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  本文關(guān)鍵詞：卡馬西平治療藥物監(jiān)測及其臨床應(yīng)用研究　出處：《新鄉(xiāng)醫(yī)學(xué)院》2016年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 治療藥物監(jiān)測 體內(nèi)藥物分析 質(zhì)量控制 卡馬西平

【摘要】：背景卡馬西平是目前臨床上常用的抗癲癇藥物,可有效控制多種類型癲癇的發(fā)作,尤其是治療癲癇全身強直-陣攣性發(fā)作和癲癇部分性發(fā)作的首選藥物之一�？R西平在臨床抗癲癇治療時,存在下面幾個特點:有效血藥濃度范圍較窄,為(4~12mg·L-1)、機體對該藥物的反應(yīng)個體差異大以及不良反應(yīng)較嚴重,因此在臨床上應(yīng)用的時候,有必要對卡馬西平進行治療藥物監(jiān)測。目前卡馬西平治療藥物監(jiān)測常見的方法是測定其在人血清中的谷濃度,關(guān)于測定方法的報道較多。而具體到如何依據(jù)卡馬西平的血清藥物濃度測定結(jié)果進行患者的個體化給藥方案設(shè)計,進而評價治療藥物監(jiān)測技術(shù)在卡馬西平治療癲癇疾病中的作用,目前該方面的報道很少見。目的建立快速、準確的測定方法進行卡馬西平的治療藥物監(jiān)測,并評價其在癲癇患者治療中的作用。方法首先建立反相高效液相色譜法,將此方法用于測定卡馬西平片劑中主藥的含量及有關(guān)物質(zhì),從而對臨床常用的卡馬西平片劑進行質(zhì)量控制;其次建立高效液相色譜法用于測定卡馬西平在人血清中的谷濃度,以二氯甲烷為萃取劑,分兩次萃取,色譜條件為:色譜柱為Hypersil BDS C18(4.6 mm×250 mm,5μm),流動相為甲醇-0.05 mol/L KH2PO4(75:25,V/V),檢測波長為238 nm,流速為1.0 m L/min,柱溫為30℃,進樣量為20μL;最后將卡馬西平治療藥物監(jiān)測應(yīng)用于臨床,觀察組患者進行卡馬西平治療藥物監(jiān)測,對照組患者未進行卡馬西平治療藥物監(jiān)測,通過兩組患者的治療有效率、不良反應(yīng)發(fā)生率及患者的滿意度評價卡馬西平治療藥物監(jiān)測在癲癇疾病治療中的作用。結(jié)果本研究建立的高效液相色譜法能夠進行卡馬西平片劑的質(zhì)量控制,能夠快速準確地測定卡馬西平在人血清中的藥物濃度。觀察組患者進行卡馬西平治療藥物監(jiān)測,其臨床治療有效率為91.45%,對照組患者沒有進行卡馬西平治療藥物監(jiān)測,其臨床治療有效率為78.95%,經(jīng)分析,兩組之間差異具有統(tǒng)計學(xué)意義;觀察組患者的不良反應(yīng)發(fā)生率低于對照組,在呼吸不規(guī)則發(fā)生率的差異存在統(tǒng)計學(xué)意義;觀察組患者的治療滿意度高于對照組,兩組差異有統(tǒng)計學(xué)意義。結(jié)論卡馬西平治療藥物監(jiān)測能夠提升癲癇患者疾病治療的有效率,降低藥物不良反應(yīng)的發(fā)生率,提升患者的滿意度,值得臨床推廣應(yīng)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.

【學(xué)位授予單位】：新鄉(xiāng)醫(yī)學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R969

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本文編號：1393569