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目的:选择健康人为受试者,从安全的初始剂量开始,观察人体对七叶通脉胶囊的耐受性,为制定本品的II期临床试验给药方案,提供安全的剂量范围。方法:筛选健康受试者50人,分别采用单次给药及连续给药观察该药的安全性和耐受性。结果:七叶通脉胶囊单剂量组出现化验室检查异常和2例腹泻症状,随访后均恢复正常,经研究者判断为与药物关系均为可能无关。连续剂量高剂量组出现腹泻症状,经研究者判断为与药物关系均为可能无关。以上安全级别均为二级。结论:正常人体对七叶通脉胶囊服用7粒/d每人的剂量耐受较好,建议本品可以进行II期临床试验,剂量可在每人7粒/d以内。
Objective: To select healthy human subjects, starting from the safe initial dose to observe the body’s tolerance to Qiyatongmai Capsules, in order to develop this product Phase II clinical trial dosing regimen, to provide a safe dose range. Methods: Fifty healthy subjects were screened, and the safety and tolerability of the drug were observed by single administration and continuous administration respectively. Results: In the single-dose Qiyatongmai capsule group, abnormal laboratory tests and 2 cases of diarrhea were observed. All patients returned to normal after the follow-up, and the relationship between them could be considered as irrelevant by the investigators. The continuous dose of high-dose group of diarrhea symptoms, the researchers determine the relationship with the drug may be irrelevant. The above security level is two. Conclusion: The normal human body dose of Qiyatongmai capsule taking 7 capsules / d per person is well tolerated. It is suggested that this product can be used for phase II clinical trial and the dosage can be within 7 capsules per day.