树舌胃可欣胶囊I期临床耐受性研究

Phase I Clinical Trail of Shusheweikexin Capsule in Healthy Volunteers

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 assess the safety and tolerance of single - dose and continuous oral of Shusheweikexin Capsule in Chinese volunteers, thus to establish the effective clinical dosage. Methods ： Tolerance test of single - dose intravenous drip ： twen- ty - four healthy volunteers were allocation into 5 single - dose groups by different gender（ 0.3,0.6,1.2,2.4 ,and 3.9g respectively）. Tolerance test of continuous intravenous drip： twelve healthy volunteers were allocation into 2 multipledose groups （2.4 or 3.9g respectively） by different gender, qd x 7d. Subjective symptoms, objective signs, vital signs including blood pressure, heart rate, respiration were observed, and routine blood tests, routine urinetests, hepatic function, renal function, clotting function, electroca - rdiogram, abdominal CDFI were monitored after medication. Results： The single - dose groups have three cases of hemoglobin,three cases of hematocrit,four cases of PT,one case of APTT,one case of TT,one case of ECG abnormalities results after treatment, in conjunction with other indicators ,judgement without clinical significance. The continuous oral groups have four cases of hematocrit, one case of PT, two cases of APTT, one case of TT abnormalities results after treatment,in conjunction with other indicators ,judgement without clinical significance. Conclusions oral administration of a single - dose shusheweikexin capsules 0.3 ～ 3.9g/dose,and continuous oral of Shusheweikexin Capsule of 2.4 or 3.9/person in China healthy male or female volunteers is safe. In Phase Ⅱ clinical trials, recommendate the clinical dosage of oral Shusheweikexin capsule for each person is 0.3 to 3.9g.