摘要
目的评价愈风宁心滴丸治疗神经性头痛(血瘀证)的临床疗效及安全性。方法采用随机、双盲对照、多中心临床试验的方法,试验组用愈风宁心滴丸15粒,愈风宁心片模拟剂5片,3次/日;对照组用愈风宁心片5片,愈风宁心滴丸模拟剂15粒,3次/d,疗程4周。试验组和对照组各60例。结果两组在神经性头痛疗效(总有效率均为90%)、中医证候疗效(总有效率试验组为95%,对照组为91.6%)、治疗后头痛发作次数、头痛发作天数、头痛每次发作平均持续时间、头痛程度、头痛症状总积分、中医证候总积分等均无统计学意义。结论愈风宁心滴丸和愈风宁心片治疗神经性头痛疗效确切,而且二者治疗作用相当,组间无显著性差异,未发现不良反应。
Objective To evaluate the effect and safety of Yufeng Ningxin drop pills in treating nervous headache with blood- stasis syndrome.Methods A double- blind,randomized,parallel- control and multi- center trial was carried out.Treatment group was treated by Yufeng Ningxin drop pills (15 pills,tid) and placebo tablet (5 tablets,tid); Yufeng Ningxin tablet (5 tablets,tid) and placebo drop pills(15 pills,tid) served as positive control.The course of treatment lasted 4 weeks.There were 60 patients in every group.Results No significant differences were found in total therapeutic effect rate( 90 % in both two groups) ,effective rate in relieving symptoms and signs( 95 % in treatment group and 91.6 % in control group) ,attacking frequency of headache,lasting- time of headache,average lasting- time of each time of headache,severity of headache,scoring of headache and scoring of symptoms and signs between the two groups.Conclusion Both Yufeng Ningxin drop pills and Yufeng Ningxin tablet are effective and safe in treating nervous headache.No obvious adverse reaction is found.
出处
《中药新药与临床药理》
CAS
CSCD
2004年第3期206-207,218,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
愈风宁心滴丸
神经性头痛
血瘀证
Yufeng Ningxin drop pills
Nervous headache
Blood- stasis syntrome
