卡马西平治疗药物监测及其临床应用研究

发布时间：2018-01-07 17:31

本文关键词：卡马西平治疗药物监测及其临床应用研究　出处：《新乡医学院》2016年硕士论文　论文类型：学位论文

【摘要】：背景卡马西平是目前临床上常用的抗癫痫药物,可有效控制多种类型癫痫的发作,尤其是治疗癫痫全身强直-阵挛性发作和癫痫部分性发作的首选药物之一。卡马西平在临床抗癫痫治疗时,存在下面几个特点:有效血药浓度范围较窄,为(4~12mg·L-1)、机体对该药物的反应个体差异大以及不良反应较严重,因此在临床上应用的时候,有必要对卡马西平进行治疗药物监测。目前卡马西平治疗药物监测常见的方法是测定其在人血清中的谷浓度,关于测定方法的报道较多。而具体到如何依据卡马西平的血清药物浓度测定结果进行患者的个体化给药方案设计,进而评价治疗药物监测技术在卡马西平治疗癫痫疾病中的作用,目前该方面的报道很少见。目的建立快速、准确的测定方法进行卡马西平的治疗药物监测,并评价其在癫痫患者治疗中的作用。方法首先建立反相高效液相色谱法,将此方法用于测定卡马西平片剂中主药的含量及有关物质,从而对临床常用的卡马西平片剂进行质量控制;其次建立高效液相色谱法用于测定卡马西平在人血清中的谷浓度,以二氯甲烷为萃取剂,分两次萃取,色谱条件为:色谱柱为Hypersil BDS C18(4.6 mm×250 mm,5μm),流动相为甲醇-0.05 mol/L KH2PO4(75:25,V/V),检测波长为238 nm,流速为1.0 m L/min,柱温为30℃,进样量为20μL;最后将卡马西平治疗药物监测应用于临床,观察组患者进行卡马西平治疗药物监测,对照组患者未进行卡马西平治疗药物监测,通过两组患者的治疗有效率、不良反应发生率及患者的满意度评价卡马西平治疗药物监测在癫痫疾病治疗中的作用。结果本研究建立的高效液相色谱法能够进行卡马西平片剂的质量控制,能够快速准确地测定卡马西平在人血清中的药物浓度。观察组患者进行卡马西平治疗药物监测,其临床治疗有效率为91.45%,对照组患者没有进行卡马西平治疗药物监测,其临床治疗有效率为78.95%,经分析,两组之间差异具有统计学意义;观察组患者的不良反应发生率低于对照组,在呼吸不规则发生率的差异存在统计学意义;观察组患者的治疗满意度高于对照组,两组差异有统计学意义。结论卡马西平治疗药物监测能够提升癫痫患者疾病治疗的有效率,降低药物不良反应的发生率,提升患者的满意度,值得临床推广应用。
[Abstract]:The background of C Masi Bing is the clinical commonly used antiepileptic drugs, can effectively control various types of epilepsy attack, especially one of the treatment of epilepsy with generalized tonic clonic seizures and partial seizures of the drug of first choice. C Masi Bing anti epilepsy treatment in the clinical setting, the presence of several features: the effective blood drug concentration range is relatively narrow, as (4~12mg - L-1), the body of individual differences of the drug and more serious adverse reactions, so in clinical practice, it is necessary to C Masi Bing for therapeutic drug monitoring. At present the common methods of C Masi Bing therapeutic drug monitoring is to detect the concentration in human serum, testing for many reports. And specific to the serum drug concentration of C Masi Bing according to measured results of the individualized dosage regimen design, and evaluate the therapeutic drug monitoring technology in the Kama Xiping's role in the treatment of epilepsy disease, at present the reports are rare. Objective to establish a rapid determination method for therapeutic drug monitoring of C Masi Bing accurately, and to evaluate its therapeutic effect in patients with epilepsy. Methods we established a RP-HPLC method for the determination of main drug tablets in C Masi Bing and the related substances, so as to control the quality of the common clinical C Masi Bing tablets; secondly, to establish a HPLC method for the determination of C Masi Bing Valley concentration in human serum, using dichloromethane as extractant, two times of extraction, chromatographic column is Hypersil BDS C18 (4.6 mm * 250 mm, 5 m), a mobile phase of methanol -0.05 mol/L KH2PO4 (75:25, V/V), the detection wavelength was 238 nm, the flow rate was 1 m L/min, the column temperature is 30 DEG C, the injection volume was 20 L; finally, C Masi Bing used in therapeutic drug monitoring Clinically, the patients in observation group were C Masi Bing therapeutic drug monitoring, patients in the control group were not C Masi Bing therapeutic drug monitoring, through the treatment of the two groups of patients with efficiency, the incidence of adverse reactions and patient satisfaction evaluation of therapeutic drug monitoring in the treatment of C Masi Bing's disease. Epilepsy results of quality control of high performance liquid chromatography was established in this study can C Masi Bing tablet, can quickly and accurately determine the drug concentration in blood serum in C Masi Bing. The patients in observation group were C Masi Bing therapeutic drug monitoring, the clinical effective rate of treatment was 91.45%, the control group of patients with no C Masi Bing therapeutic drug monitoring, the clinical effective rate was 78.95%, according to the analysis, the difference was statistically significant in two groups between; the observation group of patients with adverse reaction rate lower than the control group, the incidence of irregular breathing differences Statistical significance; the observation group patients satisfaction was higher than the control group, there was significant difference between two groups. Conclusion C Masi Bing therapeutic drug monitoring of patients with epilepsy disease can improve the treatment efficiency, reduce the incidence of adverse drug reactions, improve patient satisfaction, it is worthy of clinical application.

【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R969

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