A postmarketing study of flunarizine in migraine and vertigo

This prospective, open multi-centre study on flunarizine focused on the risk/benefit ratio of the use of flunarizine in the prophylaxis of migraine and in the treatment of vertigo, due to disorder of the vestibular system. The assessment of risks focused on the incidence of new events of depression and/or extrapyramidal syndrome during flunarizine treatment. For migraine, flunarizine was compared to propranolol in 686 patients; for vertigo, flunarizine was compared to betahistine in 198 patients. The incidence of depression during follow-up in this study was significantly higher in the flunarizine group than in the propranolol group in the condition of migraine. There were no observations of an extrapyramidal syndrome. There was a suggestion that flunarizine has more benefits than propranolol in the condition of migraine, and that betahistine has more benefit than flunarizine in the condition of vertigo. Differences in dosages could possibly explain these differences.     

Flunarizine. A reappraisal of its pharmacological properties and therapeutic use in neurological disorders

Flunarizine is a class IV calcium antagonist with a pharmacological profile which suggests its therapeutic potential in a number of neurological and cerebrovascular disorders. It is an effective prophylactic treatment for common or classic migraine in children and adults, and it appears at least as effective as a number of other agents which act by different pharmacological mechanisms, including pizotifen (pizotyline), cinnarizine, methysergide, nimodipine, metoprolol, propranolol, aspirin and cyclandelate. Flunarizine is also effective in reducing the frequency of seizures, when used as an 'add-on' treatment, in some patients with partial or generalised epilepsy resistant to maximal therapy with a combination of several conventional antiepileptic drugs. Placebo-controlled studies show that flunarizine is effective in the treatment of vertigo and associated symptoms of either peripheral or central origin, and in the treatment of cerebrovascular insufficiency where psychological symptoms, rather than vertigo, are the primary symptoms. In the treatment of vertigo, flunarizine appears at least as effective as cinnarizine and more effective than nicergoline, betahistine dichlorhydrate, pentoxifylline (oxpentifylline) and vincamine. Flunarizine therefore is useful in the prophylaxis of migraine, an effective treatment for vertigo and a worthwhile alternative as 'add-on' therapy in patients with epilepsy resistant to conventional drugs.     

氟桂利嗪治疗偏头痛及对血浆神经肽Y的影响

目的 :观察氟桂利嗪治疗偏头痛的疗效及其对血浆神经肽Y (NPY)水平的影响。方法 :选择偏头痛病人 6 0例 ,随机分为 2组 ,分别予氟桂利嗪和普萘洛尔治疗 ,观察 2组疗效。并分别测定治疗前后血浆NPY水平 ,做统计学分析。结果 :2组比较 ,氟桂利嗪组与普萘洛尔组偏头痛控制率 (5 4 % ,2 1% )及总有效率 (93% ,71% )的差异有显著意义(均P <0 .0 5 )。治疗后 ,氟桂利嗪组NPY水平降低了 (32± 5 3)ng·L- 1,经t检验 ,差异有显著意义 (P<0 .0 5 ) ,而普萘洛尔组差异无显著意义 (P >0 .0 5 )。结论 :氟桂利嗪治疗偏头痛有效 ,且治疗后血浆神经肽水平降低 ,提示氟桂利嗪可有解除血管痉挛的作用     

盐酸氟桂利嗪联合盐酸倍他司汀治疗血管痉挛性头痛

目的观察氟桂利嗪联合盐酸倍他司汀治疗血管痉挛性头痛的临床疗效和安全性。方法将220例血管性头痛患者随机分为A组和B组各组110例,两组均予氟桂利嗪5mg,2次/d,A组加服倍他司汀4mg,3次/d,分别于治疗前后观察临床症状及颅多普勒超声（TCD）检测。结果治疗后临床总有效率A组明星优于B组（P〈0.01）。结论氟桂利嗪联合盐酸倍他司汀治疗血管性头痛疗效明显优于氟桂利嗪。     

复方天麻蜜环糖肽片联用甲磺酸倍他司汀片治疗颈性眩晕

目的：观察复方天麻蜜环糖肽片联用甲磺酸倍他司汀片治疗颈性眩晕的疗效。方法：将94例以眩晕为主要症状的颈椎病患者,随机分为两组。治疗组47例,用复方天麻蜜环糖肽片联用甲磺酸倍他司汀片;对照组47例,单纯用甲磺酸倍他司汀片治疗,疗程为14d。结果：治疗组总有效率93.6%,显效率70.2%;对照组总有效率87.2%,显效率51.1%。治疗组治疗后血脂和血流变学明显改善。结论：复方天麻蜜环糖肽片联用甲磺酸倍他司汀片治疗颈性眩晕的疗效高于单用甲磺酸倍他司汀片。     

A fixed combination of cinnarizine/dimenhydrinate for the treatment of patients with acute vertigo due to vestibular disorders : a randomized, reference-controlled clinical study

BACKGROUND AND OBJECTIVE: Vestibular dysfunction commonly leads to - often severe - vertigo symptoms. The objective of this study was to compare the antivertiginous efficacy and tolerability of a fixed combination of cinnarizine/dimenhydrinate with those of betahistine in patients with acute vertigo due to vestibular disorders. METHODS: Sixty-six patients experiencing acute vertigo attacks participated in this prospective, double-blind, three-centre, comparative study. Patients who assessed at least one vertigo symptom as being of medium intensity (> or =2) on a 5-point visual analogue scale (VAS; from 0 = no symptoms to 4 = very severe symptoms) were randomly allocated to treatment with the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg three times daily or betahistine 12 mg three times daily for 4 weeks. The primary efficacy endpoint was change in mean vertigo score, as determined by patients' assessments of 12 individual vertigo symptoms on the 5-point VAS after 4 weeks of treatment. RESULTS: Treatment with the fixed combination led to significantly greater improvements in mean vertigo scores than the reference therapy betahistine after 4 weeks of therapy (p = 0.013). The differences were clinically relevant, based on the Mann-Whitney estimator. Furthermore, the incidence of vertigo-associated vegetative symptoms was significantly reduced after 1 (p = 0.004) and 4 weeks (p = 0.023) in the fixed-combination group relative to the betahistine group. Three patients, all of them in the betahistine group, reported adverse events, none of which was considered serious. Almost all patients (n = 62) rated the tolerabilities of both medications as very good or good. CONCLUSION: The fixed combination of cinnarizine/dimenhydrinate was shown to be an effective and very well tolerated treatment option for patients with acute vertigo due to vestibular disorders. The combination proved to be significantly more efficient in reducing vertigo and associated vegetative symptoms than betahistine in such patients.     

天麻钩藤饮联合倍他司汀治疗眩晕症患者的价值

目的 对眩晕症患者接受天麻钩藤饮联合倍他司汀进行治疗的临床疗效以及应用价值进行讨论.方法 80例眩晕症患者,根据入院顺序不同分为对照组和研究组,每组40例.对照组患者给予甲磺酸倍他司汀治疗,研究组患者给予天麻钩藤饮联合甲磺酸倍他司汀治疗.比较两组患者的临床疗效以及血液粘稠度.结果 研究组患者总有效率90.0％高于对照组...     

曲美他嗪联合倍他司汀治疗眩晕症88例临床观察

目的观察曲美他嗪联用倍他司汀治疗眩晕症的临床疗效。方法将门诊176例眩晕症病人随机分成两组,所有病人均予静脉点滴等量能量合剂和山莨菪碱10mg治疗组88例,采用曲美他嗪和倍他司汀内服;对照组88例,给予复方丹参20ml静脉点滴和口服安定10mg治疗,比较两组疗效。结果治疗组较对照组治愈率提高,两组比较差异有极显著性（P〈0．01）。结论曲美他嗪联用倍他司汀治疗眩晕症效果理想。     

苯海拉明联合盐酸氟桂利嗪及山莨菪碱治疗周围性眩晕的疗效

目的:探析苯海拉明联合盐酸氟桂利嗪及山莨菪碱治疗周围性眩晕的疗效。方法:研究对象为2017年9月~2018年8月于某院就诊的98例周围性眩晕患者,随机分为对照组和观察组各49例。对照组给予盐酸氟桂利嗪治疗,观察组增加苯海拉明、山莨菪碱治疗,比较两组的治疗有效性和安全性。结果:比较两组患者的治疗有效率,发现观察组的总有效率明显高于对照组,两组有显著差异;从两组的不良反应发生率比较上来看,两组不良反应发生率比较无显著差异(P>0.05)。结论:单一盐酸氟桂利嗪治疗周围性眩晕效果不明显,尤其是病情严重者需增加苯海拉明、山莨菪碱进行治疗,兼具有效性和安全性。     

帕罗西汀联合氟桂利嗪治疗伴情绪障碍的偏头痛69例

目的 观察帕罗西汀与氟桂利嗪联合治疗伴焦虑、抑郁情绪的偏头痛患者的疗效与不良反应.方法 将138例伴情绪障碍的偏头痛患者随机均分为两组,治疗组给予帕罗西汀和氟桂利嗪口服,对照组单用氟桂利嗪,均以6周为1个疗程,根据治疗前后头痛发作次数、持续时间及头痛严重程度的变化进行疗效评定,并用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)进行评分.自制副反应量表记录不良反应.结果 两种治疗方法均可显著减少偏头痛发作次数,缩短头痛发作时间,减轻头痛程度(P<0.01);治疗组还可明显减轻患者的抑郁焦虑症状,治疗后2,4,6周HAMD和HAMA评分的改善优于对照组(P<0.01);治疗组头痛持续时间的缩短也优于对照组(P<0.01).结论 帕罗西汀联合氟桂利嗪治疗伴有情绪障碍的偏头痛有较好疗效,不良反应不需作特殊处理.     

乐脉颗粒并用氟桂利嗪治疗颈性眩晕

目的 :观察乐脉颗粒加氟桂利嗪对颈性眩晕的疗效。方法 :诊断为颈性眩晕的病人 70例分为治疗组 35例 [男性 10例 ,女性 2 5例 ,年龄 71a±s12a(5 3～ 85a) ],给予乐脉颗粒 3g ,po ,tid ,加氟桂利嗪 5mg ,po ,qd ;对照组 35例 [男性 8例 ,女性2 7例 ,年龄 70a± 7a(5 5～ 78a) ],单用氟桂利嗪 5mg ,po ,bid。 2组疗程均为 10wk。结果 :随访 3mo ,治疗组总有效率 97% ,对照组为 71% (P <0 .0 5 )。结论 :乐脉颗粒加氟桂利嗪治疗颈性眩晕较单用氟桂利嗪的效果好     

银杏叶片联合倍他司汀治疗良性阵发性位置性眩晕手法复位后残留症状的疗效观察

目的 探讨银杏叶片联合倍他司汀治疗良性阵发性位置性眩晕手法复位后残留症状的临床效果。方法 选取2019年1月—2020年8月天津中医药大学第一附属医院收治的120例良性阵发性位置性眩晕患者经成功手法复位后仍有残留症状者,采取随机数字表法将随机分成对照组（n=60）和治疗组（n=60）。对照组口服甲磺酸倍他司汀片,6 mg/次,3次/d。治疗组在对照组基础上口服银杏叶片,1片/次,3次/d。两组均连续治疗7 d。观察两组的临床疗效,比较两组头晕、平衡障碍的缓解时间、前庭症状指数（VSI）、头晕残障问卷（DHI）总分及焦虑自评量表（SAS）、抑郁自评量表（SDS）评分及半年复发率。结果 治疗后,治疗组总有效率是96.7%,较对照组的81.7%显著提高（P<0.05）。治疗后,治疗组头晕缓解时间、平衡障碍缓解时间均显著短于对照组（P<0.05）。两组治疗后VSI总分、DHI总分、SAS评分、SDS评分均显著降低（P<0.05）;且治疗后,治疗组相关量表评分低于对照组（P<0.05）。随访6个月,治疗组复发率为8.3%,较对照组21.7%显著降低（P<0.05）。结论 银杏叶片联合倍他司汀对良性阵发性位置性眩晕经成功手法复位后仍有残余症状患者具有确切的临床疗效,可安全有效且迅速地改善患者残留症状,并对患者焦虑及抑郁症状亦有显著的改善作用,是提高患者生活质量、降低复发风险的良好途径,值得临床推广应用。     

倍他司汀联合氟桂利嗪治疗椎基底动脉供血不足的临床研究

目的：观察倍他司汀联合氟桂利嗪治疗椎基底动脉供血不足的疗效。方法：将所有病例随机分为氟桂利嗪组和联合治疗组。氟桂利嗪组给予氟桂利嗪胶囊治疗;联合治疗组在此基础上给予倍他司汀口服治疗。治疗后使用经颅多普勒血流诊断系统（TCD）检测血流情况,观察两组治疗效果。结果：联合治疗组的有效率高于氟桂利嗪组,P＜0.05。两组经过治疗,血流异常情况得到改善,联合治疗组血流异常情况的改善情况要优于氟桂利嗪组,P＜0.05。结论：倍他司汀联合氟桂利嗪治疗椎基底动脉供血不足安全有效。     

氟桂嗪治疗脑动脉硬化症、偏头痛和眩晕339例

本文报道以盐酸氟桂嗪治疗脑动脉硬化症、偏头痛和眩晕共339例,总有效率为95％。对照组168例用桂利嗪(脑益嗪)治疗,总有效率为87.5％。治疗组与对照组的有效率相比差异显著(p<0.05),表明氟桂嗪治疗脑缺血性疾病的疗效优于桂利嗪且副作用较少,值得临床推荐使用。     

氟桂利嗪联合正天丸治疗偏头痛的疗效分析

目的：观察氟桂利嗪与正天丸合用治疗偏头痛的临床疗效。方法：将86例偏头痛患者随机分为对照组和观察组,各43例,对照组单用氟桂利嗪治疗,观察组联合应用氟桂利嗪与正天丸治疗,比较两组临床疗效。结果：与本组治疗前比较,两组患者疼痛程度、疼痛持续的时间和发作次数均有明显改善（P＜0.01）,但观察组改善较对照组更为显著（P＜0.01）;观察组治愈率为41.9%,总有效率为93.1%,均分别高于对照组的16.3%、76.8%（P＜0.05或P＜0.01）。结论：氟桂利嗪与正天丸合用治疗偏头痛较单用氟桂利嗪的疗效显著,值得临床推广。     

养血清脑颗粒治疗偏头痛的临床观察

目的:观察养血清脑颗粒与盐酸氟桂利嗪联合治疗偏头痛的疗效。方法:偏头痛患者80例随机分成观察组(40例)和对照组(40例),观察组服用养血清脑颗粒和盐酸氟桂利嗪,对照组只用盐酸氟桂利嗪,观察两组的疗效。结果:观察组疗效明显优于对照组(P<0.05)。结论:养血清脑颗粒治疗偏头痛安全有效,和盐酸氟桂利嗪合用可提高疗效。     

养血清脑颗粒联合盐酸培他司汀注射液治疗眩晕临床疗效观察

目的:观察养血清脑颗粒联合盐酸培他司汀注射液治疗眩晕症的临床疗效。方法:50例眩晕症患者随机分为治疗组25例,应用养血清脑颗粒4g,口服3次/d,并联合应用盐酸培他司汀注射液4mg静滴,每日1次;对照组25例,应用复方丹参20ml加入5%葡萄糖(或生理盐水)注射液250ml中静滴,每日1次,疗程5天。结果:治疗总有效率96%,对照组总有效率68%,两组比较有显著性差异(P<0.05)。结论:养血清脑颗粒治疗眩晕症,可显著提高疗效。     

通心络联合倍他司汀治疗椎—基底动脉供血不足性眩晕的疗效观察

目的观察通心络联合倍他司汀治疗椎—基底动脉供血不足(VBI)性眩晕的临床疗效。方法将60例VBI性眩晕患者随机分为2组。治疗组30例给予通心络胶囊4粒口服,每天3次;倍他司汀8mg口服,每天3次。对照组30例仅口服倍他司汀8mg,每天3次。治疗后观察2组临床疗效。结果治疗组总有效率为93.3%高于对照组的73.3%,差异有统计学意义(P<0.05)。2组治疗中未出现任何不良反应。结论通心络联合倍他司汀治疗VBI性眩晕疗效显著,安全性好,值得临床推广应用。     

Nimodipine in migraine: clinical efficacy and endocrinological effects

Summary Serum prolactin is increased during chronic flunarizine treatment of patients suffering from migraine. In order to clarify the role of calcium in control of the secretion of anterior pituitary hormones, a study has now been made of the effects of chronic nimodipine and propranolol treatment of migraine patients on prolactin (PRL), luteinizing hormone (LH) and growth hormone (GH) levels. 11 patients were treated with nimodipine and 8 with propranolol for four months. A statistically significant reduction in the frequency of the attacks was demonstrated in both groups. No significant change was found in the hormones levels during nimodipine treatment.     

Patient baseline characteristics in an open-label multinational study of betahistine in recurrent peripheral vestibular vertigo: the OSVaLD study

ABSTRACT

Objectives and methods: OSVaLD (Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48?mg/day on quality of Life and Dizziness symptoms) is a 3?month, open-label, multi-national post-marketing surveillance study of betahistine 48?mg/day in the management of patients with vertigo of less than 5 years in duration. The aim of the study is to examine the burden of disease associated with vertigo, as determined by scores on the Dizziness Handicap Inventory (DHI), Short Form-36 (SF-36) questionnaire and the Hospital Anxiety and Depression Scale (HADS). Changes in DHI, SF-36?and HADS scores between baseline and 3 months are used to assess the therapeutic effects of betahistine.

Results: Participants (n = 2037) have been recruited from 13 countries in four continents (North and South America, Asia and Europe), representing a wide range of cultural and linguistic traditions. Approximately two-thirds of the patients are women. Sixty per cent of patients have diagnoses of peripheral vestibular vertigo of unknown pathology or benign paroxysmal positional vertigo; 13% have a diagnosis of Ménière's disease. All three of the instruments used characterize this as a population with extensive vertigo-attributable morbidity at baseline. The mean DHI score of the population is 63.7 ± 15.7 (DHI scale: 0 = no handicap; 100 = major self-perceived handicap), SF-36?scores?in all domains are below the population average for the USA and the HADS indicated that > 50% of patients exhibit symptoms of anxiety or depression or both, including 9% who have severe manifestations of either or both conditions.

Conclusions: This report describes the design and implementation of OSVaLD and presents baseline demographic and clinical features of the patients. Full results of the study, anticipated in 2007, will provide more details about the manifestations of vertigo in routine practice and the response to betahistine.