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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 tolerability of Yan-sheng oral solution to determine its safe dose. METHODS: A total of 38 healthy subjects (aged 18-32 years) were included in the tolerability study and underwent either single-dose or multi-dose clinical trials. The single-dose regimen was an open-label study and 26 subjects were divided into five groups: 5 ml (4), 10 ml (4), 20 ml (6), 30 ml (6) and 40 ml people). The multiple-dose regimen was a randomized, double-blind, placebo-controlled study in which 12 subjects were divided into two groups: the extended-dose group (6) and the placebo group (6). The ratio of men to women in each group was 1: 1. During the test, the subjects’ vital signs and adverse events were observed and recorded. The blood, urine and feces routine tests, blood biochemical tests (including serum potassium, serum sodium, serum calcium, blood chlorine, alanine aminotransferase, aspartate Acid aminotransferase, total bilirubin, alkaline phosphatase, urea nitrogen, creatinine, etc.) and ECG testing, and the results were statistically analyzed. RESULTS: There were no significant differences in age, sex, weight, and height between the 4 dose groups of the single-dose regimen (40 mL group canceled due to intolerability) and the 2 dose-multiple regimen groups. The maximum tolerated dose of a single dose regimen was 30 ml and a total of 20 subjects completed the test. The dose of multi-dose regimen was 20ml / time, 3 times / d orally for 7 days. There were no statistically significant changes in vital signs, blood, urine, fecal routine, and blood biochemical test results following single or multiple dose regimens. In the single-dose regimen, sinus bradycardia occurred in one of the 20 ml and 30 ml groups, respectively; the multi-dose regimen was normal after electrocardiogram. The main adverse reactions after treatment were mild nausea and vomiting. In the single-dose regimen, nausea and vomiting occurred in 1 patient and 3 nausea and vomiting in 1 patient and 2 patients in 5 ml and 20 ml groups, nausea and vomiting in 6 patients in 30 ml group; And vomiting; all ease after 30min. Conclusion: Yanshen oral solution dose of 20ml three times a day can be well tolerated, no serious adverse reactions.