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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,评估红花丹皮酚膏的耐受性以确定其安全剂量,为制定本品Ⅱ期临床试验的给药方案提供依据。方法:共有46名健康受试者纳入耐受性研究,接受开放、随机、剂量递增、自身对照的单剂量方案或多剂量方案的临床试验。单剂量方案试验药物剂量分别为含生药量2.16 g(4人)、4.32 g(6人)、6.48 g(6人)、8.62 g(6人)、11.46 g(6人)、15.24 g(6人),每日1次,每次涂敷24 h。多剂量方案试验药物剂量为8.62 g(6人)、11.46g(含生药量)(6人),每日1次,每次涂敷24 h,连续涂敷给药7 d。结果:单次给药安全剂量最大为15.24 g(含生药量),多次给药安全剂量最大为8.62 g(含生药量)。不良事件发生率较低(2.17%),可经药物治疗恢复,未出现严重不良事件。结论:本研究证实了红花丹皮酚膏单次给药和多次给药在正常人体应用的安全性,为Ⅱ期临床使用奠定了基础。
Objective: To select healthy human subjects, starting from the safe initial dose, evaluate the tolerability of safflower paeonol cream to determine its safe dose, to provide the basis for formulating the drug regimen for phase Ⅱ clinical trial. METHODS: A total of 46 healthy subjects were included in the tolerability study and were randomized, dosed, dosed, self-controlled, single-dose or multi-dose clinical trials. The dose of the single-dose regimen was 2.16 g (4 persons), 4.32 g (6 persons), 6.48 g (6 persons), 8.62 g (6 persons), 11.46 g (6 persons) and 15.24 g Person) once daily for 24 h each. The dose of the multi-dose regimen was 8.62 g (6 persons) and 11.46 g (6 animals), once daily for 24 hours, with continuous application for 7 days. Results: The maximum safe dose of single administration was 15.24 g (containing crude drug) and the safe dose of multiple administration was 8.62 g (containing crude drug). A lower incidence of adverse events (2.17%), can be recovered after drug treatment, no serious adverse events. Conclusion: This study confirmed the safflower paeonol phenolic cream single administration and multiple administration in normal human safety, for the clinical application of the foundation.