6名受试者均出现恶心和呕吐;多剂量方案延参组有2名出现轻度恶心和呕吐;均在30min后缓解。结论:延参口服液剂量20ml一日3次可良好耐受,无严重不良反应。
Objective： To study the tderance of Yanshen oral solution and to determine its safe dosage. Methods： A total of 38 healthy volunteers （aged 18-32 years） entered the tolerance study and received a single-dose regimen or a multi-dose regimen in clinical trials. The single-dose regimen was an open study, 26 subjects were divided into 5 groups： the 5 ml dose group （n =4）, the 10 ml dose group （n =4） , the 20 ml dose group （n =6） , the 30 ml dose group （n =6） , and the 40 ml dose group （n =6）. The multiple-dose regimen was a randomized, ciouble-blinded, and placebo-controlled study, 12 subjects were divided into 2 groups： the Yanshen group （n = 6） and the placebo grc,up （n = 6）. The ratio of male to female in each group was 1 to . During the study period, the subjects＇vital signs and adverse events were observed and recorded; routine blood, urine, and stool tests, blood biochemical tests （including the levels of K ＋ , Na ＋ , Ca2＋ , Cl, glutamic-pyruvic transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, urea nitrogen, creatinine, etc. ） , and electrocardiogram （ECG） were performed and all the results were statistically analyzed. Results： There were no differences in the age, gender, body weight and height among the 4 single-dose groups （the 40 ml dose group was canceled because of intolerance） and between the 2 multiple-dose groups. The maximum tolerance dose was 30 ml in the single-dose regimen and 20 subjects completed the study. A dose of 20 ml thrice daily for 7 consecutive days was selected for the multiple-dose regimen study. There were ro statistically significant changes in vital signs, the routine blood, urine, and stool tests, and blood biochemical tests in all subjects after receiving the single-dose or multiple dose regimens. In the single-dose regimen study, sinus bradycardia occurred in 1 subject each in the 20 ml dose and 30 ml dose groups. All subjects receiving the multi-dose regimen had normal ECG. The main adverse reactions after drug administration were mild nausea and vomiting. In the single-dose regimen study, nausea occurred in 1 subject in the 5 ml dose group and 3 subjects in the 20 ml dose group, vomiting occurred in 1 subject in the 5 ml dose group and 2 subjects in the 20 ml dose group; in addition, all 6 subjects in the 30 ml dose group developed nausea and vomiting. In the multiple-dose regimen study, mild nausea and vomiting occurred in 2 subjects in the Yanshen group ; however, the symptoms improved 30 min after developing adverse reactions. Conclusion： Yanshen oral solution could be well tolerated in a dose of 20 ml thrice daily with no severe adverse reactions.
出处
《药物不良反应杂志》
2011年第3期137-141,共5页
Adverse Drug Reactions Journal
关键词
延参口服液
I期临床试验
耐受性
安全性
Yanshen oral solution
phase I clinical trials
tolerance
safety
