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目的:观察健康人体对塞络通胶囊的单次给药以及连续给药的耐受性及安全性,为Ⅱ期临床试验推荐安全剂量。方法:单次给药试验中30例受试者随机分为7个剂量组(60,120,180,240,300,420,540 mg);连续给药试验采用随机、单盲、安慰剂对照设计,24例受试者分为低剂量组(180 mg)和高剂量组(300 mg),每组12例受试者。结果:单次给药受试者未见重要生命体征有明显改变。连续给药试验中两组受试者症状性不良事件、实验室不良事件发生率无显著差异。主要症状性不良事件有胃部不适、荨麻疹复发、局部皮肤疼痛、腹泻、皮肤瘙痒、口干、腹胀、胃灼热、头晕、恶心。结论:塞络通胶囊安全性和耐受性较好。推荐临床试验剂量不超过540 mg.d-1。
OBJECTIVE: To observe the tolerance and safety of the single oral administration and continuous administration of the medicine to the healthy human body, and recommend the safe dose for the phase Ⅱ clinical trial. METHODS: Thirty subjects in a single-dose study were randomly assigned to 7 doses (60,120,180,240,300,420,540 mg); continuous-dose trials were randomized, single-blind, placebo-controlled design, and 24 subjects were divided into low-dose group (180 mg) and high-dose group (300 mg) with 12 subjects in each group. RESULTS: There was no significant change in vital vital signs in single-dose subjects. There was no significant difference in the incidence of adverse events in the two groups of subjects in the continuous dosing trial. The main symptoms of adverse events were stomach upset, urticaria recurrence, local skin pain, diarrhea, itchy skin, dry mouth, bloating, heartburn, dizziness, nausea. Conclusion: Mailuotong capsule is safe and well tolerated. Recommended clinical trial dose does not exceed 540 mg.d-1.