大剂量二十五味珊瑚丸吞服治疗偏头痛的临床对照研究

Clinal study of two does of er-shi-wu-wei shanhu pill in treatment of migraine

目的观察大剂量、分次吞服二十五味珊瑚丸治疗偏头痛的疗效及安全性。方法采用临床前瞻性对照研究,分常规剂量及服法组及大剂量两次吞法二十五味珊瑚丸组,使用通用的疼痛量表-数字分级法(NRS)评定各组不同时点的疼痛程度,统计分析各组前后及两组的疗效情况,并使用临床药物不良反应量表(TESS)观察药物不良反应。结果研究发现在使用大剂量二十五味珊瑚丸在不同时点治疗偏头痛的疗效明显优于常规剂量组,并且临床不良反应两者相比较差异无统计学意义。改为吞服后不良反应明显有减少。结论认为大剂量二十五味珊瑚丸治疗偏头痛的疗效更为显著,改为吞服不良反应更少,值得临床推广研究。

Objective To evaluate the efficacy and safety of big dose er-shi-wu-wei shanhu pill with swallow in the treatment of migraine.Methods Four hundred and eighty outpatients with migraine were randomly assigned to receive er-shi-wu-wei shanhu pill 4# qd（ n = 245）/er-shi-wu-wei shanhu pill 3# bid （ n = 235） for up to 4 weeks in this randomized, paralled 2 group study. Therapeutic efficacy was assessed with the numeric rating Scales （NRS）. Safety profile was assessed with the treatment emergent symptom scale （TESS） .Results ①Tbe tberapeutie efficiency in treating Migrain was statistically different between 4 # qd daily group and 3 # bid group（ P 〈0.05）②Safety：The side effects was statistically different between gastrointenstinal tract reaction in two groups. Conclusion The therapeutic effect on migrain is different between big dose group and abnomal dose group. The side effect of gastrointenstinal tract reaction in big dose er-shi-wu-wei shanhu pill group appears lesser than abnormal dose er-shi-wu-wei shanhu pill with swallow group.