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首页> 外文期刊>The Internet Journal of Neurology >Efficacy Of Monotherapy With Carbamazepine And Valproic Acid In Patients With Bronchial Asthma: Is Asthma A Neurological Disease?
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Efficacy Of Monotherapy With Carbamazepine And Valproic Acid In Patients With Bronchial Asthma: Is Asthma A Neurological Disease?

机译：卡马西平和丙戊酸单药治疗支气管哮喘的疗效：哮喘是神经病吗？

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Antiasthmatic activity of carbamazepine and sodium valproate was investigated in 28 patients (open-label trial) with moderate and severe bronchial asthma. Stable and complete remission was achieved in 10 patients of the carbamazepine group (n=14), and in 11 patients of the sodium valproate group (n=14). A follow-up study showed high and stable antiasthmatic efficacy of carbamazepine or sodium valproate monotherapy. Based on the high efficacy of these anticonvulsants in patients with bronchial asthma we suppose that bronchial asthma can be considered as mainly neurogenic paroxysmal and inflammatory disease. Introduction Bronchial asthma is widely recognized as a disease of civilization. The study of bronchial asthma etiopathogenesis is limited mainly to investigation of mediators of airways chronic inflammation on cellular or tissue level1 Respectively, the treatment of bronchial asthma is aimed on the pharmacological effect on these mediators. Significant attention is paid to the investigation of immune mechanisms of bronchial asthma. But bronchial asthma also is a disease with paroxysmal clinical picture and it seems interesting to investigate antiasthmatic activity of anticonvulsive medicines in patients with asthma. We performed small open-lable trial of carbamazepine and valproate sodium in patients with bronchial asthma. The objective of this study was to assess effect of 3-months-long peroral administration of carbamazepine or sodium valproate on pulmonary function assessed by PEFVR and incidence of asthma attacks in patients with moderate-to-severe bronchial asthma. Method Eligibility criteria: non-stable efficacy of conventional asthma therapy, disease duration more than 1 year, frequency of asthma exacerbations 1 or more per month and absence of stable and long-term remissions. Patients had remained on their previously prescribed antiasthmatic treatment (inhaled hormones, beta-agonists, antihistamines, sodium cromoglycate, cholinolytics). Exclusion criteria: presence of concomitant severe diseases, age younger than 18 years.Study design: 28 patients eligible to participate the trial were assigned to a 12-week phase of treatment with either a carbamazepine (N=14) or sodium valproate (N=14). The number of patients without asthmatic attacks and peak-flow parameters were registered before, during and after the treatment of asthma by carbamazepine or sodium valproate. We also have registered concomitant usage of other antiasthmatic medicines before and during investigation. The patients were allowed to abandon previously prescribed routine antiasthmatic treatment in case of high efficacy of the carbamazepine or sodium valproate, except of long-term high dose peroral or parenteral hormonal therapy, but no patient had received such a treatment in our cases.Our study is compliant with Helsinki Declaration and GCP principles, and study was approved by Ethical Committee and subjects gave their consent to participate.The trial was conducted in 2000.Endpoint definition: the efficacy of carbamazepine and sodium valproate was evaluated by disappearance of any asthmatic syndrome and normalization of peak-flow rates, and also by abandoning of any other antiasthmatic therapy except carbamazepine or sodium valproate.Limitation of the Study: insufficient quantity of peak flow-meters drove us to register peak-flow rates of our patients weekly in the morning during 3 month when visiting their doctor, instead of every day patients’ self-measurements. Statistical AnalysisThe null hypothesis for patients enrolled in trial was that carbamazepine or sodium valproate does not improve symptoms of asthma when added to an existing treatment regimen. Wilcoxon signed rank test was used throughout for statistical analysis of data. For statistical analysis of data we used SPSS for Windows (Release 11.0). Data are presented as Mean ± Standard Deviation. Results Patient populationIn total, 28 patients with moderate persistent or severe asthma (14 of car
机译：卡马西平和丙戊酸钠对28例中度和重度支气管哮喘患者的抗哮喘活性进行了研究（开放标签试验）。卡马西平组10例（n = 14）和丙戊酸钠组11例（n = 14）实现了稳定和完全缓解。一项后续研究表明，卡马西平或丙戊酸钠单药具有较高且稳定的抗哮喘功效。基于这些抗惊厥药在支气管哮喘患者中的高疗效，我们认为支气管哮喘可被认为是主要的神经源性阵发性和炎性疾病。引言支气管哮喘被广泛认为是一种文明疾病。支气管哮喘发病机制的研究主要限于在细胞或组织水平上研究气道慢性炎症的介质1，支气管哮喘的治疗主要针对这些介质的药理作用。重视支气管哮喘的免疫机制研究。但是支气管哮喘也是一种具有阵发性临床症状的疾病，研究抗惊厥药物对哮喘患者的抗哮喘活性似乎很有趣。我们进行了卡马西平和丙戊酸钠对支气管哮喘患者的小型开放试验。这项研究的目的是评估经3个月口服卡马西平或丙戊酸钠对通过PEFVR评估的肺功能的影响以及中重度支气管哮喘患者哮喘发作的发生率。方法入选标准：常规哮喘治疗疗效不稳定，疾病持续时间超过1年，每月哮喘发作次数增加1次或以上且缺乏稳定和长期缓解。患者仍接受以前规定的抗哮喘治疗（吸入激素，β-激动剂，抗组胺药，色甘酸钠，胆碱溶解剂）。排除标准：伴有严重疾病，年龄小于18岁。研究设计：将28名符合条件的患者纳入卡马西平（N = 14）或丙戊酸钠（N = 14）。在卡马西平或丙戊酸钠治疗哮喘之前，期间和之后，记录没有哮喘发作的患者人数和峰值流量参数。在调查之前和调查期间，我们还记录了其他抗哮喘药的同时使用。如果卡马西平或丙戊酸钠疗效高，患者可以放弃先前开的常规哮喘治疗，但长期高剂量经口或肠胃外激素治疗除外，但本例中没有患者接受过这种治疗。符合赫尔辛基宣言和GCP原则，研究获得伦理委员会批准，受试者同意参加.2000年进行该试验。终点定义：卡马西平和丙戊酸钠的疗效通过任何哮喘综合征的消失和限制峰值流量的正常化，并且放弃除卡马西平或丙戊酸钠以外的任何其他哮喘治疗药物。研究的局限性：峰值流量计数量不足，导致我们无法在每天早上的24小时内记录患者的峰值流量3个月去看医生时，而不是每天患者的自我测量。统计分析参加试验的患者的零假设是，卡马西平或丙戊酸钠在现有治疗方案中未改善哮喘症状。全文使用Wilcoxon签名秩检验进行数据统计分析。为了对数据进行统计分析，我们使用了Windows的SPSS（版本11.0）。数据表示为平均值±标准偏差。结果患者人数总共28例中度持续性或重度哮喘患者（14车

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