知参解郁胶囊Ⅰ期耐受性临床研究

A phase Ⅰ study for evaluating the safety and tolerability of Zhishenjieyu capsule

目的:评价健康受试者对知参解郁胶囊的耐受性和安全性。方法:共选取38名健康受试者,单次给药组28名受试者随机分为5组,分别单次口服729 mg(3粒),972 mg(4粒),1458 mg(6粒),1944mg(8粒),2187 mg(9粒)知参解郁胶囊;10名受试者连续服药7 d,每日2次服用,每次4粒(972 mg)。观察药物的不良反应、实验室检查、心电图以及生命体征。结果:单次服药组,对健康受试者的生命体征和肝肾功能没有明显影响;部分高剂量组(服用1944 mg和2187 mg组)健康受试者出现不良反应,主要有口干、手心发热;多次给药组,服药期间出现的不良反应包括脸红、血压降低或升高、心电图异常、鼻衄、皮疹、头晕和心动过速,所有的不良反应均为轻度,无需特殊处理,不影响日常活动,停药后消失。结论:在观察剂量范围内,单次给药和连续给药耐受性试验表明该药具有良好的耐受性和安全性。

Objective： To evaluate the safety and tolerability of Zhishenjieyu capsule in Chinese heahhy volunteers. Methods： Thirty-eight healthy volunteers were recruited. Twenty-eight volunteers receiving single dose medication were randomly divided into 5 dosage groups; their oral doses were 729, 927, 1 458, 1 944 and 2 187 mg, respectively. The other 10 were assigned to the muhiple-dose group, and orally received 1 944 mg daily for 7 days. The safety profiles and tolerability were evaluated based on vital signs, routine blood and urine tests, hepatic and renal function examinations, blood electrolytes, electrocardiogram and incidence of adverse events. Results： Single doses did not affect the vital sign, hepatic or renal function of the subjects. High doses induced some adverse events, such as dry-mouth and hot feeling in palms. Multiple dose medication had more adverse events, including blush, increase or decrease of blood pressure, abnormal ECG, epistaxs, rash, dizziness and tachyrhythemia. All of the adverse events were mild, had no obvious effect on daily life, and disappeared after the medication without specific treatment. Conclusion： Zhishenjieyu capsule has good safety and tolerability in the dosage range by single or multiple medication.