香莲祛痛霜Ⅰ期临床耐受性试验研究

Clinical study of the tolerance of Xianglian Qutong cream

目的:观察人体对香莲袪痛霜的耐受性,确定安全耐受的人用剂量,了解在此剂量下的不良反应,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:采用随机、盲法、安慰剂对照的单中心临床研究,选择70名健康受试者,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:70例受试者完成试验,6例受试者实验室检查结果异常,均为试验药组,单次给药5例,连续给药1例,与药物关系为可能无关。结论:单次给药,安全剂量范围为不大于10.0g/日;连续给药,安全剂量范围为不大于10.0g/日,疗程为7天。

Objective： To observe the human tolerance of Xianglian Qutong cream, determine the safety tolerance with dose, to understand the adverse reactions at this dose, provide safe dose range of the dose for drawing up the Program of Medication in the phase of the phase II clinical trial. Methods： A randomized,double blinded, placebo-controlled method was adopted in the single center clinical trial. Filter 70 healthy volunteers, we can adopt the way of Single medication and Continuous medication seperately to observe the tolerance and safty of the Xianglian Qutong cream. Results： 70 subjects completed the trial, 6 subjects were abnormal of laboratory examination,they were all belong to test group, among them,5 subjects come from the single-dose group ,and 1 subject come from the continuous-dose group ,reesearehers judge that it may have no relation to the drug. Conclusion： Normal person have a good tolerance to the Xianglian Qutong cream single-dose within 10. 0g; Normal person have a good tolerance to the Xianglian Qutong cream continuous -dose within 10.0g per day, the course of treatment is well tolerated in 7 days.