清肝解郁方对偏头痛患者基于患者报告的结局(PRO)评价量表的临床研究

Study of Qinggan Jieyu herbal formula granule on migraine with the patients-reported outcomes

[目的]在清肝解郁方治疗偏头痛的随机对照临床研究中,应用偏头痛缓解期基于患者报告的结局(PRO)评价量表,对偏头痛患者进行综合评价。[方法]采用随机对照的试验设计,纳入60例患者,治疗4周后,对头痛情况、躯体症状、精神心理状态、功能状态4个维度及头痛频次进行评价。[结果]1)治疗后两组头痛PRO量表各维度得分比较,躯体症状、精神心理状态及PRO总分比较有统计学差异。2)治疗前后两组PRO量表各项目得分变化率组间比较,精神心理状态、功能状态及总分均有统计学意义。3)治疗后,两组头痛发作次数减半率组间比较差异有统计学意义(P<0.05)。[结论]PRO量表可以多维度的评价清肝解郁方治疗肝郁化热证偏头痛患者的临床疗效,尤其能对患者的主观精神心理状态的改善进行评价,可较全面地反应清肝解郁方治疗偏头痛肝郁化热证的效果。

[Objective] To comprehensively evaluate the efficacy of Qinggan Jieyu herbal formula granule in the treatment of migraine with the patients-reported outcomes(PRO) scale. [Methods] In this randomized controlled trial, we recruited 60 eligible patients and gave then a 4-week treatment. After the treatment, we evaluated the four dimensions of the PRO scale and the migraine frequency. [Results]1)After treatment, compared the scores of each dimension of the migraine PRO scale, physical symptoms, mental status and total PRO scores had statistically significance between the two groups. 2)Compared the deviation of the baseline and the scores after treatment between two groups, mental status, functional status and PRO scores had statistically difference. 3)After treatment, the responder rate of migraine attack frequency had statistical significance between two groups(P<0.05). [Conclusion] PRO scale can evaluate the effects of Qinggan Jieyu herbal formula granule in the treatment of migraine from multiple aspects, especially in the improvement of the mental state of patients.