目的:评估曲唑酮联合托吡酯疗法治疗药物过度使用性头痛的疗效和安全性。方法:采用前瞻性研究,将105例药物过度使用性头痛(medication overuse headache,MOH)病人随机分为两组:对照组52例,服用托吡酯治疗,观察组53例,在托吡酯治疗的同时加用曲唑酮,疗程均为3个月。所有受试者接受治疗期间撤去急性期止痛药及其他药物。采用汉密尔顿焦虑量表(hamilton anxiety scale,HAMA)评估戒断性焦虑,评估两组治疗效果及不良反应发生率。结果:接受治疗后第7天、15天、30天、90天,观察组HAMA评分明显低于对照组,差异有统计学意义(P<0.05)。观察组治疗总有效率94.3%,高于对照组的65.4%,差异有统计学意义(P<0.05)。针对不良反应发生率,观察组(16.98%)与对照组(15.38%)的差异无统计学意义。结论:曲唑酮联合托吡酯治疗药物过度使用所致的戒断性焦虑、头痛有良好疗效,耐受性好,可用于MOH的治疗。 Objective: To evaluate the efficacy and safety of trazodone combined with topiramate in the treatment of drug overuse headache. Method: A prospective study, 105 cases of medication overuse headache (medication overuse headache, MOH) were randomly divided into two groups: 52 patients taking topiramate 53 observation group, plus at the same time topiramate treatment Trazodone, treatment are 3 months. All subjects were withdrawn during the treatment of acute painkillers and other drugs. The Hamilton anxiety scale (HAMA) was used to evaluate the withdrawal anxiety, and the therapeutic effect and incidence of adverse reactions were evaluated in both groups. Results: On the 7th, 15th, 30th and 90th days after treatment, the HAMA score of the observation group was significantly lower than that of the control group (P <0.05). The total effective rate of observation group was 94.3%, which was higher than that of control group (65.4%), the difference was statistically significant (P <0.05). There was no significant difference in the incidence of adverse reactions between the observation group (16.98%) and the control group (15.38%). CONCLUSION: Trazodone and topiramate are effective in treatment of withdrawal-induced anxiety and headache due to overuse of drugs. They are well tolerated and can be used in the treatment of MOH.