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目的与阳性对照药物氟哌啶醇比较,评价利司培酮治疗儿童多发性抽动的疗效及其安全性。方法采用随机对照试验方法,将60例多发性抽动患儿分成利司培酮组(0.5～2.0 mg.d-1)和氟哌啶醇组(2.0～12.0 mg.d-1)。3 d清洗后,治疗第1-3天利司培酮和氟哌啶醇的剂量分别为0.5～1.0 mg.d-1和2.0～4.0 mg.d-1,第4天根据患者情况调整药物剂量,药物剂量范围利司培酮1.0～2.0 mg.d-1,氟哌啶醇2.0～12.0 mg.d-1,维持4周。利用YALE综合抽动严重程度量表、临床总体疗效评定量表和药物不良反应量表评价药物疗效及其不良反应。结果利司培酮组总有效率为69.23%,氟哌啶醇组为68.97%,治疗前后2组总有效率比较差异无统计学意义(χ2=0.537,P=0.552)。利司培酮组无锥体外系不良反应,且其他不良反应明显少。结论利司培酮是一种有效、安全的抗抽动药物,不良反应较轻。
Objective To evaluate the efficacy and safety of risperidone in children with multiple twitch compared with the positive control drug haloperidol. Methods Sixty children with multiple tics were divided into two groups according to a randomized controlled trial. The patients were divided into two groups: risperidone group (0.5-2.0 mg.d-1) and haloperidol group (2.0-12.0 mg.d-1). After 3 days of treatment, the doses of risperidone and haloperidol on day 1-3 were 0.5-1.0 mg.d-1 and 2.0-4.0 mg.d-1, respectively, and on the fourth day, the doses of drugs The dose and drug dosage range of risperidone 1.0 ~ 2.0 mg.d-1, haloperidol 2.0 ~ 12.0 mg.d-1, for 4 weeks. The efficacy and adverse reactions of the drug were evaluated using YALE comprehensive tic severity scale, clinical overall efficacy rating scale and adverse drug reaction scale. Results The total effective rate was 69.23% in the risperidone group and 68.97% in the haloperidol group. There was no significant difference in the total effective rate between the two groups before and after treatment (χ2 = 0.537, P = 0.552). The risperidone group had no extrapyramidal adverse reactions, and other adverse reactions were significantly less. Conclusion Lislitazone is an effective and safe anti-tic drug with less adverse reactions.