Gharabawi Georges M, Bossie Cynthia A, Zhu Young, Mao Lian, Lasser Robert A
Medical Affairs Division, Janssen Pharmaceutica Products, L.P., 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA.
Schizophr Res. 2005 Sep 15;77(2-3):129-39. doi: 10.1016/j.schres.2005.03.015.
Treatment-emergent tardive dyskinesia (TD) can be a serious side effect of antipsychotic treatment. Atypical antipsychotics are associated with a lower risk for TD than are conventional agents. A long-acting atypical antipsychotic, with more stable blood levels and lower peak blood levels than an oral formulation, may provide differential benefit regarding side effects, including movement disorders. This analysis assessed TD by defined research criteria in patients receiving long-acting, injectable risperidone.
Clinically stable subjects with schizophrenia or schizoaffective disorder participated in a 50-week, open-label trial of long-acting, injectable risperidone. TD was studied by defined research criteria (Schooler, N.R., Kane, J.M., 1982. Research diagnosis for tardive dyskinesia. Arch. Gen. Psychiatry. 39, 486-487; Americal Psychiatric Association, 2000. Diagnostic and Statistical Manual of Mental Disorders, fourth ed. American Psychiatric Association, Washington, DC). The severity of dyskinesia and other movement disorders were rated by the Extrapyramidal Symptom Rating Scale (ESRS).
ESRS dyskinesia data were available for 662 patients. Five of 530 subjects without dyskinesia at baseline (0.94%) met the predefined criteria for emergent persistent TD during therapy. Based on either exposure to study medication or Kaplan-Meier analysis, the 1-year rate was 1.19%. Among the 132 subjects with dyskinesia at baseline, the mean score on the ESRS physician's exam for dyskinesia improved significantly at endpoint (-2.77; P<0.0001), regardless of anticholinergic drug use. (P=0.243 for patients with versus without anticholinergic drug use.)
In this open-label study, treatment with long-acting risperidone was associated with a low rate of emergent persistent TD. Significant improvement in existing dyskinesias was noted. The TD rate reported here is consistent with other reports of atypical antipsychotics and substantially lower than with conventional antipsychotics.
治疗中出现的迟发性运动障碍（TD）可能是抗精神病药物治疗的一种严重副作用。与传统药物相比，非典型抗精神病药物引发TD的风险较低。一种长效非典型抗精神病药物，其血药浓度比口服制剂更稳定，血药峰值更低，在副作用（包括运动障碍）方面可能具有不同的优势。本分析根据明确的研究标准评估了接受长效注射用利培酮治疗的患者的TD情况。
患有精神分裂症或分裂情感性障碍的临床稳定受试者参与了一项为期50周的长效注射用利培酮开放标签试验。通过明确的研究标准（Schooler, N.R., Kane, J.M., 1982. Research diagnosis for tardive dyskinesia. Arch. Gen. Psychiatry. 39, 486 - 487; Americal Psychiatric Association, 2000. Diagnostic and Statistical Manual of Mental Disorders, fourth ed. American Psychiatric Association, Washington, DC）对TD进行研究。运动障碍和其他运动紊乱的严重程度通过锥体外系症状评定量表（ESRS）进行评分。
662例患者有ESRS运动障碍数据。530例基线时无运动障碍的受试者中有5例（0.94%）在治疗期间符合新发持续性TD的预定义标准。根据研究药物暴露情况或Kaplan - Meier分析，1年发生率为1.19%。在132例基线时有运动障碍的受试者中，无论是否使用抗胆碱能药物，ESRS医生检查的运动障碍平均评分在终点时显著改善（-2.77；P<0.0001）。（使用抗胆碱能药物与未使用抗胆碱能药物的患者相比，P = 0.243。）
在这项开放标签研究中，长效利培酮治疗引发持续性TD的发生率较低。观察到现有运动障碍有显著改善。此处报告的TD发生率与其他非典型抗精神病药物的报告一致，且显著低于传统抗精神病药物。
