妥泰转换单药治疗部分性癫痫的疗效耐药性研究

目的 观察妥泰在部分性发作伴或不伴发全身性发作癫痫患者转换成单药治疗的可能性大小、疗效、耐药性以及探索转移的最佳方法。方法 将妥泰加用治疗后达控制或有效的（发作减少≥50％）64例癫痫患者,按每两周减去原用抗癫痫药（AEDs）约1／4量或一种一种减去的方法,逐渐将原用AEDs完全撤去,转换成妥泰单药治疗。结果 减撤成功18例（28．13％）,半成功35例（54．69％）,失败11例（17．19％）。合用的AED种类越少,转换成单药的可能性越大。卡马平减用成功的机会似较丙戊略高一点。结论 妥泰转换成单药是可能的,成功率可达28．13％。卡马西平减撤时较丙戊酸相对容易,可能与减去卡马西平时相对提高服泰的血药浓度有关。在合用多种AEDs时,则以先后减撤法为宜,原则上先减去量少的一种,次减肝酶诱导药,再减另一种。即使减撤未获完全成功,至少全用的AEDs种类养活,符合联合用药的原则。     

妥泰加用治疗成人难治性部分性癫痫的疗效观察

目的：观察妥泰（TPM）加用治疗成人难治性部分性伴或不伴随继发身性发作（GTCS）的疗效,安全性及耐受性。方法：56例在不动原用抗癫痫药（AEDs)的基础上加用TPM治疗20周、前8周为加量期,后12周为维持治疗的稳定期,治疗前（基础期）记录好作频率,用药情况。体重等作为自身对照。TPM自25mg/d开始,逐渐加量,目标剂量为200mg/d,治疗及治疗结束各查基础AEDs血药浓度进行比较,治疗结束行全面疗效分析。结果：TPM加用治疗20周后,与基础期发作频率比较,64．29％患者发作频率降低≥50％;25．00％,患者发生频率降低≥75％＜100％;16．07％完全不发。不良反应轻至中度,但与合AEDs的多少有关。50％患者体重可有不同程度的下降。TPM对止痛民西平及丙戊酸钠血药浓度影响不大。结论：TMP是治疗难治性部分性伴或不伴继发GTCS的表效的药物。     

单用妥泰治疗儿童癫痫近期疗效初探

目的:观察单用妥泰治疗儿童癫痫的有效性和安全性。方法:对18例临床确诊的癫痫患儿单独应用妥泰治疗,并追踪观察4个月,治疗起始剂量是0.5mg/kg/d,每周增量0.5mg/kg/d ,目标剂量为4mg/kg/d,增量期8周,然后维持用药。治疗前及治疗过程中详细记录发作次数,发作表现形式,不良反应等,4个月后进行疗效评价。结果:根据2月平均月发作频率与用药前月平均发作频率比较,总有效率为74％,有效剂量为2.0～3.5mg/kg/d,未发现严重的不良反应。结论:单用妥泰治疗儿童癫痫是有效的和较安全的。     

妥泰添加及药物转换治疗儿童癫痫94例疗效观察

目的　观察妥泰 ( TPM)添加治疗儿童癫痫的疗效及癫痫发作完全控制后转换为 TPM单药治疗的可行性。方法　对 94例应用一线抗癫痫药控制不满意的患儿 ,其中部分性发作 ( PS) 5 2例 ,全身性发作 ( GS) 4 2例 ,在原用抗癫痫药 ( AEDs)的基础上加用 TPM 0 .5～ 1.0 mg/ kg.d,日 2次 ,口服 ,每 5～ 7d加量一次 ,直至达到目标剂量。治疗 12周后根据发作频率将疗效分为完全控制、显效、有效和无效。对发作完全控制后的癫痫患儿 8～ 12周后 ,逐渐减去其它抗癫痫药 ,转换为 TPM单药治疗。结果　 5 2例 PS患儿应用 TPM治疗后得到完全控制 2 9例 ,显效 10例 ,有效 6例 ,无效 7例 ,总有效率为 86 .5 %;42例 GS患儿治疗后完全控制 16例 ,显效 9例 ,有效 8例 ,无效9例 ,总有效率为 78.6 %;在完全控制发作的 2 9例 PS中 ,及 GS的 16例中 ,转换为单用 TPM治疗达 2个月以上尚未见发作的分别为 7例、4例。94例加用 TPM后 2 9例出现的不良反应 ,占 30 .9%,其中以食欲减退多见 ,其次为困倦及体重下降等 ,在加量期过后大多消失 ,治疗前后血、尿常规、肝、肾功能未发现有临床意义的改变。结论　 TPM是一种广谱、高效、安全的 AEDs,适用于小儿各型癫痫的联合和单药治疗。     

妥泰治疗难治性癫痫的临床疗效观察

目的：观察妥泰（TPM）单药对难治性癫痫（RE）的临床疗效和安全性。方法：RE41例,添加TPM治疗后逐渐撤去原服用的抗癫痫药物,而用TPM单药治疗。以添加TPM前12周平均每4周发作频率为基线,与评价前12周平均每4周发作频率进行个体自身比较。按常规计算完全控制率和有效率。并进行临床观察和实验室检查。结果：完全控制率34．1％,有效率65．9％。不良反应25例次, 但绝大部分轻微,可自行消失。结论：TPM对RE疗效显著,安全性好。     

妥泰治疗儿童癫痫60例临床疗效观察

目的 观察妥泰单药或添加治疗儿童癫痫，方法 观察部分性发作及继发性全身性发作15例。West综合征18例。Lennox-Gastaut综合征27例，对其中已应用传统抗癫痫药物治疗控制不理想的病例添加妥泰治疗，而对新诊断病 列应用妥泰单一治疗，进行自身对照研究。结果 （1）妥泰治疗儿童癫痫60例，平均疗程6个月。其总的疗效为发作减少≥50%者13例（72.2%)。发作13例（86.7%)。发作减少≥75%者9例（60.0%)，未发作8例（53.3%);West综合征组18例，发作减少≥50%者13例（72.2%)。发作减少≥75%者9例（50.0%)。未发作6例（33.3%);Lennox-Gastaut综合征组27例，发作减少≥50%者17例（63.0%)。发作减少≥75%者14例（51.9%)。未发作者10例（37.0%)；（3）添加妥泰治疗对丙戊酸钠和卡马西平的添加治疗前后的血浓度没有明显影响。（4）不良反应；嗜睡12例（20.0%)。反应淡漠4例（6.7%)。纳差15例（25.0%)。结论 妥泰对部分性发作及继发性全身发作，West综合征和Lennox-Gastaut综合征治疗有效。安全，副作用轻。     

妥泰治疗癫痫50例临床疗效分析

目的研究妥泰单药治疗各类癫痫后的疗效。方法分析50例为我院2005-01以来治疗的各类癫痫病人的疗效。结果发作完全控制22例（56.8%）,发作减少≥75%8例（20.0%）,发作减少≥50例（22.7%）,总有效率为88.0%。无效10例（13.6%）。结论妥泰单药治疗癫痫疗效确切,完全控制率较高,疗程延长,治疗效果同步增加。     

妥泰治疗小儿癫痫的疗效观察

目的　探讨妥泰治疗小儿癫痫的疗效及其副作用。方法　对 78例不同发作类型的小儿癫痫患者给予妥泰添加或单药治疗 ,起始剂量为 0 5～ 1 0mg/ (kg·d) ,分 2次口服 ,每周增加 0 5～ 1 0mg/ (kg·d) ,经过 8周加量期 ,直达目标剂量 4～ 8mg/ (kg·d)或 2 0 0mg/d。结果　总有效率达 79.49% ,其中控制 34例(43 59% )。副作用多表现为一过性的嗜睡、厌食、多食、腹痛及乏力等。结论　妥泰是一新型有效广谱的抗癫痫药 ,对各种类型小儿癫痫均有效。起始量小、单一用药、缓慢加量 ,是防止不良反应发生的有效方法之一     

妥泰治疗癫痫92例临床观察

目的 观察妥泰对各型癫痫的疗效及不良反应。方法 采用开放性试验方法对门诊或住院的92例癫痫患予妥泰加用或单药治疗，随访其疗效及副作用。完成初始研究后再作追踪随访1年。结果 妥泰单药和加用治疗总有效率分别为82．1％，78．1％。比较对不同类型的疗效：全身性发作优于部分性发作，而单纯部分性优于复杂部分性发作。副作用发生率：单药治疗组少见，加用治疗组为18．3％。长期随访未发现耐药和反跳现象。结论 妥泰对临床各型癫痫均有较好疗效，不良反应轻，值得临床推广应用。     

A double-blind, placebo-controlled study of topiramate in adult patients with refractory partial epilepsy

PURPOSE: The efficacy and safety of topiramate (TPM) as adjunctive therapy in the treatment of adult Chinese patients with refractory partial epilepsy were investigated in a randomized, double-blind, placebo-controlled study. METHODS: A total of 46 patients who had four or more complex partial seizures with or without secondary generalization within an 8-week baseline phase were enrolled. Patients were assigned randomly to receive TPM (n = 23) or placebo (n = 23). TPM or placebo was titrated to target doses of 300 mg/d for 6 weeks and maintained at stabilized levels for another 8 weeks. Concomitant antiepileptic drugs remained at constant previous levels during the trial. RESULTS: In all, 41 patients completed the trial (TPM group, n = 20; placebo group, n = 21). The proportion of patients with a > or =50% reduction from baseline in complex partial seizures was 11 of 23 (47.8%) in the TPM group and 3 of 23 (13.0%) in the placebo group (p = 0.01). In addition, patients treated with TPM had significantly better investigator (p = 0.014) and patient (p = 0.0005) global assessment scores than patients in the placebo group. Adverse events were mostly mild and transient, with no significant differences between treatment groups. Two patients with TPM therapy complained of weight loss. Routine blood cell counts and other laboratory results showed no significant changes from baseline in either treatment group. CONCLUSIONS: TPM 300 mg/d is effective and well tolerated as treatment for refractory partial epilepsy in adults.     

托吡酯治疗癫癎的长期疗效观察

目的观察托吡酯治疗不同类型癫癎的长期疗效及安全性.方法采用开放性试验的方法,给予115例不同类型癫癎患者托吡酯单药或添加治疗,6个月后进行疗效评定,1年和2年时计算控制率和托吡酯保留率,记录不良反应.结果 (1) 6个月时总有效率单药治疗组为83.9%,添加治疗组为66.1%,对各型癫癎均有一定疗效,各组间发作控制率和总有效率比较差异无显著性;(2)稳定期儿童组有效剂量为(105.72±48.28) mg/d,成人组为(176.36±62.81) mg/d;(3)控制率1年为40.0%,2年为28.7%;保留率1年为67.8%,2年为46.1%;(4)34例(29.6%)出现不良反应,为轻、中度的中枢神经系统症状以及厌食和体质量减轻.结论托吡酯是较好的广谱抗癫癎药物,长期应用仍有较好的疗效和安全性.     

Seizure worsening with Topiramate amongst Indians with refractory epilepsy

In a prospective open label add-on study on 95 patients (age 1-63 years, mean 17.76 +/- 13.83 years) with seizures refractory to conventional antiepileptic drugs (AEDs) and other new AEDs, the addition of Topiramate (TPM) resulted in seizure worsening in 18 patients (19%) necessitating drug withdrawal over an average follow-up period of 4.94 +/- 1.69 months. Patients who had seizure worsening were older (P = 0.02), were more likely to have had a history of status epilepticus in the past (P = 0.03), were on three conventional AEDs (P = 0.027) or had tried one of the other new AEDs in the past with poor response (P = 0.04). Seven of 18 patients who had seizure worsening with TPM (7.4%) experienced initial seizure worsening, probably representing the subgroup with 'true' seizure worsening whilst 11 (11.6%) had initial improvement followed by 'apparent' seizure worsening. Initial seizure worsening was noted to be significantly more in females when compared with males who worsened after initial improvement (P = 0.05).     

Topiramate or valproate in patients with juvenile myoclonic epilepsy: a randomized open-label comparison

Few randomized, controlled trials evaluating antiepileptic drug (AED) efficacy and tolerability have focused solely on patients with juvenile myoclonic epilepsy (JME). We conducted a pilot, randomized controlled trial comparing topiramate (N=19) and valproate (N=9) in adolescents/adults with JME to evaluate clinical response when these broad-spectrum agents are titrated to optimal effect. Rating scales were used to systematically assess tolerability. Among patients completing 26 weeks of treatment, 8 of 12 (67%) in the topiramate group and 4 of 7 (57%) in the valproate group were seizure-free during the 12-week maintenance period. Median daily dose was 250mg topiramate or 750mg valproate. Two (11%) topiramate-treated patients and one (11%) valproate-treated patient discontinued due to adverse events. Systemic toxicity scores, but not neurotoxicity scores, differed substantially between the two groups; greater systemic toxicity was associated with valproate. Our preliminary findings that topiramate may be an effective, well-tolerated alternative to valproate warrant validation in a double-blind trial.     

托吡酯单用及添加治疗癫痫302例临床分析

目的　观察托吡酯添加和单药治疗癫痫的临床疗效及不良反应 ,并探讨单药治疗的理想给药模式。方法　入组患者分为 3组 ,A组 10 2例采用托吡酯添加治疗 ,B组 2 0 0例采用托吡酯单药治疗 ,按初始剂量及加量速度不同 B组又分为 B1组、B2组。B1组 10 5例 ,妥泰初始剂量 2 5 mg/ d,增量 2 5 m g/ w至 2 0 0 m g/ d;B2组 95例 ,妥泰初始剂量 5 0 mg/ d,增量 5 0 m g/ w至 2 0 0 m g/ d。维持治疗 12周。记录发作情况及不良反应。结果　 A组总有效率及控制率分别为 6 0 .8%、2 4 .5 % ,B组总有效率及控制率为 76 .8%、4 1.5 % ,两组疗效差异有显著性意义 (P<0 .0 5 )。 B1组总有效率及控制率分别为 77.9%、4 1.9% ,B2组总有效率及控制率分别为 75 .8%、4 0 .0 % ,两组疗效差异无显著性意义 (P>0 .0 5 )。托吡酯对各型部分性发作及强直 -阵挛性发作的疗效差异无显著性意义 (P>0 .0 5 )。B2组不良反应高于 B1组 ,差异有显著性意义 (P<0 .0 5 )。结论　托吡酯添加及单药治疗癫痫具有良好的疗效 ,对发作频率较低的患者宜选用小剂量起始缓慢加量的治疗方法 ,对发作频率较高的患者可考虑予较大起始剂量并以较快速度加量以尽快控制发作     

Topiramate Monotherapy for Partial Onset Seizures

Summary: Purpose: Evaluation of topiramate (TPM) as monotherapy in patients with uncontrolled partial onset seizures.
Methods: A total of 48 patients were evaluated in a doubleblind, parallel-group trial. During a 56-day baseline period, patients had at least eight partial onset seizures while being treated with one or two standard antiepileptic drugs (AEDs). After 1–2 weeks of open-label treatment with TPM 100 mg/day, patients were randomly assigned, in equal proportions, to receive double-blind therapy with TPM 100 or 1,000 mg/day in a 5-week conversion and an 11-week monotherapy period. The study endpoint was completion of 112 study days (success) or fulfillment of one or more exit criteria: doubling of average 28- day or highest 2-day baseline seizure rate, a generalized tonic-clonic seizure (GTCS) if none had occurred at baseline, or significant prolongation of generalized seizure duration.
Results: Time until exit was longer (p = 0.002) and success frequency was higher (p = 0.005) with TPM 1,000 as compared with 100 mg/day. Seizure-rate reductions of 50, 75, or 100% were achieved by 46, 25, and 13% of the 1,000-mg/day group, respectively, as compared with 13, 8, and 0% of the 100-mg/day group, respectively. Most adverse events (AE) were mild or moderate in severity.
Conclusions: Monotherapy with TPM 1,000 mg/day for partial onset seizures with or without secondarily generalized seizures was effective, with a favorable safety profile.     

托吡酯长期治疗对成年癫疒间患者血清甲状腺激素水平的影响

目的 探讨托吡酯(TPM)长期治疗对成年癫疒间患者血清甲状腺激素水平的影响.方法 用化学发光分析法测定成年癫疒间组患者(32例)TPM治疗前、后的血清甲状腺激素水平,并与健康对照组(40人)进行比较. 结果治疗前成年癫疒间组患者甲状腺激素水平与健康对照组比较无统计学意义(均P>0.05);TPM治疗后3个月、6个月、12个月及24个月的甲状腺激素水平与治疗前及健康对照组比较差异亦无统计学意义(均P>0.05).结论 TPM短期与长期治疗对成年癫疒间患者的甲状腺激素水平没有影响.