中国临床药理学杂志

目的观察舒马曲坦联合左乙拉西坦对顽固性偏头痛的治疗效果以及安全性。方法将52例患者依据随机数字法分为对照组26例与试验组26例。对照组给予琥珀酸舒马普坦片,每次100 mg,qd,口服。试验组在对照组的基础上给予左乙拉西坦片,每次250 mg,qd,口服。2组治疗时间均为10周,在治疗期间若发生难以忍受的头部疼痛,则给予布洛芬片,每次200 mg,sos,口服。比较2组患者的头痛发作频率、视觉模拟评分(VAS)、平均发作持续时间、血清5-羟色胺(5-HT)、治疗过程中的布洛芬使用量、疗效和药物不良反应发生情况。结果试验组和对照组的总有效率分别为88.46%(23例/26例)和65.38%(17例/26例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的头痛发作频率分别为(0.52±0.07)和(1.20±0.68)次/周,VAS分别为(1.42±0.68)和(2.55±1.12)分,平均发作持续时间分别为(75.35±21.10)和(102.25±50.01)min,血清5-HT分别为(177.91±32.51)和(154.38±21.69)pg·L^-1,差异均有统计学意义(均P<0.05)。试验组和对照组在治疗期间的布洛芬使用量分别为(468.22±140.25)和(742.35±201.68)mg,差异有统计学意义(P<0.05)。试验组和对照组在治疗过程中的药物不良反应发生率分别为11.54%(3例/26例)和19.23%(5例/26例),差异无统计学意义(P>0.05)。结论采取舒马曲坦联合左乙拉西坦的方式治疗顽固性偏头痛,可加速病情的改善,提升5-HT水平,降低镇痛药物使用剂量,改善疗效且安全性比较可靠。

Objective To observe the clinical effect and safety of sumatriptan combined with levetiracetam in the treatment of patients with refractory migraine. Methods The 52 patients were divided into 26 cases in control group and 26 cases in treatment group according to random numbers. Control group was given sumatriptan succinate tablets, 100 mg each time, qd, orally. Treatment group was given levetiracetam tablets, 250 mg each time, qd, orally on the basis of control group. The treatment time of the two groups was 10 weeks. If unbearable head pain occurs during the treatment, ibuprofen tablets was given to patients, 200 mg each time, sos, orally. The headache frequency, visual analogue score(VAS), average duration of attacks, serum 5-hydroxytryptamine(5-HT), the amount of ibuprofen used during treatment, clinical efficacy and adverse drug reactions in two groups were compared.Results The total effective rates of treatment group and control group were 88. 46%( 23 cases/26 cases) and65. 38%( 17 cases/26 cases),with significant difference( P < 0. 05). After treatment,the frequency of headache attacks in treatment group and control group were( 0. 52 ± 0. 07) and( 1. 20 ± 0. 68) times/week,VAS were( 1. 42 ± 0. 68) and( 2. 55 ± 1. 12) points, the average attack the durations were( 75. 35 ± 21. 10) and( 102. 25 ± 50. 01) min,the serum 5-HT were( 177. 91 ± 32. 51) and( 154. 38 ± 21. 69) pg · L-1,all with significant difference( all P < 0. 05). The amount of ibuprofen used in treatment group and control group during the treatment period were( 468. 22 ± 140. 25) and( 742. 35 ± 201. 68) mg,the difference was statistically significant( P < 0. 05). The incidence of adverse drug reactions in treatment group and control group during the treatment were11. 54%( 3 cases/26 cases) and 19. 23%( 5 cases/26 cases),without significant difference( P > 0. 05).Conclusion Sumatriptan combined with levetiracetam in the treatment of patients with refractory migraine can accelerate the improvement of the condition,increase the level of 5-HT,reduce the dosage of analgesics,improve the efficacy and have a more reliable safety.