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坎地沙坦酯预防治疗偏头痛的疗效及安全性
The Observation of Effect and Safety of Candesartan Cilexetil in Migraine Prophylaxis
【作者】 万林;
【导师】 陈春富;
【作者基本信息】 山东大学 , 临床医学(专业学位), 2013, 硕士
【摘要】 背景偏头痛是一种十分常见的疾病,其主要特征为反复发作的头痛及非痛性症状。偏头痛在西方国家人群中的男女性发病率分别为6%-8%和15%-25%,女性多于男性,严重影响人们的日常工作、学习、生活与睡眠,是威胁人们健康的主要疾病之一。世界卫生组织(WHO)已将其列入20大严重影响生活质量疾病之列,在其发布的2001年世界卫生报告将常见疾病按健康寿命损失年(Years Lived with Disability, YLD)进行排列,偏头痛位列前20位,并将严重偏头痛定为最致残的慢性疾病之一,类同于痴呆、四肢瘫痪和严重精神病。目前国际上对于偏头痛发作的预防性治疗已取得了一定的成果,但仍有部分患者未能从中获益,因而相关研究仍需进行,人们仍在继续寻找有治疗意义的临床策略。目的偏头痛是神经系统常见疾病,其发病率呈逐年升高趋势,发病机制仍不完全清楚,临床中有关偏头痛的诊断与治疗已经取得了良好的效果。虽然目前坎地沙坦已用于临床预防偏头痛,但国内外相关研究报道较少,因此本研究在了解相关专业知识及临床实践的基础上对坎地沙坦酯及盐酸氟桂利嗪预防性治疗偏头痛的效果进行了临床对比观察,以探讨坎地沙坦治疗的有效性及安全性。方法选取山东省立医院门诊及病房的偏头痛患者104例,随机分为两组,其中坎地沙坦组52人:男15例,女37例,平均年龄39.3岁;氟桂利嗪组52人:男13例,女39例,平均年龄37.2岁。患者经IHS标准诊断为偏头痛,分别给予坎地沙坦酯及盐酸氟桂利嗪治疗,连续不间断用药3个月,观察并记录治疗前后头痛发作次数、头痛持续时间、头痛程度的相关症状评分及不良反应等指标,比较两组患者上述指标变化的差异。结果(1)两组患者的偏头痛发作均得到有效控制;(2)在先兆发生、头痛发生频率、头痛时数、头痛程度及头痛伴随症状等方面,两组患者治疗前后均有明显改善(P<0.05),以上指标在两组间同时点比较无显著性差异(P)>0.05);(3)坎地沙坦组出现轻度头晕伴乏力1例,氟桂利嗪组出现头晕2例,乏力2例,肥胖3例,患者均坚持治疗至试验终止,无严重的不良反应出现。结论(1)坎地沙坦和氟杜利嗪对偏头痛的治疗均有较好效果。(2)坎地沙坦和氟桂利嗪对偏头痛的预防治疗效果相近。(3)坎地沙坦治疗偏头闯时不良反应发生率较低,药物安全性较好。
【Abstract】 Backgrounds:Migraine is a common disease, which is characterized by recurrent attacks of headache and non-headache phenomenon. It was reported that the morbidity of migraine of males and females in western countries were6%-8%and15%-25%respectively. Migraine is one of the most serious threatens as it affects normal works, studies and sleep so that it’s in the list of the serious disease. In the health report of diseases with Years Lived with Disability (YLD) from WHO in2001, migraine was in the first20ones. Serious migraine was the most disabled disease just as dementia, quadriplegic and serious psycosis. At the present, some prophylactic methods have been acquired in treatment although not all patients could get benefits. So with the related researches, clinical practice should be taken to find out the ideal way in migraine prophylaxis.Objectives:Migraine is a common disease in clinic. Its prevalence is rising up and the mechanism is not clear yet. Although there have been favorable effects about the diagnosis and treatment, related studies are still needed in the field of the prophylactic treatment of migraine. In order to grope for the effectiveness and safety of candesartan, we designed this trial to investigate the effectiveness of candesartan and flunarizine on migraine.Methods: From September2012to February2013,104patients with migraine in out-patient clinic (OPD) of Shandong Provincial Hospital (SDPH) were randomly assigned to candesartan (n=52,15males,37females, average age=39.3) and flunarizine (n=52,13males,39females, average age=37.2) groups. All patients were diagnosed with the IHS criteria. The patients were treated with candesartan and flunarizine in two groups respectively for3months. The results in two groups were compared about mean monthly migraine frequency, migraine duration, migraine severity and migraine index.Results:(1)Both candesartan and flunarizine were potentially effective in the prophylaxis for patients with migraine.(2)Both candesartan and flunarizine were markedly effective in the improvements of aura occurrence, headache frequencies, headache hours, headache degrees and accompanied symptoms (P<0.05). There were no statistical differences between the two groups in the present evaluating indicators (P>0.05).(3)Adverse reactions:one case with dizziness and fatigue in candesartan group;2cases with dizziness and drowsiness,2with fatigue and3with adiposity in flunarizine group. No serious adverse reactions occurred.Conclusions:(1)Both candesartan and flunarizine are effective in migraine prophylaxis treatment.(2)The effects of the two drugs in migraine prophylaxis are similar.(3)Candesartan is lower in the incidence of adverse reactions and its safety is better.
【Key words】 candesartan; flunarizine; migraine; prophylaxis; treatment;