论文部分内容阅读
目的观察左乙拉西坦(LEV)单药治疗脑性瘫痪(脑瘫)并癫婴幼儿的疗效和不良反应。方法将78例新诊断癫婴幼儿根据Gesell发育量表和临床诊断分为脑瘫组(n=37)和发育正常组(n=41)。应用LEV进行治疗,采用开放、前瞻、短期(8周)的临床试验研究。2组患儿均给予LEV,从10 mg.kg-1.d-1开始,分2次口服,每7 d加量1次,每次加量10 mg.kg-1.d-1,直至达到发作控制或目标剂量50 mg.kg-1.d-1,加量期为4周。以治疗前4周的发作次数为基础,与加量结束后的发作次数进行比较以判断疗效,并观察治疗过程中的不良反应。结果脑瘫组37例患儿均完成为期8周的临床观察,发育正常组41例中8例退出研究。脑瘫组19例完全控制,显效7例,有效6例,无效5例,总有效率86.5%,完全控制率51.4%;发育正常组33例完全控制17例,显效6例,有效5例,无效5例,总有效率84.8%,完全控制率51.5%。二组总有效率、完全控制率比较均无统计学差异(Pa>0.05)。78例中发生不良反应者26例(占33.3%)。发育正常组发生烦躁及行为改变11例,食欲减退、睡眠增多各2例,呕吐1例,其中4例因烦躁及行为改变退出观察;脑瘫组出现呕吐4例,食欲减退3例,睡眠增多2例,一过性皮疹1例,未见烦躁等不良反应。不良反应均于加量期出现,加量期后减轻或消失。未见体质量、血常规、尿常规及肝、肾功能改变。结论 LEV对合并癫的脑瘫婴幼儿疗效较好,且无严重不良反应,适合在合并癫的脑瘫患儿中应用。
Objective To observe the efficacy and adverse reactions of levetiracetam (LEV) monotherapy in the treatment of cerebral palsy (cerebral palsy) and epileptic infants. Methods 78 cases of newly diagnosed epilepsy infants were divided into cerebral palsy group (n = 37) and normal development group (n = 41) according to Gesell scale and clinical diagnosis. The use of LEV for treatment, using open, prospective, short-term (8 weeks) clinical trial. Two groups of children were given LEV, starting from 10 mg.kg-1.d-1, 2 times orally, every 7 d dose 1, each dose of 10 mg.kg-1.d-1, until To seizure control or target dose of 50 mg.kg-1.d-1, the amount of 4 weeks. Based on the number of seizures in the first 4 weeks of treatment, the number of seizures was compared with the number of seizures to determine the efficacy and to observe the adverse reactions during the treatment. Results 37 cases of children with cerebral palsy group were completed for a period of 8 weeks of clinical observation, development of normal group of 41 patients in 8 out of the study. In the cerebral palsy group, 19 cases were completely controlled, 7 cases were markedly effective, 6 cases were effective and 5 cases were ineffective. The total effective rate was 86.5% and complete control rate was 51.4%. 33 cases of normal control group had 17 cases completely controlled, 6 cases markedly effective, 5 effective and 5 ineffective In 5 cases, the total effective rate was 84.8% and the complete control rate was 51.5%. There was no significant difference between the two groups in total effective rate and complete control rate (Pa> 0.05). Among 78 cases, 26 cases (33.3%) had adverse reactions. There were 11 cases of dysphoric and behavioral changes in the normal control group, 2 cases of anorexia and 2 cases of sleep increase, 1 case of vomiting, 4 cases of which were retreated due to irritability and behavioral changes. 4 cases of vomiting, 3 cases of loss of appetite and 2 cases of sleep increase For example, a transient rash in 1 case, no irritability and other adverse reactions. Adverse reactions were added in the period, after the amount of reduced or disappeared. No body weight, blood, urine and liver and kidney function changes. Conclusion LEV is effective in infants with cerebral palsy complicated by epilepsy and has no serious side effects. It is suitable for children with cerebral palsy complicated by epilepsy.