脑络清注射液Ⅰ期临床耐受性试验研究

Naoluoqing Injection Phase Ⅰ Clinical Trial of Tolerance

[目的]选择健康人为受试者,从安全的初始剂量开始,观察人体对脑络清注射液的耐受性,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60例,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]脑络清注射液单剂量组出现化验室检查异常和7例口干症状,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口干症状,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]正常人体对脑络清注射液服用30g/d/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30g/d/人以内。

[ Objective] Select healthy man as subjects to study the tolerance to man to the capsule of Na- oluoqing. Beginning with the initial and safe dose. In this way, we can provide the safe range of the dose for drawing up the Program of Medication in the phase of Ⅱ trial. [ Method ] Filter 60 healthy volunteers, we can adopt the way of Singte medication and Continuous medication seperately to observe the tolerance and safty of the injecta. [ Result ] The single - dose group appear the abnormal of laboratory examination and the seven symptoms of thirst and dizzy. In the following - up, the result all return to normal. Researchers judge that it may have no relation to the drug. The Continuous - dose group appear the symptoms of thirst and dizzy. Re- searchers judge it have no relation to the drug. Above all, both the Security level is 2. [ Conclusion ] Normal person have a good tolerance to the dosage of Naoluoqing as 30 gram per day per person. Suggestion ： phase of II clinical trials can go within the range of dose is 30 gram per day per person.