Levetiracetam治療癲癇病患之療效、生活品質、 認知功能、心理與情緒之研究

Abstract

研究目的：癲癇症為一種慢性神經性疾病，不僅疾病本身，治療方法所引起的副作用亦會造成病人生活品質、認知功能、心理情緒狀態造成影響。Levetiracetam，中文品名為優閒，為目前台灣最新一代抗癲癇藥品，其具有良好的治療效果、特殊性的藥理作用機轉與病人對藥物的耐受度高，因此常用以癲癇發作控制不佳或無法忍受其他藥品的副作用的輔助治療。本研究的目的為探討在癲癇發作控制不佳或無法忍受其他藥品負作用的台灣癲癇病患使用LEV是否能改善病人的生活品質、認知功能與心理情緒狀態，並且評估LEV藥物療效。 研究方法：此研究為前瞻、開放性、單一群組觀察性研究，在台大醫院、長庚醫院、彰化基督教醫院與花蓮慈濟醫院四家醫院收納一年內癲癇發作次數超過四次或無法忍受藥品副作用的病人，給予LEV藥物治療，且在使用前與使用後三個月給予病人填寫癲癇生活品質量表-10（QOLIE-10）、簡易智能量表（MMSE）與修訂版症狀量表-90（SCL-90R）藉以評估病人生活品質、認知功能與心理情緒狀態。 結果：在所有完成三個月治療且前後測評估的77位病患，可發現有統計上顯著性的改善生活品質、認知功能與心理情緒狀態。在LEV治療之後，病人在QOLIE-10項目中的「社會功能」、「認知功能」、「藥物的影響」與「總分」有顯著性的改善，且在癲癇發作次數減少一半以上的病人，改善的情形更為明顯。此外，病人在MMSE中的項目「短期記憶」、「語言理解能力」與「總分」改善情形較為明顯。在SCL-90R有「強迫症」、「憂慮」與「焦慮」項目中，病人在此三個項目都可發現具有顯著性的改善。而療效部分，可發現LEV確實可以顯著性的降低病人癲癇發作次數(中位數)由7降至3。此外，併用藥品數目與LEV藥物療效對於病人的生活品質具有顯著性的影響，但對於改善認知功能與心理情緒狀態卻是由於藥物本身作用結果所導致。 結論：癲癇病患使用LEV確實可以改善生活品質、認知功能與心理情緒狀態，且確實可以控制病人的癲癇發作次數。

Objective: Epilepsy is a chronic neurologic disease. Not only the disease itself, but also the treatment may have a significant impact on patient’s quality of life, cognitive function, psychological and emtional status. Levetiracetam is the newest anti-epileptic drugs (AEDs) in Taiwan, and it has good efficacy, unique mechanism of action from other AEDs and good tolerablility for patients. Therefore, it is often used as alternative drug because of the lack of efficacy or poor tolerability of their current AEDs. The objective of the study was to assess the impact of LEV on quality of life, cognitive function, psychological and emotional status in Taiwanese patients who their current AEDs have poor efficacy or poor tolerability and also assess its efficacy on seizure control. Method: This perspective, open-label, signle-arm observational study is conducted in National Taiwan University Hospital, Chang Gung Memorial Hospital Changhua Christian Hospital and Hualien Tzu Chi General Hospital. The patients who are recruited should meet one of the following inclusion criterions: minimal seizure frequency should be equal or more than 4 times in past one year regardless of seizure types, or can’t tolerate current AEDs. All of the patients will be gived LEV treatment and administrated the QOLIE-10, MMSE and SCL-90R to assess their quality of life, cognitive function, and psychological and emotional status, respectively in baseline and three- month treatment end. Result: For all 77 patients who completed the QOLIE-10, MMSE and SCL-90R, at baseline and 3 month treatment period, a significant improvement was noted in quality of life, cognitive function, psychological and emotional stautus. The performance of patients in 「social function」, 「cognitive function」,「medicational effect」and 「total score」 QOLIE-10 subitems were statistically improved. Furthermore , patients’ cognitive function in 「short term memory」「language comprehension」「total score 」in MMSE were also found improved significantly. Finally, 「obessive compulsive disease」「depression」and「anxiety」in SCL-90R, patients were also improved significantly. In addition, the seizure frequency (median) was reduced from 7 to 3 in three-month periods. In addition, the number of AEDs concurrent used and LEV efficacy had significant impact on patient’s improvement in quality of life. However, the improvement in cognitive function, psychological and emotional status may be probably because of the nature of the LEV. Conclusion: LEV controlled seizure attacks in epileptic patients in Taiwan. Furthermore, after treatment of LEV, quality of life, cognitive function, psychologic and emotional status of patients significantly improved.