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目的:评价健康志愿者单次及连续口服树舌胃可欣胶囊的安全性和耐受性,推荐临床安全有效的用药剂量。方法:单次给药的耐受性试验:24名健康受试者,按不同性别分别分配到5个剂量组,分别给予树舌胃可欣胶囊0.3、0.6、1.2、2.4、3.9g。多次给药的耐受性试验:12名健康受试者按不同性别分别分配到2.4g/人或3.9g/人组,每日1次,连续给药7d。观察各组用药后的临床症状、生命体征,检查心电图、血尿常规、肝肾功能、凝血功能、腹部彩超等。结果:单次给药组出现3例血红蛋白、3例红细胞压积、4例PT、1例APTT、1例TT、1例心电图的结果异常,结合其他指标,判断无临床意义。多次给药组出现4例红细胞压积、1例PT、2例APTT、1例TT结果异常,结合其他指标,判断无临床意义。结论:中国健康男性或女性志愿者单次口服树舌胃可欣胶囊在0.3~3.9g/次的剂量范围及多次口服2.4g或3.9g/人是安全的。在II期临床试验中,建议口服树舌胃可欣胶囊的临床用药剂量在每人每次0.3~3.9g范围内可以应用。
OBJECTIVE: To evaluate the safety and tolerability of a single and continuous oral administration of the Tongyinwei Kexin Capsule for healthy volunteers and to recommend safe and effective doses for clinical use. METHODS: Tolerance test for single dose: 24 healthy subjects were divided into 5 dose groups according to different genders and given 0.3, 0.6, 1.2, 2.4, and 3.9 g respectively. Multi-dose tolerance test: 12 healthy subjects were divided into 2.4g/person or 3.9g/person groups according to different genders, once a day for 7 days. Observe the clinical symptoms and vital signs after treatment in each group, and check the electrocardiogram, hematuria, liver and kidney function, coagulation function, and abdominal ultrasound. Results: There were 3 hemoglobins, 3 hematocrit, 4 PT, 1 APTT, 1 TT, and 1 ECG abnormal results in the single-dose group. No other clinical indicators were found. In the multi-dose group, there were 4 cases of hematocrit, 1 case of PT, 2 cases of APTT, and 1 case of abnormal TT. Combined with other indicators, there was no clinical significance. Conclusion: It is safe for Chinese healthy male or female volunteers to take a single oral dose of Glossy Tween Kexin Capsule in a dose range of 0.3 to 3.9g/dose and multiple oral doses of 2.4g or 3.9g/person. In Phase II clinical trials, it is recommended that the clinical dose of oral Tongyinwei Kexin Capsule be applied within the range of 0.3 to 3.9g per person per time.