摘要
目的在中国健康成年志愿者中评价口服青蒿素哌喹片(抗疟药)的耐受性。方法用随机双盲平行组设计,筛选健康志愿者26名,观察药物不良反应及临床症状、体征、实验室指标变化,并进行数据统计处理。结果各组服药后,实验室各项检查和心电图检查,均未见异常改变;若超过推荐临床剂量,则出现头晕、嗜睡、脸麻等自限性症状;但未发现严重不良事件。结论健康受试者对青蒿素哌喹2片临床推荐剂量有良好的耐受性。
Objective To evaluate the tolerance of oral artemisinin-piperaquine tablets in Chinese healthy volunteers. Methods Twenty-six Chinese healthy volunteers were screened in randomized double-blind parallel design. Adverse events,clinical symptoms,vital signs and laboratory tests were observed or examined before and after administration of the drug. All data were statistically analyzed. Results The laboratory examinations and electrocardiographic examination in all the groups had not changed after administration.Self-limited symptoms were observed over the clinical dosage such as dizziness, lethargy, face anesthesia etc. There are no serious adverse effect. Conclusion The recommended dose of artemisinin-piperaquine to healthy volunteers was well tolerant.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2009年第5期405-407,共3页
The Chinese Journal of Clinical Pharmacology
基金
科技部科技型中小企业技术创新基金资助项目(06C26214401605)
关键词
青蒿素哌喹片
耐受性
安全性
artemisinin-piperaquine tablets
tolerance
safety