McLean M J, Morrell M J, Willmore L J, Privitera M D, Faught R E, Holmes G L, Magnus-Miller L, Bernstein P, Rose-Legatt A
Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee 37212, USA.
Epilepsia. 1999 Jul;40(7):965-72. doi: 10.1111/j.1528-1157.1999.tb00804.x.
To evaluate the tolerability and safety of gabapentin (GBP) as add-on therapy for seizure control.
Conducted in an outpatient setting and reflecting usual practice, this study compared tolerability of GBP dosages < or = 1,800 versus >1,800 mg/day, when these doses were required to achieve the most effective seizure control. Two analyses of adverse events are presented: tolerability and safety. In the tolerability analysis, each patient served as his or her own control to compare the occurrence of adverse events at GBP < or =1,800 versus >1,800 mg/day. The safety analysis required patients to receive at least one dose of GBP and have a follow-up contact.
A total of 2,216 patients enrolled in this open-label, 16-week study and were evaluable for safety. Of these, 74.0% completed the 16-week study, and 281 met the tolerability criteria. Within these 281 patients, two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose). Three adverse events (asthenia, headache, and dizziness) were observed in a statistically significantly larger number of patients at only the low dose than in the group reporting these same adverse events at only the high dose, suggesting that patients who tolerated GBP at < or = 1,800 mg/day did not experience a significant increase in adverse events with dosages >1,800 mg/day. Overall, 10.6% of the 2,216 patients in the safety population prematurely withdrew because of adverse events, and 3.5% discontinued because of lack of efficacy. Safety and tolerability of GBP was rated as excellent or good for 78.5% of all patients.
Gabapentin doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events.
评估加巴喷丁（GBP）作为癫痫控制辅助治疗的耐受性和安全性。
本研究在门诊环境中进行，反映了常规治疗情况，比较了每日剂量≤1800毫克与＞1800毫克的GBP的耐受性，当需要这些剂量来实现最有效的癫痫控制时。给出了两种不良事件分析：耐受性和安全性。在耐受性分析中，每位患者作为自身对照，比较GBP剂量≤1800毫克/天与＞1800毫克/天不良事件的发生情况。安全性分析要求患者至少接受一剂GBP并进行随访。
共有2216名患者参加了这项开放标签的16周研究，并可进行安全性评估。其中，74.0%完成了16周研究，281名符合耐受性标准。在这281名患者中，比较了两个相互排斥的组：（a）仅在≤1800毫克/天（低剂量）时报告不良事件的患者；（b）仅在＞1800毫克/天（高剂量）时报告不良事件的患者。仅在低剂量组中观察到三种不良事件（乏力、头痛和头晕）的患者数量在统计学上显著多于仅在高剂量组报告这些相同不良事件的组，这表明在≤1800毫克/天耐受GBP的患者在剂量＞1800毫克/天时不良事件没有显著增加。总体而言，安全性人群中的2216名患者中有10.6%因不良事件提前退出，3.5%因缺乏疗效而停药。78.5%的患者对GBP的安全性和耐受性评价为优秀或良好。
每日剂量＞1800毫克的加巴喷丁与剂量≤1800毫克/天的耐受性相同，且不良事件并未增多。
