A follow-up study on newer anti-epileptic drugs as add-on and monotherapy for partial epilepsy in China

Background  Recently, new anti-epileptic drugs (AEDs) have been more frequently selected to treat epilepsy. In the present study, we evaluated the dynamic changes of efficacy and safety of three newer AEDs for treating partial epilepsy in China.

Methods  Patients were collected sequentially and were divided into three groups which accepted oxcarbazepine (OXC), lamotrigine (LTG) or topiramate (TPM) therapy. Each group included monotherapy and add-on therapy subgroups. We followed all patients for one year and recorded the indexes of efficacy and safety in detail.

Results  A total of 909 patients finished the follow-up observation. No significant difference was found in proportion of patients with > or =50% reduction, > or =75% reduction and 100% seizure reduction in the LTG and OXC groups between the first and the second six months. In the TPM group there was a statistical difference between the first and the second six months in proportion of patients with > or =50% reduction (P=0.002), > or =75% reduction (P <0.0001) and 100% seizure reduction (P=0.009) in the monotherapy subgroup, and about > or = 75% reduction and 100% seizure reduction in the add-on therapy subgroup (P <0.0001). The efficacy between the add-on and monotherapy subgroups showed a statistical difference. The safety of the three newer AEDs was good.

Conclusions  The three newer AEDs all showed good efficacy and tolerability for partial epilepsy. And the efficacy can be maintained for at least one year.

     

常用抗癫(癎)药物对大鼠认知功能的影响

目的研究常用抗癫癎药物(AEDs)对大鼠认知功能的影响。方法选用健康雄性青春期SD大鼠70只,随机均分为7组。随机选取1组作为正常对照组(NS组),其余6组用戊四氮(PTZ)点燃,致癎后随机选取1组作为癫癎对照组(PTZ组),其余5组分别给予卡马西平(CBZ组)、苯妥英钠(PHT组)、丙戊酸钠(VPA组)、妥泰(TPM组)及拉莫三嗪(LTG组)以控制癫癎发作。治疗2周后采用Morris水迷宫进行认知功能测试。统计学处理采用方差分析。结果TPM组大鼠完成每次测试所用时间大多长于其他6组。TPM组每天测试所用时间均明显长于PTZ、CBZ、VPA和LTG组(P值均<0.05)。将各组之间完成6次测试总时间进行两两比较,TPM组明显长于其他6组(P值均<0.01),PHT组明显长于其余5组(P值分别<0.05、0.01);LTG组明显短于其他6组(P值分别<0.05、0.01)。将各组之间完成4 d测试总时间进行两两比较,TPM组均明显长于CBZ、VPA、PTZ和LTG组(P值分别<0.05、0.01)。TPM组大鼠定向寻找平台象限的时间明显长于其他6组(P值均<0.01)。TPM组定向逗留平台象限的时间明显短于CBZ和LTG组(P值分别<0.05、0.01)。结论TPM和PHT损害大鼠的认知功能,VPA、CBZ和LTG对大鼠的认知功能有一定改善作用。     

奥卡西平治疗儿童癫痫导致脑电图恶化1例报告并文献分析(英文)

目的伴有中央颞区尖波的儿童良性癫痫(benign epilepsy of childhood with centro-temporal spikes,BECT)是儿童中常见的部分性癫痫,卡马西平、奥卡西平、丙戊酸钠等药物治疗有效。文中观察奥卡西平对伴有中央颞区尖波的儿童良性癫痫的治疗效果。方法回顾性报道1例神经系统影像学检查未发现异常的6岁部分性癫痫患儿。结果最初以奥卡西平治疗,其原有的癫痫症状很快被控制,但脑电图随访过程中发现该例新诊断为部分性癫痫患者在奥卡西平单药治疗过程中脑电图恶化。随后,奥卡西平逐渐减量,并换用丙戊酸钠。当丙戊酸钠加至0.5g/d,该患者无癫痫发作且常规脑电图正常。结论虽然奥卡西平被认为是比卡马西平和苯妥英更易耐受的治疗部分性癫痫的一线药物,但应认识到它可能诱发新的癫痫发作形式和加重脑电图的异常。     

奥卡西平与卡马西平治疗部分性癫痫的对照研究

目的比较奥卡西平（oxcarbazepine,OXC）及卡马西平（camamazepjne,CBZ）单药治疗成人部分性癫痫的有效性和耐受性。方法将80例部分性癫痫患者（〉16岁）分为OXC组（38例）、CBZ组（42例）,分别给予OXC或CBZ单药治疗,对两组患者进行为期1年的临床对比观察。结果两组患者治疗后的保留率及治疗后3、6、12个月发作完全控制、显效、无效、恶化率的差异均无统计学意义（均P〉0．05）。OXC组总不良反应发生率（237％）明显低于CBZ组（4512％）,差异有统计学意义（P〈0．05）;治疗后3个月两组患者不良反应发生率的差异无统计学意义（P〉O．05）,治疗后6、12个月OXC组的不良反应发生率低于CBZ组,差异有统计学意义（均P〈O05）。结论OXC单药治疗部分‘性癫痫的有效性与CBZ相当。OXC的不良反应发生率低于CBZ,且OXC的不良反应易发生于用药初期。     

卡马西平、托吡酯与丙戊酸钠治疗102例脑炎继发癫痫疗效分析

目的分析卡马西平(CBZ)、托吡酯(TPM)与丙戊酸钠缓释片(VPA)对脑炎继发癫痫(SEVE)的疗效及不良反应。方法回顾性分析1998~2008年102例脑炎继发癫痫患者病历资料,根据不同的癫痫发作类型、患者年龄和性别,分组评价CBZ、TPM和VPA治疗12个月后的疗效,并分析药物不良反应。结果 3种抗癫痫药的总有效率及完全控制率差异无统计学意义;CBZ对部分性发作的控制率为62.50%及总有效率为100.00%明显高于部分性继发全面强直阵挛发作的40.00%及64.00%,VPA和TPM对各型发作的疗效差异无统计学意义;3种药物对不同性别、不同年龄组的疗效差异无统计学意义。结论在单药治疗时,CBZ对部分性发作的疗效良好,TPM、VPA适用于脑炎继发癫痫的各型发作,且TPM不良反应更少。     

Intracytoplasmic Sperm Injection Fertilization Rate Does Not Depend on the Proportion of Round-headed Sperm,Small-acrosomal Sperm,or Morphologically Normal Sperm in Patients with Partial Globozoospermia

Background:

Generally, intracytoplasmic sperm injection (ICSI) may be the preferable method to treat partial globozoospermia, but whether there exist some correlations between ICSI fertilization rate and the proportion of round-headed sperm or morphologically normal sperm remains open. This study was to explore the correlation between ICSI fertilization rate and the sperm morphology in patients with partial globozoospermia.

Methods:

Thirty-four patients diagnosed with partial globozoospermia accepted the following assisted fertilization treatments – 2 cases accepted in-vitro fertilization (IVF) alone, 26 cases accepted ICSI alone, and 6 accepted split IVF/ICSI. Detailed morphological characteristics were described using Diff-Quik rapid staining. Sixty cases accepting IVF or ICSI treatment in our reproductive center were considered as the control group after being matched by relevant criteria. Fertilization rate, embryo quality, embryo implantation rate and clinical pregnancy rate were calculated.

Results:

Besides very high proportion of round-headed sperm, partial globozoospermia also showed very high proportion of small-acrosomal sperm and very low proportion of morphologically normal sperm. Fertilization rate of IVF (IVF alone plus split IVF) was very low in partial globozoospermia (25.4% ± 17.4%), but ICSI (ICSI alone plus split ICSI) achieved satisfying fertilization rate compared with the control group (66.2% ± 22.5% vs. 68.8% ± 29.4%, P > 0.05). In patients with partial globozoospermia, there were no correlations between ICSI fertilization rate and the proportion of round-headed sperm, small-acrosomal sperm, or morphologically normal sperm.

Conclusions:

There was high proportion of small-acrosomal sperm in partial globozoospermia. For patients with partial globozoospermia, ICSI is more preferable than IVF. ICSI fertilization rate does not depend on the proportion of round-headed sperm, small-acrosomal sperm, or morphologically normal sperm.     

奥卡西平与左乙拉西坦治疗新诊断部分性发作癫痫患儿的疗效分析

目的观察奥卡西平与左乙拉西坦对新诊断部分性发作癫痫患儿的疗效和安全性。方法将80例新诊断部分性发作癫痫患儿随机分为2组,奥卡西平组和左乙拉西坦组各40例。奥卡西平组给予奥卡西平,开始剂量10 mg·kg-1·d-1,分2次服用,以后每周增加1次剂量,每次加量5 mg·kg-1·d-1,至最小有效量,最大剂量60 mg·kg-1·d-1,左乙拉西坦组给予左乙拉西坦,开始剂量5 mg·kg-1·d-1,分2次服用,以后每周增加1次剂量,每次加量5 mg·kg-1·d-1,至最小有效量,最大剂量60 mg·kg-1·d-1,2组均观察6～12个月。观察2组的疗效及不良反应。结果奥卡西平组实际完成治疗39例,因皮疹退出1例,癫痫发作完全控制26例,出现不良反应8例,其中头晕2例,嗜睡1例,认知功能减退5例;左乙拉西坦组实际完成治疗38例,因经济原因退出2例,癫痫发作完全控制28例,出现脾气暴躁不良反应2例。结论奥卡西平与左乙拉西坦治疗儿童部分性发作均有效,但左乙拉西坦更安全,对认知功能无明显影响,缺点是价格偏高。     

The efficacy and tolerability of lamotrigine adjunctive/ monotherapy in patients with partial seizures refractory to poly-AEDs

Objective: This study was designed as an open-label trial to assess the effects of changing the antiepileptic drugs (AEDs) regi-men to lamotrigine (LTG) as adjunctive/monotherapy in patients with partial seizures who were dissatisfied with their drug regimen because of intractable seizures. Methods: The patients were recruited from multicenters using the following criteria: age≥18 years; at least 3 seizures per month during the last 16 weeks; previous use of at least 3 AEDs. The study involved a baseline phase and 2 experimental phases: LTG was first added to the regimen, and then patients could gradually change to LTG monotherapy if their seizures were reduced by at least 50 percent/month. Tolerability, the primary end point, was assessed using the Liverpool Adverse Experience Profile (LAEP). Secondary end points included quality of life, as measured with the Quality of Life in Epilepsy-31 inven-tory. Reductions in seizures from baseline throughout each phase were also analyzed. Results: One hundred and fourteen patients aged between 18 and 52 years (age 27.8±13.2 years; 71 men and 43 women) were enrolled. After adding LTG, 105 patients (92.11%) completed adjunctive therapy. Upon completion of the adjunctive phase, mean improvement from baseline was 2.6 points on the LAEP (p=0.037). The overall score on the QOLIE-31 improved by 8.49 points from baseline (p=0.023). At the end of the trial, 26 (22.81%) of patients completed LTG monotherapy, and 65 patients (57.02%) experienced at least 50% reduction in seizure frequency compared to baseline, The mean improvement from baseline was 5.1 points on the LAEP (p=0.0059), and the overall score on the QOLIE-31 score improved by 12.72 points from baseline(p=0.0071). Twenty-two (19.30%) patients reported adverse effects and 9 patients discontinued participation in the trial because of adverse effects. Conclusion: For patients with partial seizures who were dissatisfied with their AED regimen because of intractable seizures, adding LTG to the drug regimen was well tolerated and effective in improving the quality of life and controlling seizures. Furthermore, switching to LTG monotherapy was associated with further improvement.     

卡马西平、丙戊酸钠、拉莫三嗪单药对新诊断部分癫痫患者额叶相关认知功能的影响

目的研究卡马西平（CBZ）、丙戊酸钠（VAP）、拉莫三嗪（LTG）对新诊断成人部分发作癫痫患者额叶相关认知功能的影响。方法采用前瞻和随机对照研究，对48例新诊断为部分发作伴或不伴全面发作的癫痫患者进行6项神经心理学测验后，随机给予CBZ、VAP、LTG单药治疗，1月后复查神经心理学检查。结果与治疗前比较CBZ组B型连线测验错误数增加（P〈0．05），汉罗塔（TowerofHanoi）平均计划时间缩短（P〈0．05）；VAP组Stroop读字正确数增加（P〈0．01），威斯康星卡片分类测验，（WSCT）错误数下降（P〈0．05）、非持续错误数下降（P〈0．01）qLTG组倒背数下降（P〈0．01）。治疗后组间比较，有6项神经心理学指标差异有显著性，分别是顺背数（P〈0．05）、词汇总数（P〈0．01）、Stroop读字时间（P〈0．01）、Stroop读字错误数（P〈0．01）、Stroop读色纠正数（P〈0．05）以及汉罗塔平均计划时间（P〈0．01）。结论抗癫痫药物的化学结构和作用机制不同，所以对认知功能的影响也不同；LTG对癫痫患者长期认知功能的影响是有利的。     

拉莫三嗪联合丙戊酸治疗各种类型癫痫患者的临床效果评价

目的探究拉莫三嗪(LTG)联合丙戊酸(VPA)治疗各种类型癫痫患者的临床效果。方法选取2018年5月至2019年10月在本院就诊的400例癫痫患者作为研究对象,分为全身性发作型患者100例、单纯性部分发作型患者100例、部分发作继发全身强直痉挛发作型患者100例、复杂性部分发作型患者100例,所有患者均给予LTG联合VPA治疗,比较不同类型癫痫的治疗效果、不良反应发生率及血清炎症因子水平。结果各类型癫痫患者治疗总有效率比较差异无统计学意义。4种类型癫痫患者不良反应发生率比较差异无统计学意义。治疗前后,4种类型癫痫患者IL-2、IL-6、TNF-α水平比较差异无统计学意义。结论 LTG联合VPA治疗不同类型癫痫患者效果显著,不良反应发生率较低,且能明显提高患者机体免疫力。     

托吡酯治疗成年癫痫患者的疗效和安全性

目的:观察及评价托吡酯单药治疗成年癫痫患者的疗效和安全性.方法:98例临床新确诊的成年癫痫患者被随机分为2组:一组予以传统抗癫痫药物(卡马西平或丙戊酸钠等)单药系统治疗(AEDs组),另一组予以托吡酯单药治疗(TPM组),即予以托吡酯初始剂量为50mg/d,每3d增加25mg至目标剂量200mg/d.2个月后比较两组的癫痫发作频率和不良反应.结果:TPM组发作次数明显减少,总有效率为79%,完全控制率为33%,不良反应的发生率较低,且症状较轻,患者耐受性良好;AEDs组的总有效率为74%,完全控制率为30%,其不良反应的发生率较高,症状多为中度,需给予对症处理或停药.结论:托吡酯能明显控制癫痫发作,且不良反应轻微,是一种广谱、有效且安全的新型一线抗癫痫药物.     

托吡酯与左乙拉西坦用于小儿癫痫添加治疗的临床疗效研究

目的:探索添加托吡酯和左乙拉西坦治疗癫痫患儿的临床疗效、安全性及其认知功能的影响。方法:46例癫痫患儿在原用药方案基础上随机分为两组,分别添加左乙拉西坦(LEV组,n=23)和托吡酯(TPM组,n=23)治疗16周,观察治疗后1个月和6个月的临床疗效及相关不良反应,评估添加治疗后患儿认知功能情况。结果:LEV组与TPM组患儿治疗后1个月总有效率分别为73.9%和82.6%,治疗后6个月时总体有效率分别为52.2%和39.1%,差异无统计学意义(P>0.05)。两组患儿治疗后1个月言语智商、操作智商及总智商差异无统计学意义(P>0.05);治疗后6个月LEV组操作智商优于TPM组(P<0.05)。结论:托吡酯和左乙拉西坦添加治疗癫痫患儿总有效率类似,但左乙拉西坦治疗后患儿认知功能优于托吡酯。     

抗癫痫药对大鼠认知及海马GluR2和Syn表达的影响

目的 探讨抗癫痫药丙戊酸钠（VPA）、奥卡西平（OXC）、左乙拉西坦（LEV）对大鼠认知、海马谷氨酸受体2（GluR2）和突触体素（Syn）表达的影响。方法 随机将60只Wistar大鼠分为正常对照组（CON组）、VPA组、LEV组、OXC组、LEV+VPA组、LEV+OXC组,每组10只,灌胃给药,90d后行Moriss水迷宫和穿梭箱实验测试,比较各组大鼠的空间和条件性学习记忆能力,采用免疫组化技术检测海马GluR2和Syn的表达。结果 与对照组比较,VPA组水迷宫测试逃避潜伏期、正确率、运行时间及穿梭箱实验主动回避次数、主动回避潜伏期、被动回避潜伏期差异均有统计学意义(P均＜0.05）,免疫组化检测显示,VPA组GluR2和Syn的表达及LEV+VPA组的GluR2表达显著下降（P均＜0.05）。结论 LEV、OXC、LEV+OXC、LEV+VPA不影响认知功能,VPA影响认知功能可能与其使GluR2和Syn的表达下降有关。     

Decrease of Glomerular Filtration Rate may be Attributed to the Microcirculation Damage in Renal Artery Stenosis

Background:

The decrease of glomerular filtration rate has been theoretically supposed to be the result of low perfusion in renal artery stenosis (RAS). But the gap between artery stenosis and the glomerular filtration ability is still unclear.

Methods:

Patients with selective renal artery angiogram were divided by the degree of renal artery narrowing, level of estimated glomerular filtration rate (eGFR), respectively. The different levels of eGFR, renal microcirculation markers, and RAS severity were compared with each other, to determine the relationships among them.

Results:

A total of 215 consecutive patients were enrolled in the prospective cohort study. Concentrations of microcirculation markers had no significant difference between RAS group (RAS ≥ 50%) and no RAS group (RAS < 50%) or did not change correspondingly to RAS severity. The value of eGFR in RAS group was lower than that in the no RAS group, but it did not decline parallel to the progressive severity of RAS. The microcirculation markers presented integral difference if grouped by different eGFR level with negative tendency, especially that plasma cystatin C (cysC) and urinary microalbumin to creatinine ratio (mACR) increased with the deterioration of eGFR, with strong (r = −0.713, P < 0.001) and moderate (r = −0.580, P < 0.001) correlations. In the subgroup analysis of severe RAS (RAS ≥ 80%), the levels of plasma cysC and urinary mACR demonstrated stronger negative associations with eGFR, (r = −0.827, P < 0.001) and (r = −0.672, P < 0.001) correlations, respectively.

Conclusions:

Severity of RAS could not accurately predict the value of eGFR, whereas microcirculation impairment may substantially contribute to the glomerular filtration loss in patients with RAS.     

儿童癫痫54例临床特点及治疗体会

目的：探讨小儿癫痫的临床特点及治疗。方法：对经临床及脑电图诊断为癫痫的54例患儿进行临床观察，并根据发作类型选药；采用丙戊酸钠(VPA)或卡马西平(CBZ)单药治疗，并监测药物浓度及随访脑电图(EEG)。结果：临床表现为全身性发作37例，局灶性发作17例。37例单用VPA治疗，6个月后发作获完全控制，VPA平均血药浓度89．2mg/L；17例单用CBZ治疗，6个月后获完全控制，CBZ平均血药浓度6．37mg/L。治疗前EEG异常52例，治疗后恢复34例。结论：小儿癫痫的发作形式多种多样，具有反复发作、暂时性的特点。丙戊酸钠或卡马西平单药治疗小儿癫痫具有良好的疗效，血药浓度监测对治疗有指导作用，脑电图不能作为判定疗效的唯一指标。     

Pregnancy Outcomes of In Vitro Fertilization with or without Ovarian Hyperstimulation Syndrome: A Retrospective Cohort Study in Chinese Patients

Background:

The effect of ovarian hyperstimulation syndrome (OHSS) on pregnancy outcomes of in vitro fertilization (IVF) patients is still ambiguous. This study aimed to analyze pregnancy outcomes of IVF with or without OHSS in Chinese patients.

Methods:

A retrospective cohort study was undertaken to compare pregnancy outcomes between 190 women with OHSS and 197 women without OHSS. We examined the rates of clinical pregnancy, multiple pregnancies, miscarriage, live birth, preterm delivery, preterm birth before 34 weeks’ gestation, cesarean delivery, low birth weight (LBW), and small-for-gestational age (SGA) between the two groups. Odds ratios (ORs) and 95% confidence intervals (CIs) of measure of clinical pregnancy were also analyzed.

Results:

The clinical pregnancy rate of OHSS patients was significantly higher than that of non-OHSS patients (91.8% vs. 43.5%, P < 0.001). After controlling for drug protocol and causes of infertility, the adjusted ORs of moderate OHSS and severe/critical OHSS for clinical pregnancy were 4.65 (95% CI, 1.86–11.61) and 5.83 (95% CI, 3.45–9.86), respectively. There were no significant differences in rates of multiple pregnancy (4.0% vs. 3.7%) and miscarriage (16.1% vs. 17.5%) between the two groups. With regard to ongoing clinical pregnancy, we also found no significant differences in the rates of live birth (82.1% vs. 78.8%), preterm delivery (20.9% vs. 17.5%), preterm birth before 34 weeks’ gestation (8.6% vs. 7.9%), cesarean delivery (84.9% vs. 66.3%), LBW (30.2% vs. 23.5%), and SGA (21.9% vs. 17.6%) between the two groups.

Conclusion:

OHSS, which occurs in the luteal phase or early pregnancy in IVF patients and represents abnormal transient hemodynamics, does not exert any obviously adverse effect on the subsequent pregnancy.     

Transjugular Intrahepatic Portosystemic Shunt Versus Surgical Shunting in the Management of Portal Hypertension

Background:

The purpose of this article was to clarify the optimal management concerning transjugular intrahepatic portosystemic shunts (TIPSs) and surgical shunting in treating portal hypertension.

Methods:

All databases, including CBM, CNKI, WFPD, Medline, EMBASE, PubMed and Cochrane up to February 2014, were searched for randomized controlled trials (RCTs) comparing TIPS with surgical shunting. Four RCTs, which were extracted by two independent investigators and were evaluated in postoperative complications, mortality, 2- and 5-year survival, hospital stay, operating time and hospitalization charges.

Results:

The morbidity in variceal rehemorrhage was significantly higher in TIPS than in surgical shunts (odds ratio [OR] = 7.45, 95% confidence interval[CI]: (3.93–14.15), P < 0.00001), the same outcomes were seen in shunt stenosis (OR = 20.01, 95% CI: (6.67–59.99), P < 0.000001) and in hepatic encephalopathy (OR = 2.50, 95% CI: (1.63–3.84), P < 0.0001). Significantly better 2-year survival (OR = 0.66; 95% CI: (0.44–0.98), P = 0.04) and 5-year survival (OR = 0.44; 95% CI: (0.30–0.66), P < 0.00001) were seen in patients undergoing surgical shunting compared with TIPS.

Conclusions:

Compared with TIPS, postoperative complications and survival after surgical shunting were superior for patients with portal hypertension. Application of surgical shunting was recommended for patients rather than TIPS.     

妥泰单药及添加治疗卒中后部分性发作癫痫46例临床分析

目的观察妥泰单药及添加治疗卒中后部分性发作癫痫的临床疗效及不良反应。方法46例患者随机分为2组,A组24例采用妥泰添加治疗,B组22例采用妥泰单药治疗。2组初始剂量均为25mg/d,每周增量25mg,最大剂量至200mg/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70.8%和20.8%,B组总有效率及控制率分别为81.8%和27.2%,2组疗效差异有显著性意义(P<0.05)。妥泰对卒中后各型部分性发作癫痫间的疗效差异无显著性意义(P>0.05)。2组主要不良反应均为体重减轻、嗜睡、恶心和找词困难。添加组不良反应多于单药组,2组比较差异有非常显著意义(P<0.01)。结论妥泰单药及添加治疗卒中后部分性发作癫痫具有良好的疗效,以前者为佳,不良反应为体重减轻、嗜睡、恶心和找词困难,添加组不良反应多于单药组。     

Vagus Nerve Stimulation for Pediatric and Adult Patients with Pharmaco-resistant Epilepsy

Background:

Over past two decades, vagus nerve stimulation (VNS) has been widely used and reported to alleviate seizure frequency worldwide, however, so far, only hundreds of patients with pharmaco-resistant epilepsy (PRE) have been treated with VNS in mainland China. The study aimed to evaluate the effectiveness of VNS for Chinese patients with PRE and compare its relationship with age cohort and gender.

Methods:

We retrospectively assessed the clinical outcome of 94 patients with PRE, who were treated with VNS at Beijing Fengtai Hospital and Beijing Tiantan Hospital between November 2008 and April 2014 from our database of 106 consecutive patients. The clinical data analysis was retrospectively examined.

Results:

Seizure frequency significantly decreased with VNS therapy after intermittent stimulation of the vagus nerve. At last follow-up, we found McHugh classifications of Class I in 33 patients (35.1%), Class II in 27 patients (28.7%), Class III in 20 patients (21.3%), Class IV in 3 patients (3.2%), and Class V in 11 patients (11.7%). Notably, 8 (8.5%) patients were seizure-free while ≥50% seizure frequency reduction occurred in as many as 60 patients (63.8%). Furthermore, with regard to the modified Engel classification, 12 patients (12.8%) were classified as Class I, 11 patients (11.7%) were classified as Class II, 37 patients (39.4%) were classified as Class III, 34 patients (36.2%) were classified as Class IV. We also found that the factors of gender or age are not associated with clinical outcome.

Conclusions:

This comparative study confirmed that VNS is a safe, well-tolerated, and effective treatment for Chinese PRE patients. VNS reduced the seizure frequency regardless of age or gender of studied patients.     

奥卡西平治疗儿童难治性癫痫的自身对照性研究

目的观察奥卡西平(OXC)治疗儿童难治性癫痫的长期疗效、耐受性和安全性。方法应用奥卡西平(OXC)治疗31例难治性癫痫患儿,起始剂量为4~5 mg/(kg.d-1),维持剂量为25~45 mg/kg.d-1,以治疗前3个月癫痫发作频度为对照,对治疗后12个月内的疗效、不良反应、耐受性及安全性进行自身对比观察。结果应用OXC后6个月、12个月后,患儿发作频率均较用药前明显减少,发作频率减少≥50%的患儿占45.2%(14/31),用药前后差异有统计学意义(P<0.05)。用药后6个月与12个月发作频率比较差异无统计学意义。不良反应的发生率为12.9%(4/31),因不良反应和经济原因退出观察者2例(5.88%)。常见的不良反应为乏力、头晕、头痛、恶心、纳差、皮疹。结论奥卡西平治疗儿童难治性癫痫疗效明显、稳定、不良反应轻、耐受性好、安全性高。在年龄小于5岁的患儿中应用OXC的安全性有待大样本研究。