针灸治疗偏头痛关键结局指标研究

Study on key outcome indexes in treatment of migraine with acupuncture and moxibustion

目的:明确针灸治疗偏头痛的关键结局指标。方法:运用文献研究法、问卷调查法、共识会议法筛选针灸治疗偏头痛的结局指标,并进行优先度排序。结果:偏头痛发作期治疗“至关重要”的结局指标包括6项疗效指标(头痛强度、头痛持续时间、头痛缓解时间、2 h内是否起效及头痛缓解程度、头痛相关生活质量、24 h内头痛缓解程度)及1项安全性指标(严重不良反应发生率);预防性治疗“至关重要”的结局指标包括6项疗效指标(头痛发作天数、头痛发作频率、头痛发作强度、有效率、头痛相关生活质量、健康相关生活质量)及1项安全性指标(严重不良反应发生率)。结论:针灸治疗偏头痛应区分发作期治疗和预防性治疗,选择不同的结局指标,并优先选择可直观体现偏头痛病情的结局指标。评价发作期治疗疗效首选头痛强度,评价工具首选视觉模拟量表(VAS)评分,评价时点首选治疗后2 h。评价预防性治疗疗效,首选头痛发作天数、头痛发作频率、头痛发作强度,评价时点首选治疗12周后,随访时点首选治疗后12周;如进行生活质量评价,首选偏头痛特异性生活质量问卷(MSQ)。无论发作期治疗或预防性治疗,均应增加对安全性及卫生经济学评价指标的关注度。

Objective To identify the key outcome indexes in treatment of migraine with acupuncture and moxibustion.Methods Using literature research,questionnaire survey and consensus conference,the key outcome indexes in treatment of migraine with acupuncture and moxibustion were screened and prioritized.Results The critical outcome indexes for the treatment in attack stage of migraine included 6 effectiveness outcome indexes(headache intensity,headache duration,headache relieve time,effectiveness and level of headache relief within 2 h,headache-related quality of life,level of headache relief within 24 h)and 1 safety outcome index(incidence of serious adverse reactions).The critical outcome indexes for prophylactic treatment included 6 effectiveness outcome indexes(headache day,headache frequency,headache intensity,effective rate,headache-related quality of life,health-related quality of life)and 1 safety outcome index(incidence of serious adverse reactions).Conclusion In terms of the attack stage treatment and prophylactic treatment with acupuncture and moxibustion,the outcome indexes are different,among which,those can directly reflect the conditions of migraine should be optioned in priority.To assess the effectiveness of attack stage,the headache intensity is preferred,using the visual analogue scale(VAS)score,and the preferred time is 2 hours after treatment.Regarding the effectiveness of prophylactic treatment,the headache day,headache frequency and headache intensity should be firstly considered in the assessment,in which,the preferred time for assessment is 12 weeks into treatment,while,the best time for follow-up should be 12 weeks after treatment completion.When the quality of life is considered,the migraine-specific quality of life questionnaire(MSQ)is the top option.For either the attack stage treatment or the prophylactic treatment,the high attention should be laid on the outcome indexes for safety and medical economics evaluation.