氨磺必利片治疗精神分裂症急性发作患者的疗效与安全性研究

Abstract

目的 评估氨磺必利片治疗精神分裂症急性发作患者的疗效和安全性.方法 根据ICD-10精神分裂症的诊断标准,纳入急性发作患者144例,给予可调节剂量氨磺必利片单药治疗8周;治疗初始剂量为200 mg/d,依据患者的临床状况调节氨磺必利片的剂量,推荐治疗量为800 mg/d,最大剂量为1200 mg/d.分别于基线、治疗第2、4、8周采用PANSS,于基线及治疗第8周采用临床总体印象量表-严重程度和总体改善(CGI-S,CGI-I)、个人与社会功能量表(Personal and Social Performance Scale,PSP)评估临床疗效;采用UKU(Udvalg for Kliniske Undersogeser)不良反应评估量表、血生化指标和心电图等评估治疗的安全性.分别采用符合方案和安全性数据集分析氨磺必利片的疗效和安全性.结果 共132例完成临床研究,脱落12例;经8周治疗,急性发作精神分裂症患者PANSS阳性症状分[(22.0±6.6)分与(10.0±3.8)分]、阴性症状分[(22.7±7.7)分与(13.9±6.8)分]、一般精神病理分[(41.6±9.0)分与(25.1±7.4)分]、总分[(86.5±16.0)分与(49.0±16.0)分]均显著降低(均P<0.01);PANSS总分有效率(PANSS总分减分率≥50%)为77.3%(102/132),CGI-I有效率为75.8%(100/132);阳性症状亚组PANSS总分有效率优于阴性症状亚组(χ2=9.52,P<0.01);经8周治疗,个人与社会表现量表总分显著提高(t=18.10,P<0.01);不良反应主要为锥体外系不良反应(29.2%)和催乳素升高(23.6%).结论 氨磺必利片可有效缓解精神分裂症急性发作患者的精神病理症状,最常见的不良反应为锥体外系不良反应和泌乳素升高,未见其他抗精神病药未发生的不良反应.

Objective To evaluate the efficacy and safety of amisulpride in acute exacerbation patients with schizophrenia.Methods In this study,one hundred and forty-four acute episode patients with schizophrenia, qualifyed with the International Classification of Diseases 10th revision, were enrolled. All patients received monotherapy of amisulpride for 8 weeks.The initial dose of amisulpride was 200 mg/d,and the dose was flexible during the 8 weeks according to the investigator judgement based upon symptoms and tolerability.Recommended therapeutic dose was 800 mg/d and maximum dose was 1 200 mg/d.The Positive and Negative Syndrome Scale (PANSS) was applied at the baseline and the 2nd, 4th, 8thweek.The Clinical Global Impression Scale-Severity and Improvement(CGI-S,CGI-I)and the Personal and Social performance Scale(PSP)were adopted at the baseline and endpoint of treatment.The safety was evaluated by the Udvalg for Kliniske Undersogeser Side Effect Rating Scale,laboratory tests and electrocardiogram.The efficacy and safety were analyzed by using perprotocol and safety sets respectively.Results One hundred and thirty two patients completed this trial,and 12 patients dropped out during the study. After 8-week treatment, the positive scores(22.0 ± 6.6 vs.10.0 ± 3.8),negative scores(22.7 ± 7.7 vs.13.9 ± 6.8),general psychopathology scores(41.6 ± 9.0 vs.25.1 ± 7.4)and the total scores(86.5 ± 16.0 vs.49.0 ± 16.0)of PANSS were significantly improved(P<0.01);77.3% patients had symptoms reduced in PANSS total scores by at least 50%,and the result was accordant to significant CGI-I improvement in 75.8% patients. Besides these, the PANSS response rate was significantly higher in positive scores than in negative scores(χ2=9.52,P<0.01).PSP was also significantly improved after 8-week treatment (t=18.10, P<0.01). The most popular side effects were extrapyramidal symptoms(29.2%) and hyperprolactinemia(23.6%). Conclusions Amisulpride is effective in treating psychopathological symptoms of acute exacerbations patients with schizophrenia, the most frequent side effects are seen in extrapyramidal symptoms and hyperprolactinemia.