甲磺酸齐拉西酮治疗精神发育迟滞伴发激越40例

Forty Cases of Therapy for Mental Retardation Associated with Agitation by Ziprasidone Mesylate

目的 观察注射用甲磺酸齐拉西酮治疗精神发育迟滞伴发急性激越症状患者的临床疗效与安全性。方法将80例精神发育迟滞急性激越症状患者以随机数字表法随机分为两组各40例,治疗组给予注射用甲磺酸齐拉西酮肌内注射,首日首次10 mg,间隔4 h肌内注射20 mg,第2天、第3天均肌内注射1次（30 mg）。对照组给予氟哌啶醇注射液肌内注射,每次5 mg,4~6 h后重复使用。氟哌啶醇每日总量20 mg。观察期间不合用其他抗精神病药物、抗躁狂药物和苯二氮类药物,不预防性使用抗帕金森病药物。于治疗前和治疗开始后1,2,4,6,8,12,24,48,72 h采用阳性与阴性量表（PANSS）减分率、临床疗效总评量表（CGI）评定疗效,治疗结束时采用不良反应症状量表（TESS）评定安全性。结果治疗结束时PANSS减分率≥30%治疗组46.31%,对照组48.81%;临床好转率治疗组80.00%,对照组82.50%,两组疗效差异无统计学意义;不良反应发生率治疗组（27.5%）低于对照组（40.0%）,差异有统计学意义（P〈0.05）。对照组锥体外系反应发生率明显高于治疗组（P〈0.05）。结论 注射用甲磺酸齐拉西酮治疗精神发育迟滞伴发急性激越症状有效,疗效与氟哌啶醇注射液相当,且锥体外系反应明显少于后者。

Objective To investigate the clinical efficacy and safety of ziprasidone mesylate injection on the acute agitation symptom in mental retardation. Methods The total of 80 patients of mental retardation with acute agitation symptoms were randomly divided into two groups：the treatment group （40 patients） were intra-muscarly given with ziprasidone mesylate injection at the initial dose of 10 mg, 20 mg 4 h later, and 30 mg once on the second day and third day. And the control group （40 patients） were treated with haloperidol injection. The volume dose of haloperidol was 20 mg everyday. Other antipsychotic drugs, antimanic drugs and benzodiazepines were not allowed to be used during the observation, neither does the prophylactic use of drugs against parkinson＇s disease. Before and 1, 2, 4, 6, 8, 12, 24, 48, 72 h after treatment, the positive and negative scale （ PANSS） reduction rate, the end of the clinical global impression scale （ CGI） were assessed. By the end of the treatment, the adverse reactions symptom, cale （ TESS） was assessed for the safety. Results By the end of treatment PANSS reduction rate was 46. 31% in the test group and 48. 81% in the control group, the clinical improvement rate was 80. 00% in the treatment group and 82. 50% in the control group. No statistically significant difference on efficacy was found between two groups. The side reaction rate in the treatment group was 27. 5%, that in the control group was 40. 0%, there was significant difference （ P〈0. 05） between two groups, but the extrapyramidal reaction in the control group was significantly more than that in the treatment group（P〈0. 05）. Conclusion Ziprasidone mesylate injection is effective on treating the symptoms of mental retardation, in corresponding to the effect of haloperidol injection,and with less extrapyramidal reactions.