| Objective:To evaluate the safety of Qu-You-Ding by means of both research on toxicology experiment and clinical observation on adverse drug reaction(ADR). Methods:In first section of research on toxicology experiment,acute skin toxicity test and skin stimulation test were performed on Japanese rabbits,while skin allergy test was performed on guinea pig.In second section of clinical observation,65 patients with verruca plana were randomly divided into two groups according to the method of randomized controlled trial(RCT):33 patients in treatment group were topically treated with Qu-You-Ding while the other 32 patients in control group were treated with Ftibamzone Liniment simultaneously.4 weeks make one treatment course in each group.The onset of adverse drug events(ADE) and its severity were recorded once a week and ADRs were evaluated 2 treatment courses later.Results:Section one indicated that Qu-You-Ding has no acute toxicity and stimulation on rabbits no matter whether the skin is complete or not,and no allergic reaction on guinea pig with complete skin.Section two showed that there is no statistically significant(P＞0.05) of ADR onset ratio when comparing Qu-You-Ding with Ftibamzone Liniment.Conclusions:Qu-You-Ding is a safe dermal topicas. |
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