[關鍵詞]
[摘要]
目的:觀察健康受試者單次和連續(xù)靜脈滴注腦絡泰注射液的耐受性和安全性,為Ⅱ期臨床試驗給藥提供安全的藥物劑量范圍。方法:篩選36名健康受試者,分別用單次及連續(xù)給藥觀察該藥的安全性和耐受性。結果:單次給藥和多次給藥均未出現(xiàn)不良反應。結論:健康人體對腦絡泰注射液的耐受性較好,臨床使用比較安全。推薦的Ⅱ期臨床試驗劑量為不超過20 mL,每日1次。
[Key word]
[Abstract]
Objective: It is to observe the tolerance and safety for health volunteers after being injected Naoluotai Injection once or continuously, so as to assess and provide the safety range for clinic use of drugs for phase Ⅱ. Methods: Selecting 36 health volunteers to observe the tolerance and safty with injection once or continuously, respectively. Results: Neither once nor continuous injection appeared adverse reaction. Conclusion: Health body has a good tolerance for Naoluotai Injection, and it is safe to use this drug. The recommended dose is 20 mL once per day in phase Ⅱ in clinical trial.
[中圖分類號]
[基金項目]