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目的:观察舒络粉针剂在健康志愿者中的安全性和耐受性。方法:单次给药剂量组32例健康志愿者被分为7个剂量组,各组例数分别为2,4,6,6,6,4,4,分别给予舒络粉针剂2.0,6.0,8.0,10.0,12.0,14.0,16.0 g.d-1。多次给药剂量组12例健康志愿者被分为2个剂量组,每组6例,分别给予舒络粉针剂6.0 g或10.0 g,qd,连续给药7 d。观察受试者的生命体征、实验室检查、心电图检查及不良事件。结果:共44例健康志愿者完成了耐受性试验。单次、多次试验中均未发生严重不良事件及过敏反应。生命体征、大小便常规、肝功能、肾功能、凝血功能及心电图均未发现异常。44例受试者中发生4例(6例次)不良事件,其中3例为白细胞减少,与试验药物可能有关。结论:舒络粉针剂在2.0～16.0 g.d-1范围内用药的安全性和耐受性良好,单次给药的最大耐受剂量为16.0 g.d-1。多次给药6.0 g及10.0 g.d-1,qd,连续给药7 d的耐受性较好。推荐II期临床试验的给药方案为6.0～10.0 g.d-1。
Objective: To observe the safety and tolerability of Shuluo injection in healthy volunteers. Methods: A single dose of 32 healthy volunteers were divided into seven dose groups, the number of cases were 2, 4, 6, 6, 6, 4, 4 respectively Shulu powder injection 2.0,6.0 , 8.0, 10.0, 12.0, 14.0, 16.0 gd-1. Twelve healthy volunteers in multiple dose groups were divided into 2 dosage groups, 6 in each group, and were given 6.0g or 10.0g of qingluo injection respectively for qd for 7 days. Subjects were observed for signs of vital signs, laboratory tests, electrocardiograms and adverse events. Results: A total of 44 healthy volunteers completed the tolerance test. A single, many trials did not occur in serious adverse events and allergic reactions. Vital signs, urine routine, liver function, renal function, coagulation and ECG were found no abnormalities. Four (6) adverse events occurred in 44 subjects, 3 of which were leukopenia, possibly related to the test drug. CONCLUSIONS: The safety and tolerability of Shuluo injection in the range of 2.0 ~ 16.0 g.d-1 is good, and the maximum tolerated dose of single dose is 16.0 g.d-1. Repeated administration of 6.0 g and 10.0 g.d-1, qd, continuous administration of 7 d is better tolerated. The recommended regimen for Phase II clinical trials is 6.0 to 10.0 g.d-1.